How to verify and validate the effectiveness of CAPA with regards to employees ?

Aphel · Mar 24, 2013

Hello!

I have problems in understanding the intention of the QSR regarding the requirements for verification and/or validation of CAPA actions to ensure they do not adversely affect the product...

A CAPA can be necessary for varios nonconformities...if a corrective action is a design change, then I understand what to do regarding verifiaction or validation.

But what if the corrective action is for example training of employees? How can I verify or validate this action to ensure that it does not adversely affect the product...??? I am a little bit confused. Can anybody help???

Thank you very much in advance!
Best regards, Aphel.

Jim Wynne · Mar 24, 2013

Aphel said:
Hello!

I have problems in understanding the intention of the QSR regarding the requirements for verification and/or validation of CAPA actions to ensure they do not adversely affect the product...

A CAPA can be necessary for varios nonconformities...if a corrective action is a design change, then I understand what to do regarding verifiaction or validation.

But what if the corrective action is for example training of employees? How can I verify or validate this action to ensure that it does not adversely affect the product...??? I am a little bit confused. Can anybody help???

Thank you very much in advance!
Best regards, Aphel.

If you have competent employees who make random and isolated mistakes, and you've conscientiously debugged the process, there should be no need for corrective action. On the other hand, if you don't have a reliable method for evaluating competence, that's the process that needs to be addressed. Competent people shouldn't need to be retrained.

Ronen E · Mar 24, 2013

Hi,

From what I've been able to find in FDA guidance, there are no specific and direct measures to be taken to ensure that CAPA involving actions not directly affecting the product (i.e. CAPA that doesn't involve design changes, manufacturing process changes etc.) does not adversely affect the product. A generic (and indirect) measure that can be taken is trending product quality issues pre and post CAPA implementation.

Verification of CAPA effectiveness is much simpler (for any sort of CAPA) -- check that the identified root cause has been eliminated.

Cheers,
Ronen.

Aphel · Mar 25, 2013

Hello Ronen,

So according your understanding...if I have a non-product-related measure "training" in my CAPA plan, I do not have to verfy or validate this measure to avoid possible side effects on the medical device...???

Best regards,
Aphel

Ajit Basrur · Mar 25, 2013

Aphel said:
Hello Ronen,

So according your understanding...if I have a non-product-related measure "training" in my CAPA plan, I do not have to verfy or validate this measure to avoid possible side effects on the medical device...???

Best regards,
Aphel

If your proposed CAPAs are effective, then the same non conformity should not recur and that is what is "effectiveness". On the other hand, if the issue pops up again, your CAPAs in the first place were not effective.

In your example, if your Root Cause Analysis had proved that the defect was caused by people and that training could help resolve it ... the issue should not come again after imparting training.

Hope that helps

ScottK · Mar 25, 2013

If you are re-training in an existing process and not making any changes to the process, design, materials, etc then it should not edversely affect the device.

The concern here is with changes... if nothing is changing then there should not be an adverse effect on the device.

If the training changes something then you have to evaluate the need for change control and revalidation.

How to verify and validate the effectiveness of CAPA with regards to employees ?

Aphel

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