Rigid rules for handling supplier audit findings

Ronen E

Problem Solver
Staff member
Moderator
#11
Slightly :topic:
The standard expects you to take a risk-based approach (in all things)
That's a widespread (well-intentioned) misconception.
The standard (13485:2016) spells out a requirement for a "risk-based approach" in a rather narrow/specific context. Other than that it suggests/guides towards risk-based practice in a number of specific contexts.
I agree that in general it's a good habit to think in risk-based terms, but let's please not attribute to the standard what isn't in it.
 
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Ronen E

Problem Solver
Staff member
Moderator
#12
"Have you seen supplier management procedures with rigid rules for handling supplier audit findings depending on supplier type and audit type?
(...) structural semi-rigid risk-based approach for categorising supplier audit findings per supplier type per audit type.
No, not in that particular level of detail.

For example, how would you handle a major finding during initial assessment of a non-critical supplier versus critical suppler?
I wanted to say "define Major vs. Minor", but Jim's post makes sense and you seem to be content with that approach.
I still do say define Critical vs. Non-Critical. That definition might guide you in what needs to happen in various situations. On the other hand, if that's not defined the whole thing starts to slide into a grey mush of subjectivity.

and how would it be different if this were to occur during surveillance audit?"
I would generally be stricter during an initial assessment, where you have no quality history to go by.
For a surveillance audit I would take such history into account as well.
 
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