ML25022A118
| ML25022A118 | |
| Person / Time | |
|---|---|
| Site: | 07100935 |
| Issue date: | 01/23/2025 |
| From: | Hector Rodriguez-Luccioni NRC/NMSS/DFM/IOB |
| To: | Platt D EnergySolutions |
| References | |
| IR 2024201 | |
| Download: ML25022A118 (1) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 205550001 David J. Platt Quality Assurance Director EnergySolutions 740 Osborn Road Barnwell, SC 29812
SUBJECT:
ENERGYSOLUTIONS - U.S. NUCLEAR REGULATORY COMMISSION INSPECTION REPORT NO. 7100935/2024-201
Dear David Platt:
On December 9, 2024, through December 12, 2024, the U.S. Nuclear Regulatory Commission (NRC) staff conducted an announced onsite inspection at the EnergySolutions (ES) corporate office in Barnwell, South Carolina, to verify and assess ES compliance with Title 10 of the Code of Federal Regulations (10 CFR) Part 71, Packaging and Transportation of Radioactive Material, and 10 CFR Part 21, Reporting of Defects and Noncompliance.
The purpose of the inspection was to verify and assess the adequacy of ES implementation and compliance with the NRC requirements for the design, modification, fabrication, assembly, testing, procurement, repair and maintenance of transportation packaging(s) to determine if ES performed these activities in accordance with the requirements of 10 CFR Part 71, Packaging and Transportation of Radioactive Material, and selected portions of 10 CFR Part 21, Reporting of Defects and Noncompliance. ES is the certificate of compliance (CoC) holder of the 3-60B, 8-120B, 10-160B and MIDUS transportation packagings.
The inspection scope included observations of fabrication, repair and maintenance activities documentation reviews, and interviews with personnel to determine whether ES design, fabricated and maintained the transportation packaging, in accordance with the commitments and requirements specified in the applicable safety analysis reports for packaging, the NRCs corresponding safety evaluation report, CoC and NRC-approved quality assurance program requirements. The enclosed report presents the results of this inspection, which were discussed with you and other ES representatives on December 12, 2024.
In accordance with 10 CFR 2.390, Public inspections, exemptions, requests for withholding, a copy of this letter, its enclosure, and your response (if any) will be available electronically for public inspection in the NRC Public Document Room (PDR) or from the Publicly Available January 23, 2025
D. Platt 2
Records component of the NRCs Agencywide Documents Access and Management System (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 18003974209 or 3014154737, between 8 a.m. and 4 p.m. eastern time (ET), Monday through Friday, except Federal holidays.
No reply to this letter is required. We appreciate your cooperation.
Sincerely, Hector Rodriguez-Luccioni, Chief Inspection and Oversight Branch Division of Fuel Management Office of Nuclear Material Safety and Safeguards Docket No. 710935
Enclosure:
NRC Inspection Report No.
7100935/2024201 Signed by Rodriguez-Luccioni, Hector on 01/23/25
ML25022A118 OFFICE NMSS/DFM NMSS/DFM NMSS/DFM NAME RPatel WWheatley HRodriguez-Luccioni DATE 1/22/2025 1/23/2025 1/23/2025
Enclosure U.S. NUCLEAR REGULATORY COMMISSION Office of Nuclear Material Safety and Safeguards Division of Fuel Management Docket:
7100935 Report.:
7100935/2024201 Enterprise Identifier: I20242010060 Certificate Holder:
EnergySolutions Facility:
Corporate Location:
Barnwell, SC Inspection Dates:
December 9 - 12, 2024 Inspection Team:
Raju Patel, Transportation and Storage Safety Inspector, Team Leader Earl Love, Senior Transportation and Storage Safety Inspector Jeremy Tapp, Senior Transportation and Storage Safety Inspector Andres Rowe, General Engineer (Trainee)
Rachel Qian, General Engineer (Trainee)
Approved By:
Hector Rodriguez-Luccioni, Branch Chief Inspection and Oversight Branch Division of Fuel Management Office of Nuclear Material Safety and Safeguards
2 U.S. NUCLEAR REGULATORY COMMISSION Office of Nuclear Material Safety and Safeguards Division of Fuel Management EXECUTIVE
SUMMARY
EnergySolutions NRC Inspection Report 7100935/2024201 On December 9, through December 12, 2024, the U.S. Nuclear Regulatory Commission (NRC) staff conducted an announced onsite inspection at the EnergySolutions (ES) corporate office in Barnwell, South Carolina. The staff held an exit meeting on December 12, 2024.
The purpose of the inspection was to verify the adequacy of activities related to design, modification, fabrication, assembly, testing, procurement, repair, and maintenance of transportation packaging components to determine if ES performed these activities in accordance with the requirements of Title 10 of the Code of Federal Regulations (10 CFR) Part 71, Packaging and Transportation of Radioactive Material, and selected portions of 10 CFR Part 21, Reporting of Defects and Noncompliance.
Based on the results of this inspection, the inspection team assessed that overall, the implementation of ES quality assurance program (QAP) was adequate.
Quality Assurance Program The team determined that ES conducted quality related activities on the transportation packaging in accordance with their NRC-approved QAP. (section 1.1)
Document Control The team determined that ES effectively implemented its document control records program and has adequate procedures in place to ensure compliance with the applicable regulations and NRC-approved QAP. (section 1.2) 10 CFR Part 21 The team determined that provisions are in place for reporting defects which could cause a substantial safety hazard for transportation packaging activities, and ES personnel were familiar with the reporting requirements of 10 CFR Part 21. (section 1.3)
Design Control The team determined, for the items selected for review and the personnel interviewed that ES implemented an adequate design control program in accordance with their approved certificate of compliance (CoC) and safety analysis report for packaging (SARP), written procedures, and design specifications, as applicable. (section 1.4)
Fabrication, Testing and Maintenance The team determined, for the items selected for observation and review that ES performed maintenance and testing in accordance with the approved SARP, written procedures, and specifications, as applicable. (section 1.5)
3 Procurement Control The team determined that, materials and components procured and received by ES for repair and maintenance activities met procurement specification, as applicable, and that the specifications conformed to the requirements in the SARP and applicable 10 CFR Part 71 requirements. This included the use of the commercial grade dedication process to procure commercial items and calibration services. The team concluded that ES was implementing its procurement control program in accordance with the requirements of regulations and QAP. (section 1.6)
Nonconformance and Corrective Action The team determined that ES effectively implemented their nonconformance and corrective action programs (CAPs) and has adequate procedures in place to ensure compliance with the applicable regulations and quality assurance (QA) requirements.
(section 1.7).
Personnel Training and Quality Assurance Oversight The team determined that ES had trained and qualified individuals performing activities affecting quality and that ES management provided appropriate oversight of quality related activities, as applicable. (section 1.8)
Audit Program The team concluded overall that for the items selected for review that ES was performing internal and external (supplier) audits in accordance with their QAP requirements for transportation packaging activities and that ES resolved deficiencies if identified during the audit in a timely manner. (section 1.9)
4 REPORT DETAILS 1.0 Applicable Portions of Inspection Procedure 86001 - Design, Fabrication, Testing, and Maintenance of Transportation Packagings 1.1 Quality Assurance Program 1.1.1 Inspection Scope The team reviewed EnergySolutions Part 71 QAP, ES-QA-PG-001, Quality Assurance Program, revision 12 and associated implementing procedures to assess the adequacy and effectiveness of ES QAP implementation. The team conducted reviews of ES quality program, policies, and procedures, to determine whether activities subject to 10 CFR Part 71 and Part 21 regulations were adequately controlled and implemented under ES NRC-approved QAP. The team also reviewed the previous two revisions of the QAP to determine if changes made without prior NRC review and approval were performed in accordance with the requirements of 10 CFR 71.106, as applicable.
The team reviewed the QAP authorities and responsibilities to determine if they were clearly defined and documented, and the QA organization functioned as an independent group. In addition, the team reviewed the QAP to determine if commercial grade dedication activities are performed by ES. The team reviewed ES graded approach to quality as documented in the QAP to verify ES identified important-tosafety components in its packaging designs in a graded approach as described.
The team reviewed procedures and documents regarding training, qualification, and certification of personnel involved in quality activities. The team reviewed the qualifications and training for selected lead auditors to determine if they met the requirements stated in the QAP. In addition, the team reviewed training records of a random selection of employees in quality related positions to determine if they received the required indoctrination to and familiarization with the QAP.
1.1.2 Observations and Findings The team assessed that ES had a QA program and implementing procedures in place that were effective in conducting activities in accordance with ES NRC-approved QAP and CoCs as well as Part 71 requirements. The team verified that the QA organization operated in a manner independent from cost and schedule, when opposed to safety considerations.
The team found that ES used a graded approach to categorize components important-tosafety in its packaging designs. The team reviewed the adequacy of the categorizations as a part of the design control review documented in section 2 of this report. The team also found that ES implemented a commercial grade dedication program, which is described in the QAP and associated implementing procedures No findings of significance were identified.
5 1.1.3 Conclusions The team determined that ES conducted quality related activities for fabrication, repair and maintenance of transportation packaging(s) in accordance with the CoCs, as well as their QAP and had effective implementing procedures in place.
1.2 Documentation Control 1.2.1 Inspection Scope The team reviewed ES documentation control program to assess the effectiveness of controls established for the approval, issuance, revision, and use of quality documents.
The team reviewed ES instructions and procedures regarding the control of documents and quality records and interviewed responsible personnel to verify that documents are retained and located in areas consistent with the instructions and procedures. The team interviewed QA personnel regarding documentation and records controls. The team also reviewed the following documents:
ES-AD-PR-001, Document Preparation, Revision 13 ES-AD-PR-002, Document Control, Revision 4 ES-AD-PR-021, OnBase Electronic Records System, Revision 2 ES-QA-PR-005, Records, Revision 5 ES-QA-PR-028, Certificate of Conformance, Revision 3 ES-QA-PR-031, NRC Certified Components Quality Assurance Records, Revision 4 ES-QA-PR-034, Handling of Electronic QA Records, Revision 1 1.2.2 Observation and Findings The team assessed that ES primarily uses an internal electronic Intraweb, which is only accessible by authorized ES personnel, for the dissemination of information and documents. All new and revised documents require an author/originator, reviewer, and approver. Generally, only electronic signatures are applied to documents. The current revision of any procedure, drawing, or other type document will be on the Intraweb for ES staff to use.
The team verified that ES uses OnBase, an Electronic Document Imaging System, for the generation, distribution, use, maintenance, storage, retention and disposition of electronic records. OnBase is the official records system to be used for archiving all ES Quality Assurance electronic records. Only authorized ES personnel have access to OnBase. Electronic records and associated hardware and software are protected by virus protection software that is updated regularly. Electronic records are stored in an environment controlled for human occupancy. Electronic record files are backed up daily and dual storage is provided at a different location. Types of record media may include paper, electronic (magnetic or optical) or specifically processed media such as radiographs, photographs, negatives, and microforms.
Based on its review, the team determined that ES was following its procedures to ensure that fabrication drawings and specifications were consistent with the ES design
6 drawings, NRC-approved licensing drawings, and design requirements/commitments.
No findings of significance were identified.
1.2.3 Conclusions The team concluded that ES effectively implemented its document control records program and has adequate procedures in place to ensure compliance with the applicable regulations and NRC-approved QAP.
1.3 10 CFR Part 21 1.3.1 Inspection Scope The team reviewed selected records and interviewed personnel to verify that ES effectively implemented a nonconformance control program in accordance with their NRC-approved QAP and the requirements of 10 CFR Part 21. The team reviewed the ES implementing procedure ES-AD-PR-006, Reportability Determinations and Postings, revision 7, to verify if provisions were in place for reporting defects that could cause a substantial safety hazard from the nonconformance reports (NCRs), and quality issues identified. The team requested a list of 10 CFR Part 21 evaluations and notifications associated with any transportation activities and interviewed personnel to verify if ES was familiar with the implementing procedure. This review also included an assessment for compliance with 10 CFR 71.95, Reports, as applicable.
1.3.2 Observation and Findings The team assessed that ES has provisions in place for evaluating deviations and reporting defects that could cause a substantial safety hazard, as required by 10 CFR Part 21. The team noted that the 10 CFR Part 21 posting at ES receiving, fabrication, and maintenance area met the applicable requirements of 10 CFR Part 21. The team also assessed that ES employees are knowledgeable of reporting requirements and training have been performed to ES Part 21 procedure.
No findings of significance were identified.
1.3.3 Conclusions The team determined that the provisions of 10 CFR Part 21 were implemented, that ES personnel were familiar with the reporting requirements of 10 CFR Part 21 and ES complied with 10 CFR 21.6, "Posting requirements."
1.4 Design Control 1.4.1 Inspection Scope The team interviewed selected personnel and reviewed selected design documentation to determine that adequate design controls are implemented. The team focused its review in the areas of design modifications, quality classification evaluation for ITS, review and control of design calculations, and verification of commercially available computer programs. The team specifically reviewed ES design activities related to CoC
7 No. 9320 for the MIDUS packaging. The team reviewed the following ES implementing procedures associated with design control to verify the procedures were adequate and adequately followed:
CG-EN-PR-201, Design Control, revision 3 CG-EN-PR-202, Preparation and Checking of Engineering Documents, revision 2 CG-EN-PR-203, Calculations, revision 4 CG-EN-PR-204, Control and Use of Acquired Analytical Software, revision 4 CG-EN-PR-205, Control and Use of Company Developed Automation Software, revision 1 CG-EN-PR-206, Quality Level Assessments for 10CFR71/72 SSCs, revision 1 CG-EN-PR-207, Engineering Personnel Qualifications, revision 0 ES Document No. TYC01-1600, MIDUS Transportation Package Safety Analysis Report, revision 7 ES CCA-000094, Safety Analysis Report for Model 8-120B Type B Shipping Packaging, revision 14 The team reviewed the latest ES amendment submitted to the NRC for its MIDUS transportation packaging. The team reviewed all the procedures associated with performing initial designs and making modifications to designs. The MIDUS amendment to add changes to leak rate test procedure was submitted to the NRC previously and received NRC approval. The team also had no concerns during its review of the latest MIDUS amendment and ES processes for performing it.
The team reviewed ES design report (ESDR) regarding safety analysis and leak test procedure changes for the MIDUS packaging. This included review of ES design plan No. ESCD-000084, revision 0. The team reviewed the design plan required by procedure. The team assessed that the plan was thorough by providing a description of the project, listing outputs, listing key personnel, listing key inputs, providing the design phases, and specifying the need for a system design verification. The team also verified that the required NRC-Certified Design form was attached and properly signed off by the appropriate approvers. The team reviewed the ESDR MIDUS Design & Licensing (O&M Phase), No. 000089, revision 0. The ESDR was reviewed to determine if ES adequately followed their design procedure CG-EN-PR-201.
The team also reviewed the initiating document that necessitated the ESDR. This was typically an associated design change request but also included a submittal letter to the NRC. The team reviewed the associated design change notice (ECN) No. ESCD 000085, revision 0, to verify ES followed CG-EN-PR-201 as required and the design changes were made in the associated safety analysis and drawings as described. The team reviewed ECN No. ESCD-00086 for safety analysis report (SAR) change of the leakage rate test procedure for MIDUS packaging fabrication, periodic/maintenance and pre-shipment leak rate tests. The team reviewed ES System Design Verification Report (SDV) form No. ESCD-0000087 revision 0 for the project where all the ECNs for the project were listed with other revised design documents. An SDV checklist was also properly filled out and the SDV electronically signed The team reviewed ES computer software listing form which lists the programs that have been commercial grade dedicated for use in performing quality related analysis. The list
8 has five programs on it and the team focused on the ANSYS/LS-DYNA (version 19.2) program which had been used to perform analysis on the initial MIDUS design project.
The team selected a sample of ES engineering staff names that were involved in some of the engineering documents and drawings reviewed by the team and requested their qualification records.
1.4.2 Observation and Findings The team determined, for the items selected for review that the leak test specifications were consistent with the design commitments and requirements documented in the SAR and CoC. The team concluded that ES is effectively implementing its design control program and has adequate procedures in place to ensure compliance with the applicable regulations and QAP requirements.
The team verified the ES engineering personnel qualification records were complying to CG-EN-PR-207 and that all ES engineering personnel selected for review were properly qualified.
The team assessed that overall, ES was effectively implementing its design control procedures as demonstrated through the review of the most recent MIDUS amendment.
The team found that all engineering quality documents were developed and processed in accordance with the applicable procedures and received the proper independent verification reviews and approvals. No concerns were identified by the team in the design control area.
The team assessed that ES has adequate and effective controls established by the implementing procedures for project planning, development of project quality requirements, implementing project controls, developing design specifications, design development and design controls, performing and reviewing design calculations, performing quality classification of structure, systems and components, performing overall design reviews, and performing competent authority design licensing.
No findings of significance were identified.
1.4.3 Conclusions The team concluded that ES is effectively implementing its design control program and has adequate procedures in place to ensure compliance with the applicable regulations and QAP requirements.
1.5 Fabrication, Assembly, Maintenance and Testing 1.5.1 Inspection Scope The team reviewed a selection of periodic or annual maintenance activities performed for the 8-120B, 10-160B, and 3-60B packaging(s) through a review of records and interviews with ES personnel. For the 8-120B and 10-160B packaging(s), the team reviewed the maintenance records to verify they were performed in accordance with applicable inspection and maintenance procedures. The team also verified that the
9 requirements in LG-MN-PR-001 adequately implements the maintenance requirements in chapter 8 of the 8-120B SAR. The team reviewed the following ES implementing procedures associated with maintenance control to verify the procedures were adequate and adequately followed:
CS-FP-PR-017, 3-60B Shipping Cask: Periodic Maintenance of Exposed Surfaces, revision 2 CS-FP-PR-016, 3-60b Shipping Cask: Inspection and Maintenance of Fasteners
& Threaded Holes, revision 2 LG-MN-PR-001,Inspection and Maintenance of NRC Licensed 8-120B & 10-160B Shipping Casks, revision 7 TR-MN-020, Maintenance Procedure for the Rework/Repair of the Lid Bolt Holes on the 8-120B Model Casks, revision 9 The team reviewed the following maintenance records:
Pre-Shipment Leak Test Report No. 106568-1 for 8-120B cask S/N 5 dated 2/27/24 Annual Inspection and Maintenance Report for 8-120B Cask serial number (S/N) 8 dated 10/8/24 Pre-Shipment Gas Pressure Drop Test Report No. GG2026-6 for 3-60B, Cask S/N 672-696-01, shipment No. 6, dated 10/16/24 1.5.2 Observation and Findings The team observed selected activities such as a Gas Pressure Drop Test of an NRC licensed Type B transportation cask (i.e. Model 8-120B-5) to determine that design and maintenance met the SARP design requirements and conducted in accordance with approved procedures. Specifically, the team observed personnel performing a demonstration of a pre-shipment gas pressure drop test on primary lid and vent port to ensure that trained personnel performed the testing in accordance with ESs approved procedure. The team also reviewed the training and certification records of the individual that performed the test to ensure that they appropriately trained, qualified and certified.
In addition, the team reviewed past cask inspection/maintenance records specific to 8-120B and 3-60B casks to determine if ES personnel performed cask inspections and maintenance activities in accordance with LG-MN-PR-001 and CS-FP-PR-017.
The team noted that prior to each shipment, all accessible package O-ring seals and fastener seals are visually inspected for any damage or defects (e.g., cracks, tears, cuts, or discontinuities) that may prevent them from sealing properly when the package is assembled. All package O-ring and fastener seals were replaced within the 12-month period prior to any shipment with new seals and fastener holes with threaded inserts were visually inspected within the 12-month period prior to any shipment to verify that the threaded inserts are not displaced or damaged. Further the team noted, exposed interior and exterior surfaces of the cask body assembly, cask lid assembly, vent port plug assembly, and impact limiter assemblies, were visually inspected within the 12-month period prior to any shipment for damage or degradation that could impair the physical condition of the package. Lifting attachments (e.g., lift lugs and trunnions) and their welded attachments to the package were inspected within the 12-month period
10 prior to any shipment, to verify that there is no evident permanent deformation and no obvious damage or defects.
Overall, the team determined that the Leak Testing Specialists, Inc., and ES personnel performed the test using human factors techniques such as crossing off steps when completed. This technique ensured that personnel performed the test in order when required. The inspectors noted that the Level Ill Leak Test Specialist was American Society of Nondestructive Testing Recommended Practice No. SNT-TC-1A, Personnel Qualification And Certification In Nondestructive Testing, certified in accordance with required procedures. Additionally, the team determined that the Leak Testing Specialists and ES personnel met all the requirements of ES-QA-PR-006. Overall, the team noted that there were no concerns identified with past annual maintenance inspections.
With respect to the Model 3-60B Type B shipping cask, the team noted that the 3-60B packaging is subjected to a maintenance program that includes routine and periodic inspection, tests, and maintenance activities to ensure continued performance of the packaging. The team reviewed cask leak test report of the 3-60B shipping cask, serial No. 672-696-01 and noted that the gas pressure drop test was performed in accordance with ES procedure No. TR-TP-007, revision 2, Gas Pressure Drop Test for 3-60B Shipping Cask dated 8/22/2023. The team noted that the leakage rate tests were performed based on the gas pressure drop or gas pressure rise methods that followed the guidelines provided in American National Standards Institute N14.5-1997, Leakage Tests for Radioactive Materials, and that the test results complied with the acceptance criterion for the pre-shipment leakage rate test as no detectable leakage when tested to a sensitivity of 1 x 10-3 ref-cm3/s. The team verified that the procedure for the pre-shipment leakage rate test was approved by a Level III qualified in the specific methods used in the leakage rate test procedure.
No findings of significance were identified.
1.5.3. Conclusions The team concluded that ES is effectively implementing its maintenance program through use of adequate qualified procedures, personnel and calibrated measuring and test equipment to ensure compliance with the applicable regulations and QAP requirements.
1.6 Procurement Control 1.6.1 Inspection Scope The team reviewed procedures and processes that addressed procurement. Those procedures and processes include receipt inspection, traceability of materials, and commercial grade dedication. The team reviewed a sample of records and drawings to verify procurement specifications for materials, fabrication, and inspection that met design commitments and requirements contain in SARs and CoCs. The team reviewed quality procedures, receipt inspection records, and sampled purchase orders (POs). The team reviewed procurement items associated with the inspection and maintenance of the 8-120B transportation package. The team reviewed the following documents:
11 ES-QA-PR-004, Procurement Document Quality Assurance Review, revision 4 ES-CO-PR-002, Contract/Purchase Order Procedure, revision 4 ES-QA-PR-010, Dedication of Commercial Grade Items and Service, revision 12 ESP-QA-PR-011, Upgrade of Commercial Items and Services, revision 7 ES-QA-PR-012, Commercial Grade Survey, revision 6 ES-QA-PR-035, Identification and Control of Materials Parts, and Components, revision 0 ES, APPROVED SUPPLIERS LIST (ASL) dated October 21, 2024 ES-PU-PR-005, Solicitation and Purchasing Agreement Procedures and Instructions revision 8 The team also reviewed the ES supplier audit program if ES scheduled, planned, and performed supplier audits in accordance with their implementing procedures, reference standards, and guidance documents.
ES-QA-PR-002, Supplier Surveillances, revision 4 ES-QA-PR-003, Supplier Evaluation, revision 13 ES-AD-PR-018, Receipt Inspection, revision 9 1.6.2 Observation and Findings The team selected 4 procurement document packages from approved suppliers for ITS Category A components that included the purchase of Helicoils, pressure gauges, O-rings, and calibration services. For each of the procurement packages reviewed, the team determined that the procurement was made consistent with their importance to safety according to the design requirements; the items were appropriately described consistent with the design documents; the information received from the supplier, including Certificates of Conformance and test reports, were adequate and met the design requirements; and ES receipt inspection form and any applicable quality control checks were performed as required. In addition, the team verified that the suppliers were on the ES ASL, as updated.
The team reviewed the external audits and supplier evaluations for the suppliers of the above procurement components and services. Each supplier was audited by the Nuclear Industry Assessment Corporation (NIAC) and evaluated and accepted by ES as required for continued placement on the ASL. The team determined that the scope of the NIAC audits were comprehensive and applicable to ES procurement activities. Annual supplier evaluations for each were also performed as required. No concerns were identified regarding the procurement from approved ITS Category A suppliers.
In addition, the team reviewed selected drawings and records to verify that selected commercial grade dedication plans and associated activities performed by ES met design requirements. The team also reviewed ES-QA-PR-010, to determine if ES was following the procedure as required. The team reviewed the commercial grade dedication documents specific to commercial grade item dedication packages CGI 001, revision 2, for calibration services of Helium Leak Standard ID number LSH-002, and CGI-22-001 revision 1 for Primary and Secondary Lid Seal O-Rings used in 10-160B transportation packages. Specifically, the team reviewed the critical characteristics identified and ES dedication activities performed to verify those critical characteristics
12 were met. The team found the critical characteristics to be appropriate and dedication activities adequate to qualify the procured components for use in ITS Category A applications. No findings of significance were identified 1.6.3 Conclusions The team determined that, materials and components procured and received by ES for fabrication, and maintenance activities met procurement specification, as applicable, and that the specifications conformed to the design commitments and requirements contained in the SAR and CoC. The team concluded that ES has been implementing its procurement control program in accordance with the requirements of regulations and QAP.
1.7 Nonconformance and Corrective Action Programs 1.7.1 Inspection Scope The team reviewed sample of ES nonconformance reports (NCRs) and condition reports (CRs) and interviewed selected personnel to verify that ES effectively implemented their nonconformance control program and CAP. The review included an evaluation of how ES nonconformance control program and CAP addressed materials, parts, and components that do not conform to requirements and identified quality deficiencies. The team also reviewed provisions for reporting defects that could cause a substantial safety hazard. The team reviewed the following ES quality procedures:
ES-AD-PR-006, Reporting of Defects and Noncompliance (10 CFR 21),
revision 7 ES-AD-PR-008, Condition Reports, revision 19 ES-AD-PR-013, Control of Nonconforming Items, revision 11 ES-AD-PR-015, Stop Work Order, revision 5 ES-AD-PR-019, 10 CFR 71 Reporting, revision 2 The team reviewed NCRs and CRs since the last NRC inspection in 2020 and reviewed one CR written due to an issue identified by the NRC during the 2020 inspection. The team discussed the nonconformances and corrective actions with the ES staff to understand the process. The team focused the NCR review on use-asis and repair type dispositions to evaluate how ES technically justified the approved dispositions. The CRs were reviewed to determine whether ES completed corrective actions for identified deficiencies in a technically sound and timely manner, including assessment of reporting in accordance with Parts 21 and 71. In addition, the team requested a list of Part 21 evaluations and notifications associated with the ES transportation packagings. The team also reviewed postings within the Barnwell facility to determine if ES complied with 10 CFR 21.6, "Posting requirements."
13 1.7.2 Observation and Findings The team found that ES has adequate procedures and controls in place for identifying, writing, and dispositioning NCRs and for reporting defects that could cause a substantial safety hazard. The team noted that there were no Part 21 reports issued since the previous inspection.
The team assessed that ES had adequate procedures and controls in place for identifying and writing CRs, documenting corrective action(s) taken, performing causal analyses and extent of condition reviews as necessary, documenting corrective actions and actions taken to prevent recurrence as applicable, and performing CR closure verification.
No issues of significance were identified.
1.7.3 Conclusions The team concluded that ES is effectively implemented its nonconformance control program and CAP and had adequate procedures in place to ensure compliance with the applicable regulations and QAP requirements.
1.8 Personnel Training and Certifications 1.8.1 Inspection Scope The team reviewed selected records and procedures and interviewed selected personnel to verify that individuals performing activities affecting quality are properly trained and qualified, and to verify that management and QA staff are cognizant and provide appropriate oversight. The team reviewed the following ES implementing procedures:
ES-TN-PR-001, Training Program, revision 5 ES-EN-PR-001, Engineering Personnel Qualification, revision 0 ES-QA-PR-006, Qualification and Certification of Nondestructive Testing Personnel, revision 7 ES-QA-PR-007, QC Personnel Qualification and Certification, revision 7 ES-QA-PR-008, Auditor Qualification, revision 5 ES-QA-PR-032, Training and Qualification of Personnel for the Pre-Shipment Leak Testing of the 10-160B Casks, revision 2 Specifically, the team reviewed the indoctrination and training records for selected ES employees that have performed design engineering activities to verify the training was adequate. The team reviewed qualification records of two leak test Level II nondestructive examination personnel to determine they were qualified in accordance with the requirements of American Society of Mechanical Engineers (ASME) Boiler and Pressure Vessel Code (B&PV)Section V, Nondestructive Examination. The team reviewed records for two QC inspectors that had performed quality related inspection activities on sample annual inspection/maintenance reports for NRC-approved CoC cask packages. The team also reviewed three lead auditor qualification records.
14 1.8.2 Observation and Findings The team found that sample of ES staff members records reviewed, each had completed the required QA indoctrination and training and attained the applicable qualifications to perform their duties.
The team also found that ES leak test procedure was qualified in accordance with ASME B&PV Code Section V requirements. The team determined the leak test Level II and III qualifications records met the requirements of ASME B&PV Code Section V and American Society of Nondestructive Testing Recommended Practice No. SNT-TC-1A.
For the nondestructive examination (NDE) personnel observed, the team found they were qualified in accordance with ES standard practice for qualification of NDE personnel.
No findings of significance were identified.
1.8.3 Conclusions The team concluded that ES had trained and qualified individuals performing activities affecting quality and that ES management provided appropriate oversight of quality related activities, as applicable.
1.9 Audit Program 1.9.1 Inspection Scope The team reviewed ES audit program to determine if ES scheduled, planned, and performed internal audits in accordance with applicable regulations and QAP requirements. The team also reviewed the qualification records to determine if they met the QAP and procedure requirements. The team reviewed the following ES quality procedures:
ES-QA-PR-002, Quality Assurance Surveillances, revision 4 ES-QA-PR-008, Auditor Qualification, revision 5 ES-QA-PR-018, Quality Assurance Audits, revision 10 The team reviewed a sample of audit schedules since 2020 to verify that all 18 QAP criteria were planned to be audited, as applicable, each year. The team reviewed and assessed a sample of the internal audits completed since the last inspection to determine if they were performed in accordance with quality procedures, used qualified lead auditors independent of the areas being reviewed, and if there were identified deficiencies, whether ES adequately addressed these deficiencies within the CAP.
The team reviewed the current procedure for the qualification of audit personnel and reviewed a sample of lead auditor qualification records to determine if they met the applicable QAP requirements. The team also reviewed a sample of surveillances performed by QA personnel since the previous NRC inspection to verify the adequacy of the assessment and that they were performed in accordance with the implementing procedure.
15 1.9.2 Observation and Findings Overall, the team assessed that for the audits sampled, ES conducted them with qualified and certified personnel, were comprehensive in nature, and covered a representative sample of ES activities in the area being audited.
No findings of significance were identified.
1.9.3 Conclusions The team concluded that ES had an adequate internal audit program in place to schedule, evaluate, and document the results. The team determined that ES appropriately identified issues and documented them in the CAP as required.
2.0 Entrance and Exit Meeting On December 9, 2024, the NRC inspection team discussed the scope of the inspection during an entrance meeting with the ES staff. On December 12, 2024, the NRC inspection team discussed the preliminary results and observations during an onsite debrief meeting with the ES staff. The team completed the inspection activities on December 12, 2024, and held an exit meeting with ES staff.
Attachment ATTACHMENT 1.
ENTRANCE/EXIT MEETING ATTENDEES AND INDIVIDUALS INTERVIEWED Name Title Affiliation Entrance Debrief Exit Raju Patel Inspection Team Leader NRC X
X X
Jeremy Tapp Inspector NRC X
X X
Earl Love Inspector NRC X
X X
Andres Rowe Inspector-In-Training NRC X
X X
Rachel Qian General Engineer NRC X
X X
David Platt Quality Assurance Director EnergySolutions X
X X
Richard Byars ES Director Quality Assurance EnergySolutions X
X X
Greg Lane VP Domestic Products EnergySolutions X
X X
Aleksandr Gelfond Director of Engineering/Licensing EnergySolutions X
X X
Phillip Thomas Director Cask Logistics EnergySolutions X
X X
Jimmy Morris Quality Assurance Supervisor EnergySolutions X
X X
Andy Veronee General Manager EnergySolutions X
X X
Thomas Bell Operations Manager EnergySolutions X
X X
2.
INSPECTION PROCEDURES USED IP 86001 Design, Fabrication, Testing, and Maintenance of Transportation Packagings NUREG/CR6314 Quality Assurance Inspections for Shipping and Storage Containers Regulatory Guide 7.10, Establishing Quality Assurance Programs for Packaging Used in the Transport of Radioactive Material 3.
LIST OF ITEMS OPENED, CLOSED, AND DISCUSSED Item Number Status Type Description None None None None
2 4.
LIST OF ACRONYMS USED 10 CFR Title 10 of the Code of Federal Regulations ADAMS Agencywide Documents Access and Management System ANSI American National Standards Institute ASME American Society of Mechanical Engineers ASNT American Society for Nondestructive Testing ASL Approved Suppliers List CAP Corrective Action Program CAR Corrective Action Report CGD Commercial Grade Dedication CoC Certificate of Compliance DCR Design Change Request ECN Engineering Change Notice ES EnergySolutions IMC Inspection Manual Chapter IP Inspection Procedure ITS Important-to-Safety NCR Nonconformance Report NIAC Nuclear Industry Assessment Corporation NRC U.S. Nuclear Regulatory Commission PDR Public Document Room PO Purchase Order QA Quality Assurance QAP Quality Assurance Program QC Quality Control SAR Safety Analysis Report SARP Safety Analysis Report for Package SSC Structure, System, and Component