AS9100C Out Of Tolerance (OOT) Equipment - Customer Approval

[AmandaMusser]

Hello fellow Covers

I hope someone can give me some input on section 7.6 Control of Monitoring and Measuring Equipment.

We are a contract manufacturer of electrical assemblies, we do NO design and have excluded section 7.3 from our QMS. I have a strong and controlled calibration system in place for both company owned and customer owned equipment. If an item is returned from the cal-house OOT, we follow internal processes to evaluate the validity of previous measurements based on our manufacturing and test engineer(s) skills and experience.

Our recent AS9100 Surveillance audit issued an observation for "... company does not have design knowledge, therefore no knowledge of if or how OOT (Out of Tolerance) condition can or will affect product. Company should assign some level for approval from the Customer for equipment that has been received Out of Tolerance"

Do you have any suggestions as to what that level might be or where I should start?

 

[dsanabria]

Re: OOT Equipment / Customer Approval?

For clarification purposes - You send out an equipment to the calibration house and it comes back - rejected "out of tolerance'.

You guys verify the results, make adjustments and put it back into the system as being calibrated and in good working conditions?

Thanks

 

[yodon]

Re: OOT Equipment / Customer Approval?

I think what the auditor is saying is that you may be assessing the validity of previous measurements but you don't mention completing the loop and coordinating the results / findings with the customer.

It sounds like you know what parts were measured with the (OOT) equipment so do you share your assessment with the customer who received the parts? They will, after all, have to decide if the risk of using the parts as is is too high. They may need to (or ask you to) re-measure the parts to determine if they are acceptable.

 

[Sidney Vianna]

Re: OOT Equipment / Customer Approval?

Do you have any suggestions as to what that level might be or where I should start?

I think you would need to evaluate that, on a case-by-case, depending on the OOT condition. It could very well be that some OOT conditions have CLEARLY no impact on product, while others might have some impact on product conformity.

For those situations where you could establish that you probably shipped nonconforming product due to the OOT condition, AS9100C requires you to

The organization’s nonconforming product control process shall provide for timely reporting of delivered nonconforming product;

From a risk management perspective, it does make sense for you to involve the customer to decide if a suspect product should be recalled and retested in those situations where the full impact of the OOT condition is not easily determined.

 

[John Broomfield]

Re: OOT Equipment / Customer Approval?

Amanda,

Feed such information into your process for dealing with nonconforming product.

The procedure will specify the actions and interfaces with the designer (customer) to review and approve or reject use-as-is and repair dispositioning proposals.

John

 

[dsanabria]

Re: OOT Equipment / Customer Approval?

I think you would need to evaluate that, on a case-by-case, depending on the OOT condition. It could very well be that some OOT conditions have CLEARLY no impact on product, while others might have some impact on product conformity.

For those situations where you could establish that you probably shipped nonconforming product due to the OOT condition, AS9100C requires you to


From a risk management perspective, it does make sense for you to involve the customer to decide if a suspect product should be recalled and retested in those situations where the full impact of the OOT condition is not easily determined.

Perfect and interesting perspective,

but now I am wondering :mg:

- if this scenario is true -why didn't the auditor raised it to the non conformance level?

 

[Sidney Vianna]

Re: OOT Equipment / Customer Approval?

Feed such information into your process for dealing with nonconforming product.

John, an OOT condition does not necessarily mean that the product is nonconforming.

why didn't the auditor raised it to the non conformance level?

As you know, a valid nonconformity has to be supported by a written requirement. What requirement would have been violated here in this scenario?

 

[dsanabria]

Re: OOT Equipment / Customer Approval?

John, an OOT condition does not necessarily mean that the product is nonconforming.

As you know, a valid nonconformity has to be supported by a written requirement. What requirement would have been violated here in this scenario?

Just wondering how the auditor came to that observation and why didn't use

Clause 7.6

a. M&M equipment are calibrated (and/or verified) at specified intervals against traceable standards.

as a starting point - (or am I reading too much into it)

 

[Sidney Vianna]

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

The requirement at play here is:

In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization shall take appropriate action on the equipment and any product affected

Unless the auditor found evidence that the organization failed to comply with that, s/he can not issue a nonconformity, as mentioned in note #3 of paragraph 4.2.2.5 in AS9101D:

NOTE 3: If there is no evidence of non-fulfillment of a requirement, the auditor cannot issue a nonconformity.

 

[John Broomfield]

Re: OOT Equipment / Customer Approval?

John, an OOT condition does not necessarily mean that the product is nonconforming.

Sidney,

True, but it would plug Amanda into the design interface she seeks to determine the status of the product measured with the OOT device.

John