Debbie Reese, Vice President, Quality & Compliance, Maetrics

1. CAPA: Challenges, Pitfalls…and How to
Overcome Them
10-June-2014

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
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3. ©2014 Maetrics. All Rights Reserved.
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C
A
P
A

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
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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
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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
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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
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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
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Best Practices in Deploying a CAPA
Program

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
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Best Practices in Deploying a CAPA Program
Implement a
good CAPA
system and
call me in
six months

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
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Best Practices in Deploying a CAPA
Program

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
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Best Practices in Deploying a CAPA
Program

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
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Best Practices in Deploying a CAPA
Program

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)
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14. Questions?
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