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Kqdelta9
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.
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.