6 methods for CAPA's effectiveness verification

1. 6 Methods for CAPA Effectiveness
Verification
Paolo Croce| QA Specialist | paolo.x.croce@gmail.com

2. Agenda
Introduction
Difficulty in determinate an appropriate CAPA Effectiveness Verification
method
Examples of CAPA Effectiveness Verification Methods
Selecting an appropriate CAPA Effectiveness Verification timeframe

3. 6 Methods for CAPA Effectiveness Verification
Verifying the effectiveness of corrective and preventive actions closes the loop between
identifying a problem and completing the actions to solve a problem. It seems reasonable to
expect that if a problem is worth solving, it is also worth verifying that the problem is actually
solved.
But, determining the best verification approach and deciding when to conduct the verification
for the wide range of problems that could occur can be elusive.
Before discussing CAPA effectiveness, it is important to look at a few of the reasons why
performing this check is often a challenge.

4. Why is it so difficult to determine an appropriate CAPA
Effectiveness Verification method?
• The problem is not well defined - Sometime breaking the mental logjam is as simple as
asking "What problem were we trying to solve?" That sounds like an easy question, but
when the answer is not well defined or stated simply, measuring success is not easy to
grasp.
• The root cause is not determined - This is a natural consequence of the first reason.
• It's not really a CAPA - without a stated problem or the determination of a root cause, it is
not a CAPA. It's just a project.
• CAPA Effectiveness Verification is used for everything - CAPA Effectiveness
Verification can be too much of a good thing when it is expected for every possible CAPA.
This usually occurs from the cascading problem of a CAPA being required for every
deviation, and a deviation being required for every conceivable blip.

5. Why is it so difficult to determine an appropriate CAPA
Effectiveness Verification method?
• Overthinking it - Rather than allowing reason to prevail, there are those who tend to
complicate just about everything. Determining and applying the effectiveness method is no
exception. Not every method of verifying effectiveness has to be labor intensive. Major
processes need not be applied to minor problems.
• It's considered not important - There are those who believe that living with an ongoing
problem is the path of least resistance when compared to conducting the same boilerplate
investigation (same problem different day) and getting on with production.

6. What are some examples of CAPA Effectiveness
Verification Methods?
• Audit Method - is used when the solution involves changes to a system where a
determination is made whether changes are in-place procedurally and in-use behaviorally.
An example: Auditing the new logbook to demonstrate effective implementation of
the new logbook system.
• Spot Check - is used for random observations of performance or review of records
provide immediate, but limited feedback. An example: Spot-checking of batch records
to ensure that the IPC test was performed correctly after training on the new
procedure.
• Sampling - is used for observations of variables or attributes per defined sampling plan.
An example of sampling: is when a statistical sample is randomly drawn from a lot X
post implementation of process improvement to confirm the absence of defect.

7. What are some examples of CAPA Effectiveness
Verification Methods?
• Monitoring - is used for real-time observations over a defined period. An example of
monitoring: is the real time observation of to verify that changes to operator
practices were implemented.
• Trend Analysis - is the retrospective review of data to verify that expected results were
achieved. An example of trend analysis is the review of environmental monitoring
(EM) data for the period covering the last 30 batches to show the downward trend in
EM excursions due to process improvements.
• Periodic Product Review - is a retrospective review at least annually of trends of multiple
parameters to confirm the state of control. An example of periodic product review is
the review of data after major changes were made to the facility and equipment as
part of a process technology upgrade.

8. How do we select an appropriate CAPA Effectiveness
Verification timeframe?
Less Time. Allow relatively less time after implementing the solution when:
• Higher opportunity for occurrence / observation
• Higher probability of detection
• Engineered solution
• Fewer observations needed for high degree of confidence
More Time. Allow relatively more time after implementing the solution when:
• Lower opportunity for occurrence/ observation
• Lower probability of detection
• Behavioral/ training solution
• More observations needed for high degree of confidence

9. Thank you for your attention.
Paolo Croce| QA Specialist | paolo.x.croce@gmail.com