ASME NQA-1-1994 Standards - Struggling with the supplement references

N

Norm Moreau

#11
You are correct there is no certification for software. The NRC however has "certified" some digital control systems for the new generation facilities. The NRC website would be a good place to find that kind of information. You are also correct that there is no certification for NQA-1 like there is for ISO.

Look's like you already have some feedback on NIAC and NUPIC. For nuclear suppliers that is a good way to reduce the number of audits and get visability for their organizations. Hope this helps.
 
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H

HBeast33

#12
My understannding of Commercial Grade Dedication is that your customer has to audit you and your suppliers and dedicate you as a commercial grade supplier. In our case, our customer refused to audit us for Commercial Grade so we are now going through the process of becoming NQA-1 compliant. We will then work with our raw material suppliers to dedicate them as Commercial Grade.
 
N

Norm Moreau

#13
Your approach is becoming more prevalent. Buyers, utilities and DOE contractors are beginning to encourage vendors to become NQA-1 suppliers. This pushes some of the risk to the supplier, but also reduces their cost. However, as suggested then the supplier must go back to their suppliers - in the case mentioned, material suppliers and dedicate their product!
 
M

MaryLou

#14
Hello,
I am still a bit confused about the dedication of commercial grade items. Are customers do audit us so does that mean we are dedicated or is it just that we are an approved supplier?

Thank you for all your responses,
 
N

Norm Moreau

#15
The audit your customer does is part of their dedication process. It simply gets you on their approved supplier list, but they have a number of other steps to perform which might include inspection/test, survey's, and/or review of history.
 
H

Hemi999

#16
Thanks for your replies. Just curious is anyone aware of any type of certification for software that is not embedded in the nuclear environment by an accreditation body other than ISO? My understanding is that there is no NQA-1 certification but there is a dedication for a commercial grade item. Any thoughts or comments?
NQA 1 is a QA program format. Correct there is not a certification program for NQA-1. Dedication is a process of taking a commercial product and verifying the critical characteristics to be able to use it in a nuclear application. There are good training classes out there for dedication. They can be performed in your facility or by attending the classes when they are given. I recommend one organization because I know the instructor but he is not the only one. Software is an area that a lot of people are not aware of. Just remember most software has to do with software that is performing some form of calculations used in design.
 
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N

Norm Moreau

#17
Be careful about software being limited to design activities. Software is everywhere. When CNC equipment is loaded with a program, who and how is that software validated? If an operating system is upgraded that holds software used to control material or track the status of a job who and how does the organization confirm that the upgraded software gives the same results as before. My basic recommendation is to do a software inventory and determine what software is being used that can have some impact on the quality of the product - that includes documentation. Then put your CM hat on and put it under control.

The comment on training is right on target. There are a number of service providers including ASME that have excellent courses.

Almost forgot. In general software found in M&TE (often referred to as firmware or embedded software) is exempt from software controls.
 
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