Raising A CAPA on Current CAPA system

#1
Hi guys

Ive recently moved company and already implemented a new NCR process as it wasn't fit for purpose.
I have raised a CAPA on the current CAPA process as again this is not fit for purpose.
My CAPA scope/Justification is as follows;

The reliability of the current CAPA process and connecting forms has been deemed unsuitable and has been identified by QE leadership as an improvement for TBS. Connecting Forms relating to the current process are being missed out during investigation and we as a company recognise this needs addressing”

Do you believe it to be okay to do this? its the best way to capture the issue and will be an improvement CAPA.
 
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Bev D

Heretical Statistician
Staff member
Super Moderator
#2
If you believe that the CAPA system is inadequate in it’s current form it is absolutely appropriate to ‘raise a CAPA’ against it. The important thing is that you are assessing your QMS and continually improving it.

One thing to consider is to articulate the effect on the business of the current system - what isn’t it doing it well? is it too slow, not effective, not focused on the right type of non-conformances, etc.
 

Pancho

wikineer
Super Moderator
#4
When you say you “raised a CAPA”, what exactly are you doing, in your system’s terminology? Is it a request for corrective action? Or are you reporting a nonconformity?

Do you believe it to be okay to do this? its the best way to capture the issue and will be an improvement CAPA.
As with any other process, if you spot a weakness or “nonconformity” then you usually raise a Nonconformity Report. Is that what you meant when you say that you “raised a CAPA”? The NCR should be as thorough as possible because it will then help you investigate and find the root cause of the NC. For example, if forms are not being completed, then isn’t that the NC to be reported? Then, if corrective action is warranted, from specific NCs you can raise corrective action requests (CARs; is this what you say you did when you “raise a CAPA”?).

When you say:

The reliability of the current CAPA process and connecting forms has been deemed unsuitable and has been identified by QE leadership as an improvement for TBS. Connecting Forms relating to the current process are being missed out during investigation and we as a company recognise this needs addressing”
In CAPA as in any other process, the corrective action process is like this: (1) Identify what is nonconforming, (2) investigate and find the root cause, (3) eliminate the root cause by modifying the process.

In your description I’m not very clear on what is nonconforming. What connecting forms are being missed out? How is that making the process reliability unsuitable? Being specific will help find the root causes and then successfully modify the process to eliminate them.
 
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