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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: Focus on Quality June 11, 2013 Francisco Vicenty DRAFT-CONFIDENTIAL 1 Agenda
  • What is the Focus on Quality project?
  • 2012 Activities
  • 2013 Plan
  • DRAFT-CONFIDENTIAL 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?
  • Scope and Direction
  • FoQ’s Methodology
  • DRAFT-CONFIDENTIAL 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
  • 2012 Activities
  • Engage stakeholders to assess quality/compliance perception gap
  • Manufacturers
  • CDRH Compliance Officers
  • ORA Investigators & Compliance Officers
  • International Regulatory Officials
  • DRAFT-CONFIDENTIAL 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 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 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 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 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 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 What is this term, “Critical to Quality?” e.g., a “CtQ tree” DRAFT-CONFIDENTIAL 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 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 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 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 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 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 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 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 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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