CAPA (Corrective and Preventive Action) - ISO 13485

K

Kqdelta9

#1
CAPA for ISO13485:

It has come to my attention that companies are opening corrective actions and during investigation, it's found other potential potential issue pertaining to the original non conformance could occur, so they open a preventative action and reference it on the corrective action form.

Is this normal?

I'm used to:
Corrective action - you are busted
Preventative action - prevents a bust

They are two separate instances and not linked at all. Ever -

Please advise.
 
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#2
Re: CAPA (Corrective and Preventive Action) Discussions are Getting Out of Hand

Howdy Kqdelta,
Welcome to the (reborn) COVE!

You might want to read through the first two pages of this thread. Those initial posts on this thread discuss in some detail exactly what you just asked...
 
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