Have You Had to Write a NC Against a Quality Manual in a Supplier Audit?

GStough

Staff member
Super Moderator
#1
Happy Friday, y'all! :bigwave:


Has anyone ever written a nonconformance using the company's quality manual as the reference standard? The company is not registered to any ISO standard, but they are registered with the FDA (not sure if 21 CFR 820 applies to them, though). Their procedures are not written in such a way that they can be used as the reference standard (at least I don't think so), however, the quality manual is.

Just curious. Anyone care to share their experience with this kind of scenario?

Thanks...:cool:
 
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Golfman25

Trusted Information Resource
#2
Seems like in that case it is a "say what you do and do what you say audit." So I suppose if they said they did something, whether in procedure or manual, and there is evidence that the didn't you could base it on that.

However, in most supplier audits I have been involved with, the audit was against what the customer wanted, regardless of any standard.
 

GStough

Staff member
Super Moderator
#5
Can you clarify what you mean by "reference standard" in this scenario?
Sure, Marc. In this case, "reference standard" would be the quality manual, since it contains certain requirements ("organization XYZ shall....") that were not fulfilled. Perhaps I should have chosen a different phrase or word for this. I didn't mean to confuse everyone. :eek:
 

GStough

Staff member
Super Moderator
#6
Seems like in that case it is a "say what you do and do what you say audit." So I suppose if they said they did something, whether in procedure or manual, and there is evidence that the didn't you could base it on that.

However, in most supplier audits I have been involved with, the audit was against what the customer wanted, regardless of any standard.
Well, there is a nonconformance for one those, too. :tg:
 

pkost

Trusted Information Resource
#8
I would agree with other comments that ask "what does the customer want?"

Most customers will say that ISO9001 is their expectation, in which case your reference standard regardless of how the supplier operates

If you use the manual as a reference standard to audit against then it could say "we do not adhere to any level of quality"; you could then not raise any issues when they failed to have any quality.....despite this not being being (I assume) what the customer intends
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#9
<snip> Most customers will say that ISO9001 is their expectation <snip>
My experience has been that customer audits might include ISO registration as a line item, but their rest of the criteria were quite customer specific.
 

howste

Thaumaturge
Super Moderator
#10
The short answer to your question is YES, I've written NCs against supplier quality manuals. The next question should probably be "is it a good idea?" It all depends on what you want from the audit. You could write a nonconformity for any "shall," "must," or "will" you find in any of their documents. If the requirement doesn't really add some benefit to what they do for you, then it's probably not that important. Try to focus on the benefits to your organization.

Having said that, probably the most important reference document in a supplier audit should be your legally binding agreement with them (contract, purchase order, supplier manual, quality clauses, etc.). This is where the rubber hits the road because this is what they agreed to do specifically for you. If you write any nonconformity against a requirement that's not included in your agreement with them, then they aren't obligated to do anything with it.
 
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