ML25058A163
| ML25058A163 | |
| Person / Time | |
|---|---|
| Site: | 07100935 |
| Issue date: | 03/03/2025 |
| From: | Gerond George NRC/NMSS/DFM/IOB |
| To: | Byars R EnergySolutions |
| References | |
| Download: ML25058A163 (1) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 March 3, 2025 Richard Byars, Group Director, Quality Assurance, Waste Management EnergySolutions 740 Osborn Road Barnwell, SC 29812
SUBJECT:
REQUEST FOR ADDITIONAL INFORMATION FOR ENERGYSOLUTIONS DOCKET NO. 0935, ES-QA-PG-001, QUALITY ASSURANCE PROGRAM, REVISION NO. 13
Dear Richard Byars:
By letter dated February 4, 2025 (Agencywide Documents Access and Management System
[ADAMS] Accession No. ML25035A308), EnergySolutions (ES) submitted proposed Revision No. 13 to ES-QA-PG-001, EnergySolutions Quality Assurance Program, for the U.S. Nuclear Regulatory Commission (NRC) review and approval under Title 10, of the Code of Federal Regulations (10 CFR) Part 71.
In connection with the staffs review, the NRC needs information identified in the enclosure to this letter. This request for additional information (RAI) is listed by chapter number and title in the applicants quality assurance program. The RAI describes the information needed by the staff to complete the review of the submittal and to determine whether the applicant has demonstrated compliance with the regulatory requirements.
The staff is available to clarify these questions, and if necessary, to meet, and discuss your proposed responses.
In accordance with 10 CFR Part 2, Agency Rules of Practice and Procedure, a copy of this letter will be available electronically for public inspection in the NRC Public Document Room (PDR) or from the Publicly Available Records component of the NRCs ADAMS. ADAMS is accessible from the NRC website at http://www.nrc.gov/reading-rm/adams.html. The PDR is open by appointment. To make an appointment to visit the PDR, please send an email to PDR.Resource@nrc.gov or call 1-800-397-4209 or 301-415-4737, between 8 a.m. and 4 p.m.
eastern time (ET), Monday through Friday, except Federal holidays.
R. Byars 2
If you have any questions regarding this RAI, please contact me at 301-415-3882 or Andres Rowe at 301-415-3565.
Sincerely, Gerond George, Acting Chief Inspection and Oversight Branch Division of Fuel Management Office of Nuclear Material Safety and Safeguards Docket No.: 71-0935
Enclosure:
- 1. Request for Additional Information Signed by George, Gerond on 03/03/25
ML25058A163 OFFICE:
NMSS/DFM NMSS/DFM NMSS/DFM NMSS/DFM NAME:
ARowe RPatel SFigueroa GGeorge DATE:
2/27/2025 2/27/2025 2/27/2025 3/3/2025 Enclosure Request for Additional Information Docket No. 0935 ES-QA-PG-001, QUALITY ASSURANCE PROGRAM, REVISION NO. 13 RAI Section 15, Nonconforming Materials, Parts, or Components Description of Issue Section 15, Control of Nonconforming Materials, Parts ES-QA-PG-001, Quality Assurance Program, revision 13, EnergySolutions (ES) deleted the Engineering responsibility, or Components, of for approving Accept-As-Is, disposition of nonconforming materials, parts, or components.
Deleting the Engineering responsibilities for the approval of Accept-as-is, disposition of nonconforming materials, parts or components from previously approved U.S. Nuclear Regulatory Commission (NRC) quality assurance program (QAP) is a reduction in commitment.
However, ES did not provide the reason for the change and the basis for deleting the Engineering responsibility for approval of the accept-as-is, disposition in table of changes.
Regulatory Basis:
In accordance with Title 10 of the Code of Federal Regulations (10 CFR) 71.106(a)(1), each QAP approval holder shall submit the following information to the NRC for review and approval changes that reduce commitments made to an approved QAP: (1) a description of a proposed changes to the approved quality assurance program description, (2) the reason for the change, and (3) the basis for concluding that the revised program incorporating the change continues to satisfy the application requirements of subpart H, Quality Assurance Program, of 10 CFR Part 71.
Request:
Please provide information to justify this change to the QAP is acceptable or revise the responsibility to align with previously approved revisions of the QAP to satisfy the requirements of Subpart H of 10 CFR Part 71.
This information is needed to ensure compliance with the requirements of 10 CFR Section 71.106 (a)(1).
RAI Section 16, Corrective Actions Description of Issue:
In section 16 of ES-QA-PG-001, ES revised the responsibility of quality assurance personnel performing follow-up on corrective actions, from required, to when required, to verify that they are effectively implemented and from required, to when required, to trend adverse conditions to determine quality tendency for management review.
2 Regulatory Basis:
ES in their Table of Revision stated that these changes are clarification on responsibilities and requirements. However, ES did not provide clear justification to the changes to the responsibilities and requirements.
Changing the responsibility of the quality assurance personnel is a reduction in commitment to the previously approved QAP.
Request:
Please provide the basis for concluding that the revised program incorporating the change continues to satisfy the requirements of Subpart H of 10 CFR Part 71.
This information is needed to ensure compliance with Title 10, of the Code of Federal Regulations Section 71.106(a)(1).
RAI Section 18, AUDITS Description of Issue:
In section 18 of the ES-QA-PG-001, ES deleted the requirement for performing internal audits of each applicable quality criterion at least once each year. In the Table of Revision ES stated that removing the requirements for annual audits of activities was to bring the QAP in alignment with NQA-1, Part III, subpart 3.1, 18A-1.
Further, section 18 states in part, that audits shall be performed every 2 years unless a more frequent audit requirement is imposed by regulations.
Deleting the requirements for performing annual audits of each quality criterion at least once each year is a reduction in commitment from previously approved QAP. Aligning the QAP to American Society of Mechanical Engineers NQA-1 does not provide a basis for the change, because the NRC has taken exception to NQA-1 requirements to internal audits as specified in regulatory guides (RGs).
Regulatory Basis:
In regulatory guide (RG) 7.10, revision 3, and RG 1.28, revision 6, Quality Assurance Program Criteria (Design and Construction), the staff has taken exception to NQA-1 requirements in the form of a regulatory position. Specifically, section C, Staff Regulatory Guidance, subsection 4.a of RG 1.28, and subsection 18.2 of RG 7.10, Internal Audits, requires that applicable elements of an organizations QAP should be audited at least once each year (annually) or at least once during the life of the activity, whichever is shorter.
Request:
Please provide information to justify this change to the QAP is acceptable or revise the audit requirements to align with previously approved revisions of the QAP to satisfy the requirements of Subpart H of 10 CFR Part 71.
This information is needed to demonstrate compliance with the requirements of 10 CFR 71.106.