Nonconformance Resolution - Is 8.3 applicable?

A

anil2187

#1
QMS- Nonconformance resolution-Is 8.3 applicable?

Dear List members,

Does 8.3- Control of Non conforming product of ISO9001:2000 is restricted to product (hardware,s/w,processed matl,Services) and not applicable to handle Quality system Non conformances?

If a system nonconformance is detected in a situation other than thru 8.2.2 Internal audit - what is the mechanism to handle the non conformances?

Anilkumar
 
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M

M Greenaway

#2
Well no-one is responding to this which I guess suggests no-one has a good answer.

Me included !

I have never yet worked at a company with what might be considered a 'formal' approach to correcting system non-conformities outside of those found at internal audit.

But then again I have never known anyone internally to spot a system non-comformity outside of internal audit.

It may come about through investigation of product non-conformance identified in-house, or from customer complaint, but the corrective action mechanism for non-conforming product would deal with this.

I have worked at companies with suggestion schemes, but I think this is probably a different issue.
 

gpainter

Quite Involved in Discussions
#3
If I remember correctly they wanted to address nonconformance but it was voted down to address nonconforming product only.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#4
Anil,

Maybe I don't understand the question, but if you happen to find a quality system NC outside of an audit, doesn't it fall under 8.5, Improvement?
 
M

M Greenaway

#5
Mike

I think by definition it would still be corrective action, and not continuous improvement as you are putting something right, not improving a system that is already 'conforming'.
 

JodiB

Still plugging along
#6
1) 8.3 is referring to product only - not to QMS nonconformance. 8.3 wants you to address nonconforming product that is delivered to you for use in your final product, as well as nonconforming product that you have produced.

2) Our corrective action procedure covers all nonconformances that are found - not just those that are discovered through internal audit. Nonconformances can be detected and reported by any employee, however these are initially reported as Improvement Notes. The determination of whether it is an actual nonconformance is left to management staff. Then it is elevated to a Corrective Action Request.

It would be possible for us to include an instance of a non-conforming product as a nonconformance because we aren't a large manufacturing facility and the occurrence is so rare. But we won't. A nonconforming product is not (to my mind) a nonconformance in itself. The nonconformance is whatever lead the product to be nonconforming - such as not following the proper procedure. We will handle any nonconforming product under our procedure for 8.3 , and -if it is a received good from a supplier- under our supplier management procedure (which I'm still working on).

If we see multiple instances of nonconforming product, we should investigate for internal nonconformance and then employ our Corrective Action procedure.

Does this make sense? it's early - the Mountain Dew hasn't kicked in yet.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#7
M Greenaway said:

Mike

I think by definition it would still be corrective action, and not continuous improvement as you are putting something right, not improving a system that is already 'conforming'.
M,

Huh? Is corrective action not under section 8.5 Improvement? That's what I meant in my Monday Morning fog. Maybe I should have said specifically 8.5.2.
 

RoxaneB

Super Moderator
Super Moderator
#8
All nonconformances (product, process, and/or internal audit) are captured within our Nonconformance System. The same form is used no matter what the issue is. We state if it is a nonconformance (a minor issue), requires corrective action (root cause analysis, etc.), or requires preventive action (based upon the analysis of an adverse trend).

We opted to have "one stop shopping" rather than one system for product/process nonconformances and one for internal audits.

We keep track of all discrepancies in an Excel log where we can filter for specific items (e.g., specific departments only, internal audit findings, product issues, etc.). It's a system that works for us, and our Registrar loves it. :)
 
M

M Greenaway

#9
We also use the same approach to corrective action, but these are all triggered by reported non-conforming product, or by non-conformance/compliance found during audit.

I think the original question was what do you do with system non-conformance/compliance found outside of internal audit ?

any takers ?
 

JodiB

Still plugging along
#10
Cool! Quickie reply option! Neat idea Marc.

Martin, two of us have already stated that all nonconformances regardless of origin will go through CA procedure.

Why should internal audit nonconformances be treated any differently from others? I can't see the reason for a distinction.
 
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