CAPA- Effective CAPA Systems


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Debbie Reese, Vice President, Quality & Compliance, Maetrics

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  • CAPA- Effective CAPA Systems

    1. 1. CAPA: Challenges, Pitfalls…and How to Overcome Them 10-June-2014
    2. 2. Learning Objectives for this Session After this session, you will: • Understand common challenges and pitfalls with CAPAs and root cause analysis and how to avoid them • Learn best practices for effective CAPA programs • Discover how to monitor the effectiveness of your CAPA program ©2014 Maetrics. All Rights Reserved. 1
    3. 3. ©2014 Maetrics. All Rights Reserved. 2 C A P A
    4. 4. Common Challenges and Pitfalls with CAPAs • The greatest challenges to an effective CAPA program include: –Writing a good problem statement, –Correctly identifying root cause, –Developing corrective actions that truly address the root cause, –Executing the CAPA in a timely manner –Having personnel who “get” what a good CAPA looks like ©2014 Maetrics. All Rights Reserved. 3
    5. 5. Common Challenges and Pitfalls with CAPAs Some of the biggest pitfalls we see with CAPAs are: • Implementing “corrective actions” for a symptom rather than the actual root cause • Driving the CAPA process on timelines rather than on deliverables • Setting unrealistic timeframes then having to issue extensions • Using the same root cause analysis tool for every CAPA • Thinking that anyone can do CAPAs • Over using “operator error” or “lack of training” as the root cause • Excessive delays in decisions and actions ©2014 Maetrics. All Rights Reserved. 4
    6. 6. Common Challenges and Pitfalls with CAPAs Additional pitfalls • Identifying the “root cause” prior to conducting an investigation • Inappropriate use or interpretation of data to get the answer that you want • Inappropriate use of statistics (For example, only 1 in 10,000 will get hurt) • Normalizing data to hide an increase in the number of complaints, failed product, etc. • Failing to list all the areas investigated or ruling out areas that were never examined ©2014 Maetrics. All Rights Reserved. 5
    7. 7. Common Challenges and Pitfalls with CAPAs Additional pitfalls • Correcting only some of the root cause elements • Omitting details because you assume that “everyone” already understands • “Over documenting” by including e-mails, etc. • For recurrent issues, need to explain why this action will fix it unlike the first time • Not identifying a corrective action for each root cause if multi-factorial ©2014 Maetrics. All Rights Reserved. 6
    8. 8. DO • Make decisions that are fact based and put patient, and user, welfare first • Evaluate human factors, not human error • Assign CAPAs to the owner/responsible person in a timely manner • Be open and honest in your problem statement – Trying to create a statement that keeps auditors form seeing the “dirt” also keeps you from effectively dealing with the issue • Look at the CAPA from a global perspective • Use statistically valid rationale • Use a process for notifying owners of missed time frames ©2014 Maetrics. All Rights Reserved. 7 Best Practices in Deploying a CAPA Program
    9. 9. DO • Have a mechanism in place for discontinuing products if the corrective action is not feasible • Include provisions for extensions –When allowed –How many per CAPA –Who approves • Always consider PoE when creating your corrective action plan • Use reasonable time frames that are based on risk ©2014 Maetrics. All Rights Reserved. 8 Best Practices in Deploying a CAPA Program Implement a good CAPA system and call me in six months
    10. 10. DO • Assure that you have all the necessary data • Examine trends • Use a CAPA Committee or Team • Include an independent reviewer on the team • Use formal documentation and good documentation practices • Consider knowledge, skills and attributes (KSA) when it comes to personnel ©2014 Maetrics. All Rights Reserved. 9 Best Practices in Deploying a CAPA Program
    11. 11. DO • Identify all inputs/feeder systems in your CAPA procedure(s) –This aids in knowing when to investigate –Includes complaints, non-conforming product, trends, service and repair reports, process deviations, returns, environmental failures, QC failures, training, etc. • Proactively look to see if an event has occurred previously and include provisions in the procedure for what to do with recurrence –Reopen previous CAPA or create new one –The same event recurring implicates the effectiveness of your POE, root cause identification and corrective action ©2014 Maetrics. All Rights Reserved. 10 Best Practices in Deploying a CAPA Program
    12. 12. DO NOT • Assign too many CAPAs to the same owner • Assign a CAPA to the wrong, untrained person, or somebody who just does not get it • Allow unjustified extensions or too many extensions • Over document • Avoid inclusion of e-mails if at all possible • Focus on meeting a due date at the expense of correctly identifying the issue and getting it corrected • Use terms like “we believe,” “we feel,” “even though,” “however,” etc. • Delay actions in order to let affected product inventory be depleted or expire ©2014 Maetrics. All Rights Reserved. 11 Best Practices in Deploying a CAPA Program
    13. 13. CAPA Program Effectiveness • Measuring effectiveness of your CAPA system is not as simple as saying x% of your CAPAs pass the Proof of Effectiveness(PoE) • Need to assess: – Repeat CAPAs for same or similar issue – Length of time it took to open a CAPA once a problem was confirmed – How long it takes to confirm a problem – How many extensions are granted – Number of procedure changes over a specific period of time – Elapsed time between procedure changes (i.e., repeated changes to the same procedure) – Number of "trainings" on same issue even if "need for training" arose from different CAPAs – Number of procedures per QS element or per operation, or department – CAPA requests rejected by CAPA committee – Internal audit observations compared to CAPA root causes (i.e., is your audit program looking at the right areas to the appropriate depth) ©2014 Maetrics. All Rights Reserved. 12
    14. 14. Questions? ©2014 Maetrics. All Rights Reserved. 13