ML24037A099
| ML24037A099 | |
| Person / Time | |
|---|---|
| Issue date: | 02/15/2024 |
| From: | Jeremy Tapp NRC/NMSS/DFM/IOB |
| To: | Center for Nuclear Waste Regulatory Analyses (CNWRA), Southwest Research Institute |
| Shared Package | |
| ML24037A098 | List: |
| References | |
| GED 2023-1 OAR?23?01 | |
| Download: ML24037A099 (7) | |
Text
U.S. NUCLEAR REGULATORY COMMISSION STAFF OBSERVATION OF THE CALENDAR YEAR 2024 GEOSCIENCES AND ENGINEERING DEPARTMENT QUALITY ASSURANCE AUDIT, GED 20231 OBSERVATION AUDIT REPORT NO.: OAR2301 Jeremy E. Tapp, Primary Observer Division of Fuel Management Office of Nuclear Material Safety and Safeguards Enclosure
2
1.0 INTRODUCTION
The Geosciences and Engineering Department (GED) of the Southwest Research Institute (SwRI) provides technical support to the U.S. Nuclear Regulatory Commission (NRC) staff through current NRC Charter Contract 31310023D0004 and Work-For-Others Contract 31310023D0005. These Contracts require GED to meet the quality assurance (QA) requirements of Title 10 of the Code of Federal Regulations (10 CFR) Part 50, Domestic Licensing of Production and Utilization Facilities; Part 63, Disposal of High-Level Radioactive Wastes in a Geologic Repository at Yucca Mountain, Nevada; Part 71, Packaging and Transportation of Radioactive Material; and Part 72, Licensing Requirements for the Independent Storage of Spent Nuclear Fuel, High-Level Radioactive Waste, and Reactor-Related Greater Than Class C Waste. On December 1214, 2023, QA auditors and technical specialists from SwRI (auditors) conducted the audit GED 20231 of two NRC funded projects performed by GED at the SwRI facility in San Antonio, Texas. An NRC staff member (observer) from the Office of Nuclear Material Safety and Safeguards (NMSS) observed the audit at the SwRI facility and was the primary observer. The GED held a preaudit meeting on December 12, 2023, on site with the auditors and NRC primary observer, and with NRC contract staff who participated virtually. The GED also held a postaudit meeting on December 14, 2023, on site with the auditors and NRC primary observer, and with NRC contract staff who participated virtually.
The scope of the audit was to evaluate the GED QA program to determine whether it meets contractually mandated QA program requirements and is being effectively implemented for NRC sponsored activities by the GED. The objective of the NRC primary observer was to evaluate the effectiveness of the audit process and the implementation of the GED QA program.
Details of the audit are available in the January 15, 2024, SwRI report for GED, "Quality Assurance Audit Report for Geosciences and Engineering Department (GED) Audit, GED 20231" (Agencywide Documents Access and Management System (ADAMS) Accession No. ML24022A085).
2.0 MANAGEMENT
SUMMARY
The auditors evaluated the adequacy of applicable QA program elements and two technical tasks during this full-scope audit. During the audit, the auditors identified two good practices, two minor nonconformances and five recommendations for improvements (see Section 9.0, Results).
The primary observer verified that the auditors were qualified and independent of the activities and technical areas they audited.
The auditors determined that: (1) the GED QA program continues to be effectively implemented and provides adequate controls over technical product development and related quality affecting activities; (2) the GED staff continues to operate in accordance with the GED Quality Assurance Manual, contracts, task-orders, project plans, technical operating procedures, QA procedures, and applicable administrative procedures; and (3) the technical staff was appropriately qualified through education, experience, and training with the technical work executed in a satisfactory manner.
The primary observer concluded that the audit process was well-planned, thorough, effective, and performed in a professional manner. The auditors developed and used audit checklists that were comprehensive and effective in providing guidance to the auditors. The audit team leader provided ample opportunities for the primary observer to provide comments and ask questions throughout the audit process. The auditors and primary observer discussed potential findings with GED management during caucuses, audit debriefs, and at the postaudit meeting.
3 The primary observer determined that the audit achieved its objectives of evaluating the GED QA program to verify that it met applicable requirements and was effectively implemented. The primary observer determined that the audit was effective in reviewing, evaluating, and determining compliance with procedural requirements in the areas controlled by the QA program.
The primary observer agreed with the auditors conclusion that the QA program was effectively implemented.
3.0 PARTICIPANTS 3.1 Auditors Colby Tate Institute Quality Systems (IQS)-Audit Team Leader Mark Ehnstrom IQS-QA Auditor 3.2 Technical Specialists David Turner, PhD Environmental Assessment St. Marys University, San Antonio, Texas Karen Carpenter Fire Technology Department SwRI, San Antonio, Texas 3.3 NRC Observer Jeremy Tapp Primary observer (NMSS/Division of Fuel Management/
Inspection and Oversight Branch Inspector) 4.0 REVIEW OF AUDIT AND AUDITED ORGANIZATION The GED provides technical support to NRC staff under NRC Contracts 31310023D0004 and 31310023D0005. These contracts require GED to meet the QA requirements of 10 CFR Parts 50, 63, 71, and 72. The GED had the audit performed to determine whether its QA program meets contractually mandated QA program requirements and was effectively implemented for NRC sponsored activities at the GED. The primary observer evaluated the conduct of the audit to determine the adequacy of the audit process and the effectiveness of the QA program implementation. The auditors performed the audit following IQS procedure IQS-P081, Audit and Surveillance Program Management. The observer evaluated the audit using the guidance of NRC Inspection Manual Chapter 2410, Conduct of Observation Audits.
5.0 SCOPE OF AUDIT The audit of GED was both compliance and performance-based. The auditors reviewed selected QA program elements to determine procedural compliance, as applicable. The audit was also performance-based in that the auditors reviewed technical activities to determine compliance with GED QA control processes and procedures. The auditors risk-informed their selection of the technical topics for the audit based on technical risk, programmatic risk, and the time since an activity was last audited. The primary observer determined that the auditors achieved the audit scope.
4 6.0 CONDUCT AND TIMING OF THE AUDIT The primary observer determined that the auditors were thorough, effective, and performed in a professional manner. The primary observer determined that the timing, length, and application of resources to complete this audit were appropriate for the current level and type of activities performed by GED under the NRC contract. The primary observer also determined that the auditors achieved the purpose of the audit.
7.0 AUDIT TEAM QUALIFICATION AND INDEPENDENCE The audit team was composed of an audit team leader, one additional QA auditor, and two technical specialists. The primary observer found the qualifications of the auditors to be acceptable and in compliance with SwRI quality system procedures. The primary observer also found the auditors to be independent of the activities they reviewed.
8.0 AREAS OF EXAMINATION 8.1 QA Elements The auditors evaluated the following QA programmatic elements:
Corresponding QA Programmatic Elements QA Manual* Chapter Organization 1
QA Program 2
Design Control Not Applicable**
Scientific/Engineering Investigation and Analysis Control 3
Procurement Document Control 4
Instructions, Procedures, and Drawings 5
Document Control 6
Control of Purchased Items and Service 7
Identification and Control of Items, Software, and Samples 8
Control of Processes 9
Inspection 10 Test Control 11 Control of Measuring and Test Equipment 12 Handling, Storage, and Shipping 13 Inspection and Test Status 14 Nonconformance Control 15 Corrective Action 16 Records Control 17 Audits 18
- QAM - GED Quality Assurance Manual
- GED does not perform design-related activities.
The auditors addressed all the QA manual chapters during the audit except for Design Control.
The auditors used checklists during the audit for the assessment of the QA programmatic and technical elements. The auditors reviewed and evaluated material and documentation related to the QA programmatic and technical elements, interviewed responsible personnel, and observed laboratory activities to determine the effectiveness of programmatic and technical processes.
5 8.2 Technical Activities The auditors selected the technical products for the audit based on the technical and programmatic risks involved and the time since an activity was last audited. The auditors evaluated the following technical products:
Assessment on Technical Information Needs and Considerations for Back-End of Molten Salt Reactor Fuel Cycles This project involved identifying and assessing potential challenges associated with the safe storage and transportation of molten salt reactor waste and determining for the NRC the information needs in the context of existing regulatory frameworks and guidance. The work involved assessing the current state of knowledge on molten salt reactor waste management and then using that information to identify the information needs and their implications for relevant U.S. regulations and regulatory guidance. (GED Project 23700.16)
Technical Assistance for Updating Inspection Manual Chapter (IMC) 0609, Appendix F and IMC 0308, Attachment 3, Appendix F The project concerns updating certain NRC inspection manual chapters associated with the fire protection significance determination process for nuclear power plants. The chapters were updated for consistency with updated methods and information in NRC guidance documents and involved various supporting computations. (GED Project 24020)
The auditors used a performance-based approach to evaluate the effectiveness of the QA program in ensuring product quality. The auditors implemented the performance-based approach by using sub-teams of technical specialists and QA auditors who evaluated activities from their individual technical perspectives and evaluated implementation of procedures and plans associated with product development.
9.0 RESULTS The results (findings) of the 2022 GED annual audit (GED 20221) were reviewed prior to the 2023 audit during a previous surveillance conducted in 2023. There was one minor nonconformance and four recommendations for improvements identified during the 2022 GED audit and these items were closed out during that previous surveillance with no 2023 audit followup action required.
For the GED 20231 audit as listed below, the auditors identified two good practices, two minor nonconformances and five recommendations for improvement.
The two good practices are:
Programmatic Good practice 1: The application of markup and track changes for the reviewed documents was well executed for both projects reviewed.
Good practice 2: Utilization of the SharePoint system for task, with its version history feature, enables project managers to promptly locate and display related documents for both projects reviewed.
6 The two minor nonconformances identified by the auditors are:
Programmatic Minor nonconformance 1: Form FRM924, Instructions to Technical Reviewers, was not completed by reviewer for Project 29500.02 prior to task closeout per TAP010702-001, Reviews of Documents, Reports, and Papers. (Reference 2023CAR0504 written to address this issue)
Minor nonconformance 2: Form FRM931, Procedure Identification and Training Record was not updated by PM for non-GED employee to reflect training updates/needs. (Reference 2023-CAR0505)
The five recommendations for improvement identified by the auditors are:
Programmatic Recommendation 1: The GED should assess spreadsheets containing formulas to verify that cells used for calculations are safeguarded against any unauthorized adjustments. (Reference 2023PAR0168)
Recommendation 2: FRM931 should be updated to remove the section stating, Need for additional procedures is evaluated each year and TAP010702-002, Quality Indoctrination and Training should be updated to reflect changes. (Reference 2023PAR0169)
Recommendation 3: Scientific notebooks should be applied across all projects, including those with minimal calculations, to document the reasoning behind decision-making processes. (Reference 2023PAR0170)
Recommendation 4: The process for tracking from the scope-ofwork identified in the project proposal to final product should be strengthened to capture deviations from initial scope to final approval from the NRC contracting officers representative. (Reference 2023PAR0171)
Recommendation 5: The GED should evaluate transitioning any new task into the SharePoint system and archiving the departments shared drive. (Reference 2023PAR0172)
The auditors determined that the QA program applied by the GED continues to be adequate and effectively implemented and the recommendations identified provide opportunities for improvements which may reduce the potential to adversely affect products in the future or enhance the products.
10.0 NRC STAFF FINDINGS/CONCLUSIONS The NRC observer concluded that the audit process was well-planned, thorough, effective, and performed in a professional manner. The NRC observer also concluded that the auditors developed and used audit checklists that were comprehensive and effective in providing guidance to the auditors. The SwRI audit team leader provided ample opportunities for the NRC staff to provide comments and ask questions throughout the audit process. The auditors and NRC observer discussed findings with GED management during the postaudit meeting.
7 The NRC observer determined that the audit achieved its objectives of evaluating the GED QA program to verify that it met applicable requirements and was effectively implemented. The NRC observer determined that the audit was effective in reviewing, evaluating, and determining compliance with procedural requirements in the areas controlled by the QA program. The NRC observer agreed with the auditors conclusion that the QA program was effectively implemented.