ML25120A011
| ML25120A011 | |
| Person / Time | |
|---|---|
| Site: | 99902135 |
| Issue date: | 05/02/2025 |
| From: | Banks I NRC/NRR/DNRL/NLIB |
| To: | Dominion Energy Services |
| References | |
| Download: ML25120A011 (1) | |
Text
Information Needs Provided by the NRC Staff for the Topical Report for Dominion Energy Services, Inc.
New Nuclear Quality Assurance Program Note: On March 21, 2025, the U.S. Nuclear Regulatory Commission (NRC) determined the topical report for the Dominion Energy Services, Inc. (Dominion Energy) New Nuclear Quality Assurance Program Description (NN QAPD) was acceptable for review (Agencywide Documents Access and Management System (ADAMS) Accession Package No.ML25073A132). In preparation for the May 20, 2025, public meeting with Dominion Energy on this topical report, the NRC staff sent the following information needs to Dominion Energy on May 2, 2025.
- 1. 10 CFR 52.17(a)(1)(xii) states, in part:
An evaluation of the [site] against [applicable sections of] the Standard Review Plan (SRP) revision in effect 6 months before the docket date of the application. The evaluation required by this section shall include an identification and description of all differences in analytical techniques and procedural measures proposed for a site and those corresponding techniques and measures given in the SRP acceptance criteria.
Where such a difference exists, the evaluation shall discuss how the proposed alternative provides an acceptable method of complying with the Commission's regulations, or portions thereof, that underlie the corresponding SRP acceptance criteria.
The SRP is not a substitute for the regulations, and compliance is not a requirement.
NUREG-0800, SRP 17.5,Section I, Areas of Review states, in part, that:
The [QA] staff reviews and evaluates [QAPDs] submitted by applicants for a [DC],
combined license (COL), early site permit (ESP), construction permit (CP), and operating license (OL). The QAPDs submitted by applicants for DC, COL, ESP, CP, and OL are reviewed and evaluated in accordance with the applicable sections of this SRP.
Issue: The cover letter of the Dominion Energy NN QAPD states the scope of applicability of the proposed QAPD is limited to preliminary site licensing activities. However, the NN QAPD Section 1.1, Scope/Applicability states that [t]he NN QAPD applies to ESP, CPA, OLA, and COLA activities affecting quality and performance of safety-related structures, systems, and components (SSCs), including, but not limited to, siting. As noted in the completeness determination email (ML25073A134), the NRC staff understands that a future revision of the NN QAPD will clarify its applicability to ESPs only.
Information Need: Please clarify the scope for the QAPD submittal and review. Some information included is not applicable to ESP applicants. For example, operations and maintenances activities or Section 3.4, Setpoint control are not applicable for ESP applicants.
- 2. Section 7, Control of Purchased Material, Equipment, and Services, Subsection 7.2, NQA-1 Commitment/Exceptions of the NN QAPD provides a list of exceptions to NQA-1 commitments, (specifically, bullet 2) states:
When purchasing commercial grade calibration services from a calibration laboratory, procurement source evaluation and selection measures need not be performed provided each of the following conditions are met: []
NRC Safety Evaluation (ML20322A019) endorses the use of NEI 14-05A, Revision 1, dated September 2020 with additional provisions the licensee shall follow. The provisions state:
- 1) The method to use accreditation by an ILAC MRA signatory in lieu of a commercial-grade survey (alternative method) is documented in the licensee and/or supplier of basic components QA program.
- 2) The method the licensee and/or supplier of basic components needs to follow, and document in their QA program, consists of:
- a. A documented review of the laboratorys accreditation is performed and includes a verification of the following:
- i. The calibration or test laboratory holds accreditation by an accrediting body recognized by the ILAC MRA. The accreditation encompasses ISO/IEC-17025:2017, General Requirements for the Competence of Testing and Calibration Laboratories.
ii. For procurement of calibration services, the published scope of accreditation for the calibration laboratory covers the needed measurement parameters, ranges, and uncertainties.
iii. For procurement of testing services, the published scope of accreditation for the test laboratory covers the needed testing services including test methodology and tolerances/uncertainty.
iv. The laboratory has achieved accreditation based on an on-site accreditation assessment by the selected AB within the past 48 months. The laboratory's accreditation cannot be based on two consecutive remote accreditation assessments.
- b. The purchase documents require that:
- i. The service must be provided in accordance with their accredited ISO/IEC-17025:2017 program and scope of accreditation.
ii. As-found calibration data must be reported in the certificate of calibration when calibrated items are found to be out-of-tolerance (for calibration services only).
iii. The equipment/standards used to perform the calibration must be identified in the certificate of calibration (for calibration services only).
iv. Subcontracting of these accredited services is prohibited.
- v. The customer must be notified of any condition that adversely impacts the laboratorys ability to maintain the scope of accreditation.
vi. Performance of the services listed on this order is contingent on the laboratory's accreditation having been achieved through an on-site accreditation assessment by the AB within the past 48 months.
vii. Any additional technical and quality requirements, as necessary, based upon a review of the procured scope of services, which may include, but are not necessarily limited to, tolerances, accuracies, ranges, and industry standards.
- c.
It is validated, at receipt inspection, that the laboratorys documentation certifies that:
- i. The contracted calibration or test service has been performed in accordance with their ISO/IEC-17025:2017 program, and has been performed within their scope of accreditation, and ii. The purchase orders requirements are met.
Issue Part 1: The NRC staff identified that the NN QAPD does not cover all the provisions/conditions for the use of the ILAC process.
Information Need #1:
a) Please clarify Dominions intention to use the ILAC process for testing services. If testing services is applicable, then the provision of 2.a.iii from above is missing.
b) The ILAC accreditation is for ANSI/ISO/IEC 17025:2017 and it must be documented as such.
c) The NN QAPD is missing the provisions and conditions of 2.a.iv, 2.b (all), and 2.c (all) from above. Please clarify if Dominion plans to add these provisions.
Issue Part 2: In addition, NN QAPD Part IV, Regulatory Guides and Quality Standard Commitments, includes NEI 14-05 A, Revision 1 as one of the standards. However, neither Section 7.1 nor this part explains whether Dominion will use this standard as a basis for the ILAC process.
Information Need #2: Please clarify if Dominion plans to use NEI 14-05A.
- 3. NN QAPD Section 7.1 Acceptance of Item or Service states that (bullet 3)
During exigent or emergency conditions, an extension of 25% may be applied to the triennial supplier audit frequency where performance is not feasible. This 25% extension is applicable to domestic and international suppliers.
Exigent conditions include, but are not limited to:
o declaration of a national emergency, o severe localized or national weather conditions, or o localized outbreak of a severe health concern to the public.
Prior to utilizing the exigent condition extension, basic component suppliers shall confirm that a quality assurance program meeting 10 CFR Part 50, Appendix B requirements is implemented. Commercial suppliers shall confirm programmatic controls related to the activity affecting quality continue to be maintained. During exigent conditions, if a contract or contract modification significantly modifies a suppliers scope, the supplier shall provide written justification that the change(s)
is (are) adequately addressed by the suppliers quality assurance program controls.
Triennial supplier audits performed during exigent conditions shall reset the clock for the particular activity. The new triennial supplier audit frequency schedule shall be based on the date the activity is performed.
In a Safety Evaluation dated August 6, 2020 (ML20216A681), the NRC staff approved a 25 percent extension of audit or survey frequency during extenuating circumstances. The 25 percent extension of audit or survey frequency is allowed if several conditions included in the SE are met. The NRC staff note that not all the conditions were included in the QAPD.
The conditions not included in the QAPD include:
- 1) The allowance would only apply to existing suppliers on the Qualified Suppliers List.
- 2) A documented evaluation must be performed to summarize why the audit or survey could not be performed prior to the end of the 90-day grace period and to provide the basis for maintaining the supplier as an approved supplier during the 25 percent (9-month) grace period.
- 3) There is verification that the supplier is still implementing a QA program that meets Appendix B to 10 CFR Part 50. For suppliers with delinquent surveys, the entity shall ensure that the suppliers have maintained adequate documented programmatic controls in place for the activity affecting quality.
NRC Note: This is different from the Dominion bullet included above. The difference between them is that Dominion is responsible for the verification of the QA controls for Appendix B suppliers and suppliers with delinquent commercial grade surveys.
- 4) Receipt inspection and industry operating experience are reviewed on an ongoing basis as the information becomes available and documented. The results of the review are promptly considered for the effects on a suppliers continued qualification and adjustments made as necessary, including corrective actions.
- 5) If there is no ongoing receipt inspection or operating experience with which to analyze the supplier for a period of 12 months since the last audit or survey, an annual documented evaluation shall be performed and include, as appropriate, the following:
- a. Review of supplier-furnished documents and records such as certificates of conformance, nonconformance notices, and corrective actions.
- b. Results of previous source verifications, audits, survey and receiving inspection activities.
- c. Operating experience of identical or similar products furnished by the same supplier.
- d. Results of audits and inspection from other sources (e.g. customer, ASME, or NRC inspection).
Information Need: Please clarify if Dominion Energy plans to commit to the conditions stated above.
- 4. Section 7, Control of Purchased Material, Equipment, and Services, Subsection 7.2, NQA-1 Commitment/Exceptions of the NN QAPD provides a list of exceptions to NQA-1 commitments, (specifically, bullet 4) states:
In establishing commercial grade item requirements, Dominion Energy commits to compliance with NQA-1-2015, Requirement 7, Section 700 and Part II, Subpart 2.14, with the following clarification:
- For commercial grade items, quality verification requirements are established and described in Dominion Energy documents to provide the necessary assurance that an item will perform satisfactorily in service. The Dominion Energy documents address determining the critical characteristics that ensure an item is suitable for its intended use, technical evaluation of the item, receipt requirements, and quality evaluation of the item.
Information Need: Please clarify if Dominion Energy will assume 10 CFR 21 reporting responsibility for all items that Dominion Energy dedicates as safety-related.
- 5. The staff notes that in Part IV of the QAPD Regulatory Commitments Dominion Energy commits to the following RG:
- a. Regulatory Guide 1.8, Rev. 4, June 2019, Qualification and Training of Personnel for Nuclear Power Plants
- b. Regulatory Guide 1.164, Rev. 0, June 2017, Dedication of Commercial-Grade Items for Use in Nuclear Power Plants
- c. Regulatory Guide 1.234, Rev. 0, April 2018, Evaluating Deviations and Reporting Defects and Noncompliance Under 10 CFR Part 21 Issue Part 1: RG 1.8 is not applicable to an ESP application.
Information Need #1: Clarify the applicability of RG 1.8 to an ESP application.
Issue Part 2: The most recent revisions of RG 1.164 and RG 1.234 are Revision 1 dated April 2024 and March 2024, respectively.
Information Need #2: Please explain the rationale for not committing to meeting the latest revision of RGs. 1.164 and 1.234.