I would appreciate any assistance which you might be able to offer:

It has been determined that we supplied a customer material which contained a hidden defect. This defect was detected by the customer and now the question arises if we are required to inform other customers about the possibility that their material could contain similar defects, which might or might not be present? The defect in question can always be present, but the severity can vary. This defect or the absence thereof does not form part of the customer specification.

Thanking you in advance!

I would appreciate any assistance which you might be able to offer:

It has been determined that we supplied a customer material which contained a hidden defect. This defect was detected by the customer and now the question arises if we are required to inform other customers about the possibility that their material could contain similar defects, which might or might not be present? The defect in question can always be present, but the severity can vary. This defect or the absence thereof does not form part of the customer specification.

Thanking you in advance!ISO 9001 8.3.3 does not MANDATE that you communicate with the other customers. Actually, one of the most controversial "official" TC 176 interpretations deal with this issue. But forget ISO 9001. Responsibility, risk management and common sense would advise you to communicate with other customers about the potential problem.
You state that the severity of the problem can vary. What if the WORST possible scenario materializes and serious injuries and/or fatalities were to happen because your organization did not forewarn customers? Could you live with that in your conscience?

I would appreciate any assistance which you might be able to offer:

It has been determined that we supplied a customer material which contained a hidden defect. This defect was detected by the customer and now the question arises if we are required to inform other customers about the possibility that their material could contain similar defects, which might or might not be present? The defect in question can always be present, but the severity can vary. This defect or the absence thereof does not form part of the customer specification.

Thanking you in advance!

What specification does the "defect" violate?

The defects in question are not governed by any specification, but when present can result in parts being rejected by the customer. It is also worth mentioning that the defects in question fall below the detection limit of our non-destructive testing equipment (state of the art) and as such are usually only found by chance or when the customer complains.

The defects in question are not governed by any specification, but when present can result in parts being rejected by the customer.

"Defects" that do not violate a specification are not defects. The fact that some anomaly displeases a customer isn't evidence to the contrary; my guess is that now that a customer has complained, the requirements will change. As for other customers, you have a risk/reward decision to make. What is the risk of not notifying? Keep in mind that you could conceivably open yourself up to all kinds of trouble if you characterize the anomaly in question as a "defect" when no customer (or other) specifications have been violated.

I agree with Jim, do not call it a "defect" if it is not out of conformance to your or your customer specifications. Does it affect fit, function, form, appearance? Look at the risk factors. If you determine it could be a potential safety problem, then you do have a moral obligation to do something to mitigate the issue.

I have a suspicion that the condition you term "defect" may be one which occurs to a greater or lesser extent in all your material (like minor voids in injection molded plastic OR inclusions or structural defects in metal castings.)

Typically, producers can modify processes to eliminate or greatly reduce the occurrence of such "anomalies," but it may be impossible (by non-destructive testing) to detect some of them without xrays or magnetic resonance imaging which add greatly to the cost of the product.

My experience has been that producers who encounter such anomalies ensure customers are made aware of them during Contract Review and any amelioration (and subsequent expense) negotiated BEFORE accepting a contract.

To the point of the original question:
Refrain from using the term "defect" when discussing the situation with other customers. Unless the material may shatter in use and create a Life, Health, Safety (LHS) situation, odds are most customers are aware of the possibility of such anomaly and have made provision for it in their design. The Contract Review function is where the supplier assures such anomaly will NOT create a LHS situation (and subsequent financial liability risk to supplier) if the material does fail in use because of the anomaly.

Getting to the question about notifying customers, does 7.2.1 B apply?

The organization shall determine requirements not stated by the customer but necessary for specified or intended us, where known.

You have a pontential problem that wasn't known before but now is known. The problem may highlight a product requirement.

Regards,

Dirk

Hi

You mention that "when present can result in parts being rejected by the customer", therefore.

Do not have the potential defect to be included in the FMA?

Getting to the question about notifying customers, does 7.2.1 B apply?

The organization shall determine requirements not stated by the customer but necessary for specified or intended us, where known.

You have a pontential problem that wasn't known before but now is known. The problem may highlight a product requirement.

Regards,

Dirk

I think 7.2.1(b) is all but unenforceable due to its vague nature and the "where known" qualifier. (d) is also a lovely example of ISOspeak:

The organization shall determine...any additional requirements determined by the organization. :frust:

If we want to dissect this subject, it could get convoluted very quickly. I understand the advice on not using the word defect, due to potential liability implications. But, in the context of ISO 9001, the definitions contained in ISO 9000:2005 are normative.
The ISO 9000 definition of defect is:

3.6.3 defect
non-fulfillment of a requirement (3.1.2) related to an intended or specified use

Since the definition above refers to the word requirement, what is the ISO 9000 definition of requirement?

3.1.2 requirement
need or expectation that is stated, generally implied or obligatory

So, following the ISO 9000/9001 logic, EVEN if the problem at hand does not violate the “specification”, but fall under the “implied” needs or expectations of the customer, IT IS A DEFECT.


PS. I don't know if this thread has been moved, but now I realize that this thread is under the TS-16949 subject. Being so, I would have to say that the notification of the non-conforming situation is mandatory, contrary to my first post in this thread when I was under the impression that we were dealing with ISO 9001 only.