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Major Finding Elevation - Do I elevate this minor finding to a major one?

phxsun2001

Involved - Posts
#1
Do I elevate this minor finding to a major one ?

There was an NCR written up against 8.5.4 C. in 2017
8.5.4.C
special handling and storage for sensitive products.
There was an ESD control and Nitrogen dry box issues on sensitive material. No expired shelf life material found.
C/A and P/A were effective during a recent certification follow-up audit.


During the certification audit recently in 2018, there was a NCR vs 8.5.4 D
8.5.4.D on Shelf life material labeling used in production on shelf life material used. Shelf life material poured from a gallon bottle was not labeled properly after transferred to a smaller bottle.
This is a different issue from the one in 2017.

Does the AS9100 standard consider this a repeat violation of requirement 8.5.4 and issue an elevated Major NCR? The violations were on different sub-clauses.
The root cause and C/A of the two NCRs are totally different. The new OASIS system does not allow auditor to enter sub-clauses. I can only enter 8.5.4. on both NCRs. I was able to enter sub-clauses before the OASIS system in AS9100C.
The 2017 NCR was closed already. The problem was fixed.

BJ
 
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phxsun2001

Involved - Posts
#3
This is not an internal audit. This a AS9100D recertification audit.
It is under the same 8.5.4 requirement , but different sub-clause, 8.5.4.C and 8.5.4.D.
Do I have to elevated to a major NCR?
 

phxsun2001

Involved - Posts
#5
Yes, I am a CB Auditor conducting a recertification audit.
I was told that as long as it is within 8.5.4, it doesn't matter if it is sub-clause C or D, it is a repeat violation and a major NCR should be issued.

I also issued a NCR vs 8.5.1.C in 2017 related to sampling inspection procedure not followed. During this 2018 recent audit, I issued 4 NCR within 8.5.1 a to q. They were not related to the one in 2017. I was told to issue four additional Major NCR because they are under 8.5.1. and they are repeats of clause 8.5.1. What are the rules on repeat violation and elevation to major N/C. Does anyone know? Do we go by upper level clauses like 8.5.1?

It is not difficult to find N/C within clauses 8.5.1 a-q, especially with this company of 1000 employees with hundreds of individual assembly operations. If I find a single N/C in 8.5.1 again in 2019, are they going to loose their certification? It is a repeat of a major N/C.
 

John Broomfield

Staff member
Super Moderator
#7
If you have evidence of a chronic (persistent) problem then it probably should be reported as a major nonconformity to get the attention of senior management.

Carefully cite all of the evidence to support your NCR.

This is an important part of your service to your client and their customers.

You may also cite the failure to take effective corrective action as another separate NCR.
 

phxsun2001

Involved - Posts
#8
Do your Operations management of the CB you work for not provide guidance?
Our CB guideline is- if one NCR was written in 2017 on 8.5.1 on any sub-clause (a-q), We have to issue a major in 2018 if I issue another NCR within 8.5.1 a to q. It doesn't matter which sub-clause. We don't follow the AS9101f to determine if the NCRs are same or different.
The same with requirement 8.5.4 and other 2nd level requirements.

AS9101f
4.2.2.5 Identifying and Recording of Audit Findings

Recurrence of the same or similar nonconformity found during consecutive audits at a particular site/location shall be considered as a major nonconformity against the corrective action process (see 9100-series standards clause 10.2).
 
#9
I give up! When that kind of "rule" permeates the certification world - and there's little/no attempt to determine the EFFECT on results, the whole thing becomes stupid, frankly. What's the point?
 
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