1 Beth Staub and Joseph Sapiente FDA Case for Quality.
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1 Beth Staub and Joseph Sapiente FDA Case for Quality
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Transcript of 1 Beth Staub and Joseph Sapiente FDA Case for Quality.
1
Beth Staub and Joseph Sapiente
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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“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 FrameworkInitiated from FDA’s 2012 Whitepaper: “Understanding the Barriers to Device
Quality”
ISO 13485
FDA QSR 21.CFR.820
Lo
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Reg
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Sta
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Product Quality Definition
How to Measure How to Implement
How to Derive the Value
How Evolve Culture from Compliance to
Quality
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Product Quality Definition
How to Measure How to Implement
How to Derive the Value
How Evolve Culture from Compliance to
Quality
Case for Quality Framework
• MDIC/Xavier Metrics• MDIC Maturity Model
• MDIC Advanced Analytics: Customer Based Scorecard
• FDA Data Transparency
• AdvaMed Library of Successful Quality Practices
• MDIC Competency Training
• FDA Library of Practices• FDA CTQ Battery Pilot• FDA Inspectional CTQ
Handbooks
• AdvaMed/FDA Definition
1010
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?
