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FDA Initiative:

FDA Initiative:. Focus on Quality June 11, 2013 Francisco Vicenty. 1. Agenda. What is the Focus on Quality project? 2012 Activities 2013 Plan. Focus on quality . Scope and Direction. Focus on Quality

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FDA Initiative:

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  1. FDA Initiative: Focus on Quality June 11, 2013 Francisco Vicenty DRAFT-CONFIDENTIAL 1

  2. Agenda • What is the Focus on Quality project? • 2012 Activities • 2013 Plan DRAFT-CONFIDENTIAL

  3. Focus on quality Scope and Direction • Focus on Quality • Encompasses FDA traditional approach to evaluating device quality: inspections, recalls, and postmarket issues. • Our hypothesis: • When a firm has constant focus on assuring device quality, why wouldn’t compliance be the outcome?

  4. Scope and Direction • FoQ’s Methodology DRAFT-CONFIDENTIAL

  5. Focus on quality The FoQ Team • Kim Lewandowski-Walker • ORA National Expert Investigator • Karen Masley-Joseph • ORA Central Region, QS Manager • Keisha Thomas • CDRH/OC, Division of Enforcement A • Cisco Vicenty • CDRH/OC, Project Manager • Bill MacFarland • CDRH/OC, Division of Enforcement B

  6. 2012 Activities • Engage stakeholders to assess quality/compliance perception gap • Manufacturers • CDRH Compliance Officers • ORA Investigators & Compliance Officers • International Regulatory Officials DRAFT-CONFIDENTIAL

  7. 2012 Activities • Interview questions on FDA approach: • On perceptions and definitions: • How do you define quality? Compliance? Overlap? • On concepts: • Measures of quality • Tools and factors that impact on quality • Recommendations: • King/queen for a day… DRAFT-CONFIDENTIAL

  8. 2012 Activities • Manufacturer Feedback • Maintaining compliance does not ensure good quality. • FDA focuses purely on compliance and not on device quality. • FDA’s indirect measure of a firm’s commitment to quality is the resources that the firm spends on quality. DRAFT-CONFIDENTIAL

  9. 2012 Activities • CDRH Compliance Officer Feedback • We do not focus on quality because that’s not what we’ve chosen to focus on. • Significant interest in focusing on device quality, not just compliance. • We need: • Work processes to focus on quality • More interaction with firms on quality • Resources DRAFT-CONFIDENTIAL

  10. 2012 Activities • ORA Investigators & Compliance Officers • Compliance programs are written to focus on compliance - quality outcomes are not captured. • Seeking more collaborative interaction with firms during inspection, provide interpretation/advice on observations. DRAFT-CONFIDENTIAL

  11. 2012 Activities • International Regulatory Official Interviews (they promote a focus on quality through…) • Focusing on manufacturing processes that directly relate to Critical to Quality. • Prioritizing audit findings based on criticality. • Focusing on how management ensures good quality. • Interacting with firm to get them back to a state of compliance. DRAFT-CONFIDENTIAL

  12. Onwards to 2013 • What is this term, “Critical to Quality” we heard about? “…the key output characteristic of a process. An example may be an element of a design or an attribute of a service that is critical in the eyes of the customer.” - Implementing Quality: A Practical Guide to Tools and Techniques. By Ron Basu “A CTQ is a product or service characteristic that must be met to satisfy a specification or requirement.” - Six Sigma Best Practices. By Dhirendra Kumar “Its purpose is to start with the high-level strategic goal of customer satisfaction and determine how this goal “flows down” into measureable goals. - The Certified Six Sigma Handbook. By TM Kubiak and Donald W. Benbow DRAFT-CONFIDENTIAL

  13. What is this term, “Critical to Quality?” e.g., a “CtQ tree” DRAFT-CONFIDENTIAL

  14. Onwards to 2013 • Assessing the interview results What can FDA do differently to drive more focus on what is “Critical to Quality”, not just compliance behaviors? • Can we prepare investigators with CtQ information going into inspections? • How can investigators triage their review of QMS subsystems based on CtQs? • How can 483 observations be prioritized based on it’s correlation with a CtQ? DRAFT-CONFIDENTIAL

  15. Onwards to 2013 • How do you define in your company what is “Critical to Quality”, and why? • That which… • Impacts the customer needs? • Limited to safety and effectiveness? Fitness for use? • Extends to customer satisfaction? • What about low risk dissatisfies? • Only design features? • …or manufacturing process characteristics as well? • Are measureable? DRAFT-CONFIDENTIAL

  16. Beyond 2013 • From the Case for Quality whitepaper1 • Compliance focused environment diverts resources away from quality investments • There is little top management focus on quality performance • Leadership “calibrates success” based on inspectional results Note1http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM277323.pdf DRAFT-CONFIDENTIAL

  17. Beyond 2013 • If the current inspectional outcomes are focused on promoting “Compliance behaviors” i.e. • Inspectional Classifications: • No Action Indicated • Voluntary Action Indicated • Official Action Indicated DRAFT-CONFIDENTIAL

  18. Beyond 2013 • What kind of inspectional outcomes would promote “Quality Behaviors” not just “Compliance Behaviors?” • How can FDA’s approach to quality promote achievement of higher levels of execution? DRAFT-CONFIDENTIAL

  19. Beyond 2013 • More specifically, aren’t there different levels of quality system execution? e.g. • Deployment of proactive quality planning across product lines • Proactive monitoring of quality characteristics that prevent defects before they occur • Refining the approach to ensuring quality through cycles of evaluation and improvement • Achieving breakthroughs in quality through innovation DRAFT-CONFIDENTIAL

  20. Beyond 2013 • So we are developing a hypothesis for the upcoming months/years: • If device firm leadership “calibrates success” based on inspectional outcomes, do inspectional outcomes need to convey the levels of quality system execution? DRAFT-CONFIDENTIAL

  21. What you can expect • 2013 • FDA prototyping an inspectional approach that promotes more focus on Critical to Quality • Beyond 2013 • FDA engaging with stakeholders on additional ways to update our approach with respect to device quality DRAFT-CONFIDENTIAL

  22. For the Breakout Session How can our approach be updated to focus more on device quality? • What can FDA do differently to drive more focus on what is “Critical to Quality”, not just compliance behaviors? • How do you define in your company what is “Critical to Quality”, and why? • What kind of inspectional outcomes would promote “Quality Behaviors” not just “Compliance Behaviors?” DRAFT-CONFIDENTIAL

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