AS9100C Out Of Tolerance (OOT) Equipment - Customer Approval

[Sidney Vianna]

Re: AS9100C Out Of Tolerance (OOT) Equipment / Customer Approval?

John, if the OP's organization can determine for themselves that the OOT condition does not represent a risk for the product conformity, no further actions are required.

On the other hand, if they can't make that determination, the product is then, suspect and/or nonconforming. In that case, the actual product will have to be dispositioned and, according to the AS9100 standard, the supplier CAN NOT disposition as UAI or repair without the consent of the design-responsible organization.

In other words, if the OOT condition leads to a suspicion (or certainty) that the product is nonconforming, other than retesting the product with a valid, properly calibrated IMTE or scrapping the parts, would necessarily require the OP organization to engage with the customer and/or the design responsible organization to properly disposition the parts.

 

[John Broomfield]

Re: AS9100C Out Of Tolerance (OOT) Equipment / Customer Approval?

John, if the OP's organization can determine for themselves that the OOT condition does not represent a risk for the product conformity, no further actions are required.

On the other hand, if they can't make that determination, the product is then, suspect and/or nonconforming. In that case, the actual product will have to be dispositioned and, according to the AS9100 standard, the supplier CAN NOT disposition as UAI or repair without the consent of the design-responsible organization.

In other words, if the OOT condition leads to a suspicion (or certainty) that the product is nonconforming, other than retesting the product with a valid, properly calibrated IMTE or scrapping the parts, would necessarily require the OP organization to engage with the customer and/or the design responsible organization to properly disposition the parts.

Sidney,

As I recommended in post #5.

John

 

[dsanabria]

Re: AS9100C Out Of Tolerance (OOT) Equipment / Customer Approval?

In other words, if the OOT condition leads to a suspicion (or certainty) that the product is nonconforming, other than retesting the product with a valid, properly calibrated IMTE or scrapping the parts, would necessarily require the OP organization to engage with the customer and/or the design responsible organization to properly disposition the parts.

Thus... The auditor had evidence of what was happening to the equipment but chose not to pursue the process to determine if product was affected - which would have been the correct flow.

In writing an observation, the auditor took the easy way out without diligence investigation into the complete process.

Granted... We don't have a lot of information but for those young auditor listening or reading this thread... please follow the process until you are completely satisfied that no products were affected by possibly OOT equipment. - and then the observation becomes irrelevant!

 

[AmandaMusser]

Re: AS9100C Out Of Tolerance (OOT) Equipment / Customer Approval?

Great discussion everyone!

Dsanabria, my company has done what we have felt is our due diligence in determining any potential impact to product, as demonstrated to the auditor. What the auditor is saying is that we lack the design knowledge to ultimately make that determination.

John, after speaking with my ME (Manufacturing Engineer), we have decided that your comment #5 is the direction we should be going

Currently we assign a DI (Documented Issue) for any OOT equipment condition to the department manager for investigation & determination, relying on their skills and experience.

Our new process will be to add the ME to the DI. The ME has the Design for Manufacturability knowledge and works closely with the customer before, during and after production. He will communicate the information to the customer and provide us with the customers response. This will be attached as objective evidence and used in our determination.

Again, thank you everyone for the great input!

 

[robbob]

Re: AS9100C Out Of Tolerance (OOT) Equipment / Customer Approval?

Hey Amanda,
we had the same Problem at our TS Audit, the Problem now:
we don't have an really good description how to do the risk analysis after reject of an measuring device. --> until now we made an comment on the cert that there were e.g. no risk for this spec because we measure this spec as well with an another device in the second measuring circle. (caliper nok , CMM will catch the Problem in the firs approval part --> set up)
Now the Auditor likes to have an very detailed procedure with an standardized documentation risk Evaluation)
Does somebody have here an good example --> description with forms for the risk Evaluation (checklist or some think like that)

Thank you guys

robbob