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Major NCRs within AS9100 - What is the most frequent reason for Major NCRs?

QMS for Medical Device Companies
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was named killer

was named killer

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#3
#3
Never have had a Major on any of the 998854662788485 Audits that I have been through. It takes a complete systemic breakdown to get one. If you get one you have not done your job right.

(Knocking on wood)
 
Sidney Vianna

Sidney Vianna

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#4
#4
was named killer said:
It takes a complete systemic breakdown to get one.
Click to expand...
Not really. In the IAQG ICOP certification process, the definition of a Major Nonconformity is from AS9101. It reads:

Annotation 2020-06-19 140314.jpg
​
So, as you can see, a single isolated, but critical issue, shall be categorized as a Major. Not mentioning the fact that two similar minor nonconformities observed during consecutive audits must also be categorized as a Major and an nonconformity against the corrective action process also triggered.

The lack of major non conformities being reported is, many times, a reflection of the auditor's caliber; not the system being audited.
 
Kronos147

Kronos147

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#5
#5
What I see is people not understanding specifications.

A drawing say install rivets per NASM41799 (I'm sure that number is wrong) or something like that and the spec says use TTP-1757 paint, and your assemblers use something else, and it is out of shelf life.

Major

Doc control
The assessor walks in, your quality policy in the lobby is Rev. C. In the conference room, for the opening meeting, it's D, and on the floor, it's B. The first shop traveler is Rev. A and the Drawing is Rev. NC, and the instructions say they got to match. Assessor finds 2 more travelers like that.

Major

Inspection records
Assessor asks the inspector for their records of inspection. The dimensions are out of tolerance. The part is about to be shipped, signed of as conforming.

Major

Basic system tools
You have no records of Management Review, or maybe Internal Audits, or you have 60 open, overdue corrective actions.

Major

Misc...
Your biggest customer complained about a major safety issue. There are no records the organization is responding...

Your objectives are all under goal and there is no record of action or correction...

Your secret side business, advertised as under scope of accreditation, is discovered during the course of the assessment in the building across the street next to the Subway...

Your material certificates show chem and phys results that don't meet spec...

Your are working for Boeing but not heat treating with a Nadcap processor (without a deviation)....

You are outsourcing painting for Lockheed without flowdown of the Lockheed paint spec....

I could keep going.
 
C

Cari Spears

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#6
#6
Last year our auditor wrote up a minor NCR in supplier management that was similar to the minor we received in supplier management the previous year. That NCR stayed a minor, but they were required to issue a major NCR for the corrective action process.

In talking with other organizations, and my own experience, I'd say supplier management and corrective action are where auditors are writing the most majors.
 
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