copy 2009 Ops A La Carte1
Mike Silverman (408) 654-0499 mikesopsalacartecom
John Cooper (650) 207-3664 johncopsalacartecom
Ops A La Carte LLC wwwopsalacartecom
Reliability amp Robust Design
for
Meet the Experts Design Forum Event
copy 2009 Ops A La Carte2
Presenterrsquos Biographical Sketch ndash Mike Silverman
Mike Silverman is founder and managing partner at Ops A La Carte a Professional
Consulting Company that has in intense focus on helping customers with end-to-end
reliability Through Ops A La Carte Mike has had extensive experience as a consultant
to high-tech companies and has consulted for over 100 different industries including the
food industry
Mike has 28 years of reliability and quality experience He is also an expert in
accelerated reliability techniques including HALTampHASS testing over 500 products for
100 companies in 40 different industries
Mike just completed his first book on Reliability called ldquo50 Ways to Improve Your Product
Reliabilityrdquo This presentation is largely based on the book material
Mike has authored and published 8 papers on reliability techniques and has presented
these around the world including China Germany Canada Taiwan India Singapore
and Korea Ops has also developed and currently teaches 31 courses on reliability
techniques
Mike has a BS degree in Electrical and Computer Engineering from the University of
Colorado at Boulder and is both a Certified Reliability Engineer and a course instructor
through the American Society for Quality (ASQ) IEEE Effective Training Associates and
Hobbs Engineering Mike is a member of ASQ IEEE SME ASME PATCA and IEEE
Consulting Society and is the current chapter president in the IEEE Reliability Society for
Silicon Valley
copy 2009 Ops A La Carte3
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
COMPANY OVERVIEW
Confidence in Reliability
Ops A La Cartendash Founded in 2001
ndash Named top 10 fastest growing private companies
in the Silicon Valley in 2006 and 2009
ndash Over 1500 projects completed in 11 years
ndash Over 500 Customers in over 30 countries
ndash Over 100 different industries 7 main verticals
bull CleanTech Consumer Electronics Defense
bull Industrial MedTech OilGas Telecom
ndash In 2012 we launched our new
Ounce of Prevention Strategy (OPS) Program
Introduction
OPS in NAmerica
Our Consultants
OPS Around the World
Singapore
Our Consultants
PST
LED Street Lighting
8copy 2009 Ops A La Carte
FREE Webinars for 2014
bull Mar 5 ndash Pattern Recognition for Electromechanical
Reliability (12-1pm)
bull CQE Prep Class ndash For preparing for the ASQ CQE exam or for a better
understanding of Quality principals (Tuesdays 6-10pm April 15-May 27)
bull Reliapedia Website ndash the most comprehensive source of reliability information in any
one place technical articles videos searchable
bull And a few more webinars from our partners at Hobbs Engineering
- March 4 Analyzing Censored Failure Time Data in Chinese Webinar ndash 3 hrs
- March 19 Preventing Thermal amp Vibration Failures Webinar ndash 3 hrs
- April 23 Cooling Techniques for Electronic Equipment Seminar - 3 hrs
- April 29-30 Shock amp Vibration ndash Webinar ndash 3 hrs
- May 8 Physics of Failure for Building Reliability Into Products - 3 hrs
Details for all are on our site at wwwopsalacartecom
9copy 2009 Ops A La Carte
Opsrsquo New Reliability Book
How Reliable Is Your Product 50 Ways to Improve Product Reliability
A new book by Ops A La Carte LLCreg FounderManaging Partner Mike Silverman
The book focuses on Mikersquos experiences working with over 500 companies in his 25 year career as an engineer manager and consultant It is a practical guide to reliability written for everyone in your organization In the book we give tips and case studies rather than a textbook full of formulas Available January 2011 in hardback for $4495 or ebook for $1995 amazoncom or httpwwwhappyaboutcomproductreliabilityphp For more info go to wwwopsalacartecom
bull Ops Solutions ndash Ops provides end-to-end solutions that target the corporate
product reliability objectives
bull Ops Individual ldquoA La Carterdquo Consulting ndash Ops identifies and solves the
missing key ingredients needed for a fully integrated reliable product
bull Ops Training ndash Opsrsquo highly specialized leaders and experts in the industry
train others in both standard and customized training seminars
bull Ops Testing ndash Opsrsquo state-of-the-art
provides comprehensive testing services
orOunce of
Prevention
Strategy
In todays world of product development product cycles are shortening
product complexity is accelerating and companies are relying more on
outside resources
Ounce of Prevention Strategy (OPS)
What do Computer Laptop Battery fires Toyota Prius crashes BP Oil Rig explosion
have in common
They all did not use our Ounce of Prevention Strategy (OPS) Our OPS methodology if
used will discover problems BEFORE your customers find them
Consulting Services
Goal
Setting
Assess-
ment
Bench-
mark
FTAFMEA
Golden
Nuggets
Component
Selection
Predict-
ions
Thermal
Analysis
Derating
Analysis
POF
DOE Tolerance
Analysis
Preventive
Mainten
EOL
Analysis
Warranty
Analysis
Test
Plan
HALT RDT ALT HALT-AFR
Calculator
FEA Software
Reliability
RCA CLCA
Vendor
AssessmtHASS ORT OOBA
Lessons
Learned
Warranty
Returns
Reliability
ReportingStatistics EDA for
Obsolesc
Out-
sourcing
Metrics
Reliability
Plan
CO
NC
EP
T
PH
AS
E
DE
SIG
N
PH
AS
E
MA
NU
FA
CT
UR
ING
PH
AS
E
PR
OT
OT
Y
PE
PH
AS
E
Gap
Analysis
Block
Diagrams
copy 2009 Ops A La Carte
14
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
Failure
Rate
Time
Quality Does
the product
work when the
customer first
receives it
first turns it on
Reliability How
often does the
product fail after
the customer
receives it
first turns it on
Reliability
How long does
the product
work until it
wears out
copy 2009 Ops A La Carte
16
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
Similarities and Differences
Between Regulatory Programs
and Reliability Programs
Food and Drug Administration FDA httpwwwfdagov
21 CFR Parts 808 812 and 820 Medical Devices Current Good
Manufacturing Practice (CGMP) Final Rule Page 2
SUPPLEMENTARY INFORMATION I Background (Design Controls)
ldquoSpecifically in January 1990 FDA published the results of an
evaluation of device recalls that occurred from October 1983 through
September 1989 in a report entitled lsquolsquoDevice Recalls A Study of Quality
Problemsrsquorsquo
FDA found that approximately 44 percent of the quality
problems that led to voluntary recall actions during this 6-
year period were attributed to errors or deficiencies that
were designed into particular devices and may have been
prevented by adequate design controls
Government Regulations
We have found that many medical companies confuse
reliability with compliance
Just because you follow the compliance regulations does
not guarantee you have a reliable product
In fact the new IEC 60601-1 3rd Edition document requires
that your testing be based on risks you discover during your
risk management process
In this presentation we will show you two different case
studies ndash one in which we met the basic reliability
requirements and a second in which we had a separate
reliability effort to address specific reliability risks
Reliability vs Compliance
bull RELIABILITY PROGRAM PLANWhich areas were the same
Which areas were new
Reliability allocations
Gap analysis
Reliability Tools Deployed General for all assemblies
Reliability Tools Deployed Specific to certain assys
How will tools be used
Metrics to be used during program
Reliability Reporting and Issues Management
Roles and Responsibilities
Reliability Deliverables
Contingency Planning
Ongoing Reliability Assurance
MEDICAL INFUSION PUMP
bull NEW ASSEMBLIES
Two new motors - one for the cassette insertion and removal and one for the air sensor to pinch the tubing in order to detect air bubbles in the line
A new power supply that was larger and also had a battery charging circuit for the new rechargeable battery
A touch screen
An IEEE 80211 wireless interface
A new rechargeable battery design
New software to handle all of these new features
MEDICAL INFUSION PUMP
bull IDENTIFY RELIABILITY RISKS
Using the Risk Analysis process we identified
as many new risks as possible
Then we set out to figure ways of mitigating
these risks
Design analysis techniques such as FEA DOE
and Thermal Analysis
Accelerated Testing techniques such as HALT
ALT and RDT
The important element here is that we always
had an eye on our goal
MEDICAL INFUSION PUMP
bull RELIABILITY TECHNIQUES USED
Motors ndash FEA ALT
Power Supply ndash HALT then RDT
Touch Screen ndash ALT Abuse Testing
Wireless Interface - HALT
Battery ndash Application Specific ALT
Software ndash Software FMEA Software
Use Case Testing
MEDICAL INFUSION PUMP
bull RESULTS
Using this process we saved time and money
We found out issues during the design
analysis that would have required a redesign
had we found them later in the design or
worse out in the field
We found out issues during the testing that
would have set our program back months
End result We developed and delivered a
very reliable product and got it to market
faster
MEDICAL INFUSION PUMP
copy 2009 Ops A La Carte
25
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte
26
DESIGN FOR
RELIABILITY (DFR)
OVERVIEW
Definition
bull DfR is knowledge-based engineering wherein starting with capture of requirements and leading to assured reliability a reliability plan is designed and executed using the full skills and knowledge of the project team
bull The goal of DfR is to work smarter through knowledge-based tailoring of the reliability plan
2262014 Ops A La Carte copy 27
bull Making a list of all possible reliability activities and then trying to cover as many as possible within the timeframe of the product development process
bull Assuming that product reliability is the sole responsibility of a reliability engineer (reliability engineer is the guide and mentor but not the owner ndash designer should be the owner)
bull Getting the product into test as fast as possible to test reliability into the product (aka Test-Analyze-and-Fix)
bull Only working on the in-house design items and not worrying about vendor items
bull Working in silos between EE Mech E Software etc (even if they apply some or most of the DfR tools) ndash all competencies must work together to reach common goals
Is NOT
2262014 Ops A La Carte copy 28
IS
bull Identifying goals and requirements consistent with customer and business objectives
bull Applying knowledge-based management and engineering to define implement and improve plans to achieve goals and requirements
bull Providing clear metrics for review Reviewing and taking timely corrective action
bull Reviewing and knowledge-capture from all activities and outputs with goal of continuous improvement
bull DfR is the process of building reliability into the design with efficiency and assurance using the best science-based methods
2262014 Ops A La Carte copy 29
Flow
A detailed evaluation of an organizationrsquos approach and processes involved in creating reliable products The assessment captures the current state and leads to an actionable reliability program plan
bull Initiate a Reliability Programbull Determine next best stepsbull Reduce customer complaints bull Select right toolsbull Improve reliability
Now
Goal
$ unreliability
$ Profits
Assessment Interviews
StatisticalData Analysis
Benchmarking
Gap Analysis
Program Plan
complaints
fieldfailures
satisfaction
marketshare
Unknown Reliability
2262014 Ops A La Carte copy 30
Key Activities
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 31
DfR Key Activities
QFD Requirements definitions Benchmarking Product usage analysisUnderstanding of customer requirements and specifications
DFMEA Cost trade-off analysisLessons LearnedProbabilistic design Cost trade-offs Tolerance Analysis
FEA Warranty Data Analysis DRBFM Reliability predictionLessons Learned Reliability Block Diagrams
HASS Control Charts Re-validation Audits Look AcrossLessons Learned ORT
HALT Evaluation Testing DRBTRReliability Growth modeling Change Point Analysis
Design and Process ValidationAccelerated Test Reliability Demonstration
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 32
Key points for implementing DfR activities
bull Start DfR activities early in the process
bull Reliability engineerrsquos job is to leadcoach the design team Reliability achievement needs to be owned by design and manufacturing teams
bull Integration of Reliability and Quality Engineers with design teams
bull Warrantyfield data analysis (both statistical and root cause analysis) needs to be fed back to both design and reliability teams
bull Reduce the number of tools in the toolbox but use the remaining well Neither all steps nor tools are necessary for all the programs
2262014 Ops A La Carte copy 33
34
Reliability Before Design
SpendingRate
Qualification Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
Reliability Spend Rate
Traditional Reliability Model
35
Reliability Before Design
SpendingRate
Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Qualification
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
New Reliability Spend Rate
$ Savings $
Reliability Before Design
Design for Reliability Method
copy Ops A La Carte LLC 2012
copy 2009 Ops A La Carte
36
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte 37
DEVELOPING AN
EFFECTIVE
RELIABILITY TEST
STRATEGY
Steps to a Good Design
In order to write better test plans
1) Understand Requirements
2) Understand Use Environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform Design amp Design Reviews
6) Write Design Verification Test plan
7) Write Reliability Test Plan
Understanding Requirements
Inputs include
ndashSpecifications
bull MRD ndash Marketing Requirements Document
bull PRD ndash Product Requirements Document
ndashCompetitive Product Solutions
ndashLessons Learned
ndashConstraints
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
copy 2009 Ops A La Carte2
Presenterrsquos Biographical Sketch ndash Mike Silverman
Mike Silverman is founder and managing partner at Ops A La Carte a Professional
Consulting Company that has in intense focus on helping customers with end-to-end
reliability Through Ops A La Carte Mike has had extensive experience as a consultant
to high-tech companies and has consulted for over 100 different industries including the
food industry
Mike has 28 years of reliability and quality experience He is also an expert in
accelerated reliability techniques including HALTampHASS testing over 500 products for
100 companies in 40 different industries
Mike just completed his first book on Reliability called ldquo50 Ways to Improve Your Product
Reliabilityrdquo This presentation is largely based on the book material
Mike has authored and published 8 papers on reliability techniques and has presented
these around the world including China Germany Canada Taiwan India Singapore
and Korea Ops has also developed and currently teaches 31 courses on reliability
techniques
Mike has a BS degree in Electrical and Computer Engineering from the University of
Colorado at Boulder and is both a Certified Reliability Engineer and a course instructor
through the American Society for Quality (ASQ) IEEE Effective Training Associates and
Hobbs Engineering Mike is a member of ASQ IEEE SME ASME PATCA and IEEE
Consulting Society and is the current chapter president in the IEEE Reliability Society for
Silicon Valley
copy 2009 Ops A La Carte3
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
COMPANY OVERVIEW
Confidence in Reliability
Ops A La Cartendash Founded in 2001
ndash Named top 10 fastest growing private companies
in the Silicon Valley in 2006 and 2009
ndash Over 1500 projects completed in 11 years
ndash Over 500 Customers in over 30 countries
ndash Over 100 different industries 7 main verticals
bull CleanTech Consumer Electronics Defense
bull Industrial MedTech OilGas Telecom
ndash In 2012 we launched our new
Ounce of Prevention Strategy (OPS) Program
Introduction
OPS in NAmerica
Our Consultants
OPS Around the World
Singapore
Our Consultants
PST
LED Street Lighting
8copy 2009 Ops A La Carte
FREE Webinars for 2014
bull Mar 5 ndash Pattern Recognition for Electromechanical
Reliability (12-1pm)
bull CQE Prep Class ndash For preparing for the ASQ CQE exam or for a better
understanding of Quality principals (Tuesdays 6-10pm April 15-May 27)
bull Reliapedia Website ndash the most comprehensive source of reliability information in any
one place technical articles videos searchable
bull And a few more webinars from our partners at Hobbs Engineering
- March 4 Analyzing Censored Failure Time Data in Chinese Webinar ndash 3 hrs
- March 19 Preventing Thermal amp Vibration Failures Webinar ndash 3 hrs
- April 23 Cooling Techniques for Electronic Equipment Seminar - 3 hrs
- April 29-30 Shock amp Vibration ndash Webinar ndash 3 hrs
- May 8 Physics of Failure for Building Reliability Into Products - 3 hrs
Details for all are on our site at wwwopsalacartecom
9copy 2009 Ops A La Carte
Opsrsquo New Reliability Book
How Reliable Is Your Product 50 Ways to Improve Product Reliability
A new book by Ops A La Carte LLCreg FounderManaging Partner Mike Silverman
The book focuses on Mikersquos experiences working with over 500 companies in his 25 year career as an engineer manager and consultant It is a practical guide to reliability written for everyone in your organization In the book we give tips and case studies rather than a textbook full of formulas Available January 2011 in hardback for $4495 or ebook for $1995 amazoncom or httpwwwhappyaboutcomproductreliabilityphp For more info go to wwwopsalacartecom
bull Ops Solutions ndash Ops provides end-to-end solutions that target the corporate
product reliability objectives
bull Ops Individual ldquoA La Carterdquo Consulting ndash Ops identifies and solves the
missing key ingredients needed for a fully integrated reliable product
bull Ops Training ndash Opsrsquo highly specialized leaders and experts in the industry
train others in both standard and customized training seminars
bull Ops Testing ndash Opsrsquo state-of-the-art
provides comprehensive testing services
orOunce of
Prevention
Strategy
In todays world of product development product cycles are shortening
product complexity is accelerating and companies are relying more on
outside resources
Ounce of Prevention Strategy (OPS)
What do Computer Laptop Battery fires Toyota Prius crashes BP Oil Rig explosion
have in common
They all did not use our Ounce of Prevention Strategy (OPS) Our OPS methodology if
used will discover problems BEFORE your customers find them
Consulting Services
Goal
Setting
Assess-
ment
Bench-
mark
FTAFMEA
Golden
Nuggets
Component
Selection
Predict-
ions
Thermal
Analysis
Derating
Analysis
POF
DOE Tolerance
Analysis
Preventive
Mainten
EOL
Analysis
Warranty
Analysis
Test
Plan
HALT RDT ALT HALT-AFR
Calculator
FEA Software
Reliability
RCA CLCA
Vendor
AssessmtHASS ORT OOBA
Lessons
Learned
Warranty
Returns
Reliability
ReportingStatistics EDA for
Obsolesc
Out-
sourcing
Metrics
Reliability
Plan
CO
NC
EP
T
PH
AS
E
DE
SIG
N
PH
AS
E
MA
NU
FA
CT
UR
ING
PH
AS
E
PR
OT
OT
Y
PE
PH
AS
E
Gap
Analysis
Block
Diagrams
copy 2009 Ops A La Carte
14
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
Failure
Rate
Time
Quality Does
the product
work when the
customer first
receives it
first turns it on
Reliability How
often does the
product fail after
the customer
receives it
first turns it on
Reliability
How long does
the product
work until it
wears out
copy 2009 Ops A La Carte
16
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
Similarities and Differences
Between Regulatory Programs
and Reliability Programs
Food and Drug Administration FDA httpwwwfdagov
21 CFR Parts 808 812 and 820 Medical Devices Current Good
Manufacturing Practice (CGMP) Final Rule Page 2
SUPPLEMENTARY INFORMATION I Background (Design Controls)
ldquoSpecifically in January 1990 FDA published the results of an
evaluation of device recalls that occurred from October 1983 through
September 1989 in a report entitled lsquolsquoDevice Recalls A Study of Quality
Problemsrsquorsquo
FDA found that approximately 44 percent of the quality
problems that led to voluntary recall actions during this 6-
year period were attributed to errors or deficiencies that
were designed into particular devices and may have been
prevented by adequate design controls
Government Regulations
We have found that many medical companies confuse
reliability with compliance
Just because you follow the compliance regulations does
not guarantee you have a reliable product
In fact the new IEC 60601-1 3rd Edition document requires
that your testing be based on risks you discover during your
risk management process
In this presentation we will show you two different case
studies ndash one in which we met the basic reliability
requirements and a second in which we had a separate
reliability effort to address specific reliability risks
Reliability vs Compliance
bull RELIABILITY PROGRAM PLANWhich areas were the same
Which areas were new
Reliability allocations
Gap analysis
Reliability Tools Deployed General for all assemblies
Reliability Tools Deployed Specific to certain assys
How will tools be used
Metrics to be used during program
Reliability Reporting and Issues Management
Roles and Responsibilities
Reliability Deliverables
Contingency Planning
Ongoing Reliability Assurance
MEDICAL INFUSION PUMP
bull NEW ASSEMBLIES
Two new motors - one for the cassette insertion and removal and one for the air sensor to pinch the tubing in order to detect air bubbles in the line
A new power supply that was larger and also had a battery charging circuit for the new rechargeable battery
A touch screen
An IEEE 80211 wireless interface
A new rechargeable battery design
New software to handle all of these new features
MEDICAL INFUSION PUMP
bull IDENTIFY RELIABILITY RISKS
Using the Risk Analysis process we identified
as many new risks as possible
Then we set out to figure ways of mitigating
these risks
Design analysis techniques such as FEA DOE
and Thermal Analysis
Accelerated Testing techniques such as HALT
ALT and RDT
The important element here is that we always
had an eye on our goal
MEDICAL INFUSION PUMP
bull RELIABILITY TECHNIQUES USED
Motors ndash FEA ALT
Power Supply ndash HALT then RDT
Touch Screen ndash ALT Abuse Testing
Wireless Interface - HALT
Battery ndash Application Specific ALT
Software ndash Software FMEA Software
Use Case Testing
MEDICAL INFUSION PUMP
bull RESULTS
Using this process we saved time and money
We found out issues during the design
analysis that would have required a redesign
had we found them later in the design or
worse out in the field
We found out issues during the testing that
would have set our program back months
End result We developed and delivered a
very reliable product and got it to market
faster
MEDICAL INFUSION PUMP
copy 2009 Ops A La Carte
25
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte
26
DESIGN FOR
RELIABILITY (DFR)
OVERVIEW
Definition
bull DfR is knowledge-based engineering wherein starting with capture of requirements and leading to assured reliability a reliability plan is designed and executed using the full skills and knowledge of the project team
bull The goal of DfR is to work smarter through knowledge-based tailoring of the reliability plan
2262014 Ops A La Carte copy 27
bull Making a list of all possible reliability activities and then trying to cover as many as possible within the timeframe of the product development process
bull Assuming that product reliability is the sole responsibility of a reliability engineer (reliability engineer is the guide and mentor but not the owner ndash designer should be the owner)
bull Getting the product into test as fast as possible to test reliability into the product (aka Test-Analyze-and-Fix)
bull Only working on the in-house design items and not worrying about vendor items
bull Working in silos between EE Mech E Software etc (even if they apply some or most of the DfR tools) ndash all competencies must work together to reach common goals
Is NOT
2262014 Ops A La Carte copy 28
IS
bull Identifying goals and requirements consistent with customer and business objectives
bull Applying knowledge-based management and engineering to define implement and improve plans to achieve goals and requirements
bull Providing clear metrics for review Reviewing and taking timely corrective action
bull Reviewing and knowledge-capture from all activities and outputs with goal of continuous improvement
bull DfR is the process of building reliability into the design with efficiency and assurance using the best science-based methods
2262014 Ops A La Carte copy 29
Flow
A detailed evaluation of an organizationrsquos approach and processes involved in creating reliable products The assessment captures the current state and leads to an actionable reliability program plan
bull Initiate a Reliability Programbull Determine next best stepsbull Reduce customer complaints bull Select right toolsbull Improve reliability
Now
Goal
$ unreliability
$ Profits
Assessment Interviews
StatisticalData Analysis
Benchmarking
Gap Analysis
Program Plan
complaints
fieldfailures
satisfaction
marketshare
Unknown Reliability
2262014 Ops A La Carte copy 30
Key Activities
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 31
DfR Key Activities
QFD Requirements definitions Benchmarking Product usage analysisUnderstanding of customer requirements and specifications
DFMEA Cost trade-off analysisLessons LearnedProbabilistic design Cost trade-offs Tolerance Analysis
FEA Warranty Data Analysis DRBFM Reliability predictionLessons Learned Reliability Block Diagrams
HASS Control Charts Re-validation Audits Look AcrossLessons Learned ORT
HALT Evaluation Testing DRBTRReliability Growth modeling Change Point Analysis
Design and Process ValidationAccelerated Test Reliability Demonstration
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 32
Key points for implementing DfR activities
bull Start DfR activities early in the process
bull Reliability engineerrsquos job is to leadcoach the design team Reliability achievement needs to be owned by design and manufacturing teams
bull Integration of Reliability and Quality Engineers with design teams
bull Warrantyfield data analysis (both statistical and root cause analysis) needs to be fed back to both design and reliability teams
bull Reduce the number of tools in the toolbox but use the remaining well Neither all steps nor tools are necessary for all the programs
2262014 Ops A La Carte copy 33
34
Reliability Before Design
SpendingRate
Qualification Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
Reliability Spend Rate
Traditional Reliability Model
35
Reliability Before Design
SpendingRate
Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Qualification
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
New Reliability Spend Rate
$ Savings $
Reliability Before Design
Design for Reliability Method
copy Ops A La Carte LLC 2012
copy 2009 Ops A La Carte
36
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte 37
DEVELOPING AN
EFFECTIVE
RELIABILITY TEST
STRATEGY
Steps to a Good Design
In order to write better test plans
1) Understand Requirements
2) Understand Use Environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform Design amp Design Reviews
6) Write Design Verification Test plan
7) Write Reliability Test Plan
Understanding Requirements
Inputs include
ndashSpecifications
bull MRD ndash Marketing Requirements Document
bull PRD ndash Product Requirements Document
ndashCompetitive Product Solutions
ndashLessons Learned
ndashConstraints
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
copy 2009 Ops A La Carte3
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
COMPANY OVERVIEW
Confidence in Reliability
Ops A La Cartendash Founded in 2001
ndash Named top 10 fastest growing private companies
in the Silicon Valley in 2006 and 2009
ndash Over 1500 projects completed in 11 years
ndash Over 500 Customers in over 30 countries
ndash Over 100 different industries 7 main verticals
bull CleanTech Consumer Electronics Defense
bull Industrial MedTech OilGas Telecom
ndash In 2012 we launched our new
Ounce of Prevention Strategy (OPS) Program
Introduction
OPS in NAmerica
Our Consultants
OPS Around the World
Singapore
Our Consultants
PST
LED Street Lighting
8copy 2009 Ops A La Carte
FREE Webinars for 2014
bull Mar 5 ndash Pattern Recognition for Electromechanical
Reliability (12-1pm)
bull CQE Prep Class ndash For preparing for the ASQ CQE exam or for a better
understanding of Quality principals (Tuesdays 6-10pm April 15-May 27)
bull Reliapedia Website ndash the most comprehensive source of reliability information in any
one place technical articles videos searchable
bull And a few more webinars from our partners at Hobbs Engineering
- March 4 Analyzing Censored Failure Time Data in Chinese Webinar ndash 3 hrs
- March 19 Preventing Thermal amp Vibration Failures Webinar ndash 3 hrs
- April 23 Cooling Techniques for Electronic Equipment Seminar - 3 hrs
- April 29-30 Shock amp Vibration ndash Webinar ndash 3 hrs
- May 8 Physics of Failure for Building Reliability Into Products - 3 hrs
Details for all are on our site at wwwopsalacartecom
9copy 2009 Ops A La Carte
Opsrsquo New Reliability Book
How Reliable Is Your Product 50 Ways to Improve Product Reliability
A new book by Ops A La Carte LLCreg FounderManaging Partner Mike Silverman
The book focuses on Mikersquos experiences working with over 500 companies in his 25 year career as an engineer manager and consultant It is a practical guide to reliability written for everyone in your organization In the book we give tips and case studies rather than a textbook full of formulas Available January 2011 in hardback for $4495 or ebook for $1995 amazoncom or httpwwwhappyaboutcomproductreliabilityphp For more info go to wwwopsalacartecom
bull Ops Solutions ndash Ops provides end-to-end solutions that target the corporate
product reliability objectives
bull Ops Individual ldquoA La Carterdquo Consulting ndash Ops identifies and solves the
missing key ingredients needed for a fully integrated reliable product
bull Ops Training ndash Opsrsquo highly specialized leaders and experts in the industry
train others in both standard and customized training seminars
bull Ops Testing ndash Opsrsquo state-of-the-art
provides comprehensive testing services
orOunce of
Prevention
Strategy
In todays world of product development product cycles are shortening
product complexity is accelerating and companies are relying more on
outside resources
Ounce of Prevention Strategy (OPS)
What do Computer Laptop Battery fires Toyota Prius crashes BP Oil Rig explosion
have in common
They all did not use our Ounce of Prevention Strategy (OPS) Our OPS methodology if
used will discover problems BEFORE your customers find them
Consulting Services
Goal
Setting
Assess-
ment
Bench-
mark
FTAFMEA
Golden
Nuggets
Component
Selection
Predict-
ions
Thermal
Analysis
Derating
Analysis
POF
DOE Tolerance
Analysis
Preventive
Mainten
EOL
Analysis
Warranty
Analysis
Test
Plan
HALT RDT ALT HALT-AFR
Calculator
FEA Software
Reliability
RCA CLCA
Vendor
AssessmtHASS ORT OOBA
Lessons
Learned
Warranty
Returns
Reliability
ReportingStatistics EDA for
Obsolesc
Out-
sourcing
Metrics
Reliability
Plan
CO
NC
EP
T
PH
AS
E
DE
SIG
N
PH
AS
E
MA
NU
FA
CT
UR
ING
PH
AS
E
PR
OT
OT
Y
PE
PH
AS
E
Gap
Analysis
Block
Diagrams
copy 2009 Ops A La Carte
14
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
Failure
Rate
Time
Quality Does
the product
work when the
customer first
receives it
first turns it on
Reliability How
often does the
product fail after
the customer
receives it
first turns it on
Reliability
How long does
the product
work until it
wears out
copy 2009 Ops A La Carte
16
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
Similarities and Differences
Between Regulatory Programs
and Reliability Programs
Food and Drug Administration FDA httpwwwfdagov
21 CFR Parts 808 812 and 820 Medical Devices Current Good
Manufacturing Practice (CGMP) Final Rule Page 2
SUPPLEMENTARY INFORMATION I Background (Design Controls)
ldquoSpecifically in January 1990 FDA published the results of an
evaluation of device recalls that occurred from October 1983 through
September 1989 in a report entitled lsquolsquoDevice Recalls A Study of Quality
Problemsrsquorsquo
FDA found that approximately 44 percent of the quality
problems that led to voluntary recall actions during this 6-
year period were attributed to errors or deficiencies that
were designed into particular devices and may have been
prevented by adequate design controls
Government Regulations
We have found that many medical companies confuse
reliability with compliance
Just because you follow the compliance regulations does
not guarantee you have a reliable product
In fact the new IEC 60601-1 3rd Edition document requires
that your testing be based on risks you discover during your
risk management process
In this presentation we will show you two different case
studies ndash one in which we met the basic reliability
requirements and a second in which we had a separate
reliability effort to address specific reliability risks
Reliability vs Compliance
bull RELIABILITY PROGRAM PLANWhich areas were the same
Which areas were new
Reliability allocations
Gap analysis
Reliability Tools Deployed General for all assemblies
Reliability Tools Deployed Specific to certain assys
How will tools be used
Metrics to be used during program
Reliability Reporting and Issues Management
Roles and Responsibilities
Reliability Deliverables
Contingency Planning
Ongoing Reliability Assurance
MEDICAL INFUSION PUMP
bull NEW ASSEMBLIES
Two new motors - one for the cassette insertion and removal and one for the air sensor to pinch the tubing in order to detect air bubbles in the line
A new power supply that was larger and also had a battery charging circuit for the new rechargeable battery
A touch screen
An IEEE 80211 wireless interface
A new rechargeable battery design
New software to handle all of these new features
MEDICAL INFUSION PUMP
bull IDENTIFY RELIABILITY RISKS
Using the Risk Analysis process we identified
as many new risks as possible
Then we set out to figure ways of mitigating
these risks
Design analysis techniques such as FEA DOE
and Thermal Analysis
Accelerated Testing techniques such as HALT
ALT and RDT
The important element here is that we always
had an eye on our goal
MEDICAL INFUSION PUMP
bull RELIABILITY TECHNIQUES USED
Motors ndash FEA ALT
Power Supply ndash HALT then RDT
Touch Screen ndash ALT Abuse Testing
Wireless Interface - HALT
Battery ndash Application Specific ALT
Software ndash Software FMEA Software
Use Case Testing
MEDICAL INFUSION PUMP
bull RESULTS
Using this process we saved time and money
We found out issues during the design
analysis that would have required a redesign
had we found them later in the design or
worse out in the field
We found out issues during the testing that
would have set our program back months
End result We developed and delivered a
very reliable product and got it to market
faster
MEDICAL INFUSION PUMP
copy 2009 Ops A La Carte
25
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte
26
DESIGN FOR
RELIABILITY (DFR)
OVERVIEW
Definition
bull DfR is knowledge-based engineering wherein starting with capture of requirements and leading to assured reliability a reliability plan is designed and executed using the full skills and knowledge of the project team
bull The goal of DfR is to work smarter through knowledge-based tailoring of the reliability plan
2262014 Ops A La Carte copy 27
bull Making a list of all possible reliability activities and then trying to cover as many as possible within the timeframe of the product development process
bull Assuming that product reliability is the sole responsibility of a reliability engineer (reliability engineer is the guide and mentor but not the owner ndash designer should be the owner)
bull Getting the product into test as fast as possible to test reliability into the product (aka Test-Analyze-and-Fix)
bull Only working on the in-house design items and not worrying about vendor items
bull Working in silos between EE Mech E Software etc (even if they apply some or most of the DfR tools) ndash all competencies must work together to reach common goals
Is NOT
2262014 Ops A La Carte copy 28
IS
bull Identifying goals and requirements consistent with customer and business objectives
bull Applying knowledge-based management and engineering to define implement and improve plans to achieve goals and requirements
bull Providing clear metrics for review Reviewing and taking timely corrective action
bull Reviewing and knowledge-capture from all activities and outputs with goal of continuous improvement
bull DfR is the process of building reliability into the design with efficiency and assurance using the best science-based methods
2262014 Ops A La Carte copy 29
Flow
A detailed evaluation of an organizationrsquos approach and processes involved in creating reliable products The assessment captures the current state and leads to an actionable reliability program plan
bull Initiate a Reliability Programbull Determine next best stepsbull Reduce customer complaints bull Select right toolsbull Improve reliability
Now
Goal
$ unreliability
$ Profits
Assessment Interviews
StatisticalData Analysis
Benchmarking
Gap Analysis
Program Plan
complaints
fieldfailures
satisfaction
marketshare
Unknown Reliability
2262014 Ops A La Carte copy 30
Key Activities
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 31
DfR Key Activities
QFD Requirements definitions Benchmarking Product usage analysisUnderstanding of customer requirements and specifications
DFMEA Cost trade-off analysisLessons LearnedProbabilistic design Cost trade-offs Tolerance Analysis
FEA Warranty Data Analysis DRBFM Reliability predictionLessons Learned Reliability Block Diagrams
HASS Control Charts Re-validation Audits Look AcrossLessons Learned ORT
HALT Evaluation Testing DRBTRReliability Growth modeling Change Point Analysis
Design and Process ValidationAccelerated Test Reliability Demonstration
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 32
Key points for implementing DfR activities
bull Start DfR activities early in the process
bull Reliability engineerrsquos job is to leadcoach the design team Reliability achievement needs to be owned by design and manufacturing teams
bull Integration of Reliability and Quality Engineers with design teams
bull Warrantyfield data analysis (both statistical and root cause analysis) needs to be fed back to both design and reliability teams
bull Reduce the number of tools in the toolbox but use the remaining well Neither all steps nor tools are necessary for all the programs
2262014 Ops A La Carte copy 33
34
Reliability Before Design
SpendingRate
Qualification Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
Reliability Spend Rate
Traditional Reliability Model
35
Reliability Before Design
SpendingRate
Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Qualification
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
New Reliability Spend Rate
$ Savings $
Reliability Before Design
Design for Reliability Method
copy Ops A La Carte LLC 2012
copy 2009 Ops A La Carte
36
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte 37
DEVELOPING AN
EFFECTIVE
RELIABILITY TEST
STRATEGY
Steps to a Good Design
In order to write better test plans
1) Understand Requirements
2) Understand Use Environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform Design amp Design Reviews
6) Write Design Verification Test plan
7) Write Reliability Test Plan
Understanding Requirements
Inputs include
ndashSpecifications
bull MRD ndash Marketing Requirements Document
bull PRD ndash Product Requirements Document
ndashCompetitive Product Solutions
ndashLessons Learned
ndashConstraints
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
COMPANY OVERVIEW
Confidence in Reliability
Ops A La Cartendash Founded in 2001
ndash Named top 10 fastest growing private companies
in the Silicon Valley in 2006 and 2009
ndash Over 1500 projects completed in 11 years
ndash Over 500 Customers in over 30 countries
ndash Over 100 different industries 7 main verticals
bull CleanTech Consumer Electronics Defense
bull Industrial MedTech OilGas Telecom
ndash In 2012 we launched our new
Ounce of Prevention Strategy (OPS) Program
Introduction
OPS in NAmerica
Our Consultants
OPS Around the World
Singapore
Our Consultants
PST
LED Street Lighting
8copy 2009 Ops A La Carte
FREE Webinars for 2014
bull Mar 5 ndash Pattern Recognition for Electromechanical
Reliability (12-1pm)
bull CQE Prep Class ndash For preparing for the ASQ CQE exam or for a better
understanding of Quality principals (Tuesdays 6-10pm April 15-May 27)
bull Reliapedia Website ndash the most comprehensive source of reliability information in any
one place technical articles videos searchable
bull And a few more webinars from our partners at Hobbs Engineering
- March 4 Analyzing Censored Failure Time Data in Chinese Webinar ndash 3 hrs
- March 19 Preventing Thermal amp Vibration Failures Webinar ndash 3 hrs
- April 23 Cooling Techniques for Electronic Equipment Seminar - 3 hrs
- April 29-30 Shock amp Vibration ndash Webinar ndash 3 hrs
- May 8 Physics of Failure for Building Reliability Into Products - 3 hrs
Details for all are on our site at wwwopsalacartecom
9copy 2009 Ops A La Carte
Opsrsquo New Reliability Book
How Reliable Is Your Product 50 Ways to Improve Product Reliability
A new book by Ops A La Carte LLCreg FounderManaging Partner Mike Silverman
The book focuses on Mikersquos experiences working with over 500 companies in his 25 year career as an engineer manager and consultant It is a practical guide to reliability written for everyone in your organization In the book we give tips and case studies rather than a textbook full of formulas Available January 2011 in hardback for $4495 or ebook for $1995 amazoncom or httpwwwhappyaboutcomproductreliabilityphp For more info go to wwwopsalacartecom
bull Ops Solutions ndash Ops provides end-to-end solutions that target the corporate
product reliability objectives
bull Ops Individual ldquoA La Carterdquo Consulting ndash Ops identifies and solves the
missing key ingredients needed for a fully integrated reliable product
bull Ops Training ndash Opsrsquo highly specialized leaders and experts in the industry
train others in both standard and customized training seminars
bull Ops Testing ndash Opsrsquo state-of-the-art
provides comprehensive testing services
orOunce of
Prevention
Strategy
In todays world of product development product cycles are shortening
product complexity is accelerating and companies are relying more on
outside resources
Ounce of Prevention Strategy (OPS)
What do Computer Laptop Battery fires Toyota Prius crashes BP Oil Rig explosion
have in common
They all did not use our Ounce of Prevention Strategy (OPS) Our OPS methodology if
used will discover problems BEFORE your customers find them
Consulting Services
Goal
Setting
Assess-
ment
Bench-
mark
FTAFMEA
Golden
Nuggets
Component
Selection
Predict-
ions
Thermal
Analysis
Derating
Analysis
POF
DOE Tolerance
Analysis
Preventive
Mainten
EOL
Analysis
Warranty
Analysis
Test
Plan
HALT RDT ALT HALT-AFR
Calculator
FEA Software
Reliability
RCA CLCA
Vendor
AssessmtHASS ORT OOBA
Lessons
Learned
Warranty
Returns
Reliability
ReportingStatistics EDA for
Obsolesc
Out-
sourcing
Metrics
Reliability
Plan
CO
NC
EP
T
PH
AS
E
DE
SIG
N
PH
AS
E
MA
NU
FA
CT
UR
ING
PH
AS
E
PR
OT
OT
Y
PE
PH
AS
E
Gap
Analysis
Block
Diagrams
copy 2009 Ops A La Carte
14
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
Failure
Rate
Time
Quality Does
the product
work when the
customer first
receives it
first turns it on
Reliability How
often does the
product fail after
the customer
receives it
first turns it on
Reliability
How long does
the product
work until it
wears out
copy 2009 Ops A La Carte
16
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
Similarities and Differences
Between Regulatory Programs
and Reliability Programs
Food and Drug Administration FDA httpwwwfdagov
21 CFR Parts 808 812 and 820 Medical Devices Current Good
Manufacturing Practice (CGMP) Final Rule Page 2
SUPPLEMENTARY INFORMATION I Background (Design Controls)
ldquoSpecifically in January 1990 FDA published the results of an
evaluation of device recalls that occurred from October 1983 through
September 1989 in a report entitled lsquolsquoDevice Recalls A Study of Quality
Problemsrsquorsquo
FDA found that approximately 44 percent of the quality
problems that led to voluntary recall actions during this 6-
year period were attributed to errors or deficiencies that
were designed into particular devices and may have been
prevented by adequate design controls
Government Regulations
We have found that many medical companies confuse
reliability with compliance
Just because you follow the compliance regulations does
not guarantee you have a reliable product
In fact the new IEC 60601-1 3rd Edition document requires
that your testing be based on risks you discover during your
risk management process
In this presentation we will show you two different case
studies ndash one in which we met the basic reliability
requirements and a second in which we had a separate
reliability effort to address specific reliability risks
Reliability vs Compliance
bull RELIABILITY PROGRAM PLANWhich areas were the same
Which areas were new
Reliability allocations
Gap analysis
Reliability Tools Deployed General for all assemblies
Reliability Tools Deployed Specific to certain assys
How will tools be used
Metrics to be used during program
Reliability Reporting and Issues Management
Roles and Responsibilities
Reliability Deliverables
Contingency Planning
Ongoing Reliability Assurance
MEDICAL INFUSION PUMP
bull NEW ASSEMBLIES
Two new motors - one for the cassette insertion and removal and one for the air sensor to pinch the tubing in order to detect air bubbles in the line
A new power supply that was larger and also had a battery charging circuit for the new rechargeable battery
A touch screen
An IEEE 80211 wireless interface
A new rechargeable battery design
New software to handle all of these new features
MEDICAL INFUSION PUMP
bull IDENTIFY RELIABILITY RISKS
Using the Risk Analysis process we identified
as many new risks as possible
Then we set out to figure ways of mitigating
these risks
Design analysis techniques such as FEA DOE
and Thermal Analysis
Accelerated Testing techniques such as HALT
ALT and RDT
The important element here is that we always
had an eye on our goal
MEDICAL INFUSION PUMP
bull RELIABILITY TECHNIQUES USED
Motors ndash FEA ALT
Power Supply ndash HALT then RDT
Touch Screen ndash ALT Abuse Testing
Wireless Interface - HALT
Battery ndash Application Specific ALT
Software ndash Software FMEA Software
Use Case Testing
MEDICAL INFUSION PUMP
bull RESULTS
Using this process we saved time and money
We found out issues during the design
analysis that would have required a redesign
had we found them later in the design or
worse out in the field
We found out issues during the testing that
would have set our program back months
End result We developed and delivered a
very reliable product and got it to market
faster
MEDICAL INFUSION PUMP
copy 2009 Ops A La Carte
25
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte
26
DESIGN FOR
RELIABILITY (DFR)
OVERVIEW
Definition
bull DfR is knowledge-based engineering wherein starting with capture of requirements and leading to assured reliability a reliability plan is designed and executed using the full skills and knowledge of the project team
bull The goal of DfR is to work smarter through knowledge-based tailoring of the reliability plan
2262014 Ops A La Carte copy 27
bull Making a list of all possible reliability activities and then trying to cover as many as possible within the timeframe of the product development process
bull Assuming that product reliability is the sole responsibility of a reliability engineer (reliability engineer is the guide and mentor but not the owner ndash designer should be the owner)
bull Getting the product into test as fast as possible to test reliability into the product (aka Test-Analyze-and-Fix)
bull Only working on the in-house design items and not worrying about vendor items
bull Working in silos between EE Mech E Software etc (even if they apply some or most of the DfR tools) ndash all competencies must work together to reach common goals
Is NOT
2262014 Ops A La Carte copy 28
IS
bull Identifying goals and requirements consistent with customer and business objectives
bull Applying knowledge-based management and engineering to define implement and improve plans to achieve goals and requirements
bull Providing clear metrics for review Reviewing and taking timely corrective action
bull Reviewing and knowledge-capture from all activities and outputs with goal of continuous improvement
bull DfR is the process of building reliability into the design with efficiency and assurance using the best science-based methods
2262014 Ops A La Carte copy 29
Flow
A detailed evaluation of an organizationrsquos approach and processes involved in creating reliable products The assessment captures the current state and leads to an actionable reliability program plan
bull Initiate a Reliability Programbull Determine next best stepsbull Reduce customer complaints bull Select right toolsbull Improve reliability
Now
Goal
$ unreliability
$ Profits
Assessment Interviews
StatisticalData Analysis
Benchmarking
Gap Analysis
Program Plan
complaints
fieldfailures
satisfaction
marketshare
Unknown Reliability
2262014 Ops A La Carte copy 30
Key Activities
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 31
DfR Key Activities
QFD Requirements definitions Benchmarking Product usage analysisUnderstanding of customer requirements and specifications
DFMEA Cost trade-off analysisLessons LearnedProbabilistic design Cost trade-offs Tolerance Analysis
FEA Warranty Data Analysis DRBFM Reliability predictionLessons Learned Reliability Block Diagrams
HASS Control Charts Re-validation Audits Look AcrossLessons Learned ORT
HALT Evaluation Testing DRBTRReliability Growth modeling Change Point Analysis
Design and Process ValidationAccelerated Test Reliability Demonstration
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 32
Key points for implementing DfR activities
bull Start DfR activities early in the process
bull Reliability engineerrsquos job is to leadcoach the design team Reliability achievement needs to be owned by design and manufacturing teams
bull Integration of Reliability and Quality Engineers with design teams
bull Warrantyfield data analysis (both statistical and root cause analysis) needs to be fed back to both design and reliability teams
bull Reduce the number of tools in the toolbox but use the remaining well Neither all steps nor tools are necessary for all the programs
2262014 Ops A La Carte copy 33
34
Reliability Before Design
SpendingRate
Qualification Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
Reliability Spend Rate
Traditional Reliability Model
35
Reliability Before Design
SpendingRate
Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Qualification
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
New Reliability Spend Rate
$ Savings $
Reliability Before Design
Design for Reliability Method
copy Ops A La Carte LLC 2012
copy 2009 Ops A La Carte
36
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte 37
DEVELOPING AN
EFFECTIVE
RELIABILITY TEST
STRATEGY
Steps to a Good Design
In order to write better test plans
1) Understand Requirements
2) Understand Use Environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform Design amp Design Reviews
6) Write Design Verification Test plan
7) Write Reliability Test Plan
Understanding Requirements
Inputs include
ndashSpecifications
bull MRD ndash Marketing Requirements Document
bull PRD ndash Product Requirements Document
ndashCompetitive Product Solutions
ndashLessons Learned
ndashConstraints
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
Ops A La Cartendash Founded in 2001
ndash Named top 10 fastest growing private companies
in the Silicon Valley in 2006 and 2009
ndash Over 1500 projects completed in 11 years
ndash Over 500 Customers in over 30 countries
ndash Over 100 different industries 7 main verticals
bull CleanTech Consumer Electronics Defense
bull Industrial MedTech OilGas Telecom
ndash In 2012 we launched our new
Ounce of Prevention Strategy (OPS) Program
Introduction
OPS in NAmerica
Our Consultants
OPS Around the World
Singapore
Our Consultants
PST
LED Street Lighting
8copy 2009 Ops A La Carte
FREE Webinars for 2014
bull Mar 5 ndash Pattern Recognition for Electromechanical
Reliability (12-1pm)
bull CQE Prep Class ndash For preparing for the ASQ CQE exam or for a better
understanding of Quality principals (Tuesdays 6-10pm April 15-May 27)
bull Reliapedia Website ndash the most comprehensive source of reliability information in any
one place technical articles videos searchable
bull And a few more webinars from our partners at Hobbs Engineering
- March 4 Analyzing Censored Failure Time Data in Chinese Webinar ndash 3 hrs
- March 19 Preventing Thermal amp Vibration Failures Webinar ndash 3 hrs
- April 23 Cooling Techniques for Electronic Equipment Seminar - 3 hrs
- April 29-30 Shock amp Vibration ndash Webinar ndash 3 hrs
- May 8 Physics of Failure for Building Reliability Into Products - 3 hrs
Details for all are on our site at wwwopsalacartecom
9copy 2009 Ops A La Carte
Opsrsquo New Reliability Book
How Reliable Is Your Product 50 Ways to Improve Product Reliability
A new book by Ops A La Carte LLCreg FounderManaging Partner Mike Silverman
The book focuses on Mikersquos experiences working with over 500 companies in his 25 year career as an engineer manager and consultant It is a practical guide to reliability written for everyone in your organization In the book we give tips and case studies rather than a textbook full of formulas Available January 2011 in hardback for $4495 or ebook for $1995 amazoncom or httpwwwhappyaboutcomproductreliabilityphp For more info go to wwwopsalacartecom
bull Ops Solutions ndash Ops provides end-to-end solutions that target the corporate
product reliability objectives
bull Ops Individual ldquoA La Carterdquo Consulting ndash Ops identifies and solves the
missing key ingredients needed for a fully integrated reliable product
bull Ops Training ndash Opsrsquo highly specialized leaders and experts in the industry
train others in both standard and customized training seminars
bull Ops Testing ndash Opsrsquo state-of-the-art
provides comprehensive testing services
orOunce of
Prevention
Strategy
In todays world of product development product cycles are shortening
product complexity is accelerating and companies are relying more on
outside resources
Ounce of Prevention Strategy (OPS)
What do Computer Laptop Battery fires Toyota Prius crashes BP Oil Rig explosion
have in common
They all did not use our Ounce of Prevention Strategy (OPS) Our OPS methodology if
used will discover problems BEFORE your customers find them
Consulting Services
Goal
Setting
Assess-
ment
Bench-
mark
FTAFMEA
Golden
Nuggets
Component
Selection
Predict-
ions
Thermal
Analysis
Derating
Analysis
POF
DOE Tolerance
Analysis
Preventive
Mainten
EOL
Analysis
Warranty
Analysis
Test
Plan
HALT RDT ALT HALT-AFR
Calculator
FEA Software
Reliability
RCA CLCA
Vendor
AssessmtHASS ORT OOBA
Lessons
Learned
Warranty
Returns
Reliability
ReportingStatistics EDA for
Obsolesc
Out-
sourcing
Metrics
Reliability
Plan
CO
NC
EP
T
PH
AS
E
DE
SIG
N
PH
AS
E
MA
NU
FA
CT
UR
ING
PH
AS
E
PR
OT
OT
Y
PE
PH
AS
E
Gap
Analysis
Block
Diagrams
copy 2009 Ops A La Carte
14
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
Failure
Rate
Time
Quality Does
the product
work when the
customer first
receives it
first turns it on
Reliability How
often does the
product fail after
the customer
receives it
first turns it on
Reliability
How long does
the product
work until it
wears out
copy 2009 Ops A La Carte
16
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
Similarities and Differences
Between Regulatory Programs
and Reliability Programs
Food and Drug Administration FDA httpwwwfdagov
21 CFR Parts 808 812 and 820 Medical Devices Current Good
Manufacturing Practice (CGMP) Final Rule Page 2
SUPPLEMENTARY INFORMATION I Background (Design Controls)
ldquoSpecifically in January 1990 FDA published the results of an
evaluation of device recalls that occurred from October 1983 through
September 1989 in a report entitled lsquolsquoDevice Recalls A Study of Quality
Problemsrsquorsquo
FDA found that approximately 44 percent of the quality
problems that led to voluntary recall actions during this 6-
year period were attributed to errors or deficiencies that
were designed into particular devices and may have been
prevented by adequate design controls
Government Regulations
We have found that many medical companies confuse
reliability with compliance
Just because you follow the compliance regulations does
not guarantee you have a reliable product
In fact the new IEC 60601-1 3rd Edition document requires
that your testing be based on risks you discover during your
risk management process
In this presentation we will show you two different case
studies ndash one in which we met the basic reliability
requirements and a second in which we had a separate
reliability effort to address specific reliability risks
Reliability vs Compliance
bull RELIABILITY PROGRAM PLANWhich areas were the same
Which areas were new
Reliability allocations
Gap analysis
Reliability Tools Deployed General for all assemblies
Reliability Tools Deployed Specific to certain assys
How will tools be used
Metrics to be used during program
Reliability Reporting and Issues Management
Roles and Responsibilities
Reliability Deliverables
Contingency Planning
Ongoing Reliability Assurance
MEDICAL INFUSION PUMP
bull NEW ASSEMBLIES
Two new motors - one for the cassette insertion and removal and one for the air sensor to pinch the tubing in order to detect air bubbles in the line
A new power supply that was larger and also had a battery charging circuit for the new rechargeable battery
A touch screen
An IEEE 80211 wireless interface
A new rechargeable battery design
New software to handle all of these new features
MEDICAL INFUSION PUMP
bull IDENTIFY RELIABILITY RISKS
Using the Risk Analysis process we identified
as many new risks as possible
Then we set out to figure ways of mitigating
these risks
Design analysis techniques such as FEA DOE
and Thermal Analysis
Accelerated Testing techniques such as HALT
ALT and RDT
The important element here is that we always
had an eye on our goal
MEDICAL INFUSION PUMP
bull RELIABILITY TECHNIQUES USED
Motors ndash FEA ALT
Power Supply ndash HALT then RDT
Touch Screen ndash ALT Abuse Testing
Wireless Interface - HALT
Battery ndash Application Specific ALT
Software ndash Software FMEA Software
Use Case Testing
MEDICAL INFUSION PUMP
bull RESULTS
Using this process we saved time and money
We found out issues during the design
analysis that would have required a redesign
had we found them later in the design or
worse out in the field
We found out issues during the testing that
would have set our program back months
End result We developed and delivered a
very reliable product and got it to market
faster
MEDICAL INFUSION PUMP
copy 2009 Ops A La Carte
25
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte
26
DESIGN FOR
RELIABILITY (DFR)
OVERVIEW
Definition
bull DfR is knowledge-based engineering wherein starting with capture of requirements and leading to assured reliability a reliability plan is designed and executed using the full skills and knowledge of the project team
bull The goal of DfR is to work smarter through knowledge-based tailoring of the reliability plan
2262014 Ops A La Carte copy 27
bull Making a list of all possible reliability activities and then trying to cover as many as possible within the timeframe of the product development process
bull Assuming that product reliability is the sole responsibility of a reliability engineer (reliability engineer is the guide and mentor but not the owner ndash designer should be the owner)
bull Getting the product into test as fast as possible to test reliability into the product (aka Test-Analyze-and-Fix)
bull Only working on the in-house design items and not worrying about vendor items
bull Working in silos between EE Mech E Software etc (even if they apply some or most of the DfR tools) ndash all competencies must work together to reach common goals
Is NOT
2262014 Ops A La Carte copy 28
IS
bull Identifying goals and requirements consistent with customer and business objectives
bull Applying knowledge-based management and engineering to define implement and improve plans to achieve goals and requirements
bull Providing clear metrics for review Reviewing and taking timely corrective action
bull Reviewing and knowledge-capture from all activities and outputs with goal of continuous improvement
bull DfR is the process of building reliability into the design with efficiency and assurance using the best science-based methods
2262014 Ops A La Carte copy 29
Flow
A detailed evaluation of an organizationrsquos approach and processes involved in creating reliable products The assessment captures the current state and leads to an actionable reliability program plan
bull Initiate a Reliability Programbull Determine next best stepsbull Reduce customer complaints bull Select right toolsbull Improve reliability
Now
Goal
$ unreliability
$ Profits
Assessment Interviews
StatisticalData Analysis
Benchmarking
Gap Analysis
Program Plan
complaints
fieldfailures
satisfaction
marketshare
Unknown Reliability
2262014 Ops A La Carte copy 30
Key Activities
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 31
DfR Key Activities
QFD Requirements definitions Benchmarking Product usage analysisUnderstanding of customer requirements and specifications
DFMEA Cost trade-off analysisLessons LearnedProbabilistic design Cost trade-offs Tolerance Analysis
FEA Warranty Data Analysis DRBFM Reliability predictionLessons Learned Reliability Block Diagrams
HASS Control Charts Re-validation Audits Look AcrossLessons Learned ORT
HALT Evaluation Testing DRBTRReliability Growth modeling Change Point Analysis
Design and Process ValidationAccelerated Test Reliability Demonstration
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 32
Key points for implementing DfR activities
bull Start DfR activities early in the process
bull Reliability engineerrsquos job is to leadcoach the design team Reliability achievement needs to be owned by design and manufacturing teams
bull Integration of Reliability and Quality Engineers with design teams
bull Warrantyfield data analysis (both statistical and root cause analysis) needs to be fed back to both design and reliability teams
bull Reduce the number of tools in the toolbox but use the remaining well Neither all steps nor tools are necessary for all the programs
2262014 Ops A La Carte copy 33
34
Reliability Before Design
SpendingRate
Qualification Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
Reliability Spend Rate
Traditional Reliability Model
35
Reliability Before Design
SpendingRate
Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Qualification
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
New Reliability Spend Rate
$ Savings $
Reliability Before Design
Design for Reliability Method
copy Ops A La Carte LLC 2012
copy 2009 Ops A La Carte
36
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte 37
DEVELOPING AN
EFFECTIVE
RELIABILITY TEST
STRATEGY
Steps to a Good Design
In order to write better test plans
1) Understand Requirements
2) Understand Use Environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform Design amp Design Reviews
6) Write Design Verification Test plan
7) Write Reliability Test Plan
Understanding Requirements
Inputs include
ndashSpecifications
bull MRD ndash Marketing Requirements Document
bull PRD ndash Product Requirements Document
ndashCompetitive Product Solutions
ndashLessons Learned
ndashConstraints
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
OPS in NAmerica
Our Consultants
OPS Around the World
Singapore
Our Consultants
PST
LED Street Lighting
8copy 2009 Ops A La Carte
FREE Webinars for 2014
bull Mar 5 ndash Pattern Recognition for Electromechanical
Reliability (12-1pm)
bull CQE Prep Class ndash For preparing for the ASQ CQE exam or for a better
understanding of Quality principals (Tuesdays 6-10pm April 15-May 27)
bull Reliapedia Website ndash the most comprehensive source of reliability information in any
one place technical articles videos searchable
bull And a few more webinars from our partners at Hobbs Engineering
- March 4 Analyzing Censored Failure Time Data in Chinese Webinar ndash 3 hrs
- March 19 Preventing Thermal amp Vibration Failures Webinar ndash 3 hrs
- April 23 Cooling Techniques for Electronic Equipment Seminar - 3 hrs
- April 29-30 Shock amp Vibration ndash Webinar ndash 3 hrs
- May 8 Physics of Failure for Building Reliability Into Products - 3 hrs
Details for all are on our site at wwwopsalacartecom
9copy 2009 Ops A La Carte
Opsrsquo New Reliability Book
How Reliable Is Your Product 50 Ways to Improve Product Reliability
A new book by Ops A La Carte LLCreg FounderManaging Partner Mike Silverman
The book focuses on Mikersquos experiences working with over 500 companies in his 25 year career as an engineer manager and consultant It is a practical guide to reliability written for everyone in your organization In the book we give tips and case studies rather than a textbook full of formulas Available January 2011 in hardback for $4495 or ebook for $1995 amazoncom or httpwwwhappyaboutcomproductreliabilityphp For more info go to wwwopsalacartecom
bull Ops Solutions ndash Ops provides end-to-end solutions that target the corporate
product reliability objectives
bull Ops Individual ldquoA La Carterdquo Consulting ndash Ops identifies and solves the
missing key ingredients needed for a fully integrated reliable product
bull Ops Training ndash Opsrsquo highly specialized leaders and experts in the industry
train others in both standard and customized training seminars
bull Ops Testing ndash Opsrsquo state-of-the-art
provides comprehensive testing services
orOunce of
Prevention
Strategy
In todays world of product development product cycles are shortening
product complexity is accelerating and companies are relying more on
outside resources
Ounce of Prevention Strategy (OPS)
What do Computer Laptop Battery fires Toyota Prius crashes BP Oil Rig explosion
have in common
They all did not use our Ounce of Prevention Strategy (OPS) Our OPS methodology if
used will discover problems BEFORE your customers find them
Consulting Services
Goal
Setting
Assess-
ment
Bench-
mark
FTAFMEA
Golden
Nuggets
Component
Selection
Predict-
ions
Thermal
Analysis
Derating
Analysis
POF
DOE Tolerance
Analysis
Preventive
Mainten
EOL
Analysis
Warranty
Analysis
Test
Plan
HALT RDT ALT HALT-AFR
Calculator
FEA Software
Reliability
RCA CLCA
Vendor
AssessmtHASS ORT OOBA
Lessons
Learned
Warranty
Returns
Reliability
ReportingStatistics EDA for
Obsolesc
Out-
sourcing
Metrics
Reliability
Plan
CO
NC
EP
T
PH
AS
E
DE
SIG
N
PH
AS
E
MA
NU
FA
CT
UR
ING
PH
AS
E
PR
OT
OT
Y
PE
PH
AS
E
Gap
Analysis
Block
Diagrams
copy 2009 Ops A La Carte
14
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
Failure
Rate
Time
Quality Does
the product
work when the
customer first
receives it
first turns it on
Reliability How
often does the
product fail after
the customer
receives it
first turns it on
Reliability
How long does
the product
work until it
wears out
copy 2009 Ops A La Carte
16
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
Similarities and Differences
Between Regulatory Programs
and Reliability Programs
Food and Drug Administration FDA httpwwwfdagov
21 CFR Parts 808 812 and 820 Medical Devices Current Good
Manufacturing Practice (CGMP) Final Rule Page 2
SUPPLEMENTARY INFORMATION I Background (Design Controls)
ldquoSpecifically in January 1990 FDA published the results of an
evaluation of device recalls that occurred from October 1983 through
September 1989 in a report entitled lsquolsquoDevice Recalls A Study of Quality
Problemsrsquorsquo
FDA found that approximately 44 percent of the quality
problems that led to voluntary recall actions during this 6-
year period were attributed to errors or deficiencies that
were designed into particular devices and may have been
prevented by adequate design controls
Government Regulations
We have found that many medical companies confuse
reliability with compliance
Just because you follow the compliance regulations does
not guarantee you have a reliable product
In fact the new IEC 60601-1 3rd Edition document requires
that your testing be based on risks you discover during your
risk management process
In this presentation we will show you two different case
studies ndash one in which we met the basic reliability
requirements and a second in which we had a separate
reliability effort to address specific reliability risks
Reliability vs Compliance
bull RELIABILITY PROGRAM PLANWhich areas were the same
Which areas were new
Reliability allocations
Gap analysis
Reliability Tools Deployed General for all assemblies
Reliability Tools Deployed Specific to certain assys
How will tools be used
Metrics to be used during program
Reliability Reporting and Issues Management
Roles and Responsibilities
Reliability Deliverables
Contingency Planning
Ongoing Reliability Assurance
MEDICAL INFUSION PUMP
bull NEW ASSEMBLIES
Two new motors - one for the cassette insertion and removal and one for the air sensor to pinch the tubing in order to detect air bubbles in the line
A new power supply that was larger and also had a battery charging circuit for the new rechargeable battery
A touch screen
An IEEE 80211 wireless interface
A new rechargeable battery design
New software to handle all of these new features
MEDICAL INFUSION PUMP
bull IDENTIFY RELIABILITY RISKS
Using the Risk Analysis process we identified
as many new risks as possible
Then we set out to figure ways of mitigating
these risks
Design analysis techniques such as FEA DOE
and Thermal Analysis
Accelerated Testing techniques such as HALT
ALT and RDT
The important element here is that we always
had an eye on our goal
MEDICAL INFUSION PUMP
bull RELIABILITY TECHNIQUES USED
Motors ndash FEA ALT
Power Supply ndash HALT then RDT
Touch Screen ndash ALT Abuse Testing
Wireless Interface - HALT
Battery ndash Application Specific ALT
Software ndash Software FMEA Software
Use Case Testing
MEDICAL INFUSION PUMP
bull RESULTS
Using this process we saved time and money
We found out issues during the design
analysis that would have required a redesign
had we found them later in the design or
worse out in the field
We found out issues during the testing that
would have set our program back months
End result We developed and delivered a
very reliable product and got it to market
faster
MEDICAL INFUSION PUMP
copy 2009 Ops A La Carte
25
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte
26
DESIGN FOR
RELIABILITY (DFR)
OVERVIEW
Definition
bull DfR is knowledge-based engineering wherein starting with capture of requirements and leading to assured reliability a reliability plan is designed and executed using the full skills and knowledge of the project team
bull The goal of DfR is to work smarter through knowledge-based tailoring of the reliability plan
2262014 Ops A La Carte copy 27
bull Making a list of all possible reliability activities and then trying to cover as many as possible within the timeframe of the product development process
bull Assuming that product reliability is the sole responsibility of a reliability engineer (reliability engineer is the guide and mentor but not the owner ndash designer should be the owner)
bull Getting the product into test as fast as possible to test reliability into the product (aka Test-Analyze-and-Fix)
bull Only working on the in-house design items and not worrying about vendor items
bull Working in silos between EE Mech E Software etc (even if they apply some or most of the DfR tools) ndash all competencies must work together to reach common goals
Is NOT
2262014 Ops A La Carte copy 28
IS
bull Identifying goals and requirements consistent with customer and business objectives
bull Applying knowledge-based management and engineering to define implement and improve plans to achieve goals and requirements
bull Providing clear metrics for review Reviewing and taking timely corrective action
bull Reviewing and knowledge-capture from all activities and outputs with goal of continuous improvement
bull DfR is the process of building reliability into the design with efficiency and assurance using the best science-based methods
2262014 Ops A La Carte copy 29
Flow
A detailed evaluation of an organizationrsquos approach and processes involved in creating reliable products The assessment captures the current state and leads to an actionable reliability program plan
bull Initiate a Reliability Programbull Determine next best stepsbull Reduce customer complaints bull Select right toolsbull Improve reliability
Now
Goal
$ unreliability
$ Profits
Assessment Interviews
StatisticalData Analysis
Benchmarking
Gap Analysis
Program Plan
complaints
fieldfailures
satisfaction
marketshare
Unknown Reliability
2262014 Ops A La Carte copy 30
Key Activities
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 31
DfR Key Activities
QFD Requirements definitions Benchmarking Product usage analysisUnderstanding of customer requirements and specifications
DFMEA Cost trade-off analysisLessons LearnedProbabilistic design Cost trade-offs Tolerance Analysis
FEA Warranty Data Analysis DRBFM Reliability predictionLessons Learned Reliability Block Diagrams
HASS Control Charts Re-validation Audits Look AcrossLessons Learned ORT
HALT Evaluation Testing DRBTRReliability Growth modeling Change Point Analysis
Design and Process ValidationAccelerated Test Reliability Demonstration
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 32
Key points for implementing DfR activities
bull Start DfR activities early in the process
bull Reliability engineerrsquos job is to leadcoach the design team Reliability achievement needs to be owned by design and manufacturing teams
bull Integration of Reliability and Quality Engineers with design teams
bull Warrantyfield data analysis (both statistical and root cause analysis) needs to be fed back to both design and reliability teams
bull Reduce the number of tools in the toolbox but use the remaining well Neither all steps nor tools are necessary for all the programs
2262014 Ops A La Carte copy 33
34
Reliability Before Design
SpendingRate
Qualification Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
Reliability Spend Rate
Traditional Reliability Model
35
Reliability Before Design
SpendingRate
Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Qualification
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
New Reliability Spend Rate
$ Savings $
Reliability Before Design
Design for Reliability Method
copy Ops A La Carte LLC 2012
copy 2009 Ops A La Carte
36
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte 37
DEVELOPING AN
EFFECTIVE
RELIABILITY TEST
STRATEGY
Steps to a Good Design
In order to write better test plans
1) Understand Requirements
2) Understand Use Environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform Design amp Design Reviews
6) Write Design Verification Test plan
7) Write Reliability Test Plan
Understanding Requirements
Inputs include
ndashSpecifications
bull MRD ndash Marketing Requirements Document
bull PRD ndash Product Requirements Document
ndashCompetitive Product Solutions
ndashLessons Learned
ndashConstraints
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
OPS Around the World
Singapore
Our Consultants
PST
LED Street Lighting
8copy 2009 Ops A La Carte
FREE Webinars for 2014
bull Mar 5 ndash Pattern Recognition for Electromechanical
Reliability (12-1pm)
bull CQE Prep Class ndash For preparing for the ASQ CQE exam or for a better
understanding of Quality principals (Tuesdays 6-10pm April 15-May 27)
bull Reliapedia Website ndash the most comprehensive source of reliability information in any
one place technical articles videos searchable
bull And a few more webinars from our partners at Hobbs Engineering
- March 4 Analyzing Censored Failure Time Data in Chinese Webinar ndash 3 hrs
- March 19 Preventing Thermal amp Vibration Failures Webinar ndash 3 hrs
- April 23 Cooling Techniques for Electronic Equipment Seminar - 3 hrs
- April 29-30 Shock amp Vibration ndash Webinar ndash 3 hrs
- May 8 Physics of Failure for Building Reliability Into Products - 3 hrs
Details for all are on our site at wwwopsalacartecom
9copy 2009 Ops A La Carte
Opsrsquo New Reliability Book
How Reliable Is Your Product 50 Ways to Improve Product Reliability
A new book by Ops A La Carte LLCreg FounderManaging Partner Mike Silverman
The book focuses on Mikersquos experiences working with over 500 companies in his 25 year career as an engineer manager and consultant It is a practical guide to reliability written for everyone in your organization In the book we give tips and case studies rather than a textbook full of formulas Available January 2011 in hardback for $4495 or ebook for $1995 amazoncom or httpwwwhappyaboutcomproductreliabilityphp For more info go to wwwopsalacartecom
bull Ops Solutions ndash Ops provides end-to-end solutions that target the corporate
product reliability objectives
bull Ops Individual ldquoA La Carterdquo Consulting ndash Ops identifies and solves the
missing key ingredients needed for a fully integrated reliable product
bull Ops Training ndash Opsrsquo highly specialized leaders and experts in the industry
train others in both standard and customized training seminars
bull Ops Testing ndash Opsrsquo state-of-the-art
provides comprehensive testing services
orOunce of
Prevention
Strategy
In todays world of product development product cycles are shortening
product complexity is accelerating and companies are relying more on
outside resources
Ounce of Prevention Strategy (OPS)
What do Computer Laptop Battery fires Toyota Prius crashes BP Oil Rig explosion
have in common
They all did not use our Ounce of Prevention Strategy (OPS) Our OPS methodology if
used will discover problems BEFORE your customers find them
Consulting Services
Goal
Setting
Assess-
ment
Bench-
mark
FTAFMEA
Golden
Nuggets
Component
Selection
Predict-
ions
Thermal
Analysis
Derating
Analysis
POF
DOE Tolerance
Analysis
Preventive
Mainten
EOL
Analysis
Warranty
Analysis
Test
Plan
HALT RDT ALT HALT-AFR
Calculator
FEA Software
Reliability
RCA CLCA
Vendor
AssessmtHASS ORT OOBA
Lessons
Learned
Warranty
Returns
Reliability
ReportingStatistics EDA for
Obsolesc
Out-
sourcing
Metrics
Reliability
Plan
CO
NC
EP
T
PH
AS
E
DE
SIG
N
PH
AS
E
MA
NU
FA
CT
UR
ING
PH
AS
E
PR
OT
OT
Y
PE
PH
AS
E
Gap
Analysis
Block
Diagrams
copy 2009 Ops A La Carte
14
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
Failure
Rate
Time
Quality Does
the product
work when the
customer first
receives it
first turns it on
Reliability How
often does the
product fail after
the customer
receives it
first turns it on
Reliability
How long does
the product
work until it
wears out
copy 2009 Ops A La Carte
16
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
Similarities and Differences
Between Regulatory Programs
and Reliability Programs
Food and Drug Administration FDA httpwwwfdagov
21 CFR Parts 808 812 and 820 Medical Devices Current Good
Manufacturing Practice (CGMP) Final Rule Page 2
SUPPLEMENTARY INFORMATION I Background (Design Controls)
ldquoSpecifically in January 1990 FDA published the results of an
evaluation of device recalls that occurred from October 1983 through
September 1989 in a report entitled lsquolsquoDevice Recalls A Study of Quality
Problemsrsquorsquo
FDA found that approximately 44 percent of the quality
problems that led to voluntary recall actions during this 6-
year period were attributed to errors or deficiencies that
were designed into particular devices and may have been
prevented by adequate design controls
Government Regulations
We have found that many medical companies confuse
reliability with compliance
Just because you follow the compliance regulations does
not guarantee you have a reliable product
In fact the new IEC 60601-1 3rd Edition document requires
that your testing be based on risks you discover during your
risk management process
In this presentation we will show you two different case
studies ndash one in which we met the basic reliability
requirements and a second in which we had a separate
reliability effort to address specific reliability risks
Reliability vs Compliance
bull RELIABILITY PROGRAM PLANWhich areas were the same
Which areas were new
Reliability allocations
Gap analysis
Reliability Tools Deployed General for all assemblies
Reliability Tools Deployed Specific to certain assys
How will tools be used
Metrics to be used during program
Reliability Reporting and Issues Management
Roles and Responsibilities
Reliability Deliverables
Contingency Planning
Ongoing Reliability Assurance
MEDICAL INFUSION PUMP
bull NEW ASSEMBLIES
Two new motors - one for the cassette insertion and removal and one for the air sensor to pinch the tubing in order to detect air bubbles in the line
A new power supply that was larger and also had a battery charging circuit for the new rechargeable battery
A touch screen
An IEEE 80211 wireless interface
A new rechargeable battery design
New software to handle all of these new features
MEDICAL INFUSION PUMP
bull IDENTIFY RELIABILITY RISKS
Using the Risk Analysis process we identified
as many new risks as possible
Then we set out to figure ways of mitigating
these risks
Design analysis techniques such as FEA DOE
and Thermal Analysis
Accelerated Testing techniques such as HALT
ALT and RDT
The important element here is that we always
had an eye on our goal
MEDICAL INFUSION PUMP
bull RELIABILITY TECHNIQUES USED
Motors ndash FEA ALT
Power Supply ndash HALT then RDT
Touch Screen ndash ALT Abuse Testing
Wireless Interface - HALT
Battery ndash Application Specific ALT
Software ndash Software FMEA Software
Use Case Testing
MEDICAL INFUSION PUMP
bull RESULTS
Using this process we saved time and money
We found out issues during the design
analysis that would have required a redesign
had we found them later in the design or
worse out in the field
We found out issues during the testing that
would have set our program back months
End result We developed and delivered a
very reliable product and got it to market
faster
MEDICAL INFUSION PUMP
copy 2009 Ops A La Carte
25
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte
26
DESIGN FOR
RELIABILITY (DFR)
OVERVIEW
Definition
bull DfR is knowledge-based engineering wherein starting with capture of requirements and leading to assured reliability a reliability plan is designed and executed using the full skills and knowledge of the project team
bull The goal of DfR is to work smarter through knowledge-based tailoring of the reliability plan
2262014 Ops A La Carte copy 27
bull Making a list of all possible reliability activities and then trying to cover as many as possible within the timeframe of the product development process
bull Assuming that product reliability is the sole responsibility of a reliability engineer (reliability engineer is the guide and mentor but not the owner ndash designer should be the owner)
bull Getting the product into test as fast as possible to test reliability into the product (aka Test-Analyze-and-Fix)
bull Only working on the in-house design items and not worrying about vendor items
bull Working in silos between EE Mech E Software etc (even if they apply some or most of the DfR tools) ndash all competencies must work together to reach common goals
Is NOT
2262014 Ops A La Carte copy 28
IS
bull Identifying goals and requirements consistent with customer and business objectives
bull Applying knowledge-based management and engineering to define implement and improve plans to achieve goals and requirements
bull Providing clear metrics for review Reviewing and taking timely corrective action
bull Reviewing and knowledge-capture from all activities and outputs with goal of continuous improvement
bull DfR is the process of building reliability into the design with efficiency and assurance using the best science-based methods
2262014 Ops A La Carte copy 29
Flow
A detailed evaluation of an organizationrsquos approach and processes involved in creating reliable products The assessment captures the current state and leads to an actionable reliability program plan
bull Initiate a Reliability Programbull Determine next best stepsbull Reduce customer complaints bull Select right toolsbull Improve reliability
Now
Goal
$ unreliability
$ Profits
Assessment Interviews
StatisticalData Analysis
Benchmarking
Gap Analysis
Program Plan
complaints
fieldfailures
satisfaction
marketshare
Unknown Reliability
2262014 Ops A La Carte copy 30
Key Activities
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 31
DfR Key Activities
QFD Requirements definitions Benchmarking Product usage analysisUnderstanding of customer requirements and specifications
DFMEA Cost trade-off analysisLessons LearnedProbabilistic design Cost trade-offs Tolerance Analysis
FEA Warranty Data Analysis DRBFM Reliability predictionLessons Learned Reliability Block Diagrams
HASS Control Charts Re-validation Audits Look AcrossLessons Learned ORT
HALT Evaluation Testing DRBTRReliability Growth modeling Change Point Analysis
Design and Process ValidationAccelerated Test Reliability Demonstration
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 32
Key points for implementing DfR activities
bull Start DfR activities early in the process
bull Reliability engineerrsquos job is to leadcoach the design team Reliability achievement needs to be owned by design and manufacturing teams
bull Integration of Reliability and Quality Engineers with design teams
bull Warrantyfield data analysis (both statistical and root cause analysis) needs to be fed back to both design and reliability teams
bull Reduce the number of tools in the toolbox but use the remaining well Neither all steps nor tools are necessary for all the programs
2262014 Ops A La Carte copy 33
34
Reliability Before Design
SpendingRate
Qualification Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
Reliability Spend Rate
Traditional Reliability Model
35
Reliability Before Design
SpendingRate
Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Qualification
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
New Reliability Spend Rate
$ Savings $
Reliability Before Design
Design for Reliability Method
copy Ops A La Carte LLC 2012
copy 2009 Ops A La Carte
36
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte 37
DEVELOPING AN
EFFECTIVE
RELIABILITY TEST
STRATEGY
Steps to a Good Design
In order to write better test plans
1) Understand Requirements
2) Understand Use Environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform Design amp Design Reviews
6) Write Design Verification Test plan
7) Write Reliability Test Plan
Understanding Requirements
Inputs include
ndashSpecifications
bull MRD ndash Marketing Requirements Document
bull PRD ndash Product Requirements Document
ndashCompetitive Product Solutions
ndashLessons Learned
ndashConstraints
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
8copy 2009 Ops A La Carte
FREE Webinars for 2014
bull Mar 5 ndash Pattern Recognition for Electromechanical
Reliability (12-1pm)
bull CQE Prep Class ndash For preparing for the ASQ CQE exam or for a better
understanding of Quality principals (Tuesdays 6-10pm April 15-May 27)
bull Reliapedia Website ndash the most comprehensive source of reliability information in any
one place technical articles videos searchable
bull And a few more webinars from our partners at Hobbs Engineering
- March 4 Analyzing Censored Failure Time Data in Chinese Webinar ndash 3 hrs
- March 19 Preventing Thermal amp Vibration Failures Webinar ndash 3 hrs
- April 23 Cooling Techniques for Electronic Equipment Seminar - 3 hrs
- April 29-30 Shock amp Vibration ndash Webinar ndash 3 hrs
- May 8 Physics of Failure for Building Reliability Into Products - 3 hrs
Details for all are on our site at wwwopsalacartecom
9copy 2009 Ops A La Carte
Opsrsquo New Reliability Book
How Reliable Is Your Product 50 Ways to Improve Product Reliability
A new book by Ops A La Carte LLCreg FounderManaging Partner Mike Silverman
The book focuses on Mikersquos experiences working with over 500 companies in his 25 year career as an engineer manager and consultant It is a practical guide to reliability written for everyone in your organization In the book we give tips and case studies rather than a textbook full of formulas Available January 2011 in hardback for $4495 or ebook for $1995 amazoncom or httpwwwhappyaboutcomproductreliabilityphp For more info go to wwwopsalacartecom
bull Ops Solutions ndash Ops provides end-to-end solutions that target the corporate
product reliability objectives
bull Ops Individual ldquoA La Carterdquo Consulting ndash Ops identifies and solves the
missing key ingredients needed for a fully integrated reliable product
bull Ops Training ndash Opsrsquo highly specialized leaders and experts in the industry
train others in both standard and customized training seminars
bull Ops Testing ndash Opsrsquo state-of-the-art
provides comprehensive testing services
orOunce of
Prevention
Strategy
In todays world of product development product cycles are shortening
product complexity is accelerating and companies are relying more on
outside resources
Ounce of Prevention Strategy (OPS)
What do Computer Laptop Battery fires Toyota Prius crashes BP Oil Rig explosion
have in common
They all did not use our Ounce of Prevention Strategy (OPS) Our OPS methodology if
used will discover problems BEFORE your customers find them
Consulting Services
Goal
Setting
Assess-
ment
Bench-
mark
FTAFMEA
Golden
Nuggets
Component
Selection
Predict-
ions
Thermal
Analysis
Derating
Analysis
POF
DOE Tolerance
Analysis
Preventive
Mainten
EOL
Analysis
Warranty
Analysis
Test
Plan
HALT RDT ALT HALT-AFR
Calculator
FEA Software
Reliability
RCA CLCA
Vendor
AssessmtHASS ORT OOBA
Lessons
Learned
Warranty
Returns
Reliability
ReportingStatistics EDA for
Obsolesc
Out-
sourcing
Metrics
Reliability
Plan
CO
NC
EP
T
PH
AS
E
DE
SIG
N
PH
AS
E
MA
NU
FA
CT
UR
ING
PH
AS
E
PR
OT
OT
Y
PE
PH
AS
E
Gap
Analysis
Block
Diagrams
copy 2009 Ops A La Carte
14
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
Failure
Rate
Time
Quality Does
the product
work when the
customer first
receives it
first turns it on
Reliability How
often does the
product fail after
the customer
receives it
first turns it on
Reliability
How long does
the product
work until it
wears out
copy 2009 Ops A La Carte
16
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
Similarities and Differences
Between Regulatory Programs
and Reliability Programs
Food and Drug Administration FDA httpwwwfdagov
21 CFR Parts 808 812 and 820 Medical Devices Current Good
Manufacturing Practice (CGMP) Final Rule Page 2
SUPPLEMENTARY INFORMATION I Background (Design Controls)
ldquoSpecifically in January 1990 FDA published the results of an
evaluation of device recalls that occurred from October 1983 through
September 1989 in a report entitled lsquolsquoDevice Recalls A Study of Quality
Problemsrsquorsquo
FDA found that approximately 44 percent of the quality
problems that led to voluntary recall actions during this 6-
year period were attributed to errors or deficiencies that
were designed into particular devices and may have been
prevented by adequate design controls
Government Regulations
We have found that many medical companies confuse
reliability with compliance
Just because you follow the compliance regulations does
not guarantee you have a reliable product
In fact the new IEC 60601-1 3rd Edition document requires
that your testing be based on risks you discover during your
risk management process
In this presentation we will show you two different case
studies ndash one in which we met the basic reliability
requirements and a second in which we had a separate
reliability effort to address specific reliability risks
Reliability vs Compliance
bull RELIABILITY PROGRAM PLANWhich areas were the same
Which areas were new
Reliability allocations
Gap analysis
Reliability Tools Deployed General for all assemblies
Reliability Tools Deployed Specific to certain assys
How will tools be used
Metrics to be used during program
Reliability Reporting and Issues Management
Roles and Responsibilities
Reliability Deliverables
Contingency Planning
Ongoing Reliability Assurance
MEDICAL INFUSION PUMP
bull NEW ASSEMBLIES
Two new motors - one for the cassette insertion and removal and one for the air sensor to pinch the tubing in order to detect air bubbles in the line
A new power supply that was larger and also had a battery charging circuit for the new rechargeable battery
A touch screen
An IEEE 80211 wireless interface
A new rechargeable battery design
New software to handle all of these new features
MEDICAL INFUSION PUMP
bull IDENTIFY RELIABILITY RISKS
Using the Risk Analysis process we identified
as many new risks as possible
Then we set out to figure ways of mitigating
these risks
Design analysis techniques such as FEA DOE
and Thermal Analysis
Accelerated Testing techniques such as HALT
ALT and RDT
The important element here is that we always
had an eye on our goal
MEDICAL INFUSION PUMP
bull RELIABILITY TECHNIQUES USED
Motors ndash FEA ALT
Power Supply ndash HALT then RDT
Touch Screen ndash ALT Abuse Testing
Wireless Interface - HALT
Battery ndash Application Specific ALT
Software ndash Software FMEA Software
Use Case Testing
MEDICAL INFUSION PUMP
bull RESULTS
Using this process we saved time and money
We found out issues during the design
analysis that would have required a redesign
had we found them later in the design or
worse out in the field
We found out issues during the testing that
would have set our program back months
End result We developed and delivered a
very reliable product and got it to market
faster
MEDICAL INFUSION PUMP
copy 2009 Ops A La Carte
25
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte
26
DESIGN FOR
RELIABILITY (DFR)
OVERVIEW
Definition
bull DfR is knowledge-based engineering wherein starting with capture of requirements and leading to assured reliability a reliability plan is designed and executed using the full skills and knowledge of the project team
bull The goal of DfR is to work smarter through knowledge-based tailoring of the reliability plan
2262014 Ops A La Carte copy 27
bull Making a list of all possible reliability activities and then trying to cover as many as possible within the timeframe of the product development process
bull Assuming that product reliability is the sole responsibility of a reliability engineer (reliability engineer is the guide and mentor but not the owner ndash designer should be the owner)
bull Getting the product into test as fast as possible to test reliability into the product (aka Test-Analyze-and-Fix)
bull Only working on the in-house design items and not worrying about vendor items
bull Working in silos between EE Mech E Software etc (even if they apply some or most of the DfR tools) ndash all competencies must work together to reach common goals
Is NOT
2262014 Ops A La Carte copy 28
IS
bull Identifying goals and requirements consistent with customer and business objectives
bull Applying knowledge-based management and engineering to define implement and improve plans to achieve goals and requirements
bull Providing clear metrics for review Reviewing and taking timely corrective action
bull Reviewing and knowledge-capture from all activities and outputs with goal of continuous improvement
bull DfR is the process of building reliability into the design with efficiency and assurance using the best science-based methods
2262014 Ops A La Carte copy 29
Flow
A detailed evaluation of an organizationrsquos approach and processes involved in creating reliable products The assessment captures the current state and leads to an actionable reliability program plan
bull Initiate a Reliability Programbull Determine next best stepsbull Reduce customer complaints bull Select right toolsbull Improve reliability
Now
Goal
$ unreliability
$ Profits
Assessment Interviews
StatisticalData Analysis
Benchmarking
Gap Analysis
Program Plan
complaints
fieldfailures
satisfaction
marketshare
Unknown Reliability
2262014 Ops A La Carte copy 30
Key Activities
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 31
DfR Key Activities
QFD Requirements definitions Benchmarking Product usage analysisUnderstanding of customer requirements and specifications
DFMEA Cost trade-off analysisLessons LearnedProbabilistic design Cost trade-offs Tolerance Analysis
FEA Warranty Data Analysis DRBFM Reliability predictionLessons Learned Reliability Block Diagrams
HASS Control Charts Re-validation Audits Look AcrossLessons Learned ORT
HALT Evaluation Testing DRBTRReliability Growth modeling Change Point Analysis
Design and Process ValidationAccelerated Test Reliability Demonstration
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 32
Key points for implementing DfR activities
bull Start DfR activities early in the process
bull Reliability engineerrsquos job is to leadcoach the design team Reliability achievement needs to be owned by design and manufacturing teams
bull Integration of Reliability and Quality Engineers with design teams
bull Warrantyfield data analysis (both statistical and root cause analysis) needs to be fed back to both design and reliability teams
bull Reduce the number of tools in the toolbox but use the remaining well Neither all steps nor tools are necessary for all the programs
2262014 Ops A La Carte copy 33
34
Reliability Before Design
SpendingRate
Qualification Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
Reliability Spend Rate
Traditional Reliability Model
35
Reliability Before Design
SpendingRate
Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Qualification
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
New Reliability Spend Rate
$ Savings $
Reliability Before Design
Design for Reliability Method
copy Ops A La Carte LLC 2012
copy 2009 Ops A La Carte
36
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte 37
DEVELOPING AN
EFFECTIVE
RELIABILITY TEST
STRATEGY
Steps to a Good Design
In order to write better test plans
1) Understand Requirements
2) Understand Use Environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform Design amp Design Reviews
6) Write Design Verification Test plan
7) Write Reliability Test Plan
Understanding Requirements
Inputs include
ndashSpecifications
bull MRD ndash Marketing Requirements Document
bull PRD ndash Product Requirements Document
ndashCompetitive Product Solutions
ndashLessons Learned
ndashConstraints
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
9copy 2009 Ops A La Carte
Opsrsquo New Reliability Book
How Reliable Is Your Product 50 Ways to Improve Product Reliability
A new book by Ops A La Carte LLCreg FounderManaging Partner Mike Silverman
The book focuses on Mikersquos experiences working with over 500 companies in his 25 year career as an engineer manager and consultant It is a practical guide to reliability written for everyone in your organization In the book we give tips and case studies rather than a textbook full of formulas Available January 2011 in hardback for $4495 or ebook for $1995 amazoncom or httpwwwhappyaboutcomproductreliabilityphp For more info go to wwwopsalacartecom
bull Ops Solutions ndash Ops provides end-to-end solutions that target the corporate
product reliability objectives
bull Ops Individual ldquoA La Carterdquo Consulting ndash Ops identifies and solves the
missing key ingredients needed for a fully integrated reliable product
bull Ops Training ndash Opsrsquo highly specialized leaders and experts in the industry
train others in both standard and customized training seminars
bull Ops Testing ndash Opsrsquo state-of-the-art
provides comprehensive testing services
orOunce of
Prevention
Strategy
In todays world of product development product cycles are shortening
product complexity is accelerating and companies are relying more on
outside resources
Ounce of Prevention Strategy (OPS)
What do Computer Laptop Battery fires Toyota Prius crashes BP Oil Rig explosion
have in common
They all did not use our Ounce of Prevention Strategy (OPS) Our OPS methodology if
used will discover problems BEFORE your customers find them
Consulting Services
Goal
Setting
Assess-
ment
Bench-
mark
FTAFMEA
Golden
Nuggets
Component
Selection
Predict-
ions
Thermal
Analysis
Derating
Analysis
POF
DOE Tolerance
Analysis
Preventive
Mainten
EOL
Analysis
Warranty
Analysis
Test
Plan
HALT RDT ALT HALT-AFR
Calculator
FEA Software
Reliability
RCA CLCA
Vendor
AssessmtHASS ORT OOBA
Lessons
Learned
Warranty
Returns
Reliability
ReportingStatistics EDA for
Obsolesc
Out-
sourcing
Metrics
Reliability
Plan
CO
NC
EP
T
PH
AS
E
DE
SIG
N
PH
AS
E
MA
NU
FA
CT
UR
ING
PH
AS
E
PR
OT
OT
Y
PE
PH
AS
E
Gap
Analysis
Block
Diagrams
copy 2009 Ops A La Carte
14
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
Failure
Rate
Time
Quality Does
the product
work when the
customer first
receives it
first turns it on
Reliability How
often does the
product fail after
the customer
receives it
first turns it on
Reliability
How long does
the product
work until it
wears out
copy 2009 Ops A La Carte
16
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
Similarities and Differences
Between Regulatory Programs
and Reliability Programs
Food and Drug Administration FDA httpwwwfdagov
21 CFR Parts 808 812 and 820 Medical Devices Current Good
Manufacturing Practice (CGMP) Final Rule Page 2
SUPPLEMENTARY INFORMATION I Background (Design Controls)
ldquoSpecifically in January 1990 FDA published the results of an
evaluation of device recalls that occurred from October 1983 through
September 1989 in a report entitled lsquolsquoDevice Recalls A Study of Quality
Problemsrsquorsquo
FDA found that approximately 44 percent of the quality
problems that led to voluntary recall actions during this 6-
year period were attributed to errors or deficiencies that
were designed into particular devices and may have been
prevented by adequate design controls
Government Regulations
We have found that many medical companies confuse
reliability with compliance
Just because you follow the compliance regulations does
not guarantee you have a reliable product
In fact the new IEC 60601-1 3rd Edition document requires
that your testing be based on risks you discover during your
risk management process
In this presentation we will show you two different case
studies ndash one in which we met the basic reliability
requirements and a second in which we had a separate
reliability effort to address specific reliability risks
Reliability vs Compliance
bull RELIABILITY PROGRAM PLANWhich areas were the same
Which areas were new
Reliability allocations
Gap analysis
Reliability Tools Deployed General for all assemblies
Reliability Tools Deployed Specific to certain assys
How will tools be used
Metrics to be used during program
Reliability Reporting and Issues Management
Roles and Responsibilities
Reliability Deliverables
Contingency Planning
Ongoing Reliability Assurance
MEDICAL INFUSION PUMP
bull NEW ASSEMBLIES
Two new motors - one for the cassette insertion and removal and one for the air sensor to pinch the tubing in order to detect air bubbles in the line
A new power supply that was larger and also had a battery charging circuit for the new rechargeable battery
A touch screen
An IEEE 80211 wireless interface
A new rechargeable battery design
New software to handle all of these new features
MEDICAL INFUSION PUMP
bull IDENTIFY RELIABILITY RISKS
Using the Risk Analysis process we identified
as many new risks as possible
Then we set out to figure ways of mitigating
these risks
Design analysis techniques such as FEA DOE
and Thermal Analysis
Accelerated Testing techniques such as HALT
ALT and RDT
The important element here is that we always
had an eye on our goal
MEDICAL INFUSION PUMP
bull RELIABILITY TECHNIQUES USED
Motors ndash FEA ALT
Power Supply ndash HALT then RDT
Touch Screen ndash ALT Abuse Testing
Wireless Interface - HALT
Battery ndash Application Specific ALT
Software ndash Software FMEA Software
Use Case Testing
MEDICAL INFUSION PUMP
bull RESULTS
Using this process we saved time and money
We found out issues during the design
analysis that would have required a redesign
had we found them later in the design or
worse out in the field
We found out issues during the testing that
would have set our program back months
End result We developed and delivered a
very reliable product and got it to market
faster
MEDICAL INFUSION PUMP
copy 2009 Ops A La Carte
25
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte
26
DESIGN FOR
RELIABILITY (DFR)
OVERVIEW
Definition
bull DfR is knowledge-based engineering wherein starting with capture of requirements and leading to assured reliability a reliability plan is designed and executed using the full skills and knowledge of the project team
bull The goal of DfR is to work smarter through knowledge-based tailoring of the reliability plan
2262014 Ops A La Carte copy 27
bull Making a list of all possible reliability activities and then trying to cover as many as possible within the timeframe of the product development process
bull Assuming that product reliability is the sole responsibility of a reliability engineer (reliability engineer is the guide and mentor but not the owner ndash designer should be the owner)
bull Getting the product into test as fast as possible to test reliability into the product (aka Test-Analyze-and-Fix)
bull Only working on the in-house design items and not worrying about vendor items
bull Working in silos between EE Mech E Software etc (even if they apply some or most of the DfR tools) ndash all competencies must work together to reach common goals
Is NOT
2262014 Ops A La Carte copy 28
IS
bull Identifying goals and requirements consistent with customer and business objectives
bull Applying knowledge-based management and engineering to define implement and improve plans to achieve goals and requirements
bull Providing clear metrics for review Reviewing and taking timely corrective action
bull Reviewing and knowledge-capture from all activities and outputs with goal of continuous improvement
bull DfR is the process of building reliability into the design with efficiency and assurance using the best science-based methods
2262014 Ops A La Carte copy 29
Flow
A detailed evaluation of an organizationrsquos approach and processes involved in creating reliable products The assessment captures the current state and leads to an actionable reliability program plan
bull Initiate a Reliability Programbull Determine next best stepsbull Reduce customer complaints bull Select right toolsbull Improve reliability
Now
Goal
$ unreliability
$ Profits
Assessment Interviews
StatisticalData Analysis
Benchmarking
Gap Analysis
Program Plan
complaints
fieldfailures
satisfaction
marketshare
Unknown Reliability
2262014 Ops A La Carte copy 30
Key Activities
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 31
DfR Key Activities
QFD Requirements definitions Benchmarking Product usage analysisUnderstanding of customer requirements and specifications
DFMEA Cost trade-off analysisLessons LearnedProbabilistic design Cost trade-offs Tolerance Analysis
FEA Warranty Data Analysis DRBFM Reliability predictionLessons Learned Reliability Block Diagrams
HASS Control Charts Re-validation Audits Look AcrossLessons Learned ORT
HALT Evaluation Testing DRBTRReliability Growth modeling Change Point Analysis
Design and Process ValidationAccelerated Test Reliability Demonstration
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 32
Key points for implementing DfR activities
bull Start DfR activities early in the process
bull Reliability engineerrsquos job is to leadcoach the design team Reliability achievement needs to be owned by design and manufacturing teams
bull Integration of Reliability and Quality Engineers with design teams
bull Warrantyfield data analysis (both statistical and root cause analysis) needs to be fed back to both design and reliability teams
bull Reduce the number of tools in the toolbox but use the remaining well Neither all steps nor tools are necessary for all the programs
2262014 Ops A La Carte copy 33
34
Reliability Before Design
SpendingRate
Qualification Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
Reliability Spend Rate
Traditional Reliability Model
35
Reliability Before Design
SpendingRate
Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Qualification
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
New Reliability Spend Rate
$ Savings $
Reliability Before Design
Design for Reliability Method
copy Ops A La Carte LLC 2012
copy 2009 Ops A La Carte
36
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte 37
DEVELOPING AN
EFFECTIVE
RELIABILITY TEST
STRATEGY
Steps to a Good Design
In order to write better test plans
1) Understand Requirements
2) Understand Use Environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform Design amp Design Reviews
6) Write Design Verification Test plan
7) Write Reliability Test Plan
Understanding Requirements
Inputs include
ndashSpecifications
bull MRD ndash Marketing Requirements Document
bull PRD ndash Product Requirements Document
ndashCompetitive Product Solutions
ndashLessons Learned
ndashConstraints
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
bull Ops Solutions ndash Ops provides end-to-end solutions that target the corporate
product reliability objectives
bull Ops Individual ldquoA La Carterdquo Consulting ndash Ops identifies and solves the
missing key ingredients needed for a fully integrated reliable product
bull Ops Training ndash Opsrsquo highly specialized leaders and experts in the industry
train others in both standard and customized training seminars
bull Ops Testing ndash Opsrsquo state-of-the-art
provides comprehensive testing services
orOunce of
Prevention
Strategy
In todays world of product development product cycles are shortening
product complexity is accelerating and companies are relying more on
outside resources
Ounce of Prevention Strategy (OPS)
What do Computer Laptop Battery fires Toyota Prius crashes BP Oil Rig explosion
have in common
They all did not use our Ounce of Prevention Strategy (OPS) Our OPS methodology if
used will discover problems BEFORE your customers find them
Consulting Services
Goal
Setting
Assess-
ment
Bench-
mark
FTAFMEA
Golden
Nuggets
Component
Selection
Predict-
ions
Thermal
Analysis
Derating
Analysis
POF
DOE Tolerance
Analysis
Preventive
Mainten
EOL
Analysis
Warranty
Analysis
Test
Plan
HALT RDT ALT HALT-AFR
Calculator
FEA Software
Reliability
RCA CLCA
Vendor
AssessmtHASS ORT OOBA
Lessons
Learned
Warranty
Returns
Reliability
ReportingStatistics EDA for
Obsolesc
Out-
sourcing
Metrics
Reliability
Plan
CO
NC
EP
T
PH
AS
E
DE
SIG
N
PH
AS
E
MA
NU
FA
CT
UR
ING
PH
AS
E
PR
OT
OT
Y
PE
PH
AS
E
Gap
Analysis
Block
Diagrams
copy 2009 Ops A La Carte
14
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
Failure
Rate
Time
Quality Does
the product
work when the
customer first
receives it
first turns it on
Reliability How
often does the
product fail after
the customer
receives it
first turns it on
Reliability
How long does
the product
work until it
wears out
copy 2009 Ops A La Carte
16
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
Similarities and Differences
Between Regulatory Programs
and Reliability Programs
Food and Drug Administration FDA httpwwwfdagov
21 CFR Parts 808 812 and 820 Medical Devices Current Good
Manufacturing Practice (CGMP) Final Rule Page 2
SUPPLEMENTARY INFORMATION I Background (Design Controls)
ldquoSpecifically in January 1990 FDA published the results of an
evaluation of device recalls that occurred from October 1983 through
September 1989 in a report entitled lsquolsquoDevice Recalls A Study of Quality
Problemsrsquorsquo
FDA found that approximately 44 percent of the quality
problems that led to voluntary recall actions during this 6-
year period were attributed to errors or deficiencies that
were designed into particular devices and may have been
prevented by adequate design controls
Government Regulations
We have found that many medical companies confuse
reliability with compliance
Just because you follow the compliance regulations does
not guarantee you have a reliable product
In fact the new IEC 60601-1 3rd Edition document requires
that your testing be based on risks you discover during your
risk management process
In this presentation we will show you two different case
studies ndash one in which we met the basic reliability
requirements and a second in which we had a separate
reliability effort to address specific reliability risks
Reliability vs Compliance
bull RELIABILITY PROGRAM PLANWhich areas were the same
Which areas were new
Reliability allocations
Gap analysis
Reliability Tools Deployed General for all assemblies
Reliability Tools Deployed Specific to certain assys
How will tools be used
Metrics to be used during program
Reliability Reporting and Issues Management
Roles and Responsibilities
Reliability Deliverables
Contingency Planning
Ongoing Reliability Assurance
MEDICAL INFUSION PUMP
bull NEW ASSEMBLIES
Two new motors - one for the cassette insertion and removal and one for the air sensor to pinch the tubing in order to detect air bubbles in the line
A new power supply that was larger and also had a battery charging circuit for the new rechargeable battery
A touch screen
An IEEE 80211 wireless interface
A new rechargeable battery design
New software to handle all of these new features
MEDICAL INFUSION PUMP
bull IDENTIFY RELIABILITY RISKS
Using the Risk Analysis process we identified
as many new risks as possible
Then we set out to figure ways of mitigating
these risks
Design analysis techniques such as FEA DOE
and Thermal Analysis
Accelerated Testing techniques such as HALT
ALT and RDT
The important element here is that we always
had an eye on our goal
MEDICAL INFUSION PUMP
bull RELIABILITY TECHNIQUES USED
Motors ndash FEA ALT
Power Supply ndash HALT then RDT
Touch Screen ndash ALT Abuse Testing
Wireless Interface - HALT
Battery ndash Application Specific ALT
Software ndash Software FMEA Software
Use Case Testing
MEDICAL INFUSION PUMP
bull RESULTS
Using this process we saved time and money
We found out issues during the design
analysis that would have required a redesign
had we found them later in the design or
worse out in the field
We found out issues during the testing that
would have set our program back months
End result We developed and delivered a
very reliable product and got it to market
faster
MEDICAL INFUSION PUMP
copy 2009 Ops A La Carte
25
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte
26
DESIGN FOR
RELIABILITY (DFR)
OVERVIEW
Definition
bull DfR is knowledge-based engineering wherein starting with capture of requirements and leading to assured reliability a reliability plan is designed and executed using the full skills and knowledge of the project team
bull The goal of DfR is to work smarter through knowledge-based tailoring of the reliability plan
2262014 Ops A La Carte copy 27
bull Making a list of all possible reliability activities and then trying to cover as many as possible within the timeframe of the product development process
bull Assuming that product reliability is the sole responsibility of a reliability engineer (reliability engineer is the guide and mentor but not the owner ndash designer should be the owner)
bull Getting the product into test as fast as possible to test reliability into the product (aka Test-Analyze-and-Fix)
bull Only working on the in-house design items and not worrying about vendor items
bull Working in silos between EE Mech E Software etc (even if they apply some or most of the DfR tools) ndash all competencies must work together to reach common goals
Is NOT
2262014 Ops A La Carte copy 28
IS
bull Identifying goals and requirements consistent with customer and business objectives
bull Applying knowledge-based management and engineering to define implement and improve plans to achieve goals and requirements
bull Providing clear metrics for review Reviewing and taking timely corrective action
bull Reviewing and knowledge-capture from all activities and outputs with goal of continuous improvement
bull DfR is the process of building reliability into the design with efficiency and assurance using the best science-based methods
2262014 Ops A La Carte copy 29
Flow
A detailed evaluation of an organizationrsquos approach and processes involved in creating reliable products The assessment captures the current state and leads to an actionable reliability program plan
bull Initiate a Reliability Programbull Determine next best stepsbull Reduce customer complaints bull Select right toolsbull Improve reliability
Now
Goal
$ unreliability
$ Profits
Assessment Interviews
StatisticalData Analysis
Benchmarking
Gap Analysis
Program Plan
complaints
fieldfailures
satisfaction
marketshare
Unknown Reliability
2262014 Ops A La Carte copy 30
Key Activities
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 31
DfR Key Activities
QFD Requirements definitions Benchmarking Product usage analysisUnderstanding of customer requirements and specifications
DFMEA Cost trade-off analysisLessons LearnedProbabilistic design Cost trade-offs Tolerance Analysis
FEA Warranty Data Analysis DRBFM Reliability predictionLessons Learned Reliability Block Diagrams
HASS Control Charts Re-validation Audits Look AcrossLessons Learned ORT
HALT Evaluation Testing DRBTRReliability Growth modeling Change Point Analysis
Design and Process ValidationAccelerated Test Reliability Demonstration
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 32
Key points for implementing DfR activities
bull Start DfR activities early in the process
bull Reliability engineerrsquos job is to leadcoach the design team Reliability achievement needs to be owned by design and manufacturing teams
bull Integration of Reliability and Quality Engineers with design teams
bull Warrantyfield data analysis (both statistical and root cause analysis) needs to be fed back to both design and reliability teams
bull Reduce the number of tools in the toolbox but use the remaining well Neither all steps nor tools are necessary for all the programs
2262014 Ops A La Carte copy 33
34
Reliability Before Design
SpendingRate
Qualification Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
Reliability Spend Rate
Traditional Reliability Model
35
Reliability Before Design
SpendingRate
Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Qualification
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
New Reliability Spend Rate
$ Savings $
Reliability Before Design
Design for Reliability Method
copy Ops A La Carte LLC 2012
copy 2009 Ops A La Carte
36
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte 37
DEVELOPING AN
EFFECTIVE
RELIABILITY TEST
STRATEGY
Steps to a Good Design
In order to write better test plans
1) Understand Requirements
2) Understand Use Environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform Design amp Design Reviews
6) Write Design Verification Test plan
7) Write Reliability Test Plan
Understanding Requirements
Inputs include
ndashSpecifications
bull MRD ndash Marketing Requirements Document
bull PRD ndash Product Requirements Document
ndashCompetitive Product Solutions
ndashLessons Learned
ndashConstraints
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
In todays world of product development product cycles are shortening
product complexity is accelerating and companies are relying more on
outside resources
Ounce of Prevention Strategy (OPS)
What do Computer Laptop Battery fires Toyota Prius crashes BP Oil Rig explosion
have in common
They all did not use our Ounce of Prevention Strategy (OPS) Our OPS methodology if
used will discover problems BEFORE your customers find them
Consulting Services
Goal
Setting
Assess-
ment
Bench-
mark
FTAFMEA
Golden
Nuggets
Component
Selection
Predict-
ions
Thermal
Analysis
Derating
Analysis
POF
DOE Tolerance
Analysis
Preventive
Mainten
EOL
Analysis
Warranty
Analysis
Test
Plan
HALT RDT ALT HALT-AFR
Calculator
FEA Software
Reliability
RCA CLCA
Vendor
AssessmtHASS ORT OOBA
Lessons
Learned
Warranty
Returns
Reliability
ReportingStatistics EDA for
Obsolesc
Out-
sourcing
Metrics
Reliability
Plan
CO
NC
EP
T
PH
AS
E
DE
SIG
N
PH
AS
E
MA
NU
FA
CT
UR
ING
PH
AS
E
PR
OT
OT
Y
PE
PH
AS
E
Gap
Analysis
Block
Diagrams
copy 2009 Ops A La Carte
14
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
Failure
Rate
Time
Quality Does
the product
work when the
customer first
receives it
first turns it on
Reliability How
often does the
product fail after
the customer
receives it
first turns it on
Reliability
How long does
the product
work until it
wears out
copy 2009 Ops A La Carte
16
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
Similarities and Differences
Between Regulatory Programs
and Reliability Programs
Food and Drug Administration FDA httpwwwfdagov
21 CFR Parts 808 812 and 820 Medical Devices Current Good
Manufacturing Practice (CGMP) Final Rule Page 2
SUPPLEMENTARY INFORMATION I Background (Design Controls)
ldquoSpecifically in January 1990 FDA published the results of an
evaluation of device recalls that occurred from October 1983 through
September 1989 in a report entitled lsquolsquoDevice Recalls A Study of Quality
Problemsrsquorsquo
FDA found that approximately 44 percent of the quality
problems that led to voluntary recall actions during this 6-
year period were attributed to errors or deficiencies that
were designed into particular devices and may have been
prevented by adequate design controls
Government Regulations
We have found that many medical companies confuse
reliability with compliance
Just because you follow the compliance regulations does
not guarantee you have a reliable product
In fact the new IEC 60601-1 3rd Edition document requires
that your testing be based on risks you discover during your
risk management process
In this presentation we will show you two different case
studies ndash one in which we met the basic reliability
requirements and a second in which we had a separate
reliability effort to address specific reliability risks
Reliability vs Compliance
bull RELIABILITY PROGRAM PLANWhich areas were the same
Which areas were new
Reliability allocations
Gap analysis
Reliability Tools Deployed General for all assemblies
Reliability Tools Deployed Specific to certain assys
How will tools be used
Metrics to be used during program
Reliability Reporting and Issues Management
Roles and Responsibilities
Reliability Deliverables
Contingency Planning
Ongoing Reliability Assurance
MEDICAL INFUSION PUMP
bull NEW ASSEMBLIES
Two new motors - one for the cassette insertion and removal and one for the air sensor to pinch the tubing in order to detect air bubbles in the line
A new power supply that was larger and also had a battery charging circuit for the new rechargeable battery
A touch screen
An IEEE 80211 wireless interface
A new rechargeable battery design
New software to handle all of these new features
MEDICAL INFUSION PUMP
bull IDENTIFY RELIABILITY RISKS
Using the Risk Analysis process we identified
as many new risks as possible
Then we set out to figure ways of mitigating
these risks
Design analysis techniques such as FEA DOE
and Thermal Analysis
Accelerated Testing techniques such as HALT
ALT and RDT
The important element here is that we always
had an eye on our goal
MEDICAL INFUSION PUMP
bull RELIABILITY TECHNIQUES USED
Motors ndash FEA ALT
Power Supply ndash HALT then RDT
Touch Screen ndash ALT Abuse Testing
Wireless Interface - HALT
Battery ndash Application Specific ALT
Software ndash Software FMEA Software
Use Case Testing
MEDICAL INFUSION PUMP
bull RESULTS
Using this process we saved time and money
We found out issues during the design
analysis that would have required a redesign
had we found them later in the design or
worse out in the field
We found out issues during the testing that
would have set our program back months
End result We developed and delivered a
very reliable product and got it to market
faster
MEDICAL INFUSION PUMP
copy 2009 Ops A La Carte
25
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte
26
DESIGN FOR
RELIABILITY (DFR)
OVERVIEW
Definition
bull DfR is knowledge-based engineering wherein starting with capture of requirements and leading to assured reliability a reliability plan is designed and executed using the full skills and knowledge of the project team
bull The goal of DfR is to work smarter through knowledge-based tailoring of the reliability plan
2262014 Ops A La Carte copy 27
bull Making a list of all possible reliability activities and then trying to cover as many as possible within the timeframe of the product development process
bull Assuming that product reliability is the sole responsibility of a reliability engineer (reliability engineer is the guide and mentor but not the owner ndash designer should be the owner)
bull Getting the product into test as fast as possible to test reliability into the product (aka Test-Analyze-and-Fix)
bull Only working on the in-house design items and not worrying about vendor items
bull Working in silos between EE Mech E Software etc (even if they apply some or most of the DfR tools) ndash all competencies must work together to reach common goals
Is NOT
2262014 Ops A La Carte copy 28
IS
bull Identifying goals and requirements consistent with customer and business objectives
bull Applying knowledge-based management and engineering to define implement and improve plans to achieve goals and requirements
bull Providing clear metrics for review Reviewing and taking timely corrective action
bull Reviewing and knowledge-capture from all activities and outputs with goal of continuous improvement
bull DfR is the process of building reliability into the design with efficiency and assurance using the best science-based methods
2262014 Ops A La Carte copy 29
Flow
A detailed evaluation of an organizationrsquos approach and processes involved in creating reliable products The assessment captures the current state and leads to an actionable reliability program plan
bull Initiate a Reliability Programbull Determine next best stepsbull Reduce customer complaints bull Select right toolsbull Improve reliability
Now
Goal
$ unreliability
$ Profits
Assessment Interviews
StatisticalData Analysis
Benchmarking
Gap Analysis
Program Plan
complaints
fieldfailures
satisfaction
marketshare
Unknown Reliability
2262014 Ops A La Carte copy 30
Key Activities
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 31
DfR Key Activities
QFD Requirements definitions Benchmarking Product usage analysisUnderstanding of customer requirements and specifications
DFMEA Cost trade-off analysisLessons LearnedProbabilistic design Cost trade-offs Tolerance Analysis
FEA Warranty Data Analysis DRBFM Reliability predictionLessons Learned Reliability Block Diagrams
HASS Control Charts Re-validation Audits Look AcrossLessons Learned ORT
HALT Evaluation Testing DRBTRReliability Growth modeling Change Point Analysis
Design and Process ValidationAccelerated Test Reliability Demonstration
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 32
Key points for implementing DfR activities
bull Start DfR activities early in the process
bull Reliability engineerrsquos job is to leadcoach the design team Reliability achievement needs to be owned by design and manufacturing teams
bull Integration of Reliability and Quality Engineers with design teams
bull Warrantyfield data analysis (both statistical and root cause analysis) needs to be fed back to both design and reliability teams
bull Reduce the number of tools in the toolbox but use the remaining well Neither all steps nor tools are necessary for all the programs
2262014 Ops A La Carte copy 33
34
Reliability Before Design
SpendingRate
Qualification Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
Reliability Spend Rate
Traditional Reliability Model
35
Reliability Before Design
SpendingRate
Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Qualification
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
New Reliability Spend Rate
$ Savings $
Reliability Before Design
Design for Reliability Method
copy Ops A La Carte LLC 2012
copy 2009 Ops A La Carte
36
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte 37
DEVELOPING AN
EFFECTIVE
RELIABILITY TEST
STRATEGY
Steps to a Good Design
In order to write better test plans
1) Understand Requirements
2) Understand Use Environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform Design amp Design Reviews
6) Write Design Verification Test plan
7) Write Reliability Test Plan
Understanding Requirements
Inputs include
ndashSpecifications
bull MRD ndash Marketing Requirements Document
bull PRD ndash Product Requirements Document
ndashCompetitive Product Solutions
ndashLessons Learned
ndashConstraints
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
Consulting Services
Goal
Setting
Assess-
ment
Bench-
mark
FTAFMEA
Golden
Nuggets
Component
Selection
Predict-
ions
Thermal
Analysis
Derating
Analysis
POF
DOE Tolerance
Analysis
Preventive
Mainten
EOL
Analysis
Warranty
Analysis
Test
Plan
HALT RDT ALT HALT-AFR
Calculator
FEA Software
Reliability
RCA CLCA
Vendor
AssessmtHASS ORT OOBA
Lessons
Learned
Warranty
Returns
Reliability
ReportingStatistics EDA for
Obsolesc
Out-
sourcing
Metrics
Reliability
Plan
CO
NC
EP
T
PH
AS
E
DE
SIG
N
PH
AS
E
MA
NU
FA
CT
UR
ING
PH
AS
E
PR
OT
OT
Y
PE
PH
AS
E
Gap
Analysis
Block
Diagrams
copy 2009 Ops A La Carte
14
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
Failure
Rate
Time
Quality Does
the product
work when the
customer first
receives it
first turns it on
Reliability How
often does the
product fail after
the customer
receives it
first turns it on
Reliability
How long does
the product
work until it
wears out
copy 2009 Ops A La Carte
16
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
Similarities and Differences
Between Regulatory Programs
and Reliability Programs
Food and Drug Administration FDA httpwwwfdagov
21 CFR Parts 808 812 and 820 Medical Devices Current Good
Manufacturing Practice (CGMP) Final Rule Page 2
SUPPLEMENTARY INFORMATION I Background (Design Controls)
ldquoSpecifically in January 1990 FDA published the results of an
evaluation of device recalls that occurred from October 1983 through
September 1989 in a report entitled lsquolsquoDevice Recalls A Study of Quality
Problemsrsquorsquo
FDA found that approximately 44 percent of the quality
problems that led to voluntary recall actions during this 6-
year period were attributed to errors or deficiencies that
were designed into particular devices and may have been
prevented by adequate design controls
Government Regulations
We have found that many medical companies confuse
reliability with compliance
Just because you follow the compliance regulations does
not guarantee you have a reliable product
In fact the new IEC 60601-1 3rd Edition document requires
that your testing be based on risks you discover during your
risk management process
In this presentation we will show you two different case
studies ndash one in which we met the basic reliability
requirements and a second in which we had a separate
reliability effort to address specific reliability risks
Reliability vs Compliance
bull RELIABILITY PROGRAM PLANWhich areas were the same
Which areas were new
Reliability allocations
Gap analysis
Reliability Tools Deployed General for all assemblies
Reliability Tools Deployed Specific to certain assys
How will tools be used
Metrics to be used during program
Reliability Reporting and Issues Management
Roles and Responsibilities
Reliability Deliverables
Contingency Planning
Ongoing Reliability Assurance
MEDICAL INFUSION PUMP
bull NEW ASSEMBLIES
Two new motors - one for the cassette insertion and removal and one for the air sensor to pinch the tubing in order to detect air bubbles in the line
A new power supply that was larger and also had a battery charging circuit for the new rechargeable battery
A touch screen
An IEEE 80211 wireless interface
A new rechargeable battery design
New software to handle all of these new features
MEDICAL INFUSION PUMP
bull IDENTIFY RELIABILITY RISKS
Using the Risk Analysis process we identified
as many new risks as possible
Then we set out to figure ways of mitigating
these risks
Design analysis techniques such as FEA DOE
and Thermal Analysis
Accelerated Testing techniques such as HALT
ALT and RDT
The important element here is that we always
had an eye on our goal
MEDICAL INFUSION PUMP
bull RELIABILITY TECHNIQUES USED
Motors ndash FEA ALT
Power Supply ndash HALT then RDT
Touch Screen ndash ALT Abuse Testing
Wireless Interface - HALT
Battery ndash Application Specific ALT
Software ndash Software FMEA Software
Use Case Testing
MEDICAL INFUSION PUMP
bull RESULTS
Using this process we saved time and money
We found out issues during the design
analysis that would have required a redesign
had we found them later in the design or
worse out in the field
We found out issues during the testing that
would have set our program back months
End result We developed and delivered a
very reliable product and got it to market
faster
MEDICAL INFUSION PUMP
copy 2009 Ops A La Carte
25
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte
26
DESIGN FOR
RELIABILITY (DFR)
OVERVIEW
Definition
bull DfR is knowledge-based engineering wherein starting with capture of requirements and leading to assured reliability a reliability plan is designed and executed using the full skills and knowledge of the project team
bull The goal of DfR is to work smarter through knowledge-based tailoring of the reliability plan
2262014 Ops A La Carte copy 27
bull Making a list of all possible reliability activities and then trying to cover as many as possible within the timeframe of the product development process
bull Assuming that product reliability is the sole responsibility of a reliability engineer (reliability engineer is the guide and mentor but not the owner ndash designer should be the owner)
bull Getting the product into test as fast as possible to test reliability into the product (aka Test-Analyze-and-Fix)
bull Only working on the in-house design items and not worrying about vendor items
bull Working in silos between EE Mech E Software etc (even if they apply some or most of the DfR tools) ndash all competencies must work together to reach common goals
Is NOT
2262014 Ops A La Carte copy 28
IS
bull Identifying goals and requirements consistent with customer and business objectives
bull Applying knowledge-based management and engineering to define implement and improve plans to achieve goals and requirements
bull Providing clear metrics for review Reviewing and taking timely corrective action
bull Reviewing and knowledge-capture from all activities and outputs with goal of continuous improvement
bull DfR is the process of building reliability into the design with efficiency and assurance using the best science-based methods
2262014 Ops A La Carte copy 29
Flow
A detailed evaluation of an organizationrsquos approach and processes involved in creating reliable products The assessment captures the current state and leads to an actionable reliability program plan
bull Initiate a Reliability Programbull Determine next best stepsbull Reduce customer complaints bull Select right toolsbull Improve reliability
Now
Goal
$ unreliability
$ Profits
Assessment Interviews
StatisticalData Analysis
Benchmarking
Gap Analysis
Program Plan
complaints
fieldfailures
satisfaction
marketshare
Unknown Reliability
2262014 Ops A La Carte copy 30
Key Activities
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 31
DfR Key Activities
QFD Requirements definitions Benchmarking Product usage analysisUnderstanding of customer requirements and specifications
DFMEA Cost trade-off analysisLessons LearnedProbabilistic design Cost trade-offs Tolerance Analysis
FEA Warranty Data Analysis DRBFM Reliability predictionLessons Learned Reliability Block Diagrams
HASS Control Charts Re-validation Audits Look AcrossLessons Learned ORT
HALT Evaluation Testing DRBTRReliability Growth modeling Change Point Analysis
Design and Process ValidationAccelerated Test Reliability Demonstration
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 32
Key points for implementing DfR activities
bull Start DfR activities early in the process
bull Reliability engineerrsquos job is to leadcoach the design team Reliability achievement needs to be owned by design and manufacturing teams
bull Integration of Reliability and Quality Engineers with design teams
bull Warrantyfield data analysis (both statistical and root cause analysis) needs to be fed back to both design and reliability teams
bull Reduce the number of tools in the toolbox but use the remaining well Neither all steps nor tools are necessary for all the programs
2262014 Ops A La Carte copy 33
34
Reliability Before Design
SpendingRate
Qualification Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
Reliability Spend Rate
Traditional Reliability Model
35
Reliability Before Design
SpendingRate
Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Qualification
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
New Reliability Spend Rate
$ Savings $
Reliability Before Design
Design for Reliability Method
copy Ops A La Carte LLC 2012
copy 2009 Ops A La Carte
36
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte 37
DEVELOPING AN
EFFECTIVE
RELIABILITY TEST
STRATEGY
Steps to a Good Design
In order to write better test plans
1) Understand Requirements
2) Understand Use Environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform Design amp Design Reviews
6) Write Design Verification Test plan
7) Write Reliability Test Plan
Understanding Requirements
Inputs include
ndashSpecifications
bull MRD ndash Marketing Requirements Document
bull PRD ndash Product Requirements Document
ndashCompetitive Product Solutions
ndashLessons Learned
ndashConstraints
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
Goal
Setting
Assess-
ment
Bench-
mark
FTAFMEA
Golden
Nuggets
Component
Selection
Predict-
ions
Thermal
Analysis
Derating
Analysis
POF
DOE Tolerance
Analysis
Preventive
Mainten
EOL
Analysis
Warranty
Analysis
Test
Plan
HALT RDT ALT HALT-AFR
Calculator
FEA Software
Reliability
RCA CLCA
Vendor
AssessmtHASS ORT OOBA
Lessons
Learned
Warranty
Returns
Reliability
ReportingStatistics EDA for
Obsolesc
Out-
sourcing
Metrics
Reliability
Plan
CO
NC
EP
T
PH
AS
E
DE
SIG
N
PH
AS
E
MA
NU
FA
CT
UR
ING
PH
AS
E
PR
OT
OT
Y
PE
PH
AS
E
Gap
Analysis
Block
Diagrams
copy 2009 Ops A La Carte
14
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
Failure
Rate
Time
Quality Does
the product
work when the
customer first
receives it
first turns it on
Reliability How
often does the
product fail after
the customer
receives it
first turns it on
Reliability
How long does
the product
work until it
wears out
copy 2009 Ops A La Carte
16
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
Similarities and Differences
Between Regulatory Programs
and Reliability Programs
Food and Drug Administration FDA httpwwwfdagov
21 CFR Parts 808 812 and 820 Medical Devices Current Good
Manufacturing Practice (CGMP) Final Rule Page 2
SUPPLEMENTARY INFORMATION I Background (Design Controls)
ldquoSpecifically in January 1990 FDA published the results of an
evaluation of device recalls that occurred from October 1983 through
September 1989 in a report entitled lsquolsquoDevice Recalls A Study of Quality
Problemsrsquorsquo
FDA found that approximately 44 percent of the quality
problems that led to voluntary recall actions during this 6-
year period were attributed to errors or deficiencies that
were designed into particular devices and may have been
prevented by adequate design controls
Government Regulations
We have found that many medical companies confuse
reliability with compliance
Just because you follow the compliance regulations does
not guarantee you have a reliable product
In fact the new IEC 60601-1 3rd Edition document requires
that your testing be based on risks you discover during your
risk management process
In this presentation we will show you two different case
studies ndash one in which we met the basic reliability
requirements and a second in which we had a separate
reliability effort to address specific reliability risks
Reliability vs Compliance
bull RELIABILITY PROGRAM PLANWhich areas were the same
Which areas were new
Reliability allocations
Gap analysis
Reliability Tools Deployed General for all assemblies
Reliability Tools Deployed Specific to certain assys
How will tools be used
Metrics to be used during program
Reliability Reporting and Issues Management
Roles and Responsibilities
Reliability Deliverables
Contingency Planning
Ongoing Reliability Assurance
MEDICAL INFUSION PUMP
bull NEW ASSEMBLIES
Two new motors - one for the cassette insertion and removal and one for the air sensor to pinch the tubing in order to detect air bubbles in the line
A new power supply that was larger and also had a battery charging circuit for the new rechargeable battery
A touch screen
An IEEE 80211 wireless interface
A new rechargeable battery design
New software to handle all of these new features
MEDICAL INFUSION PUMP
bull IDENTIFY RELIABILITY RISKS
Using the Risk Analysis process we identified
as many new risks as possible
Then we set out to figure ways of mitigating
these risks
Design analysis techniques such as FEA DOE
and Thermal Analysis
Accelerated Testing techniques such as HALT
ALT and RDT
The important element here is that we always
had an eye on our goal
MEDICAL INFUSION PUMP
bull RELIABILITY TECHNIQUES USED
Motors ndash FEA ALT
Power Supply ndash HALT then RDT
Touch Screen ndash ALT Abuse Testing
Wireless Interface - HALT
Battery ndash Application Specific ALT
Software ndash Software FMEA Software
Use Case Testing
MEDICAL INFUSION PUMP
bull RESULTS
Using this process we saved time and money
We found out issues during the design
analysis that would have required a redesign
had we found them later in the design or
worse out in the field
We found out issues during the testing that
would have set our program back months
End result We developed and delivered a
very reliable product and got it to market
faster
MEDICAL INFUSION PUMP
copy 2009 Ops A La Carte
25
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte
26
DESIGN FOR
RELIABILITY (DFR)
OVERVIEW
Definition
bull DfR is knowledge-based engineering wherein starting with capture of requirements and leading to assured reliability a reliability plan is designed and executed using the full skills and knowledge of the project team
bull The goal of DfR is to work smarter through knowledge-based tailoring of the reliability plan
2262014 Ops A La Carte copy 27
bull Making a list of all possible reliability activities and then trying to cover as many as possible within the timeframe of the product development process
bull Assuming that product reliability is the sole responsibility of a reliability engineer (reliability engineer is the guide and mentor but not the owner ndash designer should be the owner)
bull Getting the product into test as fast as possible to test reliability into the product (aka Test-Analyze-and-Fix)
bull Only working on the in-house design items and not worrying about vendor items
bull Working in silos between EE Mech E Software etc (even if they apply some or most of the DfR tools) ndash all competencies must work together to reach common goals
Is NOT
2262014 Ops A La Carte copy 28
IS
bull Identifying goals and requirements consistent with customer and business objectives
bull Applying knowledge-based management and engineering to define implement and improve plans to achieve goals and requirements
bull Providing clear metrics for review Reviewing and taking timely corrective action
bull Reviewing and knowledge-capture from all activities and outputs with goal of continuous improvement
bull DfR is the process of building reliability into the design with efficiency and assurance using the best science-based methods
2262014 Ops A La Carte copy 29
Flow
A detailed evaluation of an organizationrsquos approach and processes involved in creating reliable products The assessment captures the current state and leads to an actionable reliability program plan
bull Initiate a Reliability Programbull Determine next best stepsbull Reduce customer complaints bull Select right toolsbull Improve reliability
Now
Goal
$ unreliability
$ Profits
Assessment Interviews
StatisticalData Analysis
Benchmarking
Gap Analysis
Program Plan
complaints
fieldfailures
satisfaction
marketshare
Unknown Reliability
2262014 Ops A La Carte copy 30
Key Activities
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 31
DfR Key Activities
QFD Requirements definitions Benchmarking Product usage analysisUnderstanding of customer requirements and specifications
DFMEA Cost trade-off analysisLessons LearnedProbabilistic design Cost trade-offs Tolerance Analysis
FEA Warranty Data Analysis DRBFM Reliability predictionLessons Learned Reliability Block Diagrams
HASS Control Charts Re-validation Audits Look AcrossLessons Learned ORT
HALT Evaluation Testing DRBTRReliability Growth modeling Change Point Analysis
Design and Process ValidationAccelerated Test Reliability Demonstration
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 32
Key points for implementing DfR activities
bull Start DfR activities early in the process
bull Reliability engineerrsquos job is to leadcoach the design team Reliability achievement needs to be owned by design and manufacturing teams
bull Integration of Reliability and Quality Engineers with design teams
bull Warrantyfield data analysis (both statistical and root cause analysis) needs to be fed back to both design and reliability teams
bull Reduce the number of tools in the toolbox but use the remaining well Neither all steps nor tools are necessary for all the programs
2262014 Ops A La Carte copy 33
34
Reliability Before Design
SpendingRate
Qualification Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
Reliability Spend Rate
Traditional Reliability Model
35
Reliability Before Design
SpendingRate
Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Qualification
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
New Reliability Spend Rate
$ Savings $
Reliability Before Design
Design for Reliability Method
copy Ops A La Carte LLC 2012
copy 2009 Ops A La Carte
36
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte 37
DEVELOPING AN
EFFECTIVE
RELIABILITY TEST
STRATEGY
Steps to a Good Design
In order to write better test plans
1) Understand Requirements
2) Understand Use Environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform Design amp Design Reviews
6) Write Design Verification Test plan
7) Write Reliability Test Plan
Understanding Requirements
Inputs include
ndashSpecifications
bull MRD ndash Marketing Requirements Document
bull PRD ndash Product Requirements Document
ndashCompetitive Product Solutions
ndashLessons Learned
ndashConstraints
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
copy 2009 Ops A La Carte
14
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
Failure
Rate
Time
Quality Does
the product
work when the
customer first
receives it
first turns it on
Reliability How
often does the
product fail after
the customer
receives it
first turns it on
Reliability
How long does
the product
work until it
wears out
copy 2009 Ops A La Carte
16
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
Similarities and Differences
Between Regulatory Programs
and Reliability Programs
Food and Drug Administration FDA httpwwwfdagov
21 CFR Parts 808 812 and 820 Medical Devices Current Good
Manufacturing Practice (CGMP) Final Rule Page 2
SUPPLEMENTARY INFORMATION I Background (Design Controls)
ldquoSpecifically in January 1990 FDA published the results of an
evaluation of device recalls that occurred from October 1983 through
September 1989 in a report entitled lsquolsquoDevice Recalls A Study of Quality
Problemsrsquorsquo
FDA found that approximately 44 percent of the quality
problems that led to voluntary recall actions during this 6-
year period were attributed to errors or deficiencies that
were designed into particular devices and may have been
prevented by adequate design controls
Government Regulations
We have found that many medical companies confuse
reliability with compliance
Just because you follow the compliance regulations does
not guarantee you have a reliable product
In fact the new IEC 60601-1 3rd Edition document requires
that your testing be based on risks you discover during your
risk management process
In this presentation we will show you two different case
studies ndash one in which we met the basic reliability
requirements and a second in which we had a separate
reliability effort to address specific reliability risks
Reliability vs Compliance
bull RELIABILITY PROGRAM PLANWhich areas were the same
Which areas were new
Reliability allocations
Gap analysis
Reliability Tools Deployed General for all assemblies
Reliability Tools Deployed Specific to certain assys
How will tools be used
Metrics to be used during program
Reliability Reporting and Issues Management
Roles and Responsibilities
Reliability Deliverables
Contingency Planning
Ongoing Reliability Assurance
MEDICAL INFUSION PUMP
bull NEW ASSEMBLIES
Two new motors - one for the cassette insertion and removal and one for the air sensor to pinch the tubing in order to detect air bubbles in the line
A new power supply that was larger and also had a battery charging circuit for the new rechargeable battery
A touch screen
An IEEE 80211 wireless interface
A new rechargeable battery design
New software to handle all of these new features
MEDICAL INFUSION PUMP
bull IDENTIFY RELIABILITY RISKS
Using the Risk Analysis process we identified
as many new risks as possible
Then we set out to figure ways of mitigating
these risks
Design analysis techniques such as FEA DOE
and Thermal Analysis
Accelerated Testing techniques such as HALT
ALT and RDT
The important element here is that we always
had an eye on our goal
MEDICAL INFUSION PUMP
bull RELIABILITY TECHNIQUES USED
Motors ndash FEA ALT
Power Supply ndash HALT then RDT
Touch Screen ndash ALT Abuse Testing
Wireless Interface - HALT
Battery ndash Application Specific ALT
Software ndash Software FMEA Software
Use Case Testing
MEDICAL INFUSION PUMP
bull RESULTS
Using this process we saved time and money
We found out issues during the design
analysis that would have required a redesign
had we found them later in the design or
worse out in the field
We found out issues during the testing that
would have set our program back months
End result We developed and delivered a
very reliable product and got it to market
faster
MEDICAL INFUSION PUMP
copy 2009 Ops A La Carte
25
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte
26
DESIGN FOR
RELIABILITY (DFR)
OVERVIEW
Definition
bull DfR is knowledge-based engineering wherein starting with capture of requirements and leading to assured reliability a reliability plan is designed and executed using the full skills and knowledge of the project team
bull The goal of DfR is to work smarter through knowledge-based tailoring of the reliability plan
2262014 Ops A La Carte copy 27
bull Making a list of all possible reliability activities and then trying to cover as many as possible within the timeframe of the product development process
bull Assuming that product reliability is the sole responsibility of a reliability engineer (reliability engineer is the guide and mentor but not the owner ndash designer should be the owner)
bull Getting the product into test as fast as possible to test reliability into the product (aka Test-Analyze-and-Fix)
bull Only working on the in-house design items and not worrying about vendor items
bull Working in silos between EE Mech E Software etc (even if they apply some or most of the DfR tools) ndash all competencies must work together to reach common goals
Is NOT
2262014 Ops A La Carte copy 28
IS
bull Identifying goals and requirements consistent with customer and business objectives
bull Applying knowledge-based management and engineering to define implement and improve plans to achieve goals and requirements
bull Providing clear metrics for review Reviewing and taking timely corrective action
bull Reviewing and knowledge-capture from all activities and outputs with goal of continuous improvement
bull DfR is the process of building reliability into the design with efficiency and assurance using the best science-based methods
2262014 Ops A La Carte copy 29
Flow
A detailed evaluation of an organizationrsquos approach and processes involved in creating reliable products The assessment captures the current state and leads to an actionable reliability program plan
bull Initiate a Reliability Programbull Determine next best stepsbull Reduce customer complaints bull Select right toolsbull Improve reliability
Now
Goal
$ unreliability
$ Profits
Assessment Interviews
StatisticalData Analysis
Benchmarking
Gap Analysis
Program Plan
complaints
fieldfailures
satisfaction
marketshare
Unknown Reliability
2262014 Ops A La Carte copy 30
Key Activities
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 31
DfR Key Activities
QFD Requirements definitions Benchmarking Product usage analysisUnderstanding of customer requirements and specifications
DFMEA Cost trade-off analysisLessons LearnedProbabilistic design Cost trade-offs Tolerance Analysis
FEA Warranty Data Analysis DRBFM Reliability predictionLessons Learned Reliability Block Diagrams
HASS Control Charts Re-validation Audits Look AcrossLessons Learned ORT
HALT Evaluation Testing DRBTRReliability Growth modeling Change Point Analysis
Design and Process ValidationAccelerated Test Reliability Demonstration
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 32
Key points for implementing DfR activities
bull Start DfR activities early in the process
bull Reliability engineerrsquos job is to leadcoach the design team Reliability achievement needs to be owned by design and manufacturing teams
bull Integration of Reliability and Quality Engineers with design teams
bull Warrantyfield data analysis (both statistical and root cause analysis) needs to be fed back to both design and reliability teams
bull Reduce the number of tools in the toolbox but use the remaining well Neither all steps nor tools are necessary for all the programs
2262014 Ops A La Carte copy 33
34
Reliability Before Design
SpendingRate
Qualification Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
Reliability Spend Rate
Traditional Reliability Model
35
Reliability Before Design
SpendingRate
Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Qualification
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
New Reliability Spend Rate
$ Savings $
Reliability Before Design
Design for Reliability Method
copy Ops A La Carte LLC 2012
copy 2009 Ops A La Carte
36
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte 37
DEVELOPING AN
EFFECTIVE
RELIABILITY TEST
STRATEGY
Steps to a Good Design
In order to write better test plans
1) Understand Requirements
2) Understand Use Environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform Design amp Design Reviews
6) Write Design Verification Test plan
7) Write Reliability Test Plan
Understanding Requirements
Inputs include
ndashSpecifications
bull MRD ndash Marketing Requirements Document
bull PRD ndash Product Requirements Document
ndashCompetitive Product Solutions
ndashLessons Learned
ndashConstraints
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
Failure
Rate
Time
Quality Does
the product
work when the
customer first
receives it
first turns it on
Reliability How
often does the
product fail after
the customer
receives it
first turns it on
Reliability
How long does
the product
work until it
wears out
copy 2009 Ops A La Carte
16
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
Similarities and Differences
Between Regulatory Programs
and Reliability Programs
Food and Drug Administration FDA httpwwwfdagov
21 CFR Parts 808 812 and 820 Medical Devices Current Good
Manufacturing Practice (CGMP) Final Rule Page 2
SUPPLEMENTARY INFORMATION I Background (Design Controls)
ldquoSpecifically in January 1990 FDA published the results of an
evaluation of device recalls that occurred from October 1983 through
September 1989 in a report entitled lsquolsquoDevice Recalls A Study of Quality
Problemsrsquorsquo
FDA found that approximately 44 percent of the quality
problems that led to voluntary recall actions during this 6-
year period were attributed to errors or deficiencies that
were designed into particular devices and may have been
prevented by adequate design controls
Government Regulations
We have found that many medical companies confuse
reliability with compliance
Just because you follow the compliance regulations does
not guarantee you have a reliable product
In fact the new IEC 60601-1 3rd Edition document requires
that your testing be based on risks you discover during your
risk management process
In this presentation we will show you two different case
studies ndash one in which we met the basic reliability
requirements and a second in which we had a separate
reliability effort to address specific reliability risks
Reliability vs Compliance
bull RELIABILITY PROGRAM PLANWhich areas were the same
Which areas were new
Reliability allocations
Gap analysis
Reliability Tools Deployed General for all assemblies
Reliability Tools Deployed Specific to certain assys
How will tools be used
Metrics to be used during program
Reliability Reporting and Issues Management
Roles and Responsibilities
Reliability Deliverables
Contingency Planning
Ongoing Reliability Assurance
MEDICAL INFUSION PUMP
bull NEW ASSEMBLIES
Two new motors - one for the cassette insertion and removal and one for the air sensor to pinch the tubing in order to detect air bubbles in the line
A new power supply that was larger and also had a battery charging circuit for the new rechargeable battery
A touch screen
An IEEE 80211 wireless interface
A new rechargeable battery design
New software to handle all of these new features
MEDICAL INFUSION PUMP
bull IDENTIFY RELIABILITY RISKS
Using the Risk Analysis process we identified
as many new risks as possible
Then we set out to figure ways of mitigating
these risks
Design analysis techniques such as FEA DOE
and Thermal Analysis
Accelerated Testing techniques such as HALT
ALT and RDT
The important element here is that we always
had an eye on our goal
MEDICAL INFUSION PUMP
bull RELIABILITY TECHNIQUES USED
Motors ndash FEA ALT
Power Supply ndash HALT then RDT
Touch Screen ndash ALT Abuse Testing
Wireless Interface - HALT
Battery ndash Application Specific ALT
Software ndash Software FMEA Software
Use Case Testing
MEDICAL INFUSION PUMP
bull RESULTS
Using this process we saved time and money
We found out issues during the design
analysis that would have required a redesign
had we found them later in the design or
worse out in the field
We found out issues during the testing that
would have set our program back months
End result We developed and delivered a
very reliable product and got it to market
faster
MEDICAL INFUSION PUMP
copy 2009 Ops A La Carte
25
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte
26
DESIGN FOR
RELIABILITY (DFR)
OVERVIEW
Definition
bull DfR is knowledge-based engineering wherein starting with capture of requirements and leading to assured reliability a reliability plan is designed and executed using the full skills and knowledge of the project team
bull The goal of DfR is to work smarter through knowledge-based tailoring of the reliability plan
2262014 Ops A La Carte copy 27
bull Making a list of all possible reliability activities and then trying to cover as many as possible within the timeframe of the product development process
bull Assuming that product reliability is the sole responsibility of a reliability engineer (reliability engineer is the guide and mentor but not the owner ndash designer should be the owner)
bull Getting the product into test as fast as possible to test reliability into the product (aka Test-Analyze-and-Fix)
bull Only working on the in-house design items and not worrying about vendor items
bull Working in silos between EE Mech E Software etc (even if they apply some or most of the DfR tools) ndash all competencies must work together to reach common goals
Is NOT
2262014 Ops A La Carte copy 28
IS
bull Identifying goals and requirements consistent with customer and business objectives
bull Applying knowledge-based management and engineering to define implement and improve plans to achieve goals and requirements
bull Providing clear metrics for review Reviewing and taking timely corrective action
bull Reviewing and knowledge-capture from all activities and outputs with goal of continuous improvement
bull DfR is the process of building reliability into the design with efficiency and assurance using the best science-based methods
2262014 Ops A La Carte copy 29
Flow
A detailed evaluation of an organizationrsquos approach and processes involved in creating reliable products The assessment captures the current state and leads to an actionable reliability program plan
bull Initiate a Reliability Programbull Determine next best stepsbull Reduce customer complaints bull Select right toolsbull Improve reliability
Now
Goal
$ unreliability
$ Profits
Assessment Interviews
StatisticalData Analysis
Benchmarking
Gap Analysis
Program Plan
complaints
fieldfailures
satisfaction
marketshare
Unknown Reliability
2262014 Ops A La Carte copy 30
Key Activities
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 31
DfR Key Activities
QFD Requirements definitions Benchmarking Product usage analysisUnderstanding of customer requirements and specifications
DFMEA Cost trade-off analysisLessons LearnedProbabilistic design Cost trade-offs Tolerance Analysis
FEA Warranty Data Analysis DRBFM Reliability predictionLessons Learned Reliability Block Diagrams
HASS Control Charts Re-validation Audits Look AcrossLessons Learned ORT
HALT Evaluation Testing DRBTRReliability Growth modeling Change Point Analysis
Design and Process ValidationAccelerated Test Reliability Demonstration
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 32
Key points for implementing DfR activities
bull Start DfR activities early in the process
bull Reliability engineerrsquos job is to leadcoach the design team Reliability achievement needs to be owned by design and manufacturing teams
bull Integration of Reliability and Quality Engineers with design teams
bull Warrantyfield data analysis (both statistical and root cause analysis) needs to be fed back to both design and reliability teams
bull Reduce the number of tools in the toolbox but use the remaining well Neither all steps nor tools are necessary for all the programs
2262014 Ops A La Carte copy 33
34
Reliability Before Design
SpendingRate
Qualification Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
Reliability Spend Rate
Traditional Reliability Model
35
Reliability Before Design
SpendingRate
Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Qualification
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
New Reliability Spend Rate
$ Savings $
Reliability Before Design
Design for Reliability Method
copy Ops A La Carte LLC 2012
copy 2009 Ops A La Carte
36
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte 37
DEVELOPING AN
EFFECTIVE
RELIABILITY TEST
STRATEGY
Steps to a Good Design
In order to write better test plans
1) Understand Requirements
2) Understand Use Environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform Design amp Design Reviews
6) Write Design Verification Test plan
7) Write Reliability Test Plan
Understanding Requirements
Inputs include
ndashSpecifications
bull MRD ndash Marketing Requirements Document
bull PRD ndash Product Requirements Document
ndashCompetitive Product Solutions
ndashLessons Learned
ndashConstraints
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
copy 2009 Ops A La Carte
16
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
Similarities and Differences
Between Regulatory Programs
and Reliability Programs
Food and Drug Administration FDA httpwwwfdagov
21 CFR Parts 808 812 and 820 Medical Devices Current Good
Manufacturing Practice (CGMP) Final Rule Page 2
SUPPLEMENTARY INFORMATION I Background (Design Controls)
ldquoSpecifically in January 1990 FDA published the results of an
evaluation of device recalls that occurred from October 1983 through
September 1989 in a report entitled lsquolsquoDevice Recalls A Study of Quality
Problemsrsquorsquo
FDA found that approximately 44 percent of the quality
problems that led to voluntary recall actions during this 6-
year period were attributed to errors or deficiencies that
were designed into particular devices and may have been
prevented by adequate design controls
Government Regulations
We have found that many medical companies confuse
reliability with compliance
Just because you follow the compliance regulations does
not guarantee you have a reliable product
In fact the new IEC 60601-1 3rd Edition document requires
that your testing be based on risks you discover during your
risk management process
In this presentation we will show you two different case
studies ndash one in which we met the basic reliability
requirements and a second in which we had a separate
reliability effort to address specific reliability risks
Reliability vs Compliance
bull RELIABILITY PROGRAM PLANWhich areas were the same
Which areas were new
Reliability allocations
Gap analysis
Reliability Tools Deployed General for all assemblies
Reliability Tools Deployed Specific to certain assys
How will tools be used
Metrics to be used during program
Reliability Reporting and Issues Management
Roles and Responsibilities
Reliability Deliverables
Contingency Planning
Ongoing Reliability Assurance
MEDICAL INFUSION PUMP
bull NEW ASSEMBLIES
Two new motors - one for the cassette insertion and removal and one for the air sensor to pinch the tubing in order to detect air bubbles in the line
A new power supply that was larger and also had a battery charging circuit for the new rechargeable battery
A touch screen
An IEEE 80211 wireless interface
A new rechargeable battery design
New software to handle all of these new features
MEDICAL INFUSION PUMP
bull IDENTIFY RELIABILITY RISKS
Using the Risk Analysis process we identified
as many new risks as possible
Then we set out to figure ways of mitigating
these risks
Design analysis techniques such as FEA DOE
and Thermal Analysis
Accelerated Testing techniques such as HALT
ALT and RDT
The important element here is that we always
had an eye on our goal
MEDICAL INFUSION PUMP
bull RELIABILITY TECHNIQUES USED
Motors ndash FEA ALT
Power Supply ndash HALT then RDT
Touch Screen ndash ALT Abuse Testing
Wireless Interface - HALT
Battery ndash Application Specific ALT
Software ndash Software FMEA Software
Use Case Testing
MEDICAL INFUSION PUMP
bull RESULTS
Using this process we saved time and money
We found out issues during the design
analysis that would have required a redesign
had we found them later in the design or
worse out in the field
We found out issues during the testing that
would have set our program back months
End result We developed and delivered a
very reliable product and got it to market
faster
MEDICAL INFUSION PUMP
copy 2009 Ops A La Carte
25
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte
26
DESIGN FOR
RELIABILITY (DFR)
OVERVIEW
Definition
bull DfR is knowledge-based engineering wherein starting with capture of requirements and leading to assured reliability a reliability plan is designed and executed using the full skills and knowledge of the project team
bull The goal of DfR is to work smarter through knowledge-based tailoring of the reliability plan
2262014 Ops A La Carte copy 27
bull Making a list of all possible reliability activities and then trying to cover as many as possible within the timeframe of the product development process
bull Assuming that product reliability is the sole responsibility of a reliability engineer (reliability engineer is the guide and mentor but not the owner ndash designer should be the owner)
bull Getting the product into test as fast as possible to test reliability into the product (aka Test-Analyze-and-Fix)
bull Only working on the in-house design items and not worrying about vendor items
bull Working in silos between EE Mech E Software etc (even if they apply some or most of the DfR tools) ndash all competencies must work together to reach common goals
Is NOT
2262014 Ops A La Carte copy 28
IS
bull Identifying goals and requirements consistent with customer and business objectives
bull Applying knowledge-based management and engineering to define implement and improve plans to achieve goals and requirements
bull Providing clear metrics for review Reviewing and taking timely corrective action
bull Reviewing and knowledge-capture from all activities and outputs with goal of continuous improvement
bull DfR is the process of building reliability into the design with efficiency and assurance using the best science-based methods
2262014 Ops A La Carte copy 29
Flow
A detailed evaluation of an organizationrsquos approach and processes involved in creating reliable products The assessment captures the current state and leads to an actionable reliability program plan
bull Initiate a Reliability Programbull Determine next best stepsbull Reduce customer complaints bull Select right toolsbull Improve reliability
Now
Goal
$ unreliability
$ Profits
Assessment Interviews
StatisticalData Analysis
Benchmarking
Gap Analysis
Program Plan
complaints
fieldfailures
satisfaction
marketshare
Unknown Reliability
2262014 Ops A La Carte copy 30
Key Activities
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 31
DfR Key Activities
QFD Requirements definitions Benchmarking Product usage analysisUnderstanding of customer requirements and specifications
DFMEA Cost trade-off analysisLessons LearnedProbabilistic design Cost trade-offs Tolerance Analysis
FEA Warranty Data Analysis DRBFM Reliability predictionLessons Learned Reliability Block Diagrams
HASS Control Charts Re-validation Audits Look AcrossLessons Learned ORT
HALT Evaluation Testing DRBTRReliability Growth modeling Change Point Analysis
Design and Process ValidationAccelerated Test Reliability Demonstration
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 32
Key points for implementing DfR activities
bull Start DfR activities early in the process
bull Reliability engineerrsquos job is to leadcoach the design team Reliability achievement needs to be owned by design and manufacturing teams
bull Integration of Reliability and Quality Engineers with design teams
bull Warrantyfield data analysis (both statistical and root cause analysis) needs to be fed back to both design and reliability teams
bull Reduce the number of tools in the toolbox but use the remaining well Neither all steps nor tools are necessary for all the programs
2262014 Ops A La Carte copy 33
34
Reliability Before Design
SpendingRate
Qualification Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
Reliability Spend Rate
Traditional Reliability Model
35
Reliability Before Design
SpendingRate
Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Qualification
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
New Reliability Spend Rate
$ Savings $
Reliability Before Design
Design for Reliability Method
copy Ops A La Carte LLC 2012
copy 2009 Ops A La Carte
36
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte 37
DEVELOPING AN
EFFECTIVE
RELIABILITY TEST
STRATEGY
Steps to a Good Design
In order to write better test plans
1) Understand Requirements
2) Understand Use Environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform Design amp Design Reviews
6) Write Design Verification Test plan
7) Write Reliability Test Plan
Understanding Requirements
Inputs include
ndashSpecifications
bull MRD ndash Marketing Requirements Document
bull PRD ndash Product Requirements Document
ndashCompetitive Product Solutions
ndashLessons Learned
ndashConstraints
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
Similarities and Differences
Between Regulatory Programs
and Reliability Programs
Food and Drug Administration FDA httpwwwfdagov
21 CFR Parts 808 812 and 820 Medical Devices Current Good
Manufacturing Practice (CGMP) Final Rule Page 2
SUPPLEMENTARY INFORMATION I Background (Design Controls)
ldquoSpecifically in January 1990 FDA published the results of an
evaluation of device recalls that occurred from October 1983 through
September 1989 in a report entitled lsquolsquoDevice Recalls A Study of Quality
Problemsrsquorsquo
FDA found that approximately 44 percent of the quality
problems that led to voluntary recall actions during this 6-
year period were attributed to errors or deficiencies that
were designed into particular devices and may have been
prevented by adequate design controls
Government Regulations
We have found that many medical companies confuse
reliability with compliance
Just because you follow the compliance regulations does
not guarantee you have a reliable product
In fact the new IEC 60601-1 3rd Edition document requires
that your testing be based on risks you discover during your
risk management process
In this presentation we will show you two different case
studies ndash one in which we met the basic reliability
requirements and a second in which we had a separate
reliability effort to address specific reliability risks
Reliability vs Compliance
bull RELIABILITY PROGRAM PLANWhich areas were the same
Which areas were new
Reliability allocations
Gap analysis
Reliability Tools Deployed General for all assemblies
Reliability Tools Deployed Specific to certain assys
How will tools be used
Metrics to be used during program
Reliability Reporting and Issues Management
Roles and Responsibilities
Reliability Deliverables
Contingency Planning
Ongoing Reliability Assurance
MEDICAL INFUSION PUMP
bull NEW ASSEMBLIES
Two new motors - one for the cassette insertion and removal and one for the air sensor to pinch the tubing in order to detect air bubbles in the line
A new power supply that was larger and also had a battery charging circuit for the new rechargeable battery
A touch screen
An IEEE 80211 wireless interface
A new rechargeable battery design
New software to handle all of these new features
MEDICAL INFUSION PUMP
bull IDENTIFY RELIABILITY RISKS
Using the Risk Analysis process we identified
as many new risks as possible
Then we set out to figure ways of mitigating
these risks
Design analysis techniques such as FEA DOE
and Thermal Analysis
Accelerated Testing techniques such as HALT
ALT and RDT
The important element here is that we always
had an eye on our goal
MEDICAL INFUSION PUMP
bull RELIABILITY TECHNIQUES USED
Motors ndash FEA ALT
Power Supply ndash HALT then RDT
Touch Screen ndash ALT Abuse Testing
Wireless Interface - HALT
Battery ndash Application Specific ALT
Software ndash Software FMEA Software
Use Case Testing
MEDICAL INFUSION PUMP
bull RESULTS
Using this process we saved time and money
We found out issues during the design
analysis that would have required a redesign
had we found them later in the design or
worse out in the field
We found out issues during the testing that
would have set our program back months
End result We developed and delivered a
very reliable product and got it to market
faster
MEDICAL INFUSION PUMP
copy 2009 Ops A La Carte
25
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte
26
DESIGN FOR
RELIABILITY (DFR)
OVERVIEW
Definition
bull DfR is knowledge-based engineering wherein starting with capture of requirements and leading to assured reliability a reliability plan is designed and executed using the full skills and knowledge of the project team
bull The goal of DfR is to work smarter through knowledge-based tailoring of the reliability plan
2262014 Ops A La Carte copy 27
bull Making a list of all possible reliability activities and then trying to cover as many as possible within the timeframe of the product development process
bull Assuming that product reliability is the sole responsibility of a reliability engineer (reliability engineer is the guide and mentor but not the owner ndash designer should be the owner)
bull Getting the product into test as fast as possible to test reliability into the product (aka Test-Analyze-and-Fix)
bull Only working on the in-house design items and not worrying about vendor items
bull Working in silos between EE Mech E Software etc (even if they apply some or most of the DfR tools) ndash all competencies must work together to reach common goals
Is NOT
2262014 Ops A La Carte copy 28
IS
bull Identifying goals and requirements consistent with customer and business objectives
bull Applying knowledge-based management and engineering to define implement and improve plans to achieve goals and requirements
bull Providing clear metrics for review Reviewing and taking timely corrective action
bull Reviewing and knowledge-capture from all activities and outputs with goal of continuous improvement
bull DfR is the process of building reliability into the design with efficiency and assurance using the best science-based methods
2262014 Ops A La Carte copy 29
Flow
A detailed evaluation of an organizationrsquos approach and processes involved in creating reliable products The assessment captures the current state and leads to an actionable reliability program plan
bull Initiate a Reliability Programbull Determine next best stepsbull Reduce customer complaints bull Select right toolsbull Improve reliability
Now
Goal
$ unreliability
$ Profits
Assessment Interviews
StatisticalData Analysis
Benchmarking
Gap Analysis
Program Plan
complaints
fieldfailures
satisfaction
marketshare
Unknown Reliability
2262014 Ops A La Carte copy 30
Key Activities
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 31
DfR Key Activities
QFD Requirements definitions Benchmarking Product usage analysisUnderstanding of customer requirements and specifications
DFMEA Cost trade-off analysisLessons LearnedProbabilistic design Cost trade-offs Tolerance Analysis
FEA Warranty Data Analysis DRBFM Reliability predictionLessons Learned Reliability Block Diagrams
HASS Control Charts Re-validation Audits Look AcrossLessons Learned ORT
HALT Evaluation Testing DRBTRReliability Growth modeling Change Point Analysis
Design and Process ValidationAccelerated Test Reliability Demonstration
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 32
Key points for implementing DfR activities
bull Start DfR activities early in the process
bull Reliability engineerrsquos job is to leadcoach the design team Reliability achievement needs to be owned by design and manufacturing teams
bull Integration of Reliability and Quality Engineers with design teams
bull Warrantyfield data analysis (both statistical and root cause analysis) needs to be fed back to both design and reliability teams
bull Reduce the number of tools in the toolbox but use the remaining well Neither all steps nor tools are necessary for all the programs
2262014 Ops A La Carte copy 33
34
Reliability Before Design
SpendingRate
Qualification Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
Reliability Spend Rate
Traditional Reliability Model
35
Reliability Before Design
SpendingRate
Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Qualification
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
New Reliability Spend Rate
$ Savings $
Reliability Before Design
Design for Reliability Method
copy Ops A La Carte LLC 2012
copy 2009 Ops A La Carte
36
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte 37
DEVELOPING AN
EFFECTIVE
RELIABILITY TEST
STRATEGY
Steps to a Good Design
In order to write better test plans
1) Understand Requirements
2) Understand Use Environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform Design amp Design Reviews
6) Write Design Verification Test plan
7) Write Reliability Test Plan
Understanding Requirements
Inputs include
ndashSpecifications
bull MRD ndash Marketing Requirements Document
bull PRD ndash Product Requirements Document
ndashCompetitive Product Solutions
ndashLessons Learned
ndashConstraints
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
Food and Drug Administration FDA httpwwwfdagov
21 CFR Parts 808 812 and 820 Medical Devices Current Good
Manufacturing Practice (CGMP) Final Rule Page 2
SUPPLEMENTARY INFORMATION I Background (Design Controls)
ldquoSpecifically in January 1990 FDA published the results of an
evaluation of device recalls that occurred from October 1983 through
September 1989 in a report entitled lsquolsquoDevice Recalls A Study of Quality
Problemsrsquorsquo
FDA found that approximately 44 percent of the quality
problems that led to voluntary recall actions during this 6-
year period were attributed to errors or deficiencies that
were designed into particular devices and may have been
prevented by adequate design controls
Government Regulations
We have found that many medical companies confuse
reliability with compliance
Just because you follow the compliance regulations does
not guarantee you have a reliable product
In fact the new IEC 60601-1 3rd Edition document requires
that your testing be based on risks you discover during your
risk management process
In this presentation we will show you two different case
studies ndash one in which we met the basic reliability
requirements and a second in which we had a separate
reliability effort to address specific reliability risks
Reliability vs Compliance
bull RELIABILITY PROGRAM PLANWhich areas were the same
Which areas were new
Reliability allocations
Gap analysis
Reliability Tools Deployed General for all assemblies
Reliability Tools Deployed Specific to certain assys
How will tools be used
Metrics to be used during program
Reliability Reporting and Issues Management
Roles and Responsibilities
Reliability Deliverables
Contingency Planning
Ongoing Reliability Assurance
MEDICAL INFUSION PUMP
bull NEW ASSEMBLIES
Two new motors - one for the cassette insertion and removal and one for the air sensor to pinch the tubing in order to detect air bubbles in the line
A new power supply that was larger and also had a battery charging circuit for the new rechargeable battery
A touch screen
An IEEE 80211 wireless interface
A new rechargeable battery design
New software to handle all of these new features
MEDICAL INFUSION PUMP
bull IDENTIFY RELIABILITY RISKS
Using the Risk Analysis process we identified
as many new risks as possible
Then we set out to figure ways of mitigating
these risks
Design analysis techniques such as FEA DOE
and Thermal Analysis
Accelerated Testing techniques such as HALT
ALT and RDT
The important element here is that we always
had an eye on our goal
MEDICAL INFUSION PUMP
bull RELIABILITY TECHNIQUES USED
Motors ndash FEA ALT
Power Supply ndash HALT then RDT
Touch Screen ndash ALT Abuse Testing
Wireless Interface - HALT
Battery ndash Application Specific ALT
Software ndash Software FMEA Software
Use Case Testing
MEDICAL INFUSION PUMP
bull RESULTS
Using this process we saved time and money
We found out issues during the design
analysis that would have required a redesign
had we found them later in the design or
worse out in the field
We found out issues during the testing that
would have set our program back months
End result We developed and delivered a
very reliable product and got it to market
faster
MEDICAL INFUSION PUMP
copy 2009 Ops A La Carte
25
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte
26
DESIGN FOR
RELIABILITY (DFR)
OVERVIEW
Definition
bull DfR is knowledge-based engineering wherein starting with capture of requirements and leading to assured reliability a reliability plan is designed and executed using the full skills and knowledge of the project team
bull The goal of DfR is to work smarter through knowledge-based tailoring of the reliability plan
2262014 Ops A La Carte copy 27
bull Making a list of all possible reliability activities and then trying to cover as many as possible within the timeframe of the product development process
bull Assuming that product reliability is the sole responsibility of a reliability engineer (reliability engineer is the guide and mentor but not the owner ndash designer should be the owner)
bull Getting the product into test as fast as possible to test reliability into the product (aka Test-Analyze-and-Fix)
bull Only working on the in-house design items and not worrying about vendor items
bull Working in silos between EE Mech E Software etc (even if they apply some or most of the DfR tools) ndash all competencies must work together to reach common goals
Is NOT
2262014 Ops A La Carte copy 28
IS
bull Identifying goals and requirements consistent with customer and business objectives
bull Applying knowledge-based management and engineering to define implement and improve plans to achieve goals and requirements
bull Providing clear metrics for review Reviewing and taking timely corrective action
bull Reviewing and knowledge-capture from all activities and outputs with goal of continuous improvement
bull DfR is the process of building reliability into the design with efficiency and assurance using the best science-based methods
2262014 Ops A La Carte copy 29
Flow
A detailed evaluation of an organizationrsquos approach and processes involved in creating reliable products The assessment captures the current state and leads to an actionable reliability program plan
bull Initiate a Reliability Programbull Determine next best stepsbull Reduce customer complaints bull Select right toolsbull Improve reliability
Now
Goal
$ unreliability
$ Profits
Assessment Interviews
StatisticalData Analysis
Benchmarking
Gap Analysis
Program Plan
complaints
fieldfailures
satisfaction
marketshare
Unknown Reliability
2262014 Ops A La Carte copy 30
Key Activities
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 31
DfR Key Activities
QFD Requirements definitions Benchmarking Product usage analysisUnderstanding of customer requirements and specifications
DFMEA Cost trade-off analysisLessons LearnedProbabilistic design Cost trade-offs Tolerance Analysis
FEA Warranty Data Analysis DRBFM Reliability predictionLessons Learned Reliability Block Diagrams
HASS Control Charts Re-validation Audits Look AcrossLessons Learned ORT
HALT Evaluation Testing DRBTRReliability Growth modeling Change Point Analysis
Design and Process ValidationAccelerated Test Reliability Demonstration
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 32
Key points for implementing DfR activities
bull Start DfR activities early in the process
bull Reliability engineerrsquos job is to leadcoach the design team Reliability achievement needs to be owned by design and manufacturing teams
bull Integration of Reliability and Quality Engineers with design teams
bull Warrantyfield data analysis (both statistical and root cause analysis) needs to be fed back to both design and reliability teams
bull Reduce the number of tools in the toolbox but use the remaining well Neither all steps nor tools are necessary for all the programs
2262014 Ops A La Carte copy 33
34
Reliability Before Design
SpendingRate
Qualification Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
Reliability Spend Rate
Traditional Reliability Model
35
Reliability Before Design
SpendingRate
Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Qualification
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
New Reliability Spend Rate
$ Savings $
Reliability Before Design
Design for Reliability Method
copy Ops A La Carte LLC 2012
copy 2009 Ops A La Carte
36
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte 37
DEVELOPING AN
EFFECTIVE
RELIABILITY TEST
STRATEGY
Steps to a Good Design
In order to write better test plans
1) Understand Requirements
2) Understand Use Environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform Design amp Design Reviews
6) Write Design Verification Test plan
7) Write Reliability Test Plan
Understanding Requirements
Inputs include
ndashSpecifications
bull MRD ndash Marketing Requirements Document
bull PRD ndash Product Requirements Document
ndashCompetitive Product Solutions
ndashLessons Learned
ndashConstraints
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
We have found that many medical companies confuse
reliability with compliance
Just because you follow the compliance regulations does
not guarantee you have a reliable product
In fact the new IEC 60601-1 3rd Edition document requires
that your testing be based on risks you discover during your
risk management process
In this presentation we will show you two different case
studies ndash one in which we met the basic reliability
requirements and a second in which we had a separate
reliability effort to address specific reliability risks
Reliability vs Compliance
bull RELIABILITY PROGRAM PLANWhich areas were the same
Which areas were new
Reliability allocations
Gap analysis
Reliability Tools Deployed General for all assemblies
Reliability Tools Deployed Specific to certain assys
How will tools be used
Metrics to be used during program
Reliability Reporting and Issues Management
Roles and Responsibilities
Reliability Deliverables
Contingency Planning
Ongoing Reliability Assurance
MEDICAL INFUSION PUMP
bull NEW ASSEMBLIES
Two new motors - one for the cassette insertion and removal and one for the air sensor to pinch the tubing in order to detect air bubbles in the line
A new power supply that was larger and also had a battery charging circuit for the new rechargeable battery
A touch screen
An IEEE 80211 wireless interface
A new rechargeable battery design
New software to handle all of these new features
MEDICAL INFUSION PUMP
bull IDENTIFY RELIABILITY RISKS
Using the Risk Analysis process we identified
as many new risks as possible
Then we set out to figure ways of mitigating
these risks
Design analysis techniques such as FEA DOE
and Thermal Analysis
Accelerated Testing techniques such as HALT
ALT and RDT
The important element here is that we always
had an eye on our goal
MEDICAL INFUSION PUMP
bull RELIABILITY TECHNIQUES USED
Motors ndash FEA ALT
Power Supply ndash HALT then RDT
Touch Screen ndash ALT Abuse Testing
Wireless Interface - HALT
Battery ndash Application Specific ALT
Software ndash Software FMEA Software
Use Case Testing
MEDICAL INFUSION PUMP
bull RESULTS
Using this process we saved time and money
We found out issues during the design
analysis that would have required a redesign
had we found them later in the design or
worse out in the field
We found out issues during the testing that
would have set our program back months
End result We developed and delivered a
very reliable product and got it to market
faster
MEDICAL INFUSION PUMP
copy 2009 Ops A La Carte
25
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte
26
DESIGN FOR
RELIABILITY (DFR)
OVERVIEW
Definition
bull DfR is knowledge-based engineering wherein starting with capture of requirements and leading to assured reliability a reliability plan is designed and executed using the full skills and knowledge of the project team
bull The goal of DfR is to work smarter through knowledge-based tailoring of the reliability plan
2262014 Ops A La Carte copy 27
bull Making a list of all possible reliability activities and then trying to cover as many as possible within the timeframe of the product development process
bull Assuming that product reliability is the sole responsibility of a reliability engineer (reliability engineer is the guide and mentor but not the owner ndash designer should be the owner)
bull Getting the product into test as fast as possible to test reliability into the product (aka Test-Analyze-and-Fix)
bull Only working on the in-house design items and not worrying about vendor items
bull Working in silos between EE Mech E Software etc (even if they apply some or most of the DfR tools) ndash all competencies must work together to reach common goals
Is NOT
2262014 Ops A La Carte copy 28
IS
bull Identifying goals and requirements consistent with customer and business objectives
bull Applying knowledge-based management and engineering to define implement and improve plans to achieve goals and requirements
bull Providing clear metrics for review Reviewing and taking timely corrective action
bull Reviewing and knowledge-capture from all activities and outputs with goal of continuous improvement
bull DfR is the process of building reliability into the design with efficiency and assurance using the best science-based methods
2262014 Ops A La Carte copy 29
Flow
A detailed evaluation of an organizationrsquos approach and processes involved in creating reliable products The assessment captures the current state and leads to an actionable reliability program plan
bull Initiate a Reliability Programbull Determine next best stepsbull Reduce customer complaints bull Select right toolsbull Improve reliability
Now
Goal
$ unreliability
$ Profits
Assessment Interviews
StatisticalData Analysis
Benchmarking
Gap Analysis
Program Plan
complaints
fieldfailures
satisfaction
marketshare
Unknown Reliability
2262014 Ops A La Carte copy 30
Key Activities
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 31
DfR Key Activities
QFD Requirements definitions Benchmarking Product usage analysisUnderstanding of customer requirements and specifications
DFMEA Cost trade-off analysisLessons LearnedProbabilistic design Cost trade-offs Tolerance Analysis
FEA Warranty Data Analysis DRBFM Reliability predictionLessons Learned Reliability Block Diagrams
HASS Control Charts Re-validation Audits Look AcrossLessons Learned ORT
HALT Evaluation Testing DRBTRReliability Growth modeling Change Point Analysis
Design and Process ValidationAccelerated Test Reliability Demonstration
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 32
Key points for implementing DfR activities
bull Start DfR activities early in the process
bull Reliability engineerrsquos job is to leadcoach the design team Reliability achievement needs to be owned by design and manufacturing teams
bull Integration of Reliability and Quality Engineers with design teams
bull Warrantyfield data analysis (both statistical and root cause analysis) needs to be fed back to both design and reliability teams
bull Reduce the number of tools in the toolbox but use the remaining well Neither all steps nor tools are necessary for all the programs
2262014 Ops A La Carte copy 33
34
Reliability Before Design
SpendingRate
Qualification Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
Reliability Spend Rate
Traditional Reliability Model
35
Reliability Before Design
SpendingRate
Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Qualification
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
New Reliability Spend Rate
$ Savings $
Reliability Before Design
Design for Reliability Method
copy Ops A La Carte LLC 2012
copy 2009 Ops A La Carte
36
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte 37
DEVELOPING AN
EFFECTIVE
RELIABILITY TEST
STRATEGY
Steps to a Good Design
In order to write better test plans
1) Understand Requirements
2) Understand Use Environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform Design amp Design Reviews
6) Write Design Verification Test plan
7) Write Reliability Test Plan
Understanding Requirements
Inputs include
ndashSpecifications
bull MRD ndash Marketing Requirements Document
bull PRD ndash Product Requirements Document
ndashCompetitive Product Solutions
ndashLessons Learned
ndashConstraints
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
bull RELIABILITY PROGRAM PLANWhich areas were the same
Which areas were new
Reliability allocations
Gap analysis
Reliability Tools Deployed General for all assemblies
Reliability Tools Deployed Specific to certain assys
How will tools be used
Metrics to be used during program
Reliability Reporting and Issues Management
Roles and Responsibilities
Reliability Deliverables
Contingency Planning
Ongoing Reliability Assurance
MEDICAL INFUSION PUMP
bull NEW ASSEMBLIES
Two new motors - one for the cassette insertion and removal and one for the air sensor to pinch the tubing in order to detect air bubbles in the line
A new power supply that was larger and also had a battery charging circuit for the new rechargeable battery
A touch screen
An IEEE 80211 wireless interface
A new rechargeable battery design
New software to handle all of these new features
MEDICAL INFUSION PUMP
bull IDENTIFY RELIABILITY RISKS
Using the Risk Analysis process we identified
as many new risks as possible
Then we set out to figure ways of mitigating
these risks
Design analysis techniques such as FEA DOE
and Thermal Analysis
Accelerated Testing techniques such as HALT
ALT and RDT
The important element here is that we always
had an eye on our goal
MEDICAL INFUSION PUMP
bull RELIABILITY TECHNIQUES USED
Motors ndash FEA ALT
Power Supply ndash HALT then RDT
Touch Screen ndash ALT Abuse Testing
Wireless Interface - HALT
Battery ndash Application Specific ALT
Software ndash Software FMEA Software
Use Case Testing
MEDICAL INFUSION PUMP
bull RESULTS
Using this process we saved time and money
We found out issues during the design
analysis that would have required a redesign
had we found them later in the design or
worse out in the field
We found out issues during the testing that
would have set our program back months
End result We developed and delivered a
very reliable product and got it to market
faster
MEDICAL INFUSION PUMP
copy 2009 Ops A La Carte
25
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte
26
DESIGN FOR
RELIABILITY (DFR)
OVERVIEW
Definition
bull DfR is knowledge-based engineering wherein starting with capture of requirements and leading to assured reliability a reliability plan is designed and executed using the full skills and knowledge of the project team
bull The goal of DfR is to work smarter through knowledge-based tailoring of the reliability plan
2262014 Ops A La Carte copy 27
bull Making a list of all possible reliability activities and then trying to cover as many as possible within the timeframe of the product development process
bull Assuming that product reliability is the sole responsibility of a reliability engineer (reliability engineer is the guide and mentor but not the owner ndash designer should be the owner)
bull Getting the product into test as fast as possible to test reliability into the product (aka Test-Analyze-and-Fix)
bull Only working on the in-house design items and not worrying about vendor items
bull Working in silos between EE Mech E Software etc (even if they apply some or most of the DfR tools) ndash all competencies must work together to reach common goals
Is NOT
2262014 Ops A La Carte copy 28
IS
bull Identifying goals and requirements consistent with customer and business objectives
bull Applying knowledge-based management and engineering to define implement and improve plans to achieve goals and requirements
bull Providing clear metrics for review Reviewing and taking timely corrective action
bull Reviewing and knowledge-capture from all activities and outputs with goal of continuous improvement
bull DfR is the process of building reliability into the design with efficiency and assurance using the best science-based methods
2262014 Ops A La Carte copy 29
Flow
A detailed evaluation of an organizationrsquos approach and processes involved in creating reliable products The assessment captures the current state and leads to an actionable reliability program plan
bull Initiate a Reliability Programbull Determine next best stepsbull Reduce customer complaints bull Select right toolsbull Improve reliability
Now
Goal
$ unreliability
$ Profits
Assessment Interviews
StatisticalData Analysis
Benchmarking
Gap Analysis
Program Plan
complaints
fieldfailures
satisfaction
marketshare
Unknown Reliability
2262014 Ops A La Carte copy 30
Key Activities
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 31
DfR Key Activities
QFD Requirements definitions Benchmarking Product usage analysisUnderstanding of customer requirements and specifications
DFMEA Cost trade-off analysisLessons LearnedProbabilistic design Cost trade-offs Tolerance Analysis
FEA Warranty Data Analysis DRBFM Reliability predictionLessons Learned Reliability Block Diagrams
HASS Control Charts Re-validation Audits Look AcrossLessons Learned ORT
HALT Evaluation Testing DRBTRReliability Growth modeling Change Point Analysis
Design and Process ValidationAccelerated Test Reliability Demonstration
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 32
Key points for implementing DfR activities
bull Start DfR activities early in the process
bull Reliability engineerrsquos job is to leadcoach the design team Reliability achievement needs to be owned by design and manufacturing teams
bull Integration of Reliability and Quality Engineers with design teams
bull Warrantyfield data analysis (both statistical and root cause analysis) needs to be fed back to both design and reliability teams
bull Reduce the number of tools in the toolbox but use the remaining well Neither all steps nor tools are necessary for all the programs
2262014 Ops A La Carte copy 33
34
Reliability Before Design
SpendingRate
Qualification Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
Reliability Spend Rate
Traditional Reliability Model
35
Reliability Before Design
SpendingRate
Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Qualification
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
New Reliability Spend Rate
$ Savings $
Reliability Before Design
Design for Reliability Method
copy Ops A La Carte LLC 2012
copy 2009 Ops A La Carte
36
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte 37
DEVELOPING AN
EFFECTIVE
RELIABILITY TEST
STRATEGY
Steps to a Good Design
In order to write better test plans
1) Understand Requirements
2) Understand Use Environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform Design amp Design Reviews
6) Write Design Verification Test plan
7) Write Reliability Test Plan
Understanding Requirements
Inputs include
ndashSpecifications
bull MRD ndash Marketing Requirements Document
bull PRD ndash Product Requirements Document
ndashCompetitive Product Solutions
ndashLessons Learned
ndashConstraints
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
bull NEW ASSEMBLIES
Two new motors - one for the cassette insertion and removal and one for the air sensor to pinch the tubing in order to detect air bubbles in the line
A new power supply that was larger and also had a battery charging circuit for the new rechargeable battery
A touch screen
An IEEE 80211 wireless interface
A new rechargeable battery design
New software to handle all of these new features
MEDICAL INFUSION PUMP
bull IDENTIFY RELIABILITY RISKS
Using the Risk Analysis process we identified
as many new risks as possible
Then we set out to figure ways of mitigating
these risks
Design analysis techniques such as FEA DOE
and Thermal Analysis
Accelerated Testing techniques such as HALT
ALT and RDT
The important element here is that we always
had an eye on our goal
MEDICAL INFUSION PUMP
bull RELIABILITY TECHNIQUES USED
Motors ndash FEA ALT
Power Supply ndash HALT then RDT
Touch Screen ndash ALT Abuse Testing
Wireless Interface - HALT
Battery ndash Application Specific ALT
Software ndash Software FMEA Software
Use Case Testing
MEDICAL INFUSION PUMP
bull RESULTS
Using this process we saved time and money
We found out issues during the design
analysis that would have required a redesign
had we found them later in the design or
worse out in the field
We found out issues during the testing that
would have set our program back months
End result We developed and delivered a
very reliable product and got it to market
faster
MEDICAL INFUSION PUMP
copy 2009 Ops A La Carte
25
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte
26
DESIGN FOR
RELIABILITY (DFR)
OVERVIEW
Definition
bull DfR is knowledge-based engineering wherein starting with capture of requirements and leading to assured reliability a reliability plan is designed and executed using the full skills and knowledge of the project team
bull The goal of DfR is to work smarter through knowledge-based tailoring of the reliability plan
2262014 Ops A La Carte copy 27
bull Making a list of all possible reliability activities and then trying to cover as many as possible within the timeframe of the product development process
bull Assuming that product reliability is the sole responsibility of a reliability engineer (reliability engineer is the guide and mentor but not the owner ndash designer should be the owner)
bull Getting the product into test as fast as possible to test reliability into the product (aka Test-Analyze-and-Fix)
bull Only working on the in-house design items and not worrying about vendor items
bull Working in silos between EE Mech E Software etc (even if they apply some or most of the DfR tools) ndash all competencies must work together to reach common goals
Is NOT
2262014 Ops A La Carte copy 28
IS
bull Identifying goals and requirements consistent with customer and business objectives
bull Applying knowledge-based management and engineering to define implement and improve plans to achieve goals and requirements
bull Providing clear metrics for review Reviewing and taking timely corrective action
bull Reviewing and knowledge-capture from all activities and outputs with goal of continuous improvement
bull DfR is the process of building reliability into the design with efficiency and assurance using the best science-based methods
2262014 Ops A La Carte copy 29
Flow
A detailed evaluation of an organizationrsquos approach and processes involved in creating reliable products The assessment captures the current state and leads to an actionable reliability program plan
bull Initiate a Reliability Programbull Determine next best stepsbull Reduce customer complaints bull Select right toolsbull Improve reliability
Now
Goal
$ unreliability
$ Profits
Assessment Interviews
StatisticalData Analysis
Benchmarking
Gap Analysis
Program Plan
complaints
fieldfailures
satisfaction
marketshare
Unknown Reliability
2262014 Ops A La Carte copy 30
Key Activities
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 31
DfR Key Activities
QFD Requirements definitions Benchmarking Product usage analysisUnderstanding of customer requirements and specifications
DFMEA Cost trade-off analysisLessons LearnedProbabilistic design Cost trade-offs Tolerance Analysis
FEA Warranty Data Analysis DRBFM Reliability predictionLessons Learned Reliability Block Diagrams
HASS Control Charts Re-validation Audits Look AcrossLessons Learned ORT
HALT Evaluation Testing DRBTRReliability Growth modeling Change Point Analysis
Design and Process ValidationAccelerated Test Reliability Demonstration
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 32
Key points for implementing DfR activities
bull Start DfR activities early in the process
bull Reliability engineerrsquos job is to leadcoach the design team Reliability achievement needs to be owned by design and manufacturing teams
bull Integration of Reliability and Quality Engineers with design teams
bull Warrantyfield data analysis (both statistical and root cause analysis) needs to be fed back to both design and reliability teams
bull Reduce the number of tools in the toolbox but use the remaining well Neither all steps nor tools are necessary for all the programs
2262014 Ops A La Carte copy 33
34
Reliability Before Design
SpendingRate
Qualification Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
Reliability Spend Rate
Traditional Reliability Model
35
Reliability Before Design
SpendingRate
Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Qualification
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
New Reliability Spend Rate
$ Savings $
Reliability Before Design
Design for Reliability Method
copy Ops A La Carte LLC 2012
copy 2009 Ops A La Carte
36
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte 37
DEVELOPING AN
EFFECTIVE
RELIABILITY TEST
STRATEGY
Steps to a Good Design
In order to write better test plans
1) Understand Requirements
2) Understand Use Environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform Design amp Design Reviews
6) Write Design Verification Test plan
7) Write Reliability Test Plan
Understanding Requirements
Inputs include
ndashSpecifications
bull MRD ndash Marketing Requirements Document
bull PRD ndash Product Requirements Document
ndashCompetitive Product Solutions
ndashLessons Learned
ndashConstraints
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
bull IDENTIFY RELIABILITY RISKS
Using the Risk Analysis process we identified
as many new risks as possible
Then we set out to figure ways of mitigating
these risks
Design analysis techniques such as FEA DOE
and Thermal Analysis
Accelerated Testing techniques such as HALT
ALT and RDT
The important element here is that we always
had an eye on our goal
MEDICAL INFUSION PUMP
bull RELIABILITY TECHNIQUES USED
Motors ndash FEA ALT
Power Supply ndash HALT then RDT
Touch Screen ndash ALT Abuse Testing
Wireless Interface - HALT
Battery ndash Application Specific ALT
Software ndash Software FMEA Software
Use Case Testing
MEDICAL INFUSION PUMP
bull RESULTS
Using this process we saved time and money
We found out issues during the design
analysis that would have required a redesign
had we found them later in the design or
worse out in the field
We found out issues during the testing that
would have set our program back months
End result We developed and delivered a
very reliable product and got it to market
faster
MEDICAL INFUSION PUMP
copy 2009 Ops A La Carte
25
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte
26
DESIGN FOR
RELIABILITY (DFR)
OVERVIEW
Definition
bull DfR is knowledge-based engineering wherein starting with capture of requirements and leading to assured reliability a reliability plan is designed and executed using the full skills and knowledge of the project team
bull The goal of DfR is to work smarter through knowledge-based tailoring of the reliability plan
2262014 Ops A La Carte copy 27
bull Making a list of all possible reliability activities and then trying to cover as many as possible within the timeframe of the product development process
bull Assuming that product reliability is the sole responsibility of a reliability engineer (reliability engineer is the guide and mentor but not the owner ndash designer should be the owner)
bull Getting the product into test as fast as possible to test reliability into the product (aka Test-Analyze-and-Fix)
bull Only working on the in-house design items and not worrying about vendor items
bull Working in silos between EE Mech E Software etc (even if they apply some or most of the DfR tools) ndash all competencies must work together to reach common goals
Is NOT
2262014 Ops A La Carte copy 28
IS
bull Identifying goals and requirements consistent with customer and business objectives
bull Applying knowledge-based management and engineering to define implement and improve plans to achieve goals and requirements
bull Providing clear metrics for review Reviewing and taking timely corrective action
bull Reviewing and knowledge-capture from all activities and outputs with goal of continuous improvement
bull DfR is the process of building reliability into the design with efficiency and assurance using the best science-based methods
2262014 Ops A La Carte copy 29
Flow
A detailed evaluation of an organizationrsquos approach and processes involved in creating reliable products The assessment captures the current state and leads to an actionable reliability program plan
bull Initiate a Reliability Programbull Determine next best stepsbull Reduce customer complaints bull Select right toolsbull Improve reliability
Now
Goal
$ unreliability
$ Profits
Assessment Interviews
StatisticalData Analysis
Benchmarking
Gap Analysis
Program Plan
complaints
fieldfailures
satisfaction
marketshare
Unknown Reliability
2262014 Ops A La Carte copy 30
Key Activities
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 31
DfR Key Activities
QFD Requirements definitions Benchmarking Product usage analysisUnderstanding of customer requirements and specifications
DFMEA Cost trade-off analysisLessons LearnedProbabilistic design Cost trade-offs Tolerance Analysis
FEA Warranty Data Analysis DRBFM Reliability predictionLessons Learned Reliability Block Diagrams
HASS Control Charts Re-validation Audits Look AcrossLessons Learned ORT
HALT Evaluation Testing DRBTRReliability Growth modeling Change Point Analysis
Design and Process ValidationAccelerated Test Reliability Demonstration
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 32
Key points for implementing DfR activities
bull Start DfR activities early in the process
bull Reliability engineerrsquos job is to leadcoach the design team Reliability achievement needs to be owned by design and manufacturing teams
bull Integration of Reliability and Quality Engineers with design teams
bull Warrantyfield data analysis (both statistical and root cause analysis) needs to be fed back to both design and reliability teams
bull Reduce the number of tools in the toolbox but use the remaining well Neither all steps nor tools are necessary for all the programs
2262014 Ops A La Carte copy 33
34
Reliability Before Design
SpendingRate
Qualification Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
Reliability Spend Rate
Traditional Reliability Model
35
Reliability Before Design
SpendingRate
Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Qualification
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
New Reliability Spend Rate
$ Savings $
Reliability Before Design
Design for Reliability Method
copy Ops A La Carte LLC 2012
copy 2009 Ops A La Carte
36
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte 37
DEVELOPING AN
EFFECTIVE
RELIABILITY TEST
STRATEGY
Steps to a Good Design
In order to write better test plans
1) Understand Requirements
2) Understand Use Environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform Design amp Design Reviews
6) Write Design Verification Test plan
7) Write Reliability Test Plan
Understanding Requirements
Inputs include
ndashSpecifications
bull MRD ndash Marketing Requirements Document
bull PRD ndash Product Requirements Document
ndashCompetitive Product Solutions
ndashLessons Learned
ndashConstraints
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
bull RELIABILITY TECHNIQUES USED
Motors ndash FEA ALT
Power Supply ndash HALT then RDT
Touch Screen ndash ALT Abuse Testing
Wireless Interface - HALT
Battery ndash Application Specific ALT
Software ndash Software FMEA Software
Use Case Testing
MEDICAL INFUSION PUMP
bull RESULTS
Using this process we saved time and money
We found out issues during the design
analysis that would have required a redesign
had we found them later in the design or
worse out in the field
We found out issues during the testing that
would have set our program back months
End result We developed and delivered a
very reliable product and got it to market
faster
MEDICAL INFUSION PUMP
copy 2009 Ops A La Carte
25
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte
26
DESIGN FOR
RELIABILITY (DFR)
OVERVIEW
Definition
bull DfR is knowledge-based engineering wherein starting with capture of requirements and leading to assured reliability a reliability plan is designed and executed using the full skills and knowledge of the project team
bull The goal of DfR is to work smarter through knowledge-based tailoring of the reliability plan
2262014 Ops A La Carte copy 27
bull Making a list of all possible reliability activities and then trying to cover as many as possible within the timeframe of the product development process
bull Assuming that product reliability is the sole responsibility of a reliability engineer (reliability engineer is the guide and mentor but not the owner ndash designer should be the owner)
bull Getting the product into test as fast as possible to test reliability into the product (aka Test-Analyze-and-Fix)
bull Only working on the in-house design items and not worrying about vendor items
bull Working in silos between EE Mech E Software etc (even if they apply some or most of the DfR tools) ndash all competencies must work together to reach common goals
Is NOT
2262014 Ops A La Carte copy 28
IS
bull Identifying goals and requirements consistent with customer and business objectives
bull Applying knowledge-based management and engineering to define implement and improve plans to achieve goals and requirements
bull Providing clear metrics for review Reviewing and taking timely corrective action
bull Reviewing and knowledge-capture from all activities and outputs with goal of continuous improvement
bull DfR is the process of building reliability into the design with efficiency and assurance using the best science-based methods
2262014 Ops A La Carte copy 29
Flow
A detailed evaluation of an organizationrsquos approach and processes involved in creating reliable products The assessment captures the current state and leads to an actionable reliability program plan
bull Initiate a Reliability Programbull Determine next best stepsbull Reduce customer complaints bull Select right toolsbull Improve reliability
Now
Goal
$ unreliability
$ Profits
Assessment Interviews
StatisticalData Analysis
Benchmarking
Gap Analysis
Program Plan
complaints
fieldfailures
satisfaction
marketshare
Unknown Reliability
2262014 Ops A La Carte copy 30
Key Activities
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 31
DfR Key Activities
QFD Requirements definitions Benchmarking Product usage analysisUnderstanding of customer requirements and specifications
DFMEA Cost trade-off analysisLessons LearnedProbabilistic design Cost trade-offs Tolerance Analysis
FEA Warranty Data Analysis DRBFM Reliability predictionLessons Learned Reliability Block Diagrams
HASS Control Charts Re-validation Audits Look AcrossLessons Learned ORT
HALT Evaluation Testing DRBTRReliability Growth modeling Change Point Analysis
Design and Process ValidationAccelerated Test Reliability Demonstration
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 32
Key points for implementing DfR activities
bull Start DfR activities early in the process
bull Reliability engineerrsquos job is to leadcoach the design team Reliability achievement needs to be owned by design and manufacturing teams
bull Integration of Reliability and Quality Engineers with design teams
bull Warrantyfield data analysis (both statistical and root cause analysis) needs to be fed back to both design and reliability teams
bull Reduce the number of tools in the toolbox but use the remaining well Neither all steps nor tools are necessary for all the programs
2262014 Ops A La Carte copy 33
34
Reliability Before Design
SpendingRate
Qualification Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
Reliability Spend Rate
Traditional Reliability Model
35
Reliability Before Design
SpendingRate
Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Qualification
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
New Reliability Spend Rate
$ Savings $
Reliability Before Design
Design for Reliability Method
copy Ops A La Carte LLC 2012
copy 2009 Ops A La Carte
36
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte 37
DEVELOPING AN
EFFECTIVE
RELIABILITY TEST
STRATEGY
Steps to a Good Design
In order to write better test plans
1) Understand Requirements
2) Understand Use Environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform Design amp Design Reviews
6) Write Design Verification Test plan
7) Write Reliability Test Plan
Understanding Requirements
Inputs include
ndashSpecifications
bull MRD ndash Marketing Requirements Document
bull PRD ndash Product Requirements Document
ndashCompetitive Product Solutions
ndashLessons Learned
ndashConstraints
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
bull RESULTS
Using this process we saved time and money
We found out issues during the design
analysis that would have required a redesign
had we found them later in the design or
worse out in the field
We found out issues during the testing that
would have set our program back months
End result We developed and delivered a
very reliable product and got it to market
faster
MEDICAL INFUSION PUMP
copy 2009 Ops A La Carte
25
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte
26
DESIGN FOR
RELIABILITY (DFR)
OVERVIEW
Definition
bull DfR is knowledge-based engineering wherein starting with capture of requirements and leading to assured reliability a reliability plan is designed and executed using the full skills and knowledge of the project team
bull The goal of DfR is to work smarter through knowledge-based tailoring of the reliability plan
2262014 Ops A La Carte copy 27
bull Making a list of all possible reliability activities and then trying to cover as many as possible within the timeframe of the product development process
bull Assuming that product reliability is the sole responsibility of a reliability engineer (reliability engineer is the guide and mentor but not the owner ndash designer should be the owner)
bull Getting the product into test as fast as possible to test reliability into the product (aka Test-Analyze-and-Fix)
bull Only working on the in-house design items and not worrying about vendor items
bull Working in silos between EE Mech E Software etc (even if they apply some or most of the DfR tools) ndash all competencies must work together to reach common goals
Is NOT
2262014 Ops A La Carte copy 28
IS
bull Identifying goals and requirements consistent with customer and business objectives
bull Applying knowledge-based management and engineering to define implement and improve plans to achieve goals and requirements
bull Providing clear metrics for review Reviewing and taking timely corrective action
bull Reviewing and knowledge-capture from all activities and outputs with goal of continuous improvement
bull DfR is the process of building reliability into the design with efficiency and assurance using the best science-based methods
2262014 Ops A La Carte copy 29
Flow
A detailed evaluation of an organizationrsquos approach and processes involved in creating reliable products The assessment captures the current state and leads to an actionable reliability program plan
bull Initiate a Reliability Programbull Determine next best stepsbull Reduce customer complaints bull Select right toolsbull Improve reliability
Now
Goal
$ unreliability
$ Profits
Assessment Interviews
StatisticalData Analysis
Benchmarking
Gap Analysis
Program Plan
complaints
fieldfailures
satisfaction
marketshare
Unknown Reliability
2262014 Ops A La Carte copy 30
Key Activities
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 31
DfR Key Activities
QFD Requirements definitions Benchmarking Product usage analysisUnderstanding of customer requirements and specifications
DFMEA Cost trade-off analysisLessons LearnedProbabilistic design Cost trade-offs Tolerance Analysis
FEA Warranty Data Analysis DRBFM Reliability predictionLessons Learned Reliability Block Diagrams
HASS Control Charts Re-validation Audits Look AcrossLessons Learned ORT
HALT Evaluation Testing DRBTRReliability Growth modeling Change Point Analysis
Design and Process ValidationAccelerated Test Reliability Demonstration
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 32
Key points for implementing DfR activities
bull Start DfR activities early in the process
bull Reliability engineerrsquos job is to leadcoach the design team Reliability achievement needs to be owned by design and manufacturing teams
bull Integration of Reliability and Quality Engineers with design teams
bull Warrantyfield data analysis (both statistical and root cause analysis) needs to be fed back to both design and reliability teams
bull Reduce the number of tools in the toolbox but use the remaining well Neither all steps nor tools are necessary for all the programs
2262014 Ops A La Carte copy 33
34
Reliability Before Design
SpendingRate
Qualification Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
Reliability Spend Rate
Traditional Reliability Model
35
Reliability Before Design
SpendingRate
Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Qualification
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
New Reliability Spend Rate
$ Savings $
Reliability Before Design
Design for Reliability Method
copy Ops A La Carte LLC 2012
copy 2009 Ops A La Carte
36
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte 37
DEVELOPING AN
EFFECTIVE
RELIABILITY TEST
STRATEGY
Steps to a Good Design
In order to write better test plans
1) Understand Requirements
2) Understand Use Environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform Design amp Design Reviews
6) Write Design Verification Test plan
7) Write Reliability Test Plan
Understanding Requirements
Inputs include
ndashSpecifications
bull MRD ndash Marketing Requirements Document
bull PRD ndash Product Requirements Document
ndashCompetitive Product Solutions
ndashLessons Learned
ndashConstraints
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
copy 2009 Ops A La Carte
25
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte
26
DESIGN FOR
RELIABILITY (DFR)
OVERVIEW
Definition
bull DfR is knowledge-based engineering wherein starting with capture of requirements and leading to assured reliability a reliability plan is designed and executed using the full skills and knowledge of the project team
bull The goal of DfR is to work smarter through knowledge-based tailoring of the reliability plan
2262014 Ops A La Carte copy 27
bull Making a list of all possible reliability activities and then trying to cover as many as possible within the timeframe of the product development process
bull Assuming that product reliability is the sole responsibility of a reliability engineer (reliability engineer is the guide and mentor but not the owner ndash designer should be the owner)
bull Getting the product into test as fast as possible to test reliability into the product (aka Test-Analyze-and-Fix)
bull Only working on the in-house design items and not worrying about vendor items
bull Working in silos between EE Mech E Software etc (even if they apply some or most of the DfR tools) ndash all competencies must work together to reach common goals
Is NOT
2262014 Ops A La Carte copy 28
IS
bull Identifying goals and requirements consistent with customer and business objectives
bull Applying knowledge-based management and engineering to define implement and improve plans to achieve goals and requirements
bull Providing clear metrics for review Reviewing and taking timely corrective action
bull Reviewing and knowledge-capture from all activities and outputs with goal of continuous improvement
bull DfR is the process of building reliability into the design with efficiency and assurance using the best science-based methods
2262014 Ops A La Carte copy 29
Flow
A detailed evaluation of an organizationrsquos approach and processes involved in creating reliable products The assessment captures the current state and leads to an actionable reliability program plan
bull Initiate a Reliability Programbull Determine next best stepsbull Reduce customer complaints bull Select right toolsbull Improve reliability
Now
Goal
$ unreliability
$ Profits
Assessment Interviews
StatisticalData Analysis
Benchmarking
Gap Analysis
Program Plan
complaints
fieldfailures
satisfaction
marketshare
Unknown Reliability
2262014 Ops A La Carte copy 30
Key Activities
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 31
DfR Key Activities
QFD Requirements definitions Benchmarking Product usage analysisUnderstanding of customer requirements and specifications
DFMEA Cost trade-off analysisLessons LearnedProbabilistic design Cost trade-offs Tolerance Analysis
FEA Warranty Data Analysis DRBFM Reliability predictionLessons Learned Reliability Block Diagrams
HASS Control Charts Re-validation Audits Look AcrossLessons Learned ORT
HALT Evaluation Testing DRBTRReliability Growth modeling Change Point Analysis
Design and Process ValidationAccelerated Test Reliability Demonstration
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 32
Key points for implementing DfR activities
bull Start DfR activities early in the process
bull Reliability engineerrsquos job is to leadcoach the design team Reliability achievement needs to be owned by design and manufacturing teams
bull Integration of Reliability and Quality Engineers with design teams
bull Warrantyfield data analysis (both statistical and root cause analysis) needs to be fed back to both design and reliability teams
bull Reduce the number of tools in the toolbox but use the remaining well Neither all steps nor tools are necessary for all the programs
2262014 Ops A La Carte copy 33
34
Reliability Before Design
SpendingRate
Qualification Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
Reliability Spend Rate
Traditional Reliability Model
35
Reliability Before Design
SpendingRate
Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Qualification
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
New Reliability Spend Rate
$ Savings $
Reliability Before Design
Design for Reliability Method
copy Ops A La Carte LLC 2012
copy 2009 Ops A La Carte
36
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte 37
DEVELOPING AN
EFFECTIVE
RELIABILITY TEST
STRATEGY
Steps to a Good Design
In order to write better test plans
1) Understand Requirements
2) Understand Use Environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform Design amp Design Reviews
6) Write Design Verification Test plan
7) Write Reliability Test Plan
Understanding Requirements
Inputs include
ndashSpecifications
bull MRD ndash Marketing Requirements Document
bull PRD ndash Product Requirements Document
ndashCompetitive Product Solutions
ndashLessons Learned
ndashConstraints
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
copy 2008 Ops A La Carte
26
DESIGN FOR
RELIABILITY (DFR)
OVERVIEW
Definition
bull DfR is knowledge-based engineering wherein starting with capture of requirements and leading to assured reliability a reliability plan is designed and executed using the full skills and knowledge of the project team
bull The goal of DfR is to work smarter through knowledge-based tailoring of the reliability plan
2262014 Ops A La Carte copy 27
bull Making a list of all possible reliability activities and then trying to cover as many as possible within the timeframe of the product development process
bull Assuming that product reliability is the sole responsibility of a reliability engineer (reliability engineer is the guide and mentor but not the owner ndash designer should be the owner)
bull Getting the product into test as fast as possible to test reliability into the product (aka Test-Analyze-and-Fix)
bull Only working on the in-house design items and not worrying about vendor items
bull Working in silos between EE Mech E Software etc (even if they apply some or most of the DfR tools) ndash all competencies must work together to reach common goals
Is NOT
2262014 Ops A La Carte copy 28
IS
bull Identifying goals and requirements consistent with customer and business objectives
bull Applying knowledge-based management and engineering to define implement and improve plans to achieve goals and requirements
bull Providing clear metrics for review Reviewing and taking timely corrective action
bull Reviewing and knowledge-capture from all activities and outputs with goal of continuous improvement
bull DfR is the process of building reliability into the design with efficiency and assurance using the best science-based methods
2262014 Ops A La Carte copy 29
Flow
A detailed evaluation of an organizationrsquos approach and processes involved in creating reliable products The assessment captures the current state and leads to an actionable reliability program plan
bull Initiate a Reliability Programbull Determine next best stepsbull Reduce customer complaints bull Select right toolsbull Improve reliability
Now
Goal
$ unreliability
$ Profits
Assessment Interviews
StatisticalData Analysis
Benchmarking
Gap Analysis
Program Plan
complaints
fieldfailures
satisfaction
marketshare
Unknown Reliability
2262014 Ops A La Carte copy 30
Key Activities
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 31
DfR Key Activities
QFD Requirements definitions Benchmarking Product usage analysisUnderstanding of customer requirements and specifications
DFMEA Cost trade-off analysisLessons LearnedProbabilistic design Cost trade-offs Tolerance Analysis
FEA Warranty Data Analysis DRBFM Reliability predictionLessons Learned Reliability Block Diagrams
HASS Control Charts Re-validation Audits Look AcrossLessons Learned ORT
HALT Evaluation Testing DRBTRReliability Growth modeling Change Point Analysis
Design and Process ValidationAccelerated Test Reliability Demonstration
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 32
Key points for implementing DfR activities
bull Start DfR activities early in the process
bull Reliability engineerrsquos job is to leadcoach the design team Reliability achievement needs to be owned by design and manufacturing teams
bull Integration of Reliability and Quality Engineers with design teams
bull Warrantyfield data analysis (both statistical and root cause analysis) needs to be fed back to both design and reliability teams
bull Reduce the number of tools in the toolbox but use the remaining well Neither all steps nor tools are necessary for all the programs
2262014 Ops A La Carte copy 33
34
Reliability Before Design
SpendingRate
Qualification Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
Reliability Spend Rate
Traditional Reliability Model
35
Reliability Before Design
SpendingRate
Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Qualification
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
New Reliability Spend Rate
$ Savings $
Reliability Before Design
Design for Reliability Method
copy Ops A La Carte LLC 2012
copy 2009 Ops A La Carte
36
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte 37
DEVELOPING AN
EFFECTIVE
RELIABILITY TEST
STRATEGY
Steps to a Good Design
In order to write better test plans
1) Understand Requirements
2) Understand Use Environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform Design amp Design Reviews
6) Write Design Verification Test plan
7) Write Reliability Test Plan
Understanding Requirements
Inputs include
ndashSpecifications
bull MRD ndash Marketing Requirements Document
bull PRD ndash Product Requirements Document
ndashCompetitive Product Solutions
ndashLessons Learned
ndashConstraints
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
Definition
bull DfR is knowledge-based engineering wherein starting with capture of requirements and leading to assured reliability a reliability plan is designed and executed using the full skills and knowledge of the project team
bull The goal of DfR is to work smarter through knowledge-based tailoring of the reliability plan
2262014 Ops A La Carte copy 27
bull Making a list of all possible reliability activities and then trying to cover as many as possible within the timeframe of the product development process
bull Assuming that product reliability is the sole responsibility of a reliability engineer (reliability engineer is the guide and mentor but not the owner ndash designer should be the owner)
bull Getting the product into test as fast as possible to test reliability into the product (aka Test-Analyze-and-Fix)
bull Only working on the in-house design items and not worrying about vendor items
bull Working in silos between EE Mech E Software etc (even if they apply some or most of the DfR tools) ndash all competencies must work together to reach common goals
Is NOT
2262014 Ops A La Carte copy 28
IS
bull Identifying goals and requirements consistent with customer and business objectives
bull Applying knowledge-based management and engineering to define implement and improve plans to achieve goals and requirements
bull Providing clear metrics for review Reviewing and taking timely corrective action
bull Reviewing and knowledge-capture from all activities and outputs with goal of continuous improvement
bull DfR is the process of building reliability into the design with efficiency and assurance using the best science-based methods
2262014 Ops A La Carte copy 29
Flow
A detailed evaluation of an organizationrsquos approach and processes involved in creating reliable products The assessment captures the current state and leads to an actionable reliability program plan
bull Initiate a Reliability Programbull Determine next best stepsbull Reduce customer complaints bull Select right toolsbull Improve reliability
Now
Goal
$ unreliability
$ Profits
Assessment Interviews
StatisticalData Analysis
Benchmarking
Gap Analysis
Program Plan
complaints
fieldfailures
satisfaction
marketshare
Unknown Reliability
2262014 Ops A La Carte copy 30
Key Activities
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 31
DfR Key Activities
QFD Requirements definitions Benchmarking Product usage analysisUnderstanding of customer requirements and specifications
DFMEA Cost trade-off analysisLessons LearnedProbabilistic design Cost trade-offs Tolerance Analysis
FEA Warranty Data Analysis DRBFM Reliability predictionLessons Learned Reliability Block Diagrams
HASS Control Charts Re-validation Audits Look AcrossLessons Learned ORT
HALT Evaluation Testing DRBTRReliability Growth modeling Change Point Analysis
Design and Process ValidationAccelerated Test Reliability Demonstration
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 32
Key points for implementing DfR activities
bull Start DfR activities early in the process
bull Reliability engineerrsquos job is to leadcoach the design team Reliability achievement needs to be owned by design and manufacturing teams
bull Integration of Reliability and Quality Engineers with design teams
bull Warrantyfield data analysis (both statistical and root cause analysis) needs to be fed back to both design and reliability teams
bull Reduce the number of tools in the toolbox but use the remaining well Neither all steps nor tools are necessary for all the programs
2262014 Ops A La Carte copy 33
34
Reliability Before Design
SpendingRate
Qualification Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
Reliability Spend Rate
Traditional Reliability Model
35
Reliability Before Design
SpendingRate
Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Qualification
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
New Reliability Spend Rate
$ Savings $
Reliability Before Design
Design for Reliability Method
copy Ops A La Carte LLC 2012
copy 2009 Ops A La Carte
36
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte 37
DEVELOPING AN
EFFECTIVE
RELIABILITY TEST
STRATEGY
Steps to a Good Design
In order to write better test plans
1) Understand Requirements
2) Understand Use Environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform Design amp Design Reviews
6) Write Design Verification Test plan
7) Write Reliability Test Plan
Understanding Requirements
Inputs include
ndashSpecifications
bull MRD ndash Marketing Requirements Document
bull PRD ndash Product Requirements Document
ndashCompetitive Product Solutions
ndashLessons Learned
ndashConstraints
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
bull Making a list of all possible reliability activities and then trying to cover as many as possible within the timeframe of the product development process
bull Assuming that product reliability is the sole responsibility of a reliability engineer (reliability engineer is the guide and mentor but not the owner ndash designer should be the owner)
bull Getting the product into test as fast as possible to test reliability into the product (aka Test-Analyze-and-Fix)
bull Only working on the in-house design items and not worrying about vendor items
bull Working in silos between EE Mech E Software etc (even if they apply some or most of the DfR tools) ndash all competencies must work together to reach common goals
Is NOT
2262014 Ops A La Carte copy 28
IS
bull Identifying goals and requirements consistent with customer and business objectives
bull Applying knowledge-based management and engineering to define implement and improve plans to achieve goals and requirements
bull Providing clear metrics for review Reviewing and taking timely corrective action
bull Reviewing and knowledge-capture from all activities and outputs with goal of continuous improvement
bull DfR is the process of building reliability into the design with efficiency and assurance using the best science-based methods
2262014 Ops A La Carte copy 29
Flow
A detailed evaluation of an organizationrsquos approach and processes involved in creating reliable products The assessment captures the current state and leads to an actionable reliability program plan
bull Initiate a Reliability Programbull Determine next best stepsbull Reduce customer complaints bull Select right toolsbull Improve reliability
Now
Goal
$ unreliability
$ Profits
Assessment Interviews
StatisticalData Analysis
Benchmarking
Gap Analysis
Program Plan
complaints
fieldfailures
satisfaction
marketshare
Unknown Reliability
2262014 Ops A La Carte copy 30
Key Activities
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 31
DfR Key Activities
QFD Requirements definitions Benchmarking Product usage analysisUnderstanding of customer requirements and specifications
DFMEA Cost trade-off analysisLessons LearnedProbabilistic design Cost trade-offs Tolerance Analysis
FEA Warranty Data Analysis DRBFM Reliability predictionLessons Learned Reliability Block Diagrams
HASS Control Charts Re-validation Audits Look AcrossLessons Learned ORT
HALT Evaluation Testing DRBTRReliability Growth modeling Change Point Analysis
Design and Process ValidationAccelerated Test Reliability Demonstration
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 32
Key points for implementing DfR activities
bull Start DfR activities early in the process
bull Reliability engineerrsquos job is to leadcoach the design team Reliability achievement needs to be owned by design and manufacturing teams
bull Integration of Reliability and Quality Engineers with design teams
bull Warrantyfield data analysis (both statistical and root cause analysis) needs to be fed back to both design and reliability teams
bull Reduce the number of tools in the toolbox but use the remaining well Neither all steps nor tools are necessary for all the programs
2262014 Ops A La Carte copy 33
34
Reliability Before Design
SpendingRate
Qualification Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
Reliability Spend Rate
Traditional Reliability Model
35
Reliability Before Design
SpendingRate
Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Qualification
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
New Reliability Spend Rate
$ Savings $
Reliability Before Design
Design for Reliability Method
copy Ops A La Carte LLC 2012
copy 2009 Ops A La Carte
36
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte 37
DEVELOPING AN
EFFECTIVE
RELIABILITY TEST
STRATEGY
Steps to a Good Design
In order to write better test plans
1) Understand Requirements
2) Understand Use Environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform Design amp Design Reviews
6) Write Design Verification Test plan
7) Write Reliability Test Plan
Understanding Requirements
Inputs include
ndashSpecifications
bull MRD ndash Marketing Requirements Document
bull PRD ndash Product Requirements Document
ndashCompetitive Product Solutions
ndashLessons Learned
ndashConstraints
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
IS
bull Identifying goals and requirements consistent with customer and business objectives
bull Applying knowledge-based management and engineering to define implement and improve plans to achieve goals and requirements
bull Providing clear metrics for review Reviewing and taking timely corrective action
bull Reviewing and knowledge-capture from all activities and outputs with goal of continuous improvement
bull DfR is the process of building reliability into the design with efficiency and assurance using the best science-based methods
2262014 Ops A La Carte copy 29
Flow
A detailed evaluation of an organizationrsquos approach and processes involved in creating reliable products The assessment captures the current state and leads to an actionable reliability program plan
bull Initiate a Reliability Programbull Determine next best stepsbull Reduce customer complaints bull Select right toolsbull Improve reliability
Now
Goal
$ unreliability
$ Profits
Assessment Interviews
StatisticalData Analysis
Benchmarking
Gap Analysis
Program Plan
complaints
fieldfailures
satisfaction
marketshare
Unknown Reliability
2262014 Ops A La Carte copy 30
Key Activities
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 31
DfR Key Activities
QFD Requirements definitions Benchmarking Product usage analysisUnderstanding of customer requirements and specifications
DFMEA Cost trade-off analysisLessons LearnedProbabilistic design Cost trade-offs Tolerance Analysis
FEA Warranty Data Analysis DRBFM Reliability predictionLessons Learned Reliability Block Diagrams
HASS Control Charts Re-validation Audits Look AcrossLessons Learned ORT
HALT Evaluation Testing DRBTRReliability Growth modeling Change Point Analysis
Design and Process ValidationAccelerated Test Reliability Demonstration
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 32
Key points for implementing DfR activities
bull Start DfR activities early in the process
bull Reliability engineerrsquos job is to leadcoach the design team Reliability achievement needs to be owned by design and manufacturing teams
bull Integration of Reliability and Quality Engineers with design teams
bull Warrantyfield data analysis (both statistical and root cause analysis) needs to be fed back to both design and reliability teams
bull Reduce the number of tools in the toolbox but use the remaining well Neither all steps nor tools are necessary for all the programs
2262014 Ops A La Carte copy 33
34
Reliability Before Design
SpendingRate
Qualification Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
Reliability Spend Rate
Traditional Reliability Model
35
Reliability Before Design
SpendingRate
Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Qualification
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
New Reliability Spend Rate
$ Savings $
Reliability Before Design
Design for Reliability Method
copy Ops A La Carte LLC 2012
copy 2009 Ops A La Carte
36
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte 37
DEVELOPING AN
EFFECTIVE
RELIABILITY TEST
STRATEGY
Steps to a Good Design
In order to write better test plans
1) Understand Requirements
2) Understand Use Environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform Design amp Design Reviews
6) Write Design Verification Test plan
7) Write Reliability Test Plan
Understanding Requirements
Inputs include
ndashSpecifications
bull MRD ndash Marketing Requirements Document
bull PRD ndash Product Requirements Document
ndashCompetitive Product Solutions
ndashLessons Learned
ndashConstraints
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
Flow
A detailed evaluation of an organizationrsquos approach and processes involved in creating reliable products The assessment captures the current state and leads to an actionable reliability program plan
bull Initiate a Reliability Programbull Determine next best stepsbull Reduce customer complaints bull Select right toolsbull Improve reliability
Now
Goal
$ unreliability
$ Profits
Assessment Interviews
StatisticalData Analysis
Benchmarking
Gap Analysis
Program Plan
complaints
fieldfailures
satisfaction
marketshare
Unknown Reliability
2262014 Ops A La Carte copy 30
Key Activities
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 31
DfR Key Activities
QFD Requirements definitions Benchmarking Product usage analysisUnderstanding of customer requirements and specifications
DFMEA Cost trade-off analysisLessons LearnedProbabilistic design Cost trade-offs Tolerance Analysis
FEA Warranty Data Analysis DRBFM Reliability predictionLessons Learned Reliability Block Diagrams
HASS Control Charts Re-validation Audits Look AcrossLessons Learned ORT
HALT Evaluation Testing DRBTRReliability Growth modeling Change Point Analysis
Design and Process ValidationAccelerated Test Reliability Demonstration
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 32
Key points for implementing DfR activities
bull Start DfR activities early in the process
bull Reliability engineerrsquos job is to leadcoach the design team Reliability achievement needs to be owned by design and manufacturing teams
bull Integration of Reliability and Quality Engineers with design teams
bull Warrantyfield data analysis (both statistical and root cause analysis) needs to be fed back to both design and reliability teams
bull Reduce the number of tools in the toolbox but use the remaining well Neither all steps nor tools are necessary for all the programs
2262014 Ops A La Carte copy 33
34
Reliability Before Design
SpendingRate
Qualification Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
Reliability Spend Rate
Traditional Reliability Model
35
Reliability Before Design
SpendingRate
Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Qualification
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
New Reliability Spend Rate
$ Savings $
Reliability Before Design
Design for Reliability Method
copy Ops A La Carte LLC 2012
copy 2009 Ops A La Carte
36
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte 37
DEVELOPING AN
EFFECTIVE
RELIABILITY TEST
STRATEGY
Steps to a Good Design
In order to write better test plans
1) Understand Requirements
2) Understand Use Environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform Design amp Design Reviews
6) Write Design Verification Test plan
7) Write Reliability Test Plan
Understanding Requirements
Inputs include
ndashSpecifications
bull MRD ndash Marketing Requirements Document
bull PRD ndash Product Requirements Document
ndashCompetitive Product Solutions
ndashLessons Learned
ndashConstraints
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
Key Activities
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 31
DfR Key Activities
QFD Requirements definitions Benchmarking Product usage analysisUnderstanding of customer requirements and specifications
DFMEA Cost trade-off analysisLessons LearnedProbabilistic design Cost trade-offs Tolerance Analysis
FEA Warranty Data Analysis DRBFM Reliability predictionLessons Learned Reliability Block Diagrams
HASS Control Charts Re-validation Audits Look AcrossLessons Learned ORT
HALT Evaluation Testing DRBTRReliability Growth modeling Change Point Analysis
Design and Process ValidationAccelerated Test Reliability Demonstration
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 32
Key points for implementing DfR activities
bull Start DfR activities early in the process
bull Reliability engineerrsquos job is to leadcoach the design team Reliability achievement needs to be owned by design and manufacturing teams
bull Integration of Reliability and Quality Engineers with design teams
bull Warrantyfield data analysis (both statistical and root cause analysis) needs to be fed back to both design and reliability teams
bull Reduce the number of tools in the toolbox but use the remaining well Neither all steps nor tools are necessary for all the programs
2262014 Ops A La Carte copy 33
34
Reliability Before Design
SpendingRate
Qualification Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
Reliability Spend Rate
Traditional Reliability Model
35
Reliability Before Design
SpendingRate
Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Qualification
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
New Reliability Spend Rate
$ Savings $
Reliability Before Design
Design for Reliability Method
copy Ops A La Carte LLC 2012
copy 2009 Ops A La Carte
36
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte 37
DEVELOPING AN
EFFECTIVE
RELIABILITY TEST
STRATEGY
Steps to a Good Design
In order to write better test plans
1) Understand Requirements
2) Understand Use Environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform Design amp Design Reviews
6) Write Design Verification Test plan
7) Write Reliability Test Plan
Understanding Requirements
Inputs include
ndashSpecifications
bull MRD ndash Marketing Requirements Document
bull PRD ndash Product Requirements Document
ndashCompetitive Product Solutions
ndashLessons Learned
ndashConstraints
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
DfR Key Activities
QFD Requirements definitions Benchmarking Product usage analysisUnderstanding of customer requirements and specifications
DFMEA Cost trade-off analysisLessons LearnedProbabilistic design Cost trade-offs Tolerance Analysis
FEA Warranty Data Analysis DRBFM Reliability predictionLessons Learned Reliability Block Diagrams
HASS Control Charts Re-validation Audits Look AcrossLessons Learned ORT
HALT Evaluation Testing DRBTRReliability Growth modeling Change Point Analysis
Design and Process ValidationAccelerated Test Reliability Demonstration
1 Concept
2 Feasibility
3 Development4 Qualification
5 Launch
6 Post-Launch
2262014 Ops A La Carte copy 32
Key points for implementing DfR activities
bull Start DfR activities early in the process
bull Reliability engineerrsquos job is to leadcoach the design team Reliability achievement needs to be owned by design and manufacturing teams
bull Integration of Reliability and Quality Engineers with design teams
bull Warrantyfield data analysis (both statistical and root cause analysis) needs to be fed back to both design and reliability teams
bull Reduce the number of tools in the toolbox but use the remaining well Neither all steps nor tools are necessary for all the programs
2262014 Ops A La Carte copy 33
34
Reliability Before Design
SpendingRate
Qualification Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
Reliability Spend Rate
Traditional Reliability Model
35
Reliability Before Design
SpendingRate
Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Qualification
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
New Reliability Spend Rate
$ Savings $
Reliability Before Design
Design for Reliability Method
copy Ops A La Carte LLC 2012
copy 2009 Ops A La Carte
36
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte 37
DEVELOPING AN
EFFECTIVE
RELIABILITY TEST
STRATEGY
Steps to a Good Design
In order to write better test plans
1) Understand Requirements
2) Understand Use Environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform Design amp Design Reviews
6) Write Design Verification Test plan
7) Write Reliability Test Plan
Understanding Requirements
Inputs include
ndashSpecifications
bull MRD ndash Marketing Requirements Document
bull PRD ndash Product Requirements Document
ndashCompetitive Product Solutions
ndashLessons Learned
ndashConstraints
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
Key points for implementing DfR activities
bull Start DfR activities early in the process
bull Reliability engineerrsquos job is to leadcoach the design team Reliability achievement needs to be owned by design and manufacturing teams
bull Integration of Reliability and Quality Engineers with design teams
bull Warrantyfield data analysis (both statistical and root cause analysis) needs to be fed back to both design and reliability teams
bull Reduce the number of tools in the toolbox but use the remaining well Neither all steps nor tools are necessary for all the programs
2262014 Ops A La Carte copy 33
34
Reliability Before Design
SpendingRate
Qualification Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
Reliability Spend Rate
Traditional Reliability Model
35
Reliability Before Design
SpendingRate
Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Qualification
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
New Reliability Spend Rate
$ Savings $
Reliability Before Design
Design for Reliability Method
copy Ops A La Carte LLC 2012
copy 2009 Ops A La Carte
36
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte 37
DEVELOPING AN
EFFECTIVE
RELIABILITY TEST
STRATEGY
Steps to a Good Design
In order to write better test plans
1) Understand Requirements
2) Understand Use Environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform Design amp Design Reviews
6) Write Design Verification Test plan
7) Write Reliability Test Plan
Understanding Requirements
Inputs include
ndashSpecifications
bull MRD ndash Marketing Requirements Document
bull PRD ndash Product Requirements Document
ndashCompetitive Product Solutions
ndashLessons Learned
ndashConstraints
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
34
Reliability Before Design
SpendingRate
Qualification Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
Reliability Spend Rate
Traditional Reliability Model
35
Reliability Before Design
SpendingRate
Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Qualification
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
New Reliability Spend Rate
$ Savings $
Reliability Before Design
Design for Reliability Method
copy Ops A La Carte LLC 2012
copy 2009 Ops A La Carte
36
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte 37
DEVELOPING AN
EFFECTIVE
RELIABILITY TEST
STRATEGY
Steps to a Good Design
In order to write better test plans
1) Understand Requirements
2) Understand Use Environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform Design amp Design Reviews
6) Write Design Verification Test plan
7) Write Reliability Test Plan
Understanding Requirements
Inputs include
ndashSpecifications
bull MRD ndash Marketing Requirements Document
bull PRD ndash Product Requirements Document
ndashCompetitive Product Solutions
ndashLessons Learned
ndashConstraints
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
35
Reliability Before Design
SpendingRate
Time
0
1
2
3
4
5
6
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Qualification
Development
Feasibility
Concept
Launch
Post-Launch
Product Development
Spend Rate
New Reliability Spend Rate
$ Savings $
Reliability Before Design
Design for Reliability Method
copy Ops A La Carte LLC 2012
copy 2009 Ops A La Carte
36
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte 37
DEVELOPING AN
EFFECTIVE
RELIABILITY TEST
STRATEGY
Steps to a Good Design
In order to write better test plans
1) Understand Requirements
2) Understand Use Environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform Design amp Design Reviews
6) Write Design Verification Test plan
7) Write Reliability Test Plan
Understanding Requirements
Inputs include
ndashSpecifications
bull MRD ndash Marketing Requirements Document
bull PRD ndash Product Requirements Document
ndashCompetitive Product Solutions
ndashLessons Learned
ndashConstraints
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
copy Ops A La Carte LLC 2012
copy 2009 Ops A La Carte
36
Seminar OverviewWed Feb 26 2014
- DFR OVERVIEW -
Introduction
Difference between Quality and Reliability
Difference between Regulatory and Reliability
Design for Reliability Overview
Developing an Effective Reliability Test Plan
copy 2008 Ops A La Carte 37
DEVELOPING AN
EFFECTIVE
RELIABILITY TEST
STRATEGY
Steps to a Good Design
In order to write better test plans
1) Understand Requirements
2) Understand Use Environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform Design amp Design Reviews
6) Write Design Verification Test plan
7) Write Reliability Test Plan
Understanding Requirements
Inputs include
ndashSpecifications
bull MRD ndash Marketing Requirements Document
bull PRD ndash Product Requirements Document
ndashCompetitive Product Solutions
ndashLessons Learned
ndashConstraints
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
copy 2008 Ops A La Carte 37
DEVELOPING AN
EFFECTIVE
RELIABILITY TEST
STRATEGY
Steps to a Good Design
In order to write better test plans
1) Understand Requirements
2) Understand Use Environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform Design amp Design Reviews
6) Write Design Verification Test plan
7) Write Reliability Test Plan
Understanding Requirements
Inputs include
ndashSpecifications
bull MRD ndash Marketing Requirements Document
bull PRD ndash Product Requirements Document
ndashCompetitive Product Solutions
ndashLessons Learned
ndashConstraints
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
Steps to a Good Design
In order to write better test plans
1) Understand Requirements
2) Understand Use Environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform Design amp Design Reviews
6) Write Design Verification Test plan
7) Write Reliability Test Plan
Understanding Requirements
Inputs include
ndashSpecifications
bull MRD ndash Marketing Requirements Document
bull PRD ndash Product Requirements Document
ndashCompetitive Product Solutions
ndashLessons Learned
ndashConstraints
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
Understanding Requirements
Inputs include
ndashSpecifications
bull MRD ndash Marketing Requirements Document
bull PRD ndash Product Requirements Document
ndashCompetitive Product Solutions
ndashLessons Learned
ndashConstraints
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
Understanding Requirements
bull Risks comes From Requirements That Are
ndash Incomplete
ndashAmbiguous
ndashConflicting
ndashNot Testable
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
Understand Use Environment
bull What are normal use conditions
bull What are typical abuse conditions
bull What are atypical (but real) abuse conditions
bull What is life of product
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
Perform FMEA
Failure Modes and Effects Analysis
(FMEA) is the process by which we
explore potential failure modes and
then prioritize by key risks
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
Perform FMEA
bull Use good brainstorming techniques breaking sessions out by different disciplinesareas
ndashUser (UFMEA)
ndashWearout (WFMEA)
ndashDesign (DFMEA)
ndashSoftware (SFMEA)
ndashProcess (PFMEA)
ndashInterface (IFMEA)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
Use Robust Design Techniques
Design for Robustness (RD) is a
systematic engineering based
methodology that develops and
manufactures high reliability
products at low cost with reduced
delivery cycle
The goal of RD is to improve RampD
productivity and reduce variation
while maintaining low cost before
shipment and minimal loss to
society after shipment
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
Example of Robust Design MIR
Space Station
bull Robustness = survivability in the face of unexpected
changes in environment (exo) or within the system (endo)
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design and design reviews
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
Designing to Requirements
Mechanicalbull Common Hardware
bull Minimize Part Count
bull Feature Integration
bull Design For Assembly
bull Design For Test
bull Design for Service
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
Designing to Requirements
Electrical
bull Select Parts With Long Lifetimes
bull Design For Assembly
bull Design For Test
ndash In-Circuit Test
ndashFunctional Test
bull Design for Service
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
Designing to Requirements
Software
bull Understand reqts before coding
bull Phase containment approach
bull Growth through defect tracking
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
Design Reviews
bull Compare plan with reality
bull How to determine actual status
ndashEngineer says hersquos 90 done but how do you know
ndashShort schedule milestones should have broken the project into short measurable pieces
bull Do your reviews ever uncover anything
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
Develop Design Verification Test
Create tests that match each requirement and can be traced back to ensure you have covered the requirements
Use trace matrix
Use FMEA to record how each failure mode is covered by which requirement
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
Steps to a Good Design
In order to write better test plans
1) Understand requirements
2) Understand use environment
3) Perform FMEA
4) Use Robust Design techniques
5) Perform design amp design reviews
6) Write design verification test plan
7) Write Reliability Test Plan
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
Write Reliability Test Plan
Start with DVT plan and then review
FMEA to determine what areas
standard tests will not guarantee
reliability
1) For Environmental tests do you
test outside specsto failure
2) For ElectricalMechanical
stresses do you test outside
specs for margin
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
What You Need to Write a
Good Test Planbull Goal
bull Sample Size
bull Time
bull Acceleration
bull Confidence
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
What Is Confidence
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
Stress-Strength Analysis continued
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
Product
Operational
Specs
Stress
Upper
Oper
Limit
Upper
Destruct
Limit
Lower
Destruct
Limit
Lower
Oper
Limit
Operating
Margin
Destruct Margin
Margin Improvement Process
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
63
Bathtub Curve with Tests
Product Life
Failu
re R
ate Wearout
Failures
ALT
Workmanship
Flaws
Traditional Product Evaluation
Various Design and Process Flaws
HALT
amp HASS
HALT
HALT
(MTBF here)
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
DFR Summary
bull Design for Reliability (DFR) is integrating
reliability into each portion of product life
cycle
bull Reliability is not just about testing
ndash You canrsquot test reliability into a product
bull You Must Design it In
bull Using DFR you will design reliability and
availability into your product to make these
more predictable
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
CONTACT INFO
Mike Silverman
Managing Partner
Ops A La Carte LLC
(408) 654-0499
mikesopsalacartecom
wwwopsalacartecom
John Cooper
johncopsalacartecom
(650) 207-3664
