DRAFT-CONFIDENTIAL 1

FDA Initiative:

Focus on QualityJune 11, 2013

Francisco Vicenty

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Agenda

• What is the Focus on Quality project?• 2012 Activities• 2013 Plan

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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?

Focus on quality

• FoQ’s Methodology

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Industry

Engagement

Process

Interview/

Assess

Evaluate/

Modify

Pilot

Analyze

Scope and Direction

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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

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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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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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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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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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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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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Onwards to 2013

• What is this term, “Critical to Quality” we heard about?

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“…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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What is this term, “Critical to Quality?”

e.g., a “CtQ tree”

Onwards to 2013

• Assessing the interview resultsWhat 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?

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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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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

DRAFT-CONFIDENTIAL 16Note1 http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM277323.pdf

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

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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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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

innovationDRAFT-CONFIDENTIAL 19

• 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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Beyond 2013

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

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For the Breakout Session

• 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?”

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How can our approach be updated to focus more on device quality?