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Beth Staub and Joanna Engelke
FDA Case for Quality
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The Medical Device Industry
• Projected $133 B 2016 • More than 6,500 companies • 80% less than 50 people
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The Case for Quality
Began the dialogue: • Focus on Compliance vs
Product Quality • Measurement and
Transparency • Culture
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The Case for Quality
“ the regulation does not prescribe in detail how a manufacturer must produce a specific device. Rather, the
regulation provides the framework that all manufacturers must follow by requiring that manufacturers develop and follow
procedures and fill in the details”
The Regulations Provide the “What”
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The “WHAT” of CAPA
PART 820.100 - Corrective and Preventive action:
• Establish and maintain procedures…
• Investigating the cause of nonconformities…
• Identifying the action needed…
• Verifying or validating the action …
• Implementing and recording changes ……
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The “HOW” of CAPA
• Containment and Interim Corrective Action
• Problem Solving - DMAIC, 8D, 5 Whys, Fishbone diagrams
• Project Management
• Metrics
• Culture - Reward and Recognition
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Defining the “How” - The Role of Industry
ISO 16949 21 CFR 210
Consensus standards Forums for regulators and industry
Training
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People • Conferences • Curriculums and
training • Culture
Continuous Improvement • Initiatives focused
on product design, process development and supply chain
Standards • For quality tools
such as FMEA, Mft. Transfer, Measurement Techniques
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Case for Quality Initiated from FDA’s 2011 white paper,
“Understanding the Barriers to Device Quality”
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“I don’t know exactly what product quality even means”
“OK, thanks for telling me what it means…how do I recognize it, measure it, know if I have it?”
“Daunting! How do I figure out the practical ‘know how’ to implement this well in my company?”
“How can we help the business people appreciate the value of quality so they will support our efforts?”
“Is FDA going to support this approach?”
The Questions We are all Asking
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Case for Quality Framework Initiated from FDA’s 2011 Whitepaper: “Understanding the
Barriers to Device Quality”
Product Quality Definition
How to Measure How to Implement
How to Derive the Value
How Evolve Enforcement from
Compliance to Quality
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Case for Quality Framework Initiated from FDA’s 2011 Whitepaper: “Understanding the
Barriers to Device Quality”
• MDIC/Xavier Metrics • Maturity Model
• MDIC Advanced Analytics: Customer Based Scorecard
• Supplier Certification such • FDA Data Transparency
• AdvaMed Library of Successful Quality Practices
• MDIC Competency Training
• MES Concepts • FDA CTQ Battery Pilot • FDA Inspectional CTQ Handbooks
Product Quality Definition
How to Measure How to Implement
How to Derive the Value
How Evolve Enforcement from
Compliance to Quality
• AdvaMed/FDA Definition
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Your Input is Needed
As you listen and interact today…
• What are your reactions? −Framework
−Projects
−Approach to working together
• What could be added, adjusted, re-prioritized?
• Any other suggestions?
• Any way you want to be more involved?
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