Date post: | 20-Jan-2015 |
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INTERNAL CERTIFICATION
EXTERNAL SUPPLIER EVALUATION & SELECTION
• Quality and Reliability• Willingness to Work Together - Responsiveness• Technical Competence• Commitment to Continuous Improvement• Geography• Price
- Total Acquisition Costs
- Processing Economics
IMPORTANCE OF SUPPLIER QA
• Amount of Purchased Product Increasing
• Poor Supplier Quality Increases Cost
• Buyers and Suppliers Are More Interdependent
• Other Factors# Cost Reduction# Inventory Control# Schedule Demands
SUPPLY CHAIN MANAGEMENT
• External Customers– Sales and Operations Planning– Smoothing Customer Demand– Developing JIT Customers
• External Supplier Relationships– Evaluation, Selection & Consolidation– Certification– Supplier Development– Vendor Managed Inventories
SUPPLIER ACTIVITIES
Outsourcing Out-partnering
Product/Capacity Buys Process/Capability Buys
Reduced Direct CostFlexibility
Name RecognitionExcess Capacity
Access to Technical ExpertiseMarket Information
RationalizationLatest Technology and Processes
EXTERNAL SUPPLIER CONSOLIDATION
• Sole Source vs.. Single Source
• Benefits– Simpler Traceability– Increased Communication– Ability to Focus on Process
• Concerns:– Traditional Focus on First-Cost
TQM OBJECTIVE• Foster a long-term relationship with a small
number of suppliers
• Because suppliers are chosen for the long term it is important to have:– Supplier Policy– Supplier Evaluation and Selection Methodology– Planning– Certification– Continuous Improvement
CHANGING RELATIONSHIPS
Traditional Relationship - Adversarial
New Relationship - Long Term - Mutual Benefit - Fewer Suppliers - Better Suppliers
• Primary Tasks– Evaluate Solicitations – Evaluate Supplier Capability– Conduct Post Contract Award Activities– Monitor Status of Delivered Product
• Program Organization– Engineers & Quality Assurance
• Data Base Management
• Primary Tasks– Evaluate Solicitations – Evaluate Supplier Capability– Conduct Post Contract Award Activities– Monitor Status of Delivered Product
• Program Organization– Engineers & Quality Assurance
• Data Base Management
ORGANIZING A SUPPLIER PROGRAM
SUPPLIER
EVALUATION
SUPPLIER CERTIFICATION
PROGRAM
SUPPLIER CONTROL
ACTIVITIESSUPPLIER
SELECTION
SUPPLIER QUALITY ASSURANCE
Supplier Control PlanningSupplier Control Planning
ADDRESS THE SIXMAGIC QUESTIONS
WHO?
WHAT?
WHY?
WHERE?
WHEN?
HOW?
Answer These QuestionsAnd You Will Have A Good Plan!!
The Keys to an ExcellentSupplier Control Plan
WHY?
WHY DO WE NEED TO ENSURE SUPPLIERQUALITY?
WHY IS THIS IMPORTANT?
POLICY STATEMENT BY TOP MANAGEMENT WOULD BE APPROPRIATE HERE!
WHO?
Who Is In Charge
Who Is Responsible For Specific Duties
How Do These Offices Interrelate
WHAT ?What Is To Be Done To Ensure Effective Supplier Control?
Maintain Certification Program
Monitor Solicitations
Participation In Pre & Post Contract Award Activities
Evaluate & Approve Contract Data Requirements List items (CDRLS)
Participation In FAAT
Etc.
WHAT ARE YOUR RESOURCES?
Financial Budget
Availability Of Personnel
Computer Support
Data Base Management
WHERE?
Where Will The Activities Identified In This Plan Occur?
At Your Facilities?
At The Suppliers Facilities?
WHEN?
WHEN SHOULD IDENTIFIED ACTIVITIES OCCUR?
SEQUENCE OF EVENTS
HOW?
How Will The Identified ActivitiesBe Accomplished
Reference More Detailed Procedures
ISO 9000 RequirementsISO 9000 Requirements
Paragraph 7.4.1: The Purchasing Process
Paragraph 7.4.2: Purchasing Information
Paragraph 7.4.3: Verification of Purchased Product
Paragraph 8.4: Analysis ofData
ISO 9000 - 2000 REQUIREMENTS
Supplier CertificationSupplier Certification
Elements of a Certification Program:• Quality Management System
• New Product/Technology/Service Control
• Sub-Supplier Management
• Process Operation & Control
• Quality Data Program
• Human Resources Involvement
• Customer/Performance Assessment
SUPPLIER CERTIFICATION
• Good (Pass)• Bad (Fail)
• Poor• Weak• Fair• Marginally
Qualified• Qualified• Outstanding
AttributeAssessment
VariableAssessment
ATTIBUTE OR VARIABLE ASSESSMENT
SUPPLIER DEFINITIONS
Approved Supplier:Minimum QualificationApproved To Supply Required Item
Preferred Supplier: Approved, Participating In Certification ProcessQuality History Is ExcellentMay Pull Samples For Customer TestingProvides Lot-specific Certificates Of Analysis
Certified Supplier:Extensive InvestigationNot Necessary To Perform Routine Testing
Partner
APPROVED
CERTIFIED
PARTNER
DIRECT MATERIAL SUPPLIERS
EXTERNAL SUPPLIER CERTIFICATION
PREFERRED
Tec
hn
olo
gy
Dev
elo
pm
ent
Strategic Business Alignment
Approved
Certified
Partner
SUPPLIER MATRIX
BUYER-SUPPLIER RELATIONSHIPS
Arm’s-LengthRelationships
Acceptance ofMutual Goals
Buyer-Supplier Spectrum of Relationships
ConfrontationTraditional Relationship
ConfrontationSuspicion
Outsourcing
Full PartnershipNew Relationship
CooperationTrust
Out-partnering
KEY RATING CRITERIA
QUALITY
DELIVERY
TECHNICAL SUPPORT
MANAGEMENT ATTITUDE
COST
QUALITY
DELIVERY
TECHNICAL SUPPORT
MANAGEMENT ATTITUDE
COST
GENERAL CERTIFICATION CRITERIA
No Product Rejections For Significant Period
No Non-Product Rejections For Stated Period Of Time
No Production- Related Negative Incidents For A Stated Period Of Time.
Passed A Recent On-site Quality System Evaluation
A Totally Agreed On Specification
Timely Copies Of Certificates Of Analysis, Inspection Data, And Test Results.
Stable and In Control Processes
BULK PROCESS INDUSTRIES
Compare Supplier’s Test Results With Your Tests
Compare Results Statistically
PIECE PART INDUSTRIES
Process Capability AnalysisDefects Per Million
Monitor SPC Data
Rolled Throughput Yield
DATA COLLECTION FOR CERIFICATION
Process AnalysisInput SpecificationsActivity PerformedOutput Specifications
Performance DataPerformance Capability StudiesExpected Defect Level
SYSTEM ADMINISTRATION
An Established Procedures
Established Quality System
Evaluation Criteria
Trained Personnel
QUALITY REQUIREMENTS
ISO 9000 - 1994
ISO 9000 - 2000
SIX SIGMA
QUALITY ASSESSMENT
Evaluate Entire Quality System
An Agreed Upon Criteria• ISO 9000• ISO 9000 Plus
Professional Audit• Audit Plan• Trained / Competent Assessors• Identify Deficiencies• Corrective Action Audit (If Necessary)• Audit Report
Manufacturing Facilities
Quality Program
Technical Support & Human Resources
Material Control
Process Control
Communication
TYPICAL SUPPLIER EVALUATION CRITERIA
QS-9000 CRITERIA
Same 20 Elements Identified By ISO 9000: 1994
Each Element Has Been Expanded
Additional ElementsProduction Part Approval ProcessContinuous ImprovementManufacturing Capabilities
Chrysler, Ford, General Motors Requirements
(CP)2 CRITERIA
Same 20 Elements As ISO 9000:1994
Additional Criteria Identified For Each Element
Assessment Criteria And Metrics For Each Element
Additional Elements:
Customer SatisfactionQuality CostsWarranty PerformanceEthics
Business PlanningSafetyEnvironmentalContinuous Improvement
Supplier Quality System ReviewProcess
Supplier Quality System ReviewProcess
Provide Supplier Clearly WordedDocumentation & Evaluation Criteria
Supplier Conducts Self Audit
Implement Corrective Action & Improvements
Evaluation Team Conducts Audit
Audit Report
Supplier Response : Continuous Improvement Plan Soon After Receiving Audit Report
Follow-up Audit To Monitor Progress And Reevaluate
THE OVERALL PROCESS
QUALIFICATIONS FOR QS AUDIT TEAM LEADER
Membership In A Quality, Supply ManagementManufacturing Or Engineering Council/team
Or Experience As A R&QA Engineer, Supplier Quality Engineer, Or Commodity Manager
Member On At Least Two Previous Supplier Qs AuditTeams
QA Training - Being A Certified Qs Lead Auditor Is A Good Idea
Supplier Control Supplier Control
Pre-award
Solicitation Review
Post-award
M&TE Review & Approval
Review & Approve Quality Plans(Identified In The Contract)
First Article Test (FAAT)
Production Audit(s)
Monitor Key Metrics• Rolled Throughput Yield• SPC Charts• Process Capability Studies
Monitor ECPsRFWs/RFDs
Monitor Items ReceivedDelivery Schedule
SUPPLIER RATING
SUPPLIER CONTROL AssistanceTraining SupportConsultation
Quality StandardsISO Certified/CompliantSix Sigma
Constant Feedback
Solicitation ReviewSolicitation Review
Identify Responsible Individual
Develop Solicitation Review Procedure
Maintain Solicitation File
Ensure Requirements Are Properly Identified
MONITOR ADEQUACY OF SOLICITATIONS
IDENTIFY RESPONSIBLE INDIVIDUAL
• REVIEW THE SOLICITATIONS
• COMMUNICATE WITH SOLICITATION POC
• MAINTAINS FILES
• MONITORS AMENDMENTS
DEVELOP & MAINTAIN PROCEDURE
WHY?
WHO?
WHAT? WHERE?
WHEN?
HOW?
Why Is This Important & Needed
Responsibilities
Tasks to Done
Location of Review & Files
Frequency of Review Process
Methodology for Performing the Review
ENSURE REQUIREMENTS AREPROPERLY LISTED
•Quality System Requirements• SPC • Criteria For Quality Plans Clearly Stated• Quality Manual Approval• Approval of SPC General & Detailed Quality Plans• Acceptance of Inspection Equipment (AIE) Methodology • First Article Acceptance Test (FAAT) Methodology• FAAT Report Distribution• “Sample” Ammunition Data Card Distribution• Proper Warranty Clauses• Proper Rework and Repair Clauses• Proper Distribution of Lot Acceptance Test Reports
COMMUNICATE WITH SOLICITATION POC
• IDENTIFY DISCREPANCIES
• MAINTAIN RECORDS
• FOLLOW-UP
Pre-Award EvaluationPre-Award Evaluation
Item Importance
Quality History
Total Cost
Delivery History
Facilities
Experience
EVALUATION OF SUPPLIERS
Is This a CertifiedSupplier?
EVALUATING SUPPLIER CAPABILITIES
• Qualify Design
• Qualify Manufacturing Process
– Prior Performance– Process Capability– Quality Survey– Approved Supplier Lists
SUPPLIER RATINGS
• Consider Quality, Price and Schedule
• Supplier Rating Plan must be– Clearly defined and communicated– Contains only necessary information– Economical to implement– Practical in coverage of materials, parts, or services– Maintainable– Auditable
ITEM IMPORTANCE
Pencils & Paper Can Be Purchased From Anybody
Important Items Require More Control
SUPPLIER QUALITY HISTORYISO Compliant / Certified?
Six Sigma?
Previously Supplied Product?
History Of Waivers & Deviations?
Quality Deficiency Reports (QDRs)?
Corrective Action Responsiveness?
COST $$$
Always Important
Total Life Cycle Costs?
DELIVERY HISTORY
Percent Of Deliveries Made On Time
Percent Of Deliveries With Correct Amount
Shipping Invoices Properly Completed
Correct Billing
FACILITIES
Building Floorspace
Special Tooling Requirements
Safety Considerations
Test Facilities
Accessibility
Availability Of Personnel
EXPERIENCE
Has The Supplier Built A Similar Item Before?
Management Experience
Technical Experience
Post-Award AssistancePost-Award Assistance
POST-AWARD ASSISTANCE
A Formal Meeting To Ensure Supplier Properly Understands:
• All Specification Requirements • All Drawing Requirements• Implementation of SPC • SPC Plan Requirements• SPC Flow-down Requirements• Special Processes• Contractual Requirements• FAAT Requirements• LAT Requirements• Production Audit
Gage Review and ApprovalGage Review and Approval
GAGE REVIEW AND APPROVAL
Supplier Needs to Identify All Gages Used to Inspect Major, Special and Critical Characteristics
These Gages Need to Be Evaluated & Approved
Appropriate / Capable
Approval Before FAAT
SPC Plan Review and ApprovalSPC Plan Review and Approval
SPC PLAN REQUIREMENTS
General And Detailed Plans
Clearly Stated In Solicitation
WHAT WILL THESE PLANS DO
Each Plan Answers The Five Magic Questions
General SPC Plan Describes OverallSPC Program
The Detailed Plan Describes SPC Operations For Specific Production Line
EVALUATING SPC PLANSMake Sure Plans Comply WithAll Requirements
May Set The Stage For FurtherContractual Compliance Issues
Approve General Plan Before FAAT
Approve Detailed Plan Before Production
BE TOUGH!!
First Article Acceptance Test(FAAT)
First Article Acceptance Test(FAAT)
FIRST ARTICLE ACCEPTANCE TEST
(FAAT)
Can the Supplier Produce the Item?
• Requirements Usually Spelled Out in the Spec• Approved Gages & Equipment• SPC Plans (General & Detailed ) Approved• Measurement & Performance Requirements• Be Tough• Now Is the Time to Cut Your Losses
DIMENSIONAL REQUIREMENTS
All Dimensions Identified On DrawingsMust Be Inspected
The Number Of Samples To Be InspectedNormally Established By Specification
All Dimensions Must Be In Compliance
Gages Used Need To Be Properly ApprovedCalibrated, Capable And Appropriate
BALLISTIC TESTING
Requirements Probably Established By Specification
May Require Specific Test Equipment
Environmental Conditioning
Ballistic And Dimensional Failures Are Equal
Production AuditProduction Audit
THE PRODUCTION AUDITNot a Surprise - Established Criteria, Detailed Audit Plan
All Specification & Drawing Requirements Accomplished?• Purchase Order Development• Incoming Inspection• Gages - Approved, Appropriate, Capable & Calibrated• In-process Inspection• SPC Operations• Process Control• Final Inspection• Check All Critical Characteristics• Check Significant Number of Major Characteristics• Destructive & Non-destructive Tests
Write a Useful Audit Report
Focus On The Product Not The Quality System!
THE AUDIT PLAN
Tell The Supplier Exactly What Will Happen
Who
What
When
Where
How
No Surprises
PURCHASE ORDER DEVLEOPMENT
Must Reflect All Specification And Drawing Requirements
Flow Down Of SPC Requirements
Plus All ISO 9000 Requirements
INCOMING INSPECTION
Incoming Material Invoices ReviewedTo Ensure Correct Item Has Arrived
Do The Invoices Match The Purchase Orders?
Is Incoming Material Handled & Stored Properly
Receiving InspectionAre Proper Characteristics InspectedAre The Right Gages Being UsedAre Gages Calibrated
GAGESHave They Been Properly Approved
Calibrated
Capable
Appropriate
Check Calibration LabReview Gage Linearity DataTraining RecordsCompliance With StandardsReview Procedures
INPROCESS INSPECTION
In Accordance With Spec. & Drawing Requirements
Documentation & Product Identification
In Accordance With IS0 Requirements
Inspection Data Sheets Done Correctly
Sampling Done Correctly
SPC OPERATIONS
Compliance With General And Detailed Plan Requirements
Charts Being Done Correctly
Out-of-control Situations Properly Identified
Control & Centerlines Being Evaluated On Regular Basis
Process Capability Studies Being Done & Reviewed
Vendor SPC Data Evaluated Properly
PROCESS CONTROL
Procedures
Suitable Work Environment
Effective Training
Preventive Maintenance
Non-conforming Material
Necessary Items Not Beyond Shelf Life
NON-DESTRUCTIVE TESTS
Training Records
Compliance With Standards
Procedures
Proper Equipment
FINAL INSPECTION
Compliance With Specification & Drawing Requirements
Appropriate Equipment Being Used
Data Sheets Are Properly Completed
CHECKING CHARACTERISTICS
All Criticals
Most Majors
Ensure Compliance With All Specification And Drawing Requirements
Watch Operations During Several Cycles If Possible
Changes, Waivers, and DeviationsChanges, Waivers, and Deviations
• Configuration Control Board
• Established Procedure
• Input From Customers
• Review Based on Engineering & Quality Assessment
• Arguments Must Have Proper Statistical Support
• Data Base Management
CHANGES, WAIVERS,& DEVIATIONS
REQUIRE PROPER STATISTICAL JUSTIFICATIONS
Paired Comparisons
Confidence Intervals
Null Hypothesis
Required Sample Sizes
Paired Comparisons
Confidence Intervals
Null Hypothesis
Required Sample Sizes
FACT BASED DECISIONS!!
Monitor Key MetricsMonitor Key Metrics
• Rolled Throughput Yield
• SPC Data
• Other Metrics
KEY METRICS
Throughput YieldThroughput Yield
NOMENCLATURE
Number Of Operation Steps = m Defects = DUnit = UOpportunities For A Defect = OYield = Y
BASIC RELATIONSHIPS
Total Opportunities (TOP) = U X O
Defects Per Unit (DPU) = D/U
Defects Per Unit Opportunity (DPO) = DPU/O = D/(U X O)
Defects Per Million Opportunities (DPMO) = DPO X 106
DISTRIBUTION OF DEFECTS IN MANUFACTURED PRODUCT
Non-Randomly Occurring Defect
Randomly Occurring Defect
Example
Result
Conclusion
Wrong part in manualinsertion parts bin
Every board contains same wrong part insame location.
Defects are easier todetect/diagnose & are less likely to be sent tonext operation
Mixed parts in manualinsertion parts bin.
Probability of a boardcontaining wrong part isequal to proportion of wrong parts in bin
Defects are harder todetect/diagnose and are more likely to be sent to next operation
GENERAL CHARACTERISTICS OF DPU
Directly Proportional To:• Parts Count • Lines of code• Die Area
Product Built In Plant Having Best Process Controls Will Have The Lowest Defects Per Unit Level
DEFECTS PER UNIT
Defect Prevents Product From Fulfilling Physical And Functional Requirements Of The Customer
A Unit• A Measure Of Volume Of Output• Observable & Countable• Is An Individual Measurement - Not An Average
Number of Defects Found at Any Review Point
Number of Units Processed Through That Review PointDefects Per Unit =
A Count of All Defects - Not a Measure of the Consequences of The Defect
PREDICTING THE QUALITY OF PRODUCTS
FTY = e-DPU DPU = -ln FTY
Estimation of units containing “q’ defects (where “q” is not limited to zero)
If we use the Poisson distribution
Becomes
(DPU)q e -DPU
q!
x e-
x!P{x} =
YIELD RELATIONSHIPS
Throughput Yield : YTP = e-DPU
Defects Per Unit: DPU = -ln(Y)
Rolled Throughput Yield: YRT = m YTPi
Total Defects Per Unit: TDPU = -ln(YRT)
Normalized Yield: Ynorm =
Defects per Normalized Unit: DPUnorm = -ln(Ynorm)
i=1
mYRT
PROBABILITY OF DEFECTS IN MANUFACTURED PRODUCT
GIVEN: (1) Average DPU For This Product Is One (DPU=1)(2) Defects are randomly distributed
What Is The Probability of Zero Defects In This Unit?
YIELDProbability with zero defects
Y = P(x = 0) =e-x
x! e-= = e-D/U = e-DPU
Specification Limit
Probability of Defect= 1 - e-DPU
Yield = e-DPU
THE HIDDEN FACTORY
Customer Quality
Operation
NotOK
Scrap
Verify
Rework
Operation
NotOK
Scrap
Verify
Rework
Ytp
Throughput Yield
Ytp
Throughput Yield
Non-Value Added(The Hidden Factory)
Value Added(The Visible Factory)
ProducersQuality
Supplier Quality
Yrt = Ytpi
m
i=10
IMPLICATIONS OF THE HIDDEN FACTORY
Y e eTP
DPU
3679
1 0 . = 1.6321
.
1.63 Equivalent Units Must Be Produced To Get Out 1 Good Unit
Every Occurrence Of A Defect Within The Manufacturing Process Requires Time To Verify, Analyze, Repair And Re-verify
Average Cycle Time Per Unit Is Directly Proportional To The Total Number Of Defects Per Unit
Cycle Time = Work In ProcessThroughput
#1
#6
#2
#7
#5
#9
#4
#8
#3
#10Final Insp..
Process Yield is 93.17% - Right??????
A FACTORY WITH 10 PROCESSES
NOT QUITE!!!
1200 Good & 88 BadItems [93.2%Found OK]
COMPARISON OF YIELDS
Y = SU
= 12001288
= .931677
S = Number of Units That PassU = Number of Units Tested
Throughput Yield Analysis Tells UsYTPI = .47774
.4774 .932Why Not???
ROLLED THROUGHPUT YIELD
Operation Defects UnitsDPU(D/U)
Throughput Yield(YTPI = e-D/U = e-DPU)
12345678910
57518726
2882703588
523851334
1202252243943894234
1200
0.009560.088130.053890.059900.023810.115230.086960.078300.149570.07333
0.990490.915640.947530.941860.976470.891160.916720.924690.861080.92929
Sum of
Operation Steps = 479 6676 0.73868 0.47774 (YRT)
47.9 667.6 0.07387 0.73868 =TDPU TDPU = -ln(YRT)
Avg.. ofOperation Steps
=
HOW MANY UNITS PRODUCED?
UNITS PRODUCED = 1 + (1 - e-DPU)
= 1 + (1 - e-73868)= 1 + (1 - .477744)= 1 + .5222558= 1.52
To Achieve 100 Conforming Units, 152 ( 1.52 X 100) Would Need To Be Produced
SPC DataSPC Data
SUMMARY OF PROCESS CAPABILITY STUDIES
Primary SPC Metric
Maintain Data Base
Insure Supplier Is Taking Action• Unacceptable Cpks• Marginal Cpks• Too Long As Unacceptable Or Marginal• Disturbing Trends
Clearly Established Triggers - Can Effect Certification
OTHER SPC DATA
Maintain Current Copies Of SPC Plans
Not Necessary To Have Copies Of All SPC Charts
Have Representative Sample• Audits• Corrective Action Situations• Special Requests
COMPARE SPC DATA
Receiving Inspections, Field Reports, Etc.Should Compare With CPK Data
If Not, Why Not?
Other MetricsOther Metrics
Provide AssistanceProvide Assistance
JOINT PLANNING
• Economic Planning
# Value Not Conformance
# Optimize Quality Cost• Technological Planning• Managerial Planning
• Economic Planning
# Value Not Conformance
# Optimize Quality Cost• Technological Planning• Managerial Planning
Statistical InferenceSPCDesign of Experiments (DOE)SamplingAll Quality Management ConceptsSix Sigma Black Belt Other Certifications • X-Ray• Soldering• Etc.
TRAINING
PROBLEM SOLVING
Technical Expertise
Operations Research
Master Black Belt Assistance
KEEP THE SUPPLIER INFORMED
Changes From Your Customer
Changes in Operations
Changes in Production Requirements
Remember This Is a Partnership - If Your SupplierDoes a Good Job, Then You Look Good!!
ASSIST WITH SIX SIGMA PLAYER CERTIFICATIONS
Champions
Master Black Belts
Black Belts
Green Belts
CHAMPIONS
Senior Managers Who Define The Projects
Do Whatever Troubleshooting Is Required
At Start Of GE Program Some Business Leaders Were Champions
Now A GE Business Has 7 - 10 Champions
Not Required To Work Full Time In The Quality Program
Suppose To Devote As Much Time As Necessary To Make Sure Program Succeeds
Training Length: 1 Week
By Spring 1999 Every Officer And Every Senior Executive Was A Champion
MASTER BLACK BELTSFull-time Teachers With A Good Deal Of Quantitative Skills
Teaching And Leadership Ability
Review And Mentor Black Belts
Length Of Training: At Least 2 Weeks
In Spring Of 1999 GE Had 700 Master Black Belts
Certification After Overseeing At Least 10 Black Belts Who Get Certified &
Approved By The Business Champion Team
BLACK BELTSFull Time Quality Executives
Lead Teams That Focus On Key Processes
Report Results Back To The Champion
Responsible For Measuring, Analyzing, Improving, And Controlling Key Processes
By Spring 1999 There Were 4,500 Black Belts At GE
To Be Certified Must Be Approved By Business Champion Team
SIX SIGMA BLACK BELTS
Mentor
Teach
Coach
Transfer
Identify
Influence
GREEN BELTS
Personnel Who Take Part In Black Belt Projects On Part-time Basis
Must Continue To Use Six Sigma Tools In Regular Jobs
TYPICAL SIX SIGMA TRAINING CURRICULUM
Week 1Six Sigma Overview & Process ImprovementProcess MappingQuality Function Deployment (QFD)Failure Mode and Effects Analysis (FMEA)Organizational Effectiveness ConceptsBasic Statistics Using MinitabProcess CapabilityMeasurement System Analysis
Week 2Review of Key Week 1 TopicsStatistical ThinkingHypothesis Testing (F, t, etc.)CorrelationPassive Multi-Vari Analysis & Regression (simple)Team assessment
Week 3Design of ExperimentsRegression AnalysisFacilitation Tools
Week 4Control PlansStatistical Process Control (SPC)Advanced Process ControlMistake-ProofingTeam DevelopmentWrap-Up of Tools
Evaluating Delivered ProductEvaluating Delivered Product
• Supplier History• Criticality of Part• Warranty History• Supplier Process Capability• Manufacturing Process• Availability of Skills/Equipment
• Supplier History• Criticality of Part• Warranty History• Supplier Process Capability• Manufacturing Process• Availability of Skills/Equipment
EVALUATING DELIVERED PRODUCT
LOGISTICS MANAGEMENT SYSTEM
InternalLogistics
InboundLogistics
OutboundLogistics
(Physicaldistribution)
Plants
OrganizationSupplier Customer
The span of the logistics management system
CONTINUOUS IMPROVEMENT
• Motivation
• Analyze Losses
• Provide Technical Assistance
• Training
• Long-Term
SUMMARYBe Involved At The Start Participate in Selection of SuppliersParticipate in Post Contract Award Activities
Post Award MeetingsM&TE ApprovalQuality Plan Review & ApprovalFAATProduction AuditsReview & Approval of ECPs, RFDs, & RFWsMonitor Key MetricsProvide Assistance
Ensure Expertise Through Product TeamsMaintain Data Base
SUPPLIER CERTIFICATION
Consider levels of supplier capability:
•Probationary
•Approved
•Certified
THE AUDIT PROGRAM
DEFINED
“Do Unto Yourself What Others Will Do Unto You”
Find Your Problems Before The Customer Does
IMPORTANT INTERNAL AUDIT CONCEPTS
AUDITOR’S MISSION STATEMENT:
To Provide Evaluations That Are:
• Independent
• Uniform
• Consistent
To an Agreed Upon Standard
&
CLEARLY ESTABLISHED CRITERIA
Everyone Should Know The Standard Against Which The Audit Will Be Conducted• ISO 9000 - 1994• ISO 9000 - 2000• QS 9000• ISO 9000 Plus• Product Specification• Product Drawings• Military Standards, Handbooks, Publications, etc.
NO SURPRISES!!
A PUBLISHED SCHEDULE
Quality System Requirements - Annual Schedule Will Work
Production Audit - 1st Week Of Production (Before Customer Arrives)
Follow-Up Audits - An established time period plus notification well prior to audit.
NO SURPRISES !!!
THE AUDITING GROUP
Independent Of Groups Being Audited - If Possible
Well Trained And Knowledgeable
Can Be A Full Time Job
Must Have Full Support Of Management
Somebody Must Audit The Audit Group
PROGRAM OBJECTIVE
To Obtain Sufficient Evidence
To Evaluate Compliance
With a Standard
PURPOSE OF AN AUDIT
A Management Tool
To Make Improvements
An Audit Can Determine:
• Future Purchases
• Certify the Organization
• Register the Organization
DEFINITIONAn Audit Is:• A Planned Systemic Process Performed
by Independent, Trained Personnel In Accordance With Previously Prepared “Game Plan”
• Results Are Documented
• Corrective Actions Are Taken
• Top Management
• Auditor
• Auditee
ELEMENTS OF AN AUDIT
• PROCESS
• PRODUCT
• QUALITY SYSTEMS
CLASSES OF AUDITS
CLASSES OF AUDITS(CONTINUED)
• PROCESS
• PRODUCT
• QUALITY SYSTEMS
CLASSES OF AUDITS(CONTINUED)
• Process
• Product
• QUALITY SYSTEMS
• ORGANIZATION
• LEAD AUDITOR
• SUBJECT MATTER EXPERTS
• Team Members
ORGANIZATION OF AN AUDIT TEAM
ORGANIZATION OF AN AUDIT TEAM
(continued)
• Organization
• Lead Auditor
• Subject Matter Experts
• TEAM MEMBERS
DUTIES
• Team Members* Objectivity
* Analysis
* Alertness
* Ethics
• Lead Auditor* Responsibility
* Management
* Decision Making
AUDITOR CONDUCT AND SKILLS
• Technical Knowledge
• Audit Training
• Good Communication Skills
• Attitude of Helpfulness
AUDITOR CONDUCT AND SKILLS
• Technical Knowledge
• Audit Training
•Good Communication Skills
•Attitude of Helpfulness
AUDIT IMPLEMENTATION
• Audit Initiation• Preliminary Meeting• Audit Planning• Pre-Audit Review• Performing the Audit• Reporting Results• Audit Conclusion, Including
* Follow-Up* Corrective Action
AUDIT INITIATION
• Purpose & Location
• Reference Standards
• Schedule
• Guidelines
• Report Distribution
• REGULATORY
• STANDARDS
• Internal Documents
REFERENCE STANDARDS
REFERENCE STANDARDS(CONTINUED)
•Regulatory
•Standards
• INTERNAL DOCUMENTS
• IDENTIFICATION OF TEAM MEMBERS
• DATES AND LOCATIONS OF THE AUDIT
• Schedule and Assignments
• Meetings
• Report Distribution
• Escorts
• Necessary Documents
SPECIFIC AREAS TO ADDRESS
SPECIFIC AREAS TO ADDRESS(CONTINUED)
• Identification of Team Members
• Dates and Locations of the Audit
• SCHEDULE AND ASSIGNMENTS
• MEETINGS
• Report Distribution
• Escorts
• Necessary Documents
SPECIFIC AREAS TO ADDRESS(CONTINUED)
• Identification of Team Members
• Dates and Locations of the Audit
• Schedule and Assignments
• Meetings
• REPORT DISTRIBUTION
• Escorts
• Necessary Documents
SPECIFIC AREAS TO ADDRESS(CONTINUED)
• Identification of Team Members
• Dates and Locations of the Audit
• Schedule and Assignments
• Meetings
• Report Distribution
• ESCORTS
• NECESSARY DOCUMENTS
COMMITMENT TO:
• Facilities
• Documents
• Personnel
• Top Management
• Corrective Actions Taken
• Preventive Actions Taken
AUDIT PLANNING
• Brief the Audit Team
* Audit Scope
* Identification of Auditors and Auditee
* Schedule
* Standards and Procedures
• Initiate Working Papers
• Brief the Audit Team
• Initiate Working Papers
AUDIT PLANNING(CONTINUED)
PRE-AUDIT REVIEW
• Review Documents
• Continue Preparation of Working Papers
• Management in-Brief
• Plant Tour
• Operational Meeting
• Audit Operations
• Daily Written Records
PERFORMING THE AUDIT
PERFORMING THE AUDIT(CONTINUED)
• Management in-Brief
• Plant Tour
• Operational Meeting
• Audit Operations
• Daily Written Records
PERFORMING THE AUDIT
• Management in-Brief
• Plant Tour
• Operational Meeting
• Audit Operations
• Daily Written Records
• PUT PERSON AT EASE
• EXPLAIN WHY HE IS BEING QUESTIONED
• Learn What He Does
• Analyze What He Does
• Determine a Tentative Conclusion
• Explain the Next Step
INTERVIEWS
INTERVIEWS (CONTINUED)
• Put Person at Ease
• Explain Why He Is Being Questioned
• LEARN WHAT HE DOES
• ANALYZE WHAT HE DOES
• Determine a Tentative Conclusion
• Explain the Next Step
• Put Person at Ease
• Explain Why He Is Being Questioned
• Learn What He Does
• Analyze What He Does
• DETERMINE A TENTATIVE CONCLUSION
• EXPLAIN THE NEXT STEP
INTERVIEWS (CONTINUED)
TYPES OF FINDINGS
• Findings or Observations
• Systemic or Isolated Problems
DETERMINING ACCEPTABILITY
• Unconditional Approval
• Conditional Approval
• Conditional Nonapproval
• Unconditional Nonapproval
FINAL OUTBRIEF
• Last Opportunity to Dispute Findings
• Senior Management Present
• No Surprises
• Purpose and Scope
• Applicable Game Plan Details
• Referenced Documents
• Audit Findings and Observations
• Recommendations (Internal Audit Only)
• Corrective Actions
FINAL WRITTEN REPORT
• CORRECTIVE ACTION REQUESTS
• Follow-up (Corrective Action) Audits
• Close-Out
• Records
FOLLOW-UP ACTIONS
• Corrective Action Requests
• FOLLOW-UP (CORRECTIVE ACTION) AUDITS
• CLOSE-OUT
• RECORDS
FOLLOW-UP ACTIONS
CORRECTIVE ACTION EVALUATION
• Correct the Problem
• Determine Its Affect on Past Performance
• Take Immediate Temporary Corrective Actions
• Take Permanent Action to Prevent Recurrence
AUDITOR REQUIREMENTS AND QUALIFICATIONS
* Communicate * Plan * Control * Gain Cooperation * Lead
*Administer * Work Independently * Good Attitude * Reach Decisions * Adaptable * Good Impression* Intelligent * Emotionally Stable* Good Character * Technical Training in Area of Expertise
AUDITOR TECHNICAL TRAINING
• Nondestructive Inspection & Test Training
* Eddy Current Testing * Heat Treatment Processes * Liquid Penetrant Testing * Welding Inspection
* Magnetic Particle Test Methods * Soldering Inspection * Radiographic Test Methods * Ultrasonic Test Methods * Drawing & Blueprint Reading
• Quality Assurance* Software Quality Assurance (32 hours)* Geometric Dimensioning and Tolerancing (40 hr.)* Weibull Risk and Uncertainty Analysis (24 hrs)* Principles of Metrology (40 hrs)* Statistical Process Control, (24 hrs)
AUDITOR TECHNICAL TRAINING (Continuing)
• Configuration Management* Configuration Management (40 hrs)* Material Review Board Procedures (4 hrs)
• Procurement* Defense Contracting for Technical Personnel (40 hrs)* Procurement Integrity (8 hrs)* Government Contract Law (24 hrs)
AUDITOR TECHNICAL TRAINING (Continuing)
• Design Control* Design Review (24 hrs)* Reliability by Design (40 hrs)
• General* Report Writing (24 hrs)* Basics of Explosive Safety (24 hrs)* Effective Written Communication (15 hrs)* Safe Assembly of Component Explosives (32 hrs)* Hazardous Waste Training (8 hrs)
MEETINGS
• Nightly Team Meetings
• Inform Auditors
• Share Information and Findings
• Change Audit Schedule
• Morning Reviews With Auditee
• Keep the Auditee Informed
PRELIMINARY MEETING
• Initiated by Correspondence
• Between Lead Auditor and Auditee
• Define Responsibilities
• Identify Requirements
PRELIMINARY MEETING(CONTINUED)
• Initiated by Correspondence
• Between Lead Auditor and Auditee • Define Responsibilities
• Identify Requirements
AUDIT TYPES
•Internal - First Party
• External - Second Party
- Third Party