CAPA effectiveness – how to verify?

CAPA is a process in which regulators expect companies to follow to detect and resolve compliance issues. As such, it’s a critical point of focus during FDA inspections and ISO QMS audits.

More than just an obligatory requirement, CAPA is the means by which companies can advance their quality system to mitigate risks and avoid issues in the future.

Great! You have determined the problem, eliminated it and make sure it won’t happen again. Is it enough? Well, no. You need to make sure that your solution is really effective! Verifying the effectiveness of CAPA finishes the circle of identifying a problem and completing the actions to solve it.

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Why?

In order to ensure that corrective actions will prevent future occurrences, you will perform an effectiveness check. You don’t want to implement corrective actions and then discover it isn’t actually prevented something.

When?

The timing depends on the severity of the problem. CAPAs with low severity can be put in the “drawer” (But not forgotten! Just dealt a bit later.), while more significant problems should be investigated and checked immediately. It is important to let enough time for the corrective action to take effect, maintaining a sense of urgency around ensuring that the issue is fixed and will not recur.

How?

There are many extremely effective approaches companies can use to make their effectiveness checks successful.

  1. Re-audit. The most liked by FDA inspectors. The non-conformity is discovered and CAPA is implemented, so go back and audit it. It’s called “re-audit”. They are intended to ensure that the operators, process or equipment are following the set corrective action documented in the CAPA.
  2. Validation report. It’s a very suitable effectiveness check since validation reports because they have built-in protocol and acceptance criteria. If there aren’t criteria what is good enough for effectiveness check, well it isn’t effectiveness check. It’s just a spot check – to see what’s going on.
  3. Trend analysis. This method can help determine if the corrective action has “fixed” the issue. Review data over a determined timeframe and check if the problem has occurred again after the corrective action was applied.
  4. Periodic Product Review. It is a retrospective review (at least annually) of trends of multiple parameters to confirm the state of control.

Until and unless, CAPA effectiveness is verified, you won’t be able to know whether the system is running smoothly or not. It will also help to analyze if anything else is needed to be done or not.

When implementing CAPA in the company, you need to make sure that everybody is getting involved in the process – starting from management to the ground level staff.

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4 replies to “CAPA effectiveness – how to verify?”

  1. Ben Bohn says:

    This article is great, keep it up!!!

  2. Holly Pierce says:

    The choice of methods depends on the type of action taken.

  3. Luis Gonzalez says:

    It is always important to detect the root of cause in order to implement the proper corrective actions. As mentioned on the article it is mandatory to always have a product revision periodically in order not to fall again into the same problem. This will ensure definitely that the product will be approved and validated.

  4. Thomas says:

    Verification is very important! We had a problem last year and that cost us a lot of money! Because of that omission, we needed to fire a lot of our employees.

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