Differences between Non-conforming Material vs. Nonconforming Product

[Big Jim]

Does ISO 9001 require to document every nonconformity, however small it is?
I understadt that if You order a fan from your supplier and upon installing it you find out it has an imbalance, you should record this.
But if a small screw is bended and you just take a new one out of a 100 pieces box, should this be recorded too?

Is it ok to set some standards how the employees can differ between problems which should be documented and smaller problems which can be solved immediately?

Or are non conformities only problems you find at some kind of checkpoint/quality gate etc. ?

If thats the case, what about problems the employees run into while assembling parts?

If you were to attempt to identify every possible nonconformity you would have no time for anything else.

If you were to attempt to perform corrective action on every nonconformance you would have little time for anything else. You are permitted to determine what nonconformances require only correction and which ones require corrective action.

Your system should have a robust method of both identifying the ones you can and effectively resolving them though.

 

[kgott]

I dealt with this by saying that minor or quick fix type remedies of non conformances do not need to be documented using the NC process.

What’s a minor or quick fix I hear the thunderous cry?

Operations staff have the freedom to use discretion and experience to make this decision talking having regard to the impact of the NC on safety, the environment, the company and the customer and the likely hood and impact of reoccurrence.

 

[kgott]

Meterry; this is a good question and is a question that many of us on the cove will benefit from, thanks for raising it.

 

[Colin]

The construction industry get away with it by calling the small N/C's 'snags'. They tend to be small items which aren't quite right e.g. a door sticking on a new build. They simply make a list of them and when they are done they get crossed off the list.

 

[kgott]

You are permitted to determine what nonconformances require only correction and which ones require corrective action.

Big Jim, I have never heard of 'correction' before, interesting, what's the difference? thanks

 

[Marcelo]

Correction is what you do to correct a particular non-conformity. Then, you need to investugate the root cause of this particular NC, and, if necessary, apply a corective action to prevent the recurrence of the problem that happened.

Regarding the product x material discussion, as ponted out by Bev D, ISO standards are focused in the final product, meaning, the main problem ISO tries to prevent is a non-conforming product reaching the market.

It does not mean that you do not have to deal with non conforming materials or other non conformances, but what is expected is that you, as the manufacturers, use your discretion to identify the needs to control what to do with these other NCs.

Please also note a non-conformity is a non-fulfillment of a requirement. If you process identifies that your raw material will, for example, always come with a defined percentage of problems (example, 1 in 10 materials will have a problem due to the process of manufacturing them) then it's not a NC if you keep your process under this, because it's a requirement of your process (a requirement of your management system).

 

[kgott]

Mmantunes; here; as I interpret what you are saying, you are talking about goods from our suppliers. Does what you are saying also apply to our product to our customer?

I.e, if we tell our customer that 1 in 10 of our products will have a problem due to the process of manufacturing them, then for so long as we keep the number of problems below the number of problems we have told the customer they can expect, then the problems in our product are not non-conformances to us as the supplier?

 

[Marcelo]

Mmantunes; here; as I interpret what you are saying, you are talking about goods from our suppliers. Does what you are saying also apply to our product to our customer?

I.e, if we tell our customer that 1 in 10 of our products will have a problem due to the process of manufacturing them, then for so long as we keep the number of problems below the number of problems we have told the customer they can expect, then the problems in our product are not non-conformances to us as the supplier?

The concept is the same. A non conformity is a non-fullfilment of a requirement. If the requirement of your process (in this case it would be a constraint requirement) is that 1 in 10 of your products, then it would not be a non-conformance, in principle, for ISO standards. Please note the in principle because, depending in what you do, it might be a non-conformity, but not because of the ISO standard. Example: if your client wants 10 in 10 devices performing, you would need to have addressed this costumer requirement in your product realization process, and then you would not be able to call 1 in 10 a conformity .

Another important point is, will your client buy your product if 1 in 10 does not perform?

As you can see, the idea is the same, and everything depens on requirements (yours or the costumer).

 

[kgott]

if your client wants 10 in 10 devices performing, you would need to have addressed this costumer requirement in your product realization process, and then you would not be able to call 1 in 10 a conformity .

Another important point is, will your client buy your product if 1 in 10 does not perform?

Yes I realise these issues, I was just making sure I understood the point you were making subject to my clarification.

thanks for your help - cheers

 

[Big Jim]

Big Jim, I have never heard of 'correction' before, interesting, what's the difference? thanks

The definition lies in ISO 9000 which include a vocabulary for quality management systems.

Correction: action to overcome a nonconformance.

Corrective action: action to overcome the CAUSE of a nonconformance.

I'm sure that I have somewhat paraphrased the definitions, so you may want to look them up yourself.