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World of CAPAs - spinoff: Effectiveness checks

In part 1, we discussed when it is worth to open CAPAs. In Part 2, we discuss how we can establish a good quality CAPA.

Now, let's see how can we measure the effectiveness of our implemented CAPA.


But before, let's talk about when not to open an effectiveness check.


Stop-signs for effectiveness checks


Let's have a working definition to start with: Effectiveness check is the verification that the root cause identified in an investigation has been eliminated.


As with any other processes, if we overwhelm ourselves with records, it never ends wells. So when can we spare opening an effectiveness check.


Eliminating 'routine' effectiveness checks

If your effectiveness check is to measure the recurrence of your root cause, you can stop yourself, since the recurrence evaluation is built in your investigation (hopefully). Why do redundant work?


Effectiveness check for Corrective actions

Since your CAPA doesn't aim to eliminate your root cause, why bother to check if it reduces the occurence?


Effectiveness check for simple CAPAs

Don’t open an Effectiveness Check when your CAPA is ‘obvious’, e.g. moving a piece of

equipment to another location.


Go-sign for effectiveness check


Use Effectiveness Checks to measure the success of your preventive action and demonstrate that you

were able to eliminate the root cause.

With Effectiveness Checks, additional impact of your preventive action can be analyzed also to see of the preventive action has caused any negative or positive impact elsewhere, as a consequence.


How to establish a good effectiveness check?


The thumbrule is similar when opening a CAPA: don't rush yourself into opening an effectiveness check without designing it. The ideal way of working is to think about the effectiveness check when opening the related CAPA. Naturally it can be finetuned/redesigned when closing out the CAPA.


How can we choose the type of the effectiveness check?

Let's see the different types:

1st trial check: this is the easiest one: you check the first product (measurement, process result etc.) immediately after your CAPA implementation. This solution may be good if you implement some physical change in your environment: a new gauge in your manufacturing line, a new valve configuration, etc.

Periodic check: you introduce some extra test e.g., after every 10th batch or testing. This may be useful if you are into controlling some performance parameters, like roboustness of a balance, or performance of a chromatographic column (not the analytical).

Trending: if you establish a new purification step in your manufacturing process, it may be definitely informative to check how the yield changed after the CAPA. This is where you need a certain period's data (e.g., 50 batches), so you can evaluate if there is a significant change in the data (with performing F-test and t-test).


Effectiveness check parameters

What should you think about when opening an effectiveness check:

  • exact activity(ies) to do

  • timelines

  • exact requirements to be able to close the effectiveness check

  • any barriers which could prohibit the check

  • key stakeholders to involve

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