FDA Case for Quality
"The FDA Case for Quality explores the importance of product quality in the medical device industry, focusing on compliance, measurement, and transparency culture. It delves into regulations, CAPA procedures, problem-solving methods, and questions surrounding product quality recognition and implementation. The framework initiated by FDA's 2012 Whitepaper aims to bridge the gap between compliance and quality, emphasizing the value of quality in device manufacturing."
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Presentation Transcript
FDA Case for Quality Beth Staub and Joseph Sapiente 1
The Medical Device Industry Projected $133 B 2016 More than 6,500 companies 80% less than 50 people 2 2
The Case for Quality Began the dialogue: Focus on Compliance vs Product Quality Measurement and Transparency Culture 3 3
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 4 4
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 5 5
The HOW of CAPA Containment and Interim Corrective Action Problem Solving - DMAIC, 8D, 5 Whys, Fishbone diagrams Project Management Metrics Culture - Reward and Recognition 6 6
The Questions We are all Asking 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? 7 7
Case for Quality Framework Initiated from FDA s 2012 Whitepaper: Understanding the Barriers to Device Quality FDA QSR 21.CFR.820 How to Implement How to Measure Local Regulations Standards Product Quality Definition How Evolve Culture from Compliance to Quality How to Derive the Value ISO 13485 8 8
Case for Quality Framework How to Implement How to Measure AdvaMed Library of Successful Quality Practices MDIC Competency Training MDIC/Xavier Metrics MDIC Maturity Model Product Quality Definition AdvaMed/FDA Definition How Evolve Culture from Compliance to Quality How to Derive the Value MDIC Advanced Analytics: Customer Based Scorecard FDA Data Transparency FDA Library of Practices FDA CTQ Battery Pilot FDA Inspectional CTQ Handbooks 9 9
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? 10 10
