Commercial Grade Dedication requirements for a 10CFR50 Appendix B Manufacturer

Bubba

Involved In Discussions
#1
I am looking for some assistance to clarify my understanding of commercial grade dedication requirements for a 10CFR50 Appendix B manufacturer that supplies items to nuclear utilities.

Situation: My company manufactures electrical components for nuclear utilities under a 10CFR50 Appendix B program that utilizes NQA-1 for the framework of our quality system documentation. We test our finished assemblies for 1E qualification using IEEE 323 and IEEE 344. We also provide 10CFR21 reportability defects discovered with our product. In this situation we are providing a basic component to our customer.

The design of our product requires us to procure commercially available items such as resistors, capacitors, relays, etc. that are used to build our finished product. Are these items that are the building blocks of our finished products in need of commercial grade dedication in accordance with industry standards (EPRI, 10CFR21, etc.) or are they merely part of our design bases in accordance with our Appendix B program used to produce a qualified basic component?

I welcome any comments I can get from those that are more experienced and well versed than I am in the nuclear industry. :confused:
 
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Stijloor

Staff member
Super Moderator
#2
I am looking for some assistance to clarify my understanding of commercial grade dedication requirements for a 10CFR50 Appendix B manufacturer that supplies items to nuclear utilities.

Situation: My company manufactures electrical components for nuclear utilities under a 10CFR50 Appendix B program that utilizes NQA-1 for the framework of our quality system documentation. We test our finished assemblies for 1E qualification using IEEE 323 and IEEE 344. We also provide 10CFR21 reportability defects discovered with our product. In this situation we are providing a basic component to our customer.

The design of our product requires us to procure commercially available items such as resistors, capacitors, relays, etc. that are used to build our finished product. Are these items that are the building blocks of our finished products in need of commercial grade dedication in accordance with industry standards (EPRI, 10CFR21, etc.) or are they merely part of our design bases in accordance with our Appendix B program used to produce a qualified basic component?

I welcome any comments I can get from those that are more experienced and well versed than I am in the nuclear industry. :confused:
Comments anyone?

Thank you!!

Stijloor.
 
P

PittsburghBrass

#3
Bubba,
I am in the beginning stages of a CGD program, though I am unsure as to how to effectively get started. My research into CGD has yielded lots of generalities but few specifics on how-to, etc. Feel free to email if we can compare notes.
Thanks.
 
R

rgunn1

#5
Just glancing at NQA-1-2008, commercial grade dedication would only apply if the item performs a safety function. Regardless, for each item in your assembly, I would maintain a documented analysis on whether or not commercial grade dedication is required per 10 CFR 50 / NQA-1. Hope this helps!
 
H

Hemi999

#6
I work mostly in materials but the basis of any dedication is Engineering must determine the critical charismatics. If you do not have an engineering department the customer must tell you the charismatics to test. In the material area it is easier to determine because the ASTM /ASME specifications give you a starting point. I would be glad to provide some specific assitance. my contact is 910-988-4399.
 

Bubba

Involved In Discussions
#7
Thank you to those that have offered their assistance. NQA-1 2008/2009a is the edition of NQA-1 that we apply to our quality program. I have recently discovered a standard from EPRI that has enlarged my understanding of CGD from a manufacturer's perspective. Our auditors consistently call out EPRI 5652 as the standard to use for CGD, but EPRI TR-102260 (Supplemental Guidance for the Application of EPRI Report NP-5652 on the Utilization of Commercial Grade Items) is much more useful for our needs. Section 3.0 is specific to Supplier Dedication Issues and contains four acceptance options in section 3.2.2. Option D is the one that applies to the original situation that I wrote about in March. It states, "the original equipment manufacturer is buying several commercial grade parts and possibly raw materials (e.g., potting compounds) that are installed into an assembly. The assembly, inspection, and testing process is performed in accordance with the supplier's nuclear quality assurance program... If the combination of the assembly, inspection and testing of the complete assembly demonstrates the acceptability of the parts, the individual commercial grade parts may be accepted and dedicated by this process."

So, to summarize my new understanding, all of the commercially procured items that become part of our manufactured basic component do need to be dedicated. However, we may dedicate them through the implementation of our 10CFR50 Appendix B program as we inspect and test the completed assembly rather than through individual component dedication procedures.

If I have not applied this guidance correctly, please let me know. I am still learning. PittsburghBrass, hopefully this discovery can be of use to you as well.
 
H

Hemi999

#8
The EPRi standards are good basis for deication but the NRC further requires that the components be dedicated before assembly unless you do a tremdous amount of testing of the assembled parts. This is one of the problems in the industry, there are standards out there but there government departments that add to those requirements.
If you have any questions contact me at 910-988-4399 if I cant give you a response that way I will research the question with some of my contacts.
Jim
 
C

crager34

#9
Some info (I pulled a few relevant sections, but the whole thing is worth a read through:

NRC - LICENSEE COMMERCIAL-GRADE PROCUREMENT AND DEDICATION PROGRAMS (GENERIC LETTER 91-05)

In NRC Generic Letter (GL) 89-02, "Actions to Improve the Detection of
Counterfeit and Fraudulently Marketed Products," the staff described its
perspective on good practices in procurement and dedication and provided the NRC's conditional endorsement of an industry standard (EPRI NP-5652) on methods of commercial-grade procurement and dedication. A number of recent inspection findings, as discussed in Enclosure 1, indicate that licensees have failed to include certain key activities, as appropriate, in the implementation of the dedication process.

The term "critical characteristics" is not contained in Appendix B and has
no special regulatory significance beyond its use and definition in various
industry guides and standards. The NRC first used the term critical
characteristics in GL 89-02 as constituting those characteristics which need
to be identified and verified during product acceptance as part of the
procurement process. The NRC has not taken the position that all design
requirements must be considered to be critical characteristics as defined
and used in EPRI NP-5652. Rather, as stated in Appendix B, Criterion III,
licensees must assure the suitability of all parts, materials, and services
for their intended safety-related applications (i.e., there needs to be
assurance that the item will perform its intended safety function when
required). The licensee is responsible for identifying the important
design, material, and performance characteristics for each part, material,
and service intended for safety-related applications, establishing
acceptance criteria, and providing reasonable assurance of the conformance
of items to these criteria.

A licensee may take different approaches for the verification of the
critical characteristics, depending on the complexity of the item. In
many cases, the licensee can verify the critical characteristics of
each item during receipt inspection testing. However, for a complex
item with internal parts which receive special processing during
manufacturing, the licensee may need to conduct a source verification of the manufacturer during production to verify the critical
characteristics identified as necessary for the item to perform its
safety function. When these methods cannot verify the critical
characteristics related to special processes and tests, certification
by the original equipment manufacturer may be an acceptable alternative

provided documented, verified traceability to the original equipment
manufacturer has been established and the purchaser has verified by
audit or survey that the original equipment manufacturer has
implemented adequate quality controls for the activity being certified.
 
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