ISO13485 Incoming Receiving Parts Verification

Marcelo

Inactive Registered Visitor
#11
You are correct since this is an ISO board. I deal with US marketed products only. I can tell you the golden rule applies to the FDA and they would find this deficient without question.
I deal with the FDA too and know that they can be too focused on documents an records at times (same as ANVISA here in Brazil), but a good rationale can always be accepted if the inspector/auditor is reasonable and know enough of quality management (instead of focusing only in the words that are written on the regulations and standards).

This is a general problem in fact, so for the risk-based approach to work, even the inspectors and auditor will have to be retrained and to have a more open mind.
 
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uhohraggy

#12
Well if you want to go down that path... the whole AQL is inadequate anyway and typically doesn't work, but that's a whole different thread on the statistics behind the AQL.
 

Ronen E

Problem Solver
Staff member
Moderator
#13
You are correct since this is an ISO board. I deal with US marketed products only. I can tell you the golden rule applies to the FDA and they would find this deficient without question.
I have to disagree. You are assuming that if the results are not documented then there's no documentation at all. It is possible that someone would document that they sampled and measured 13 units, the extremes were such and such (which implies that all other results were in between), and sign-off on everything. This is documenting the fact that the measurement took place. If FDA would challenge that I would politely ask them to cite a clause showing deficiency. Can you please point to such a clause?

I still think such a practice doesn't marry AQL, but in itself it is sound documentation.

Cheers,
Ronen.
 
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