CPA (Corrective and Preventive Action) Verification and Validation Process Steps

[arrowbay]

I've been researching all over the place and can't find anything specific on how to verify implemention of a CPA, (Corrective/Preventive Action) followed by validating its effectiveness. We are trying to create a reference document that describes how to first verify implementation (corrective actions were completed) and then how to validate the effectivenss (did the corrective action prevent the recurrence of the problem).

Does anyone have such a guideline that they could share with me?

[CarolX]

Hi arrowbay and welcome to the Cove-

Go to the search link on the top right, go to advance search, select this board and use keyword of "effectiveness" in the thread title only - you will find at least 5 threads with similar discussions.

[Duke Okes]

In Reply to Parent Post by arrowbay

I've been researching all over the place and can't find anything specific on how to verify implemention of a CPA, (Corrective/Preventive Action) followed by validating its effectiveness. We are trying to create a reference document that describes how to first verify implementation (corrective actions were completed) and then how to validate the effectivenss (did the corrective action prevent the recurrence of the problem). Does anyone have such a guideline that they could share with me?

Based on how the language is used for other applications I would say that:

- verification involves auditing to confirm that the recommended actions are actually being done
- validation involves using some sort of performance metrics to determine whether or not the desired effect/outcome was achieved

[Sidney Vianna]

In Reply to Parent Post by arrowbay

Does anyone have such a guideline that they could share with me?

I would guess you must work for a governmental entity or aerospace/space organization. How complicated can it be for someone (who is competent and well versed in CA/PA techniques) to verify that the proposed actions were indeed put in place and the existing or potential problem is no longer an occurrence?
Trying to create a guidance document for this would unnecessarily (in my view point) complicate the activity. You might have specific/particular situations when you can not verify implementation and effectiveness of CA/PA's right away, but a guidance document would never be able to replace common sense and knowledge.

[confused1]

In Reply to Parent Post by arrowbay

I've been researching all over the place and can't find anything specific on how to verify implemention of a CPA, (Corrective/Preventive Action) followed by validating its effectiveness. We are trying to create a reference document that describes how to first verify implementation (corrective actions were completed) and then how to validate the effectivenss (did the corrective action prevent the recurrence of the problem).

Does anyone have such a guideline that they could share with me?

I have no giudline or reference document.
As an internal auditor what I have done when I wanted to be sure of the effectiveness is this:
Verify that the corrective action indicated was taken, then I will trend the results.
I usually reserve this tactic for serious problems.
This basically amounts to an audit with a very specific scope, but has worked for me.
If it is a repetitive problem I hit that same item on repetitive audits. Rarely has this happened.
I don't know if (in those cases) I am dealing with a mgr who just does'nt get it or gets tired of answering corrective actions.
I don't really like it, my gut tells me that I am using my authority as an internal auditor to be a bully. But I have not been able to come up with another way to get a corrective action to be anything other than a bandaid.

Hope this helps!

[Coury Ferguson]

In Reply to Parent Post by confused1

I have no giudline or reference document.
As an internal auditor what I have done when I wanted to be sure of the effectiveness is this:
Verify that the corrective action indicated was taken, then I will trend the results.
I usually reserve this tactic for serious problems.
This basically amounts to an audit with a very specific scope, but has worked for me.
If it is a repetitive problem I hit that same item on repetitive audits. Rarely has this happened.
I don't know if (in those cases) I am dealing with a mgr who just does'nt get it or gets tired of answering corrective actions.
I don't really like it, my gut tells me that I am using my authority as an internal auditor to be a bully. But I have not been able to come up with another way to get a corrective action to be anything other than a bandaid.

Hope this helps!

Confused1,

Have these issues be brought to the attention of your Management Team, during any management reviews sessions (how ever you handle them)?

Have you asked the Manager the big question "Why?"

Has it been explained to all parties concerned the importance of the CAPA program to the success of the organization?

These are just some of the questions you may want to look at.

[alekra]

My suggestion is to search an evidence of the corrective action (you have to be convinced that it has really ocurred). To verify its efectiveness, it´s a nice idea to use any metrics comparing the former situation and the actual. If it is possible to show that in a period of time there is no recurrence of the nonconformity, I would say that the corrective action was effective.

If you take a look at 8D reports, they bring this sequence of solving problems, it depends on the way people fill it.

Good luck!

[JamiBeth]

There seems to be confusion here on this--which I've also found to be typical of the confusion in industry.

Verification of CAPA effectiveness is NOT the confirmation check that action items to carry out correction/remediation/preventive action/etc are now complete. This should be done before closing out the "work in progress" phases of the CAPA.

Ver of CAPA Effectiveness is a re-examination (whether through audit, metric review, inspection of logs, etc) which seeks to confirm the problem(s) (both the original problem issue and the determined root problem) have been addressed as intended (e.g. eliminated, reduced in frequency, controlled through inspection, mitigated in terms of severity, etc) as the CAPA's solution plan. This means this portion of the CAPA occurs only *AFTER* the solution has been put in place and *AFTER* time has elapsed (think months).

CAPA lifecycles may vary from weeks to a year or even sometimes more. During that time, there may be cross-leveraging of WIP CAPAs and increases in scope to WIP CAPAs to accomodate new issues.requests for correction. As investigations, decisions, and action plans are generated and as the action item plans are executed, there is potential to lose the plot or to miss something or go off track and end up with a resulting situation where the intended effect of the CAPA was NOT accomplished. This is an ineffective CAPA.

Verifying the Effectiveness of a CAPA is about re-examining the problem and confirming that the solution put in place by the CAPA addressed the problem as intended.