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Copyright 2010-2013 John Cachat
Harmonize Your QMS
Model to Meet ISO
13485 Regulations
John M. [email protected]
Copyright 2010-2013 John Cachat
Housekeeping
Phones are muted
Use the question
block for questions Copy of presentation
available upon request
Copyright 2010-2013 John Cachat
About John M. Cachat
• Driving Business Performance
– Helping companies align their business and technology
– Focus on people, process, and then the technology
– Subject matter expert on business process management
– On-going research into next generation of technology for enterprise
systems
• 28 years experience in enterprise systems
– USAF Research Project (1985)
– Founder of enterprise quality software company (1988)
– Chair of ASQ technical committee on computerizing quality (1992)
• Trusted advisor to global organizations, government agencies,
and professional groups
http://www.linkedin.com/in/johncachat
Copyright 2010-2013 John Cachat
Agenda
• The requirements of ISO 13485
• Why you should become registered to this
standard
• The best quality management software
strategy to help you achieve compliance
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Copyright 2010-2013 John Cachat
• The medical device market will present greater opportunity and greater challenges for device companies, as it grows by 19.9 percent from 2009-2013
• The medical market is one of the most demanding sectors to serve, as rigorous oversight from regulators and customers requires "robust operational management"
• United States remains the largest consumer and producer of medical devices, others are growing rapidly
• United States’ medical device market was valued at more than $100 billion in 2008, accounting for roughly 42% of the world’s total
Medical Device Opportunity
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Copyright 2010-2013 John Cachat
ISO13485 Concepts Apply to ALL Markets
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Copyright 2010-2013 John Cachat
ISO13485 = ISO9000 plus
• The promotion and awareness of regulatory requirements as a management responsibility. An example of market specific regulatory requirements is 21 CFR 820 Quality System Regulation for Medical Devices sold in the United States.
• Controls in the work environment to ensure product safety
• Focus on risk management activities and design transfer activities during product development
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Copyright 2010-2013 John Cachat
ISO13485 = ISO9000 plus
• Specific requirements for inspection and
traceability for implantable devices
• Specific requirements for documentation and
validation of processes for sterile medical
devices
• Specific requirements for verification of the
effectiveness of corrective and preventive
actions
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Copyright 2010-2013 John Cachat
Comparison of ISO900 and ISO13485(source 13485store.com)
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Blue Text = This Clause Has Additional Requirements for ISO 13485 Beyond ISO 9001
Copyright 2010-2013 John Cachat
Comparison of ISO900 and ISO13485(source 13485store.com)
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Blue Text = This Clause Has Additional Requirements for ISO 13485 Beyond ISO 9001
Copyright 2010-2013 John Cachat
Comparison of ISO900 and ISO13485(source 13485store.com)
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Blue Text = This Clause Has Additional Requirements for ISO 13485 Beyond ISO 9001
Copyright 2010-2013 John Cachat
Comparison of ISO900 and ISO13485(source 13485store.com)
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Blue Text = This Clause Has Additional Requirements for ISO 13485 Beyond ISO 9001
Copyright 2010-2013 John Cachat
Comparison of ISO900 and ISO13485(source 13485store.com)
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Blue Text = This Clause Has Additional Requirements for ISO 13485 Beyond ISO 9001
Copyright 2010-2013 John Cachat
“Quality” in Your Organization
Is it just a cost of doing business?
OR
Is it a competitive advantage?
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Copyright 2010-2013 John Cachat
Quality as a Competitive Advantage
• Quality professionals need a better
understanding of financial terms
and methods
• Executives need a better
understanding of Quality terms and
methods
• Everyone need to focus on
profitable business growth
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Copyright 2010-2013 John Cachat
Are We That Different?
Finance – SOX, GAAP Quality
Documentation Documentation
Training Training
Audits Audits
Risk Management Controls
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Copyright 2010-2013 John Cachat
Are We That Different?
Finance Quality
Likes Numbers Likes Numbers
Likes Processes and Audits Likes Processes and Audits
Discusses Cash, Profit, etc. Discusses PPM, CAR, Cpk, etc.
Reports what happened Can explain why it happened
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Copyright 2010-2013 John Cachat
The Disconnect between
Accounting and Manufacturing
• Finance has been consumed with GAAP and audited financial statements for external
reporting
• These traditional GAAP reports do not help manufacturing
• What information can Quality provide the organization to help make better decisions?
• How can this “quality” stuff help profitable growth?
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Copyright 2010-2013 John Cachat
Quality Costs Model
• Prevention—cost to
prevent mistakes
• Inspection—cost to
find mistakes
• Failure—cost of
mistakes (internal &
external)
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Copyright 2010-2013 John Cachat
Management Accounting
• Information for internal business support
• Great gains can be made by Quality and
Accounting working together
• The main focus should be cause and effect
analysis
• What makes this number go up or down?
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Copyright 2010-2013 John Cachat
Cause and Effect ExampleIncrease Profit on New Products
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PEOPLE
MFG PROCESS
EQUIPMENTPRODUCT
DESIGN PROCESS PURC PROCESS
INCREASE
PROFIT ON
NEW PRODUCTS
Copyright 2010-2013 John Cachat
Increase Profit on New Products
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INCREASE
PROFIT ON
NEW PRODUCTS
0
20
40
60
80
100
120
Design Proto Pre-Prod Production
Program A
Program B
Number of Engineering Changes by Product Stage
Copyright 2010-2013 John Cachat
Increase Profit on New Products
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Supplier Changes by Program
0
2
4
6
8
10
12
New Suppliers Suppliers Dropped Same Suppliers
Program A
Program B
INCREASE
PROFIT ON
NEW PRODUCTS
Copyright 2010-2013 John Cachat
Cause and Effect Example
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PEOPLE
MFG PROCESS
EQUIPMENTPRODUCT
DESIGN PROCESS PURC PROCESS
INCREASE
MARKET SHARE
INCREASE CUSTOMER
SATISFACTION
REDUCE COST OF
NONCONFORMACE
REDUCE
INVENTORY LEVELS
INCREASE
PRODUCTIVITY
Copyright 2010-2013 John Cachat
Why ISO13485?
• The goal of ISO
13485 compliance
and the FDA's 21
CFR Part 820
requirements is to
ensure medical
device quality,
safety, and
effectiveness
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Copyright 2010-2013 John Cachat
The Business Goal for ISO13485
• Reduce costs
• Reduce risk
• Fast product launch
• Increase market
share
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Copyright 2010-2013 John Cachat
Strategy & Culture of a Quality
Management System
• Adoption must be a strategic decision
• Design and implementation is influenced by:
– Needs
– Objectives
– Products provided
– Processes employed
– Size and structure of the organization
• It is not the intent to imply uniformity in the structure or uniformity of documentation
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Copyright 2010-2013 John Cachat
QMS Model
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Copyright 2010-2013 John Cachat
Quality Management System (Next Level of Detail)
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PROJECT MANAGEMENT
New Business Product/Process Validation Risk Management
PEOPLE
Customers Employees Suppliers
DOCUMENTATION
Process Flows/Procedures Product Information Records
EQUIPMENT
Capital Tooling Inspection
MANUFACTURING
Receiving Work Orders, Routers, Inspection Shipping
CONTINUOUS IMPROVEMENT
NCM and CAPA Project Teams Audits
Copyright 2010-2013 John Cachat
Should We Use a Business Model?
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Copyright 2010-2013 John Cachat
Business Model(Next Level of Detail)
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Copyright 2010-2013 John Cachat
My Quality Projects
Never Get Funded!
• You are choosing
between several projects
• You have limited money
to invest
• How do you decide
which project to fund?
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Copyright 2010-2013 John Cachat
Too Expensive? Compared to What?
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Copyright 2010-2013 John Cachat
Finance Terms
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• Return on Investment (ROI)
• Net Present Value (NPV)
• Internal Rate of Return (IRR )
• Payback Period
Copyright 2010-2013 John Cachat
Cost Justification
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MaterialTimeLabor Increase Revenue
Copyright 2010-2013 John Cachat
Cost Justification
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LaborPrevention
• People that design parts/processes• People that work with suppliers• People that define customer expectations
Inspection• People that check parts• People that check paperwork
Failure• People that scrap, rework, repair parts• People that scrap, rework, repair
paperwork• People that put out fires
Copyright 2010-2013 John Cachat
Cost Justification
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Time Prevention
• Time to design new parts/processes
• Time to process ECRs
• Time to generate reports
Inspection
• Delays in receiving inspection
• Manufacturing waiting on inspection
• Cannot ship until paperwork is done
Failure
• Time to get MRB disposition
• Time to solve problems
Copyright 2010-2013 John Cachat
Cost Justification
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Material Failure (Scrap, Rework, Repair)
• Buying incorrect material
• Making to incorrect revision
• ECR makes inventory obsolete
• Downgrades
• MRB inventory sitting around
Copyright 2010-2013 John Cachat
Cost Justification
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Increase Revenue
I want to give you this $10M order,
but you are only a $5M company.
I am concerned about the risk of
rapid growth at your company.
Copyright 2010-2013 John Cachat
How Do I Get Started?
• Where Am I?
• Costs/Risks
• People/Process IssuesPoint A
• Where Do I Want to Go?
• Savings/Benefits
• Technology RequiredPoint B
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Copyright 2010-2013 John Cachat
ISO13485 Implementation Program
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• ISO13485 Overview
• Gap Analysis
• Registrar Liaison
• Management Representative Selection
• Process/Procedures Implementation
• Internal Audit Assistance
• Corrective Action Assistance
• Pre-assessment of prior to registration audit
• Consulting during the registration audit
Copyright 2010-2013 John Cachat
ISO13485 Maintenance Program
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• Internal Audits, which are a crucial
component in QMS checks and balances
• Corrective Actions, which are performed
after surveillance audits to close out
nonconformities
• Software technology support
Copyright 2010-2013 John Cachat
Software Technology Support
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Copyright 2010-2013 John Cachat
Software Technology Support
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WORKFLOW
BUILT IN REPORTING
SUPPORT
MOBILE
DEVICES
Copyright 2010-2013 John Cachat
About Us
John Cachat
Contact
Proven expertise in business
information systems
Rapid Solution
Development™ process
ServicesAssess Current Status
Develop Short and Long
Term Plans
Develop Specific Solutions
to Your Problems
Assist in ROI Analysis
45
Copyright 2010-2013 John Cachat
FREE Proof of Concept
46
WeWe
Copyright 2010-2013 John Cachat
Harmonize Your QMS Model to Meet ISO 13485 Regulations
&
Contact:
John Cachat
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