ML22032A138
| ML22032A138 | |
| Person / Time | |
|---|---|
| Issue date: | 03/31/2021 |
| From: | Jon Woodfield Division of Fuel Management |
| To: | |
| J WOODFIELD NRC/NMSS/DFM 3014158727 | |
| Shared Package | |
| ML22032A130 | List: |
| References | |
| OAR-21-01 | |
| Download: ML22032A138 (7) | |
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U.S. NUCLEAR REGULATORY COMMISSION STAFF OBSERVATION OF THE FISCAL YEAR 2021 CENTER FOR NUCLEAR WASTE REGULATORY ANALYSES QUALITY ASSURANCE AUDIT 2021-1 OBSERVATION AUDIT REPORT NO.: OAR-21-01 Jon Woodfield, Primary Observer Division of Fuel Management Office of Nuclear Material Safety and Safeguards Enclosure
1.0 INTRODUCTION
The Center for Nuclear Waste Regulatory Analyses (CNWRA) of the Southwest Research Institute (SwRI) provides technical support to the U.S. Nuclear Regulatory Commission (NRC) staff through current NRC Charter Contract 31310018D0001 and Work-For-Others (WFO) Contract 31310018D0002. These Contracts require CNWRA 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 7-8, 2021, QA auditors and technical specialists from SwRI (auditors) conducted the CNWRA Audit 2021-1 of two NRC funded projects performed by CNWRA in San Antonio, Texas. An NRC staff member (observer) from the Office of Nuclear Material Safety and Safeguards (NMSS) observed the whole audit virtually and was the primary observer. Other NRC staff observed virtually only parts of the audit sessions. The CNWRA held a post-audit virtual meeting with the auditors, NRC primary observer, NRC Contracting Officer Representative and other NRC staff on December 9, 2021.
The scope of the audit was to evaluate the CNWRA QA program to determine whether it meets contractually mandated QA program requirements and is being effectively implemented for NRC sponsored activities by the CNWRA. The objective of the NRC primary observer was to evaluate the effectiveness of the audit process and the implementation of the CNWRA QA program.
Details of the audit are available in the January 4, 2021, SwRI report for CNWRA, "Quality Assurance Audit Report for Center for Nuclear Waste Regulatory Analyses Audit, CNWRA 2021-1" (ML22031A143).
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 and four 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 CNWRA QA program continues to be effectively implemented and provides adequate controls over technical product development and related quality affecting activities; (2) the CNWRA staff continues to operate in accordance with the CNWRA 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 CNWRA management during caucuses, audit debriefs, and at the post-audit meeting.
The primary observer determined that the audit achieved its objectives of evaluating the CNWRA 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 Ross Cantu Institute Quality Systems (IQS) - Audit Team Leader Mark Ehnstrom IQS - QA Auditor Colby Tate IQS - QA Auditor 3.2 Technical Specialists Dave Turner, PhD Environmental Assessment Saint Marys University, San Antonio, Texas Roland Benke, PhD Nuclear Engineering and Radiation Safety Independent Consultant 3.3 NRC Observers Jon Woodfield Primary observer (NMSS/DFM/IOB Inspector) 4.0 REVIEW OF AUDIT AND AUDITED ORGANIZATION The CNWRA provides technical support to NRC staff under NRC Contract 31310018D0001. This contract requires CNWRA to meet the QA requirements of 10 CFR Parts 50, 63, 71, and 72.
CNWRA 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 CNWRA. 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 CNWRA Quality Assurance Procedure 11 (QAP-011),
Internal Audits. The observer evaluated the audit using the guidance of NRC Inspection Manual Chapter 2410, Conduct of Observation Audits.
5.0 SCOPE OF AUDIT The CNWRA audit was both compliance and performance based. The auditors reviewed selected QA program elements to determine compliance with applicable procedures. The audit was also performance based in that the auditors reviewed completed technical products to determine compliance with CNWRA QA control processes and procedures. CNWRA risk-informed its selection of the technical topics for the audit based on the time since the previous audit of the areas and the importance of the activity, particularly regarding risk insights. The primary observer determined that the auditors achieved the audit scope.
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 CNWRA 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, two additional QA auditors, and two technical specialists. The primary observer found the qualifications of the auditors to be acceptable and in compliance with the CNWRA QA program. The primary observer also found the auditors to be independent of the activities they reviewed.
8.0 AREAS OF EXAMINATION AND RESULTS 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 **
Scientific/Engineering Investigation and Analysis Control 3 Procurement Document Control 4 Instructions, Procedures, and Drawings 5 Document Control 6 Procurement Control 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 - CNWRA Quality Assurance Manual
- CNWRA 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 and interviewed responsible personnel to determine the effectiveness of implementing procedures and technical processes.
8.2 Technical Activities The auditors selected the technical products for the audit based on the level of activity, technical and programmatic risks involved, and the time since each technical area was last audited. The auditors evaluated the following technical products:
- MELCOR Accident Consequence Code System (MACCS) The objective of this task was to test functions in the MACCS code independent from the software developers.
The MACCS code is used for the computation of consequences of accidents causing release of radioactivity to the environment. The testing primarily focused on verifying that the mathematical equations described in the MACCS Theory Manual were properly interpreted and implemented in the code. Testing covered functions of the MACCS modules named ATMOS (atmospheric release), EARLY (consequences a few days after the accident), and CHRONC (long-term consequences, a few years after the accident).
Additional code functions will be evaluated in follow up projects. (Task Order 31310020F0081 Under NRC Contract 31310018D0002) (CNWRA Project 24013)
- Interim Storage Partners (ISP) Environmental Impact Statement (EIS) The objective of this task was to provide the NRCs Office of Nuclear Material Safety and Safeguards with technical assistance for (i) reviewing the license amendment request from ISP, (ii) developing draft and final environment impact statements, (iii) conducting activities in accordance with the National Historic Preservation Act (NHPA) of 1966 for Section 106 consultation activities, and (iv) if necessary, providing support for a potential adjudicatory hearing. (Task Order 31310018F0126 Under NRC Contract 31310018D0001) (CNWRA Project 23700.06)
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 2020 CNWRA annual audit (Report CNWRA 2020-1) were reviewed by a member of the 2021 audit team prior to the 2021 audit under follow-up Southwest Research Institute Surveillance Report 2021-SR-0362, approved June 15, 2021. There were two minor nonconformances and nine recommendations for improvements identified during the 2020 audit.
It was documented in Surveillance Report 2021-SR-0362 that the two minor nonconformances and nine recommendations had been closed since the 2020 audit with seven of the recommendations closed completely with no 2021 audit follow-up action absolutely required
[Preventive Action Requests (PARs) 2020-PAR-0178, 2020-PAR-0179, 2020-PAR-0180, 2020-PAR-0181, 2020-PAR-0183, 2020-PAR-0184, 2020-PAR-0186]. Although noted as being closed, it was also determined during the surveillance that Corrective Action Reports (CARs) 2020-CAR-0639 and 2020-CAR-0640 along with PARs 2020-PAR-0182 and 2020-PAR-185 needed further evaluation during the 2021 audit to make a more informed judgement for their closure based on a longer period to review if the actions taken were effective. During the 2021 audit the audit team again reviewed the closeout of all the 2020 audit findings and found their closeout satisfactory.
Specifically, the 2021 audit team determined after further evaluation the two CARs and two PARs, previously identified during the 2021-SR-0362 surveillance as needing further review, were adequately closed and there were no further concerns identified with how all the findings were resolved or addressed. This was documented on the 2021 audit programmatic checklist.
For the 2021 audit as listed below, the auditors identified two good practices and four recommendations for improvement.
The two good practices identified by the auditors were:
- 1) The project team has prepared and periodically updates an internal Lessons Learned document, which is an important part of the CNWRAs environmental review process. This is noted as a good practice for the following reasons:
- It provides an opportunity to identify and apply good practices from previous and ongoing projects
- It can form a basis for future revisions and updates to NRC guidance (e.g.,
- 2) The project team has developed a comprehensive archive record for the project.
This is noted as a good practice because it positions the team to respond efficiently, especially in the event of contentions and Freedom of Information Act (FOIA) requests.
The four recommendations for improvements identified by the auditors are:
- Programmatic Recommendation 1: The CNWRA should consider keeping all scientific notebooks in Sharepoint to ensure version control is followed. (Reference Preventive Action Request
[PAR] 2021-PAR-0159)
- CNWRA Project 24013 - MELCOR Accident Consequence Code System Recommendation 2: The project should consider highlighting inconsistencies found in MACCS example files to NRC. Example files are included in the MACCS distribution to users. (Reference 2021-PAR-0160)
Recommendation 3: Project staff should review documentation to confirm users are provided with adequately detailed instructions and examples.
The review should confirm that the combined treatment of radionuclide decay chains and dosimetry (including chemical-form and lung-absorption-type dependencies) does not result in undercounting or overcounting across multiple MACCS modules.
Documentation would include relevant reports from the State-of-the-Art Reactor Consequence Analysis (SOARCA) Project. (Reference 2021-PAR-0161)
- CNWRA Project 23700.06 - Interim Storage Partners Environmental Impact Statement Recommendation 4: The environmental review team should consider adding the following information to the Lessons Learned document:
- Clear language stating that non-safety-related commitments in applicants environmental report are incorporated by reference in the NRC license.
- A document review section to remind CNWRA technical and programmatic reviewers to check specifically for revisions committed to in the comment response process, and make sure that they are incorporated in the EIS. (Reference 2021-PAR-0162)
The auditors determined that the QA program applied by the CNWRA 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 observers discussed findings with CNWRA management during the post-audit meeting.
The NRC observers determined that the audit achieved its objectives of evaluating the CNWRA QA program to verify that it met applicable requirements and was effectively implemented. The NRC observers 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 observers agreed with the auditors conclusion that the QA program was effectively implemented.