CAPA Verification - ISO 13485:2016 Requirements and Objective Evidence

#1
Hi All,

I am curious as to how members here are going about meeting the requirement for verifying CAs and PAs do not adversely affect the ability to meet applicable regulatory requirements or the safety and performance of the medical device (8.5.2 e) and 8.5.3 d))? Do auditors want to see a checkbox with a sign off from a member of RA/QA? What documentation (if any) would you provide as objective evidence that a proper verification was performed?

Thanks in advance,
Robert
 
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yodon

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#2
Well, this has been hanging out there too long so I'll give it a shot.

I don't think JUST a checkbox asserting the CA does not adversely affect the ability to meet applicable regulatory requirements or the safety and performance of the device has any value. I would think there would be an expectation for some rationale and/or evidence.

Just walking through the thought process: does the corrective action 'touch' any of
- the essential requirements
- the Risk Analysis (in particular the controls)
- the functional or performance requirements

If the answer is yes to any of the above, why does the corrective action not impact them or if it does, what evidence can you provide to show everything is still compliant?

Hopefully this will get the discussion rolling and others will weigh in with their thoughts.
 
#3
These were great points and maybe you would want to incorporate a checklist - the basis of the checklist has been pretty much given to you!
- the essential requirements
- the Risk Analysis (in particular the controls)
- the functional or performance requirements
Answer with statements not just check boxes. Your CAPA form may need to be more than 1 page, Maybe attach all supporting evidence FMEA, Control Plans, evidence you investigated rather than just saying so.

Be aware that an auditor may also follow the CAPA to see if you linked it to the FMEA or Control chart - Especially if (Whatever it was that spurred the CAPA) was not part of the original FMEA or Control plans. They "Auditors" think of the FMEA as a living record (Who knew - most just do FMEA in the beginning and forget it.)

Don't forget the Device History Card if the CAPA was a result of something product related or complaint related... Make sure every thing is linked if the auditor follows the CAPA path past just the corrective action. So glad I am not in Medical anymore! :notme: But the thinking never leaves you once you have lived it, especially once you live through a real FDA audit.
 
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