Engineering Drawing Review and Approval Requirements

DietCoke1953

Starting to get Involved
#1
Our external auditor cited us with a minor finding because our Design & Development process does not require a person separate from the one who created an engineering drawing to review and approve it.

Is the separate review and approval of a drawing required by ISO 9001:2015?

Thank you for your input.
 
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Jim Wynne

Staff member
Admin
#2
In issuing the NC, the auditor is supposed to cite the requirement from the standard. Was this done? Can you post the entirety of the NC statement?
 
#3
Not that I am aware. Does your internal procedure specify an independent review?

I'm with Jim Wynne and many auditors are failing to back up their NCs with any substance.
 

DietCoke1953

Starting to get Involved
#5
CAT2 (Minor) Drawing approval Requirement: Engineering drawings/sketches required to be checked by someone other than drawn personal.

Nonconformity: Drawing checking box not completed for the issued drawings.

Evidence: E.g. Skid fabrication drawing - HFP-CT-011 3115 Rev.1 issued to vendor

ISO 9001:2015 7.5.3.2
 
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Eredhel

Quality Manager
#6
You should be able to appeal this pretty easily. Plus the auditor is even calling out document control rather than design stuff anyway.
 

Pancho

wikineer
Super Moderator
#9
I would rather not hang the auditor just yet.

Hopefully the OPs documented information makes clear which drawings need or not approval. If that is not specified in the system, then there’s certainly an unidentified risk, or an opportunity for improvement, perhaps even a nonconformity.

Many drawing templates have a “checked” or “approved” box that, if left empty, may imply that a check or an approval is missing rather than simply not required. I can see it leading to confusion in suppliers, clients or consultants. I think it may be good practice to mark such box with N/R if such check is not required. This way no one can be confused as the auditor may have been.

So, in summary, at least two small improvements can come of this: (1) clarification in the system of which drawings need approval, and (2) a documented distinction between drawings where approval is not required and those where approval has not yet been done.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#10
Hopefully the OPs documented information makes clear which drawings need or not approval.
If that were the case the CB auditor should have referenced the source of the requirement, accordingly.

The CB audit and reporting protocol allows for a few categories of audit findings, ranging from noteworthy efforts to major nonconformities, passing through observations, opportunities for improvement, etc.

When a CB auditor reports a finding as a nonconformity, s/he HAS to tie the evidence to a VALID requirement. In this case, s/he has obviously failed to comply with the protocol. It is that simple and if we allow CB auditors to ignore the standards they have to follow we are injecting valueless disruption into the process.
 
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