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Using a Quality System Maturity Model (QSMM) to Drive Continuous Improvement

Michele Zammit, 25 July 2017

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Agenda

• What is a Quality System Maturity Model (QSMM)?

• Background/History

• Challenges Experienced

• Success Factors

• Lessons Learned

• Results

• Conclusion

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What is a QSMM?

A Continuous Improvement Tool that utilizes a Maturity Model methodology to provide a structured approach to transitioning from a reactive to a proactive Quality System

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How the QSMM Works:

• The QSMM is comprised of 27 QS elements (Used 21CFR 820, 210, 211, ISO 13485, ICH Q10 as references)

• Each QS element contains approx. 40 criteria across 5 maturity levels (approx. 1000 criteria total)

• Criteria developed based on the book: “Get it Right: A Guide to Strategic Quality Systems” by Ken Imler, 2006, ASQ Quality Press

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How the QSMM Works:

Each element’s criteria are a combination of 3 characteristics:

• People (Roles & Responsibilities, Training)

• Process (Process is defined, implemented, monitored, improved)

• Linkages (connections between QS elements)

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How the QSMM Works:

• Each Quality System Element (Examples: CAPA, Validation, Change Control) has 5 maturity levels of criteria.

• As the maturity level increases, the overall compliance risk and business risk decreases.

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How the QSMM Works:

Each Quarter, each manufacturing site performs a self-assessment against the criteria.

Annually, each site receives an independent assessment.

• Most assessments are “on-site”, by a cross-functional assessment team

• More mature sites can opt for a “Desk Assessment” conducted via Webex every other year.

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QSMM Background

• Deployed in 2014-15 to 21 FDA regulated manufacturing sites (Drugs & Devices), plus several logistics centers

• Expanded in 2016 to all (~50) manufacturing locations. Also began deployment in Global Technical Services organization.

• QSMM has become a standing component of Management Review at the Site, Region/Business Unit, and Corporate Levels.

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Challenges Experienced (and how they were

addressed)

Convincing sites that this is not another “flavor of the month”

• Perseverance. Consistent, visible & active support from Senior Management.

• Continuous Communication. Newsletters. SharePoint Sites. Webexes. Assessments.

• Incorporated into the Quality System (Proceduralized, made part of Mgmt. Review)

Breaking the mindset to only follow global procedures (which would only get to Level 3, and “compliance”)

• Going beyond Compliance. Breaking the paradigm. Being proactive cannot be proceduralized!

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Challenges Experienced (and how they were

addressed)

Assuring consistent interpretation of criteria across 4 global regions, 25 countries.

• Constant PDCA of the criteria. Updating based on results of significant audits. Clarifying. Removing redundancies. Adding Examples.

Assessing functions that span more than one location, or involves multiple functional groups (examples: R&D, Product Surveillance, Engineering, etc.)

• Still a work in progress. Some tailoring of criteria to Manufacturing facilities Vs “General Office” locations.

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Factors Contributing to Success

Centralized, dedicated support to manage the program, but emphasis on cross functional involvement with assessments (the more cross-functional, the better).

The assessment visit model was refined as sites matured. More mature sites’ assessments focus

on results Vs calibration. (Based on Situational Leadership II approach)

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Factors Contributing to Success (Continued)

• Assessments are not Audits! Discussion-based. Respect for the sites. Positive atmosphere focused on continuous improvement.

• Communication (Newsletters, Teleconferences, Recorded seminars, etc.)

• Knowledge sharing - Showcasing Best Practices for others to see

• Full transparency between groups/locations to promote communication and knowledge sharing.

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Common feedback received from enrollees in the QSMM program

“Provides a ‘Roadmap’ to the Quality System – Takes the mystery out of Quality”

“Audits seem like random observations. “QSMM” is much more systematic.”

“The assessment was very collaborative – it did not feel like an audit.”

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Lessons Learned (aka Things to Avoid)

Setting goals based on the levels.

If you set goals to achieve a certain level by a certain date, then it becomes all about the level, rather than about the criteria, and what the criteria represent. This can have unintended consequences.

Check the box

Enrollees need to view the criteria critically, and really need to demonstrate that a criteria is consistently and sustainably executed before claiming to achieve it.

Having QQ be solely the responsibility of the Quality Function

Cross functional involvement is much preferred over just Quality Organization

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Results

But first, a brief disclaimer…

The improved Quality System Results experienced over the past several years have a strong correlation to the rollout of QSMM, but claims cannot be made as to direct causation, as there were MANYimprovements being implemented during this time.

QSMM is the scorecard by which the Quality System’s Improvement (maturity) is measured over time.

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Conclusion

The use of a Quality System Maturity Model allowed a systematic, thorough assessment of the Quality System, identifying and closing gaps across 50+ manufacturing locations, and significantly improving the Quality System’s performance over the past 3+ years.

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ANY QUESTIONS?