10 CFR 50 App B, NQA-1, NCA-3800 - Separate Manuals?

T

TamTom

#1
Hello,

I've read a lot of thread here know, but still have one major question:

How is your "QA program" organized, have you one manual that covers both ISO and Nuclear or have you separated it?

We are working for all kind of industries, and our manual follows ISO 9001 and the automotive standard ISO/TS 16949, which is for higher volume production, to add the Nuclear part is very complicated but to make a separate Manual is make the manual looks like a bunch of paper nobody need. Any experiences?

TamTom
 
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B

BadgerMan

#2
Our QM is strictly a policy level document addressing the Aerospace and FAA requirements and is supported by many procedures and work instructions. I have seen similar systems where the organization serves different industries and they maintain matrices for each showing which documents apply to which specific industry requirements.
 
R

rgunn1

#3
My interpretation is that NQA-1, while written by ASME, is an interpretation of 10 CFR 50; appendix B. NCQ-3800 is the actual B&PVC code that ASME will audit you against. I believe that it is possible to have an NQA-1 based program (manual) which you will operate under and that can adhere to the requirements of 3800, but you will still need a manual geared directly towards 3800 for ASME audit purposes.
 
H

Hemi999

#4
You don't have to have a seperate manual for NQA 1 and ISO but it is a lot easier. The procedures that are in place will work very well with little change for NQA 1. As for NCA 3800 I would need to know more about the product produced and how will it be marketed to say if just an NCA 3800 program or QSC certification is required by ASME.
 
#5
We started with a combined manual and split them later. Much work there.

The reason we split them is because the level of control needed in an NQA-1 QAP is greater than that required for ISO 9001. Also, the focus of NQA-1 differs from ISO 9001 in that one is focused on compliance and saftey the other on customer satisfication through process improvement.

These are not necessarily mutually exclusive concepts. We found though that running the NQA-1 QAP and ISO 9001 QMS as a single program resulted in higher production cost than needed on the ISO side and a greater risk of noncompliance on the NQA-1 side.
 
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