1. Focus on Quality FDA Initiative: June 11, 2013 Francisco Vicenty
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2. Agenda What is the Focus on Quality project? 2012 Activities 2013 Plan
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3. Focus on Quality Scope and Direction
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?
We’re finding that we’re needing to think outside the box on how the agency and industry collectively assure good device quality.
So what does that mean? Well first, we need to better define the problem – why isn’t compliance a natural outflow of constant attention to device quality?
Focus on quality

4. FoQ’s Methodology Scope and Direction Industry Engagement Process
Interview/
Assess
Evaluate/
Modify
Pilot
Analyze
FoQ’s Methodology
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5. Kim Lewandowski-Walker Karen Masley-Joseph Keisha Thomas Cisco Vicenty
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
Focus on quality

6. 2012 Activities
Engage stakeholders to assess quality/compliance perception gap
Manufacturers
CDRH Compliance Officers
ORA Investigators & Compliance Officers
International Regulatory Officials
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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…
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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.
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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
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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.
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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.
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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
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13. What is this term, “Critical to Quality?” e.g., a “CtQ tree”
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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?
This isn’t exclusively a question for FDA, i.e. what can firms do to promote focus on Critical to Quality. Right now our team is focused on our FDA approach.
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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?
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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
Getting harder to justify investments in quality infrastructure, page 30
There is a regulatory disincentive around quality, page 30-31
There is little top management focus on quality performance, page 32
Compliance focused environment diverts resources away from quality investments, 34
Note1
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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
An OAI inspection classification occurs when significant objectionable conditions or practices were found and regulatory action is warranted to address the establishment's lack of compliance with statute(s) or regulation(s).
A VAI inspection classification occurs when objectionable conditions or practices were found that do not meet the threshold of regulatory significance. Inspections classified with VAI violations are typically more technical violations of the FDCA.
An NAI inspection classification occurs when no objectionable conditions or practices were found during the inspection or the significance of the documented objectionable conditions found does not justify further actions.
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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?
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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
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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?
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21. What you can expect 2013 Beyond 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
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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?”
What aspects of your interaction with FDA/Industry enhance a focus on device quality?
What aspects of your interaction with FDA/Industry COULD enhance a focus on device quality?
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