AS9100 Clause 7.2.2 - Documenting "Special Requirements" and risks

K

Kirk Teutschbein

#1
On our recent 9100C "upgrade" audit, we received the following nonconformance under Clause 7.2.2 in our Sales process:

"There is a lack of documented evidence that Special requirements of the product are determined, and risks have been identified."

Typical "Special Requirements" for us would be new materials, unproven applications, short delivery times, etc. While we do a good job resolving these before contract acceptance, there doesn't seem to be an easy, clear, consistent way of:
1) Indicating in our ERP system "Yes/No" as to whether an order includes any "Special Requirements"
2) Documenting the evidence that we have identified, evaluated, mitigated and/or accepted the risks involved.

Does anyone have a good method of dealing with this clause? Any ideas as to how to respond to the nonconformance?
 
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dsanabria

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#2
On our recent 9100C "upgrade" audit, we received the following nonconformance under Clause 7.2.2 in our Sales process:

"There is a lack of documented evidence that Special requirements of the product are determined, and risks have been identified."

Typical "Special Requirements" for us would be new materials, unproven applications, short delivery times, etc. While we do a good job resolving these before contract acceptance, there doesn't seem to be an easy, clear, consistent way of:
1) Indicating in our ERP system "Yes/No" as to whether an order includes any "Special Requirements"
2) Documenting the evidence that we have identified, evaluated, mitigated and/or accepted the risks involved.

Does anyone have a good method of dealing with this clause? Any ideas as to how to respond to the nonconformance?
First, you know you could appeal the NCR.

Second, was the auditor clear in his statement about "Lack of Documented evidence" since it is not a clear requirement but an implied requirement - if there are any special requirements.

NOTE AS9101 D - 4.2.2.5 - NOTE 3: If there is no evidence of non-fulfillment of a requirement, the auditor cannot issue a nonconformity.

and finally, the information you provided is not sufficient to provide you with scenario on how to approach it.

I hope that you and the auditor came to a clear understanding of the NCR - if not call the registrar and ask them ro review the evince or send a PM.
 
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