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World of CAPAs - part 1

CAPA is basic process in all pharma companies, being not only a mandatory one, but can (should, must) be also an asset in continuous improvement.

However, poor CAPA management in a company can lead into a chaotic situation: CAPAs that can be never closed (e.g., due to financial reasons), multiple inappropriate CAPAs unable to eliminate one single root cause, etc.

Instead of evaluating the possibilities for the whole system, let's discuss where you can have your control in operative level, not to bother with trying to re-gain the control later.


What is a good CAPA?

There is a simple psychology behind the need of a CAPA: if you identified the root cause behind the deviation, it feels like needing a CAPA. And let me add, the less QA is expert on the topic of the deviation, the more this feeling is going to be there (at least in QA's mind).

So our job is to take a step back and think through if we really need a CAPA.


When is a CAPA worth to be opened? Let's be pragmatic here for a moment, and go with the answer 'if we can reduce/eliminate the recurrence of the deviation (preventive action), or we can increase the detectability of it and reacts to the phenomenon (corrective action)'. If you are familiar with the RPN (Risk Priority Number) concept on deviation classifications, this may be not new to you. Anyway, if your CAPA is neither, you may feel it's not worth to be opened.


Actions not as a CAPA

There (at least) two scenarios when it's against ourselves to define an action as a CAPA:


Training/retraining

There are some instances when your investigation tell you the root cause was some kind of human error. It may indeed happen sometimes, but le me quickly add the if you categorize a large number of root cause as human error, it draws a lot of attention: either your company has a poor quality mindset, or your training system fails, as a whole.

Let's get back to the CAPA topic. So if you identify the need for a (relatively quick and simple) training, don't bother to open, define and submit a CAPA, instead document the training as a part of the deviation. You may spare several hours later for you and for QA, as well.


Investment

If your investigation tells you you need to do some major change in your equipment train or utility, be strong and don't capture that need in a CAPA. Since the CAPA will be out from the quality universe to the real world, you will need financial approval, long time to implement, with less control on the CAPA from you.

Furthermore, the CAPA itself can give you a false confortability that your system is in a good shape, because you did what you could: opened a CAPA.

So if you run into an investigation like this, try and think about other, maybe also quicker CAPAs to at least temporarily reduce/eliminate the root cause, until you get your money to update your system.


After you made your decision to open a CAPA, let's talk about how to define an exact CAPA well in a next post.



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