Verification of Effectiveness of CAPA

Hi there!

We are updating our CAPA procedure and form at the moment. One of the items we want to review is the verification of effectiveness. Currently we have not specified when and how to do this, which results in a signature from QA that closes the CAPA administratively. Any suggestions how to describe this step in the procedure and on the form? In another post I read that it consists of checking that the root cause is gone, is that really all there is to it?

Wow!
Great subject to discuss.
My recollection is that for Correction, it is an easy call to review the effectiveness.
For Corrective action ... well, we are now getting into uncertainty though. All we can say is that at the time when we were visited the effectiveness, it is looks okay. There is no guarantee overall that the corrective action universally effective, because it can happen that later on it comes up again, and we need to revisit it again.
For Preventative action I do not think if we can asses the effectiveness, due to because there is no root cause ... so it is a really slippery surface to declare effectiveness over preventative actions.

Bear in mind it is solely my opinion, that's all.

Regards

It is the very definition of the root cause that once it is eliminated the problem is gone forever. So when you really have identified it and your corrective action was to eliminate the root cause than you indeed only have to verify elimination of the root cause to prove effectiveness of your corrective action.
In real life things typically are not so easy:
1) Did you really catch the root cause or would a further "Why?" have revealed some deeper cause?
2) What proof do you have for your hypothesis that this is the root cause?
And even if you really know the root cause it may be that it lies outside of your sphere of influence so that you cannot eliminate it. Is your corrective action really elimination of the root cause than verification is easy and the crux lies with 2)
If your CA are measures that prevent occurence of the root cause instead of eliminating it, than simple verification is not enough as it only shows you the "Now". In such cases I start to think in terms of validation, monitoring and trending (like for complaints in the post market surveillance activities).

Hope this helps...

Luwak said:

Hi there!

We are updating our CAPA procedure and form at the moment. One of the items we want to review is the verification of effectiveness. Currently we have not specified when and how to do this, which results in a signature from QA that closes the CAPA administratively. Any suggestions how to describe this step in the procedure and on the form? In another post I read that it consists of checking that the root cause is gone, is that really all there is to it?

Click to expand...

I would suggest to use something like:

"On, or immediately after the due date for implementation of corrective action, the CAPA issuer will follow up with an inquiry or an audit to determine if the corrective action has been implemented and if it is effective.

The CAPA issuer will be responsible for the verification of corrective action.

When there is objective evidence that the corrective action is effective, the nonconformity report is closed out. If more work is needed to fully implement the action, a new follow-up date is agreed upon."

The CAPA issuer will be responsible for the verification of corrective action.

Click to expand...

Would it not be better to have the QA manager review the effectiveness instead of the CAPA issuer?

Luwak said:

Would it not be better to have the QA manager review the effectiveness instead of the CAPA issuer?

Click to expand...

Why would it be better? (a QA manager that did not do the audit, did not collect the objective evidence, was not there during the audit, so an outsider for this CAPA)

I just gave an example. Change as you please.

In my experience, CAPAs typically are handled by a team and generally QA is at least part of that team if they do not lead the effort. So the team leader is responsible for the CAPA including finding the root cause, implementing the corrective actions and their verification. Of course she/he can and will not do everything herself but will delegate tasks. All tasks that somehow are relevant to the questions of "Is this sound; did we do it right; did we follow our procedures?" would naturally go to the QA team member... Especially if verification is not so easy and requires an elaborate plan (maybe with a little bit of statistics), then QA would own this and would also follow up on the verification.
If the non-conformity is simple and does not require a full-blown CAPA I would agree with Kales that it should be done by the owner who is most familiar with the issue. However I think there are a lot of companies out there where a QA manager would have to sign off/approve closure of all NCs and CAPAs...

TWA

What we've done that seems to have worked well is to wait for the following years internal audit to go over the CAPA and see if the root cause has truly been eliminated. This gives significant time to assure the root cause has truly been eliminated and will not re-occur. Once it has been verified via internal audit, the CAPA can be closed and our verification will say something along the line of "Corrective Action verified for effectiveness during internal audit ####. No further actions required."

Kales Veggie said:

Why would it be better? (a QA manager that did not do the audit, did not collect the objective evidence, was not there during the audit, so an outsider for this CAPA)

Click to expand...

Good question.. in our situation the QA manager is in practice always involved in a finding. Since he is also responsible for a proper functioning of the CAPA system as a whole, I would say that it makes sense that he reviews and closes each CAPA to make sure that the outcome satisfies the requirements.

Dear,

Good day. Attached sample 8D report may help you.

Regards,

Ghulam Mustafa