Root Cause for Minor Non-conformance regarding Supplier Delegation

L

lamahed

#1
Hi,
My company recently received a minor non-conformance in re-cert audit to AS9100 Rev. C, Statement of Non-Conformity was "Supplier delegation requirements were not fully met" referencing Clause No. 7.4.3 of AS9100 Standard.

Stated Objective Evidence was: Requirements for supplier delegation were not defined nor were there a register of delegations maintained.

Obviously, it's a pretty easy fix. However, I'm having a terrible time with the Root Cause. I am extremely hesitant to say something like, "Company failed to understand Standard, Poor Training of Standard Requirements" ect." I know we should be looking at what in the system failed that caused the non-conformance but I'm having a really hard time figuring out where in the system the company failed in implementing the standard...

Anyone had experience with this or something similar? Any advice would be appreciated.

Thank you
 
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Mikishots

Trusted Information Resource
#2
I would look at two things: the process documentation that defines how suppliers are controlled with respect to inspection activities, and the internal audit process. I'm aware that a documented procedure isn't a hard requirement, but you've been found to be missing defined requirements as well as the register.

Based on the auditor's finding, there is no evidence that there is a defined method of delegating requirements, or of a register of delegations (we've already established this, correct?). So...the next question might be why didn't the internal audit pick this up? An organization is required to ensure that its processes meet the cited requirements of the standard; this requirement is very plainly stated.

I'm curious - does your quality manual make no mention of this either?

Whenever a process is documented, it needs to be reviewed to ensure that it has been proven to be adequate prior to issue (4.2.3). The omission was never seen because the review of requirements was likely not carried out.

No comment on the "minor" classification - I'm not in agreement...:cool:
 
L

lamahed

#3
Thank you for the feedback. Actually, our Quality Manual does mention the requirement, however, I believe the requirement was misunderstood and poorly written in the manual from the beginning.

Manual States: Where the organization delegates verification activities to the supplier, the requirements for verification shall be defined and a register of delegation maintained on the appropriate purchase order.

This may be a reason it was never caught in the internal audits (or multiple external audits).
 

Wes Bucey

Prophet of Profit
#4
Thank you for the feedback. Actually, our Quality Manual does mention the requirement, however, I believe the requirement was misunderstood and poorly written in the manual from the beginning.

Manual States: Where the organization delegates verification activities to the supplier, the requirements for verification shall be defined and a register of delegation maintained on the appropriate purchase order.

This may be a reason it was never caught in the internal audits (or multiple external audits).
Thus it would appear you have answered your own question - the written procedure/process for initially delegating and ror continued monitoring and recording of the effectiveness of such delegation was vague or confusing in describing the process or procedure. The corrective action is to rewrite the procedure/process in more clear language and ACTUALLY implement the rewritten [revised] procedure/process.

Why not discuss with those who actually are expected to follow the procedure/process and thus develop a workable process once everyone understands the need and motive behind effective delegation?
 

Mikishots

Trusted Information Resource
#5
Thank you for the feedback. Actually, our Quality Manual does mention the requirement, however, I believe the requirement was misunderstood and poorly written in the manual from the beginning.

Manual States: Where the organization delegates verification activities to the supplier, the requirements for verification shall be defined and a register of delegation maintained on the appropriate purchase order.

This may be a reason it was never caught in the internal audits (or multiple external audits).

I'm curious by your meaning of "register of delegation maintained on the appropriate purchase order". A PO is not the appropriate place for a register of delegation.
 
L

lamahed

#6
Wes - Thank you, I think you may be correct.'

Mikishots - Yes, a PO is not an appropriate place for a register of delegation. Again, I believe there was a misinterpretation/lack of understanding of this requirement - i.e.: verification activities delegated to supplier would be recorded on a PO.
Delegation and/or register of delegation was misunderstood here.
Thanks again.
 
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