Are inputs to the nonconformance process required to be identified?

[Ajit Basrur]

I have a question on ISO 9001:2015, section 8.7.1, where it describes that "The organization shall ensure that the outputs that do not conform to their requirements are identified and controlled to prevent their unintended use or delivery"

I am in an audit and noticed that the supplier has a procedure that describes what actions to be taken when nonconformance is identified; but the procedure does not describe which type of inputs could lead to a nonconformance.

Per the ISO 9001:2015, is it required to identify the inputs to the nonconformance process?

 

[AMIT BALLAL]

Hi!

As per my understanding, the intent of the requirement is that the status of nonconformity should be known (by identification) and should be prevented from unintended use and delivery.

What we do is do red tagging of nonconforming products and these parts are kept in a defined area and the area is locked to prevent unintended use and delivery.

I don't think there is a requirement in ISO 9001 of identifying inputs to non-conformance process.

 

[Marc]

<snip> Per the ISO 9001:2015, is it required to identify the inputs to the nonconformance process?

I have updated the discussion title to be more specific.

I think this will be an interesting discussion, especially if folks give some examples of potential nonconformance system inputs.

 

[somashekar]

I have a question on ISO 9001:2015, section 8.7.1, where it describes that "The organization shall ensure that the outputs that do not conform to their requirements are identified and controlled to prevent their unintended use or delivery"

I am in an audit and noticed that the supplier has a procedure that describes what actions to be taken when nonconformance is identified; but the procedure does not describe which type of inputs could lead to a nonconformance.

Per the ISO 9001:2015, is it required to identify the inputs to the nonconformance process?

If the supplier's procedure is addressing the controls on the detected NC product, he does not have to mention about the inputs.
His another procedure about the Nonconformity and corrective action (10.2) must be addressing the causes of NC (inputs)

 

[Marc]

<snip> the supplier has a procedure that describes what actions to be taken when nonconformance is identified <snip>

Is the specific question only with regard to product nonconformances?

When I see "nonconformance system" I think of many potential inputs. E.g.:

• Process audit nonconformances?
• System audit nonconformnces?
• Compliance (to a standard - E.g.: ISO 9001) failure?
• Compliance (to a national or international regulation) failure?
• Product defect(s)?
• Process failure(s)?

I guess I'm questioning what the definition of "nonconformance system" is in the starting discussion post. I'm probably over thinking this.

 

[jmech]

No, because there is no requirement in ISO 9001:2015 to identify the inputs to the non-conformance process.
Note that 8.7.2 and 10.2.2 already require the organization to retain documented information that describes the (nature of the) nonconformity and any actions taken. Would it add any value to require the organization to identify the inputs to the nonconformity process?

 

[Mark Meer]

Strictly by the standard, no this is not required to be explicitly stated.

However, the inputs are presumably implied, be it in a process-interaction description/flowchart, or simply in enumerating different types of non-conformities (see, for example, Marc's post above). Also, people involved with the process should know what the inputs are.

There may be a suggestion for improvement, but not a finding.

 

[Ajit Basrur]

Thanks for all the responses.

From my FDA regulated background, I also felt that it would be good if the inputs types are identified but seems like the ISO 9001 has no requirements. Yes, not a finding but something for them to consider.

 

[Marc]

Ajit, I agree with you 100%.

 

[somashekar]

Thanks for all the responses.

From my FDA regulated background, I also felt that it would be good if the inputs types are identified but seems like the ISO 9001 has no requirements. Yes, not a finding but something for them to consider.

If you are auditing the area "Control of NC outputs" and looking for /asking about inputs types here, then its not the approach. These is no scope for any improvement or any consideration.
ISO 9001 certainly addresses the input types contributing to a NC output in the "NC and corrective action"...