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

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.

If I remember correctly they wanted to address nonconformance but it was voted down to address nonconforming product only.

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?

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'.

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.

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.

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. :)

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 ?

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.

My original question was to understand why ISO 9001 does not give methodology to handle a deliberate system non conformance? CL 8.3 is for product. Deviation permit (cl 3.6.12 of iso9000) is for product.
I would like to know what is the equivalent mechanism for a deviation permit to QMS? Or more clearly how shall we deviate from a qms ( say for example quality Mnual) requirement to meet an emergent customer requirement violating an internal procedure without - ofcourse revising it?

Can we evolve a system deviation permit with MR as the authority to accept such deviation ? And later analyse such system deviation and trigger corrective action.

Let us consider a case like this; Company xyz has a mandatory internal procedure to physically evaluate a vendor prior to release a purchase order,. Now let us say a customer ABC to XYZ say vendor PQR is ok for him. Now how can XYZ proceed procuring the item from PQR without revising the internal vendor evaluation procedure of XYZ? If he just by pass the internal procedure and tell customer I buy from PQR but I am not responsible for its performance as I have not evaluated it - will it not become as a factored product?

Anilkumar

GE is a good one to do this. We just have it documented that the customer required the use of said supplier. It is usually in the contract.

OK, I can see what you're getting at. How can you grant a variance to a documented procedure....

Why not simply build flexibility into each procedure that allows "special circumstance" ? Has anyone here done that? A simple statement that XXX has authority to waive a requirement of the procedure with documentation of circumstance and just cause?

Anil

We use exactly the same deviation system for product deviation from specification, and procedural/process deviation.

Lucinda said:

OK, I can see what you're getting at. How can you grant a variance to a documented procedure....

Why not simply build flexibility into each procedure that allows "special circumstance" ? Has anyone here done that? A simple statement that XXX has authority to waive a requirement of the procedure with documentation of circumstance and just cause?
Yep, I call 'em "weasel words". Sometimes unforseen circumstances pop up (s**t happens) and we don't want to be handcuffed by our procedures -- they should serve us not the other way around. So, for example in a test procedure I might say "do it this way unless otherwise specified in writing by XXX" with "XXX" being the responsible test engineer (usually me). In other cases, similar statements are used, like in our purchasing procedures we have just such a clause allowing us to buy from an "unqualified vendor" in an emergency if the PO is approved by the PM and QM. With reasonable checks and balances in place the exceptions don’t become the rule. Now, on occasion, I’ve had people who wanted to violate procedures where there are not and IMHO should not be weasel words present. I make my argument as to why we should not and cannot do that and stand my ground, but we all have bosses in the real world. So, as a last resort I always say if the President, who is everyone’s boss and who approved the Quality Manual, signs off on it as a deviation to the procedure, it can happen, so off we go to state our cases to the “Supreme Court”. On rare occasions, it happens – the President approves a special waiver that violates the quality manual or procedure or whatever -- maybe even violates ISO. I don’t like it, but to fight it further would mean I lose my job AND the policy gets violated anyway. Sometimes you fight the good fight but you have to know when it is in your best interest to retreat.