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Inside NIRMA Summer 2021

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would set a precedent that other utilities/plants could<br />

take advantage of, or 2) insert electronic records<br />

guidance into a subsequent version of NQA-1 (more on<br />

that later).<br />

Duke Energy Safety Evaluation Report Request<br />

In March 2015, Duke Energy Carolinas submitted a<br />

request to the NRC to approve a change to the Quality<br />

Assurance Topical Report (QATR) for its three nuclear<br />

stations. The request was to revise the QATR to<br />

reference the 2011 versions of the TGs. The NRC<br />

found it acceptable that the requirements of 10 CFR 50<br />

Appendix B would still be satisfied through compliance<br />

with the TGs. Therefore, the Duke SER satisfied one<br />

of the alternatives cited in the PP06 position paper.<br />

Bottomline: If you want to have electronic records management for<br />

your site, the NRC approves the use as long as your electronic<br />

records comply with these 2011 versions of the TGs.<br />

[On the <strong>NIRMA</strong> website, for these TGs, you will<br />

find a folder called “NRC-SER Endorsed <strong>NIRMA</strong> TGs<br />

(2011)” under the Technical Guidelines section of the<br />

Reference Documents area.]<br />

Regulatory Guide 1.28, Revision 5<br />

Quality Assurance Program Criteria<br />

(Design and Construction)<br />

In October 2017, the NRC issued Revision 5 of<br />

Regulatory Guide 1.28. Prior to that, in Revision 4, the<br />

NRC stated that, if electronic QA records were being<br />

stored and managed, its position on electronic records<br />

was based on Generic Letter 88-18 and RIS 2000-18<br />

that references the 1998 <strong>NIRMA</strong> guidelines (TG-11, TG<br />

-15, TG-16, TG-21). In Revision 5, the NRC stated:<br />

“For the management of electronic records,<br />

appropriate controls on quality assurance include the<br />

following:<br />

(a) No deletion or modification of records unless<br />

authorized pursuant to the record retention rule<br />

(b) Redundancy (system backup, dual storage, etc.) is<br />

provided<br />

(c) Legibility is required of each record<br />

(d) Records media are properly maintained<br />

(e) Inspections to ensure no degradation of records<br />

(f) Records are acceptably converted into any new<br />

system before the old system is taken out of<br />

service<br />

The Nuclear Information and Records Management<br />

Association (<strong>NIRMA</strong>) technical guides (TGs), as<br />

listed…, provide guidance to establish the<br />

appropriate quality controls that incorporates the<br />

implementation of enterprise content management<br />

systems, web-based technologies, and higher capacity<br />

LAN/WAN networks. The NRC approves for use<br />

the 2011 versions of the <strong>NIRMA</strong> TGs.”<br />

Bottomline: The NRC, in Revision 5, essentially leveraged its<br />

position stated in the Duke SER and approves the use of the<br />

2011 <strong>NIRMA</strong> TGs.<br />

American Society of Mechanical Engineers:<br />

Quality Assurance Requirements for<br />

Nuclear Facility Applications<br />

<strong>NIRMA</strong> members, in 2015, began to participate in<br />

the Programs Management Process (PMP)<br />

Subcommittee of NQA-1. It was surmised that the<br />

<strong>NIRMA</strong> TG content is very extensive, but wordy, so<br />

<strong>NIRMA</strong> TG (2011) requirements were reduced or<br />

summarized to fit the ASME NQA-1 format and scope.<br />

The advantages for the industry are that the<br />

manufacturers can use these changes very quickly; NSSS<br />

vendors and new build facilities can adjust, as needed.<br />

ASME NQA-1 is the “go-forward” strategy for industry<br />

and NRC review. It will not be tied to any specific TG<br />

version, so the standard can adjust as technology<br />

changes. From a <strong>NIRMA</strong> perspective, there will be<br />

many ASME interpretations, of which answers can then<br />

be sought in the full <strong>NIRMA</strong> TGs.<br />

Bottomline: The electronic records requirements are published as<br />

part of ASME NQA-1-2017. (Caution: You have to be<br />

committed to/and use this standard/year to take advantage of<br />

this.)<br />

Whew! Thanks for hanging in there with me. It’s<br />

been quite a ride in guidance space for over 30+ years,<br />

and <strong>NIRMA</strong> has been in the thick of it! In future<br />

columns, I intend to continue with addressing the other<br />

aspects of nuclear electronic records, such as<br />

authentication, sustainability, disaster planning and<br />

recovery, and more! Stay tuned!<br />

Eugene has been a member of <strong>NIRMA</strong> for over<br />

34 years. At the time he joined, <strong>NIRMA</strong> had<br />

only been in existence for 11 years. He would love<br />

to hear about stories and anecdotes from others, so<br />

please email him at eugene.yang@kismetconsulting.com.<br />

Back to Content | <strong>Inside</strong> <strong>NIRMA</strong> <strong>NIRMA</strong>.org <strong>Summer</strong> <strong>2021</strong> 25

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