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Verifying the effectiveness of corrective and preventive actions (CAPAs) closes the loop
between identifying a problem and completing the actions to solve it. Its reasonable to
assume that if a problem is worth solving, its also worth
verifying that the solution worked. However, given the wide range of problems that
could occur, determining the best verification approach and time frame to implement
it can often seem elusive.
Before we discuss CAPA effectiveness, we need to look at a few of the reasons why per-
forming this check is often a challenge. Here are six:
1.
The problem isnt well defined
Sometimes 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 isnt well defined or stated simply, measuring success isnt
easy to do.
2.
The root cause isnt determined
This is a natural consequence of the first reason. Its next to impossible
to determine the root cause for a fuzzy problem, or one that seems too
complicated to explain. Those who try also get a fuzzy root cause.
3.
Its not really a CAPA
All too often, the CAPA system has become a quality work-order system
(aka dumping ground) because the commonly used data management
systems, provide project management structure and visibility. But without
a stated problem or determining a root cause, its not a CAPA; its just a
project.
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4. CAPA effectiveness verification is used for everything
CAPA effectiveness verification can be too much of a good thing when its
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. Soon you become a drowning
victim of your own making.
5. We over-think it
Rather than allowing reason to prevail, there are those who tend to
complicate just about everything. Determining and applying an appropriate
verification method is no exception. Yes, we operate in a scientific
environment, but not every method of verifying effectiveness must be
labor-intensive. Major processes need not be applied to minor problems.
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3. Sampling is used for observations of variables or attributes, per
defined sampling plan. An example of sampling a statistical sample
randomly drawn from lot XYZ123 to confirm that a defect has been
removed after implementing a process improvement.
6.
Periodic product review 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.
Now that we have a real CAPA and a selected a method to verify its effectiveness, we
must determine an appropriate time frame to perform the verification. Time frames
are subjective, but there must be a basis for the decision. Here are points to consider
when determining an appropriate time frame for CAPA effectiveness verification.
Allow relatively less time after implementing the solution when there is:
Higher opportunity for occurrence and observation
Higher probability of detection
An engineered solution
In these cases, fewer observations are needed for a high degree of confidence.
Allow relatively more time after implementing the solution when there is:
Lower opportunity for occurrence and observation
Lower probability of detection
A behavioral or training solution
In these cases, more observations are needed for a high degree of confidence.
http://theqapharm.blogspot.com.au/2015/03/6-methods-for-capa-effectiveness.html