ISO 9000:2000 Clause 8.3 - Control of Non-Conforming Product

[anil2187]

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

[Claes Gefvenberg]

Hi Anilkumar,

System nonconformancies should be handled as described in 8.5.2 Corrective action.

/Claes

[M Greenaway]

Hows about this take....

System non-conformances should only be identified outside of internal audit if they relate to product non-conformance. Corrective action, by definition, must always relate to the 'system'.

[M Greenaway]

Good question Jim, i'm just trying to use the lingo of others.

To my simple mind non-conformance can only relate to the product, and is simply when the product does not meet the customers requirements.

Some people talk of system non-conformance, I always prefer the term non-compliance as it avoids potential confusion. System non-compliance is simply not doing what our system says we have to do, or system ineffectiveness in meeting customer requirements.

System non-compliance is normally identified through internal audit, but there are other methods of process monitoring which also serve this purpose. They may also be found as the result of root cause investigation following discovery of product non-conformance.

[Claes Gefvenberg]

Jim Wade said:
I don't believe that it's practical - or even good practice - to seek causes of EVERY problem that occurs.

rgds Jim

Amen to that. We all do a lot of problem solving in our everyday work. Anyway, I share Martins view here.

/Claes

[Jamie]

Me too. I agree with Martin on this one.

Jamie

[JodiB]

Just to stir the pot a little bit regarding verbiage:

I don't consider a product that doesn't meet specs as a nonconformance, I would refer to it as a non-conforming product. The nonconformity that makes it a non-conforming product could be caused by a nonconformance of the system however.

In other words, I see nonconformance as not following described procedure or process -a nonconforming product may or may be a result.

On the flipside, not all nonconforming product is a result of a nonconformance - if everything was done correctly but variance is expected and handled according to planned arrangements, then there is no nonconformance of the system.

[M Greenaway]

Interesting angle Lucinda.

I would personally prefer to think that every instance of non-conforming product does represent a failure of the system (call it nonconformance/compliance or whatever).

However we should recognise that our processes will vary, and some nonconforming product is inevitable. The level of nonconforming product might be within our known capability of our system, however each is still a failure of that system.

The clever bit is sorting the common causes from the special causes, and targeting our actions appropriately.