ML24142A464
| ML24142A464 | |
| Person / Time | |
|---|---|
| Site: | 07109375 |
| Issue date: | 05/24/2024 |
| From: | Rodriguez H NRC/NMSS/DFM/IOB |
| To: | Singh K Holtec |
| References | |
| IR 2024201 | |
| Download: ML24142A464 (1) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 May 24, 2024 Dr. K. P. Singh, President, and Chief Executive Officer Holtec International Krishna P. Singh Technology Campus 1 Holtec Boulevard Camden, NJ 08104
SUBJECT:
U.S. NUCLEAR REGULATORY COMMISSION INSPECTION REPORT NO. 71-09375/2024-201
Dear Dr. Singh:
On April 8, 2024, through April 10, 2024, the U.S. Nuclear Regulatory Commission (NRC) conducted an announced onsite team inspection at your Holtec Manufacturing Division (HMD) in East Pittsburgh, Pennsylvania. HMD is one of the subsidiaries of Holtec International, Incorporated (Holtec) used in the fabrication of components associated with the certificate of compliance number (No.) 71-9375, HI-STAR ATB 1T. The team discussed the preliminary results of this inspection with Mark Solar, Vice President of Quality, and other Holtec representatives on April 10, 2024. The enclosed report presents the results of this inspection.
The purpose of the inspection was to verify and assess the adequacy of activities related to the design, fabrication, assembly, testing, procurement, and repair for the transportation packaging of the HI-STAR ATB 1T to determine if Holtec 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.
The inspection scope included observations of fabrication activities, documentation reviews, and interviews with personnel to determine whether Holtec fabricated the transportation packaging in accordance with the commitments and requirements specified in the safety analysis report for packaging, and Holtecs NRC-approved quality assurance program requirements.
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 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,
Dr. Singh 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, Chief Inspection and Oversight Branch Division of Fuel Management Office of Nuclear Material Safety and Safeguards Docket No. 719375
Enclosure:
NRC Inspection Report Love, Earl signing on behalf of Rodriguez-Luccioni, Hector on 05/24/24
ML24142A464 C = COVER E = COVER & ENCLOSURE N = NO COPY
- via email OFFICE NMSS/DFM NMSS/DFM NMSS/DFM NAME MDavis Sfigueroa for WWheatley ELove for H Rodriguez DATE 5/23/2024 5/24/2024 5/24/2024
Enclosure U.S. NUCLEAR REGULATORY COMMISSION Office of Nuclear Material Safety and Safeguards Division of Fuel Management Inspection Report Docket No.:
7109375 Report No.:
7109375/2024201 Enterprise Identifier:
I-2024-201-0030 (HI-STAR ATB 1T at HMD)
Certificate Holder:
Holtec International Location:
Holtec Manufacturing Division 700 Braddock Ave East Pittsburgh, Pennsylvania Inspection Dates:
April 8 - April 10, 2024 Inspectors:
Marlone Davis, Senior Transportation and Storage Safety Inspector, Team Leader Earl Love, Senior Transportation and Storage Safety Inspector Raju Patel, Transportation and Storage Safety Inspector Daneira Melendez-Colon, Project Manager (Observer)
Approved by:
Hector Rodriguez, 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
Holtec International NRC Inspection Report 7109375/2024201 On April 8, 2024, through April 10, 2024, the U.S. Nuclear Regulatory Commission (NRC) conducted an announced onsite team inspection at Holtec Manufacturing Division (HMD)
International in East Pittsburgh, Pennsylvania. HMD is one of the subsidiaries of Holtec International, Incorporated (Holtec) used in the fabrication of components associated with the certificate of compliance (CoC) number (No.) 71-9375 (Revision 1), HI-STAR ATB 1T. Holtec designed the HI-STAR ATB 1T for the transportation of radioactive non-fuel waste such as segmented reactor internals, and related hardware waste. As described in the CoC No. 71-9375 (Revision 1), the HI-STAR ATB 1T is a rectangular transportation package with a closure lid secured by a custom design locking system. This fabrication inspection reviewed activities associated with the first production article of the HI-STAR ATB 1T, which was being fabricated for Sweden. As discussed during the inspection, the second production article maybe for the Holtec decommissioning fleet in the United States.
The purpose of the inspection was to verify and assess the adequacy of activities related to the design, fabrication, assembly, testing, procurement, and repair of the transportation packaging for the HI-STAR ATB 1T to determine if Holtec 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.
The inspection scope included observations of fabrication activities, documentation reviews, and interviews with personnel to determine whether Holtec fabricated the transportation packaging in accordance with the commitments and requirements specified in the safety analysis report for packaging, and Holtecs NRC-approved quality assurance program (QAP) requirements. The inspection team verified that the fabrication activities surrounding the transportation packaging for the HI-STAR ATB 1T complied with the Holtec quality assurance program and 10 CFR Parts 21 and 71 requirements in general as summarized below and in this enclosed report.
Quality Assurance Program The team determined that Holtec conducted quality related activities on the transportation packaging in accordance with their NRC approved QAP (section 1.1).
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 that Holtec personnel were familiar with the reporting and posting requirements of 10 CFR Part 21 (section 1.2).
3 Design Control The team determined, for the items selected for review and the personnel interviewed that Holtec implemented an adequate design control program in accordance with their approved CoC and safety analysis report for packaging (SARP), written procedures, and design specifications, as applicable (section 1.3).
Fabrication, Assembly, Maintenance and Testing The team determined, for the items selected for observation and review that Holtec performed fabrication, assembly and testing in accordance with the approved SARP, written procedures, and specifications, as applicable (section 1.4).
Procurement The team determined that materials, components, and other equipment received by Holtec for fabrication activities met procurement specifications, and the specifications conform 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 using NRC endorsed guidance documents (section 1.5).
Non-Conformance and Corrective Action The team concluded that Holtec effectively implemented its nonconformance and corrective action control programs and has adequate procedures in place to ensure compliance with applicable regulations and quality assurance requirements (section 1.6).
Personnel Training and Quality Assurance Oversight The team determined that Holtec had trained and qualified individuals performing activities affecting quality and that Holtec management provided appropriate oversight of quality related activities, as applicable (section 1.7).
Audit Program The team determined for the most part that the licensee performed internal and external (supplier) audits as scheduled in accordance with QAP requirements for transportation packaging activities and that Holtec resolved deficiencies if identified during the audit in a timely manner (section 1.8).
4 REPORT DETAILS 1.0 Design, Fabrication, Testing, and Maintenance of Transportation Packagings (Inspection Procedure (IP) 86001) 1.1 Quality Assurance Program 1.1.1 Inspection Scope The team reviewed the Holtec Nuclear Quality Assurance Manual (NQAM) CD-03, revision 15 and various Holtec implementing procedures designated as Holtec Quality Procedures (HQPs) and Holtec Standard Procedures (HSPs) to assess the effectiveness of their Quality Assurance (QA) program implementation. The team conducted reviews of Holtecs quality program, policies, and procedures, to determine whether Holtec adequately controlled and implemented activities under their NRC approved QA program and activities subject to 10 CFR Parts 71 and 21 regulations. The team reviewed procedures to verify if Holtec clearly defined and documented the quality program authorities and responsibilities and that the quality assurance organization functioned as an independent group. The team also reviewed procedures for the use of a graded approached for identifying Important-to-Safety (ITS) components and whether Holtec applied this graded quality level to procurement documents for HI-STAR ATB 1T.
The team reviewed the following specific HQPs and HSPs:
HQP-1.0, Organization and Responsibilities, revision 45 HQP-2.0, Quality Assurance Program, revision 25 HSP-100101, Organization, revision 4 HSP-100201, QA Manual and Procedures, revision 2 HSP-100204, Measurement and Analysis of QA Program Effectiveness, revision 2 1.1.2 Observation and Findings The team assessed that Holtec has an adequate QA program that included applicable implementing procedures in place to conduct effective quality activities in accordance with the transportation packaging safety analysis report (SAR), CoC, and 10 CFR Parts 21 and 71 requirements. The team also verified that Holtec clearly defined and documented the quality program authorities and responsibilities and that the quality assurance organization functioned as an independent group as described in Holtecs NQAM. Additionally, the team verified that Holtecs quality assurance procedures discussed a graded approach for identifying ITS components.
No findings were identified.
1.1.3 Conclusions The team determined that the fabricator conducted quality related activities on the transportation packaging in accordance with the CoC, as well as their NQAM, and had effective implementing procedures in place.
1.2 10 CFR Part 21
5 1.2.1 Inspection Scope The team reviewed selected records and interviewed personnel to verify that Holtec effectively implemented a nonconformance control program in accordance with their NRC approved QA Program, and the requirements of 10 CFR Parts 21. The team reviewed Holtecs approved procedure HSP-101501, "Reporting of Defects per 10 CFR 21 or 10 CFR 50.55e, revision 2, to determine if provisions were in place for reporting defects that could cause a substantial safety hazard from the nonconformance reports (NCRs) and quality issues (QIs) identified. This review also included, and assessment of NCRs and QIs logs for compliance with 10 CFR 71.95, Reports, as applicable.
1.2.2 Observation and Findings The team assessed that Holtec 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 the HMD facility met the applicable requirements of 10 CFR Part 21.
No findings were identified.
1.2.3 Conclusions The team determined that provisions are in place for reporting defects which could cause a substantial safety hazard, personnel were familiar with the reporting requirements of 10 CFR Part 21; and the fabricator complied with 10 CFR 21.6, "Posting requirements."
1.3 Design Control 1.3.1 Inspection Scope The team interviewed selected personnel and reviewed the procurement/fabrication specification and fabrication drawings against the engineering and licensing drawings to determined that Holtec implemented adequate design controls. The team verified the consistency of material specifications and critical dimensions as well as testing and inspection requirements to determine whether the procurement/fabrication specifications were consistent with the design. Specifically, the team focused on the translation of design commitments and requirements for the ITS category A, B, and C components of the HI-STAR ATB 1T and design specifications, including associated licensing drawings in the SARP, and subsequent fabrication plans. The team reviewed the following documents associated with design control during fabrication to verify proper implementation. The documents are as follows:
Project Specification Document No. PS-2404-0006, Purchase Specification for Fabrication of HI-STAR ATB 1T Cask revision 4 HI-2146312, Safety Analysis Report for the HI-STAR ATB 1T Package, revision 5 HI-2167519, Important to Safety Categorization of HI-STAR ATB 1T Transportation Cask, revision 3, DWG-9786, HI-STAR ATB 1T, sheets 1-9, revision 10 DWG-12182, HI-STAR ATB 1T - Bill of Materials and Fabrication, revision 6
6 DWG-12183, HI-STAR ATB 1T - Fabrication, revision 6 The team also reviewed a sample of quality classification evaluations for the HI-STAR ATB 1T packaging documented in HI-2167519, ITS Categorization of HI-STAR ATB 1T Transport Cask, revision 3. The team selected components classified as ITS category B and C to determine if Holtec classified the component in accordance with the guidance in NUREG/CR6407 Classification of Transportation Packaging and Dry Spent Fuel Storage System Components According to Importance to Safety.
1.3.2 Observation and Findings Based on the teams review, there were no unexplained discrepancies between the design and fabrication activities including the licensing and fabrication drawings. The team noted that Holtec captured all requirements reviewed from the purchase order (PO) and procurement/fabrication specification associated with the design and fabrication of the HI-STAR ATB 1T. The team noted that Holtec had appropriate justification for the quality classification of the ITS components and were consistent with the descriptions in the SARP.
No findings were identified.
1.3.3 Conclusions The team determined that for the items selected for review that Holtec implemented adequate design control measures. The procurement/fabrication specification was consistent with the design commitments and requirements documented in the SARP and the transportation packaging CoC No. 9375 for the HI-STAR ATB 1T.
1.4 Fabrication 1.4.1 Inspection Scope The team reviewed selected drawings, procedures, and records, and observed selected activities related to the HI-STAR ATB 1T containment boundary assembly (CBA) components to determine if the fabrication, testing, and assembly activities met the SARP design commitments and requirements documented in the CoC. The team selected the CBA based on the ITS category of the component. The team also interviewed selected personnel and reviewed the HI-STAR ATB 1T fabrication specification, drawings, and travelers to determined that Holtec implemented adequate instructions, requirements, and acceptance criteria controls. The team observed welding and nondestructive examinations on the CBA. The team reviewed the following documents:
HSP-100502, Standard and Project Procedures, revision 4 HPP-2404-0004, Inspection and Test Plan for the HI-STAR ATB 1T Cask, revision 4, dated March 25, 2024 Project Specification Document No. PS-2404-0006, Purchase Specification for Fabrication of HI-STAR ATB 1T Cask, revision 4
7 HI-2146157, Reconciliation Report, (identification of differences in the conditions and acceptance criteria between Swedish, U.S., and Holtec Regulations, Codes and Standards), revision 1 Fabrication Travelers PWRPL 2404115H-1218252-1-A, Containment Wall Welding, dated April 8, 2024, PWRPL 2404115H-12182003-A, Item 003: Containment End Wall, Hybrid Laser, dated April 9, 2024 (Machining)
PWRPL 2404115H-1-1-A Weld 5-2 Indications, dated April 8, 2024, (Weld repairs and NDE) 1.4.2 Observation and Findings The team assessed that Holtec established appropriate means to control the HI-STAR ATB 1T CBA fabrication activities and special processes that met the SAR design commitments and requirements documented in the CoC. The team examined Holtecs procurement/fabrication specification, design and fabrication drawings, work control procedures, and travelers and confirmed that the fabrication and testing activities were adequate. The team noted that the shop travelers identified the applicable drawings, material specifications, work instructions, and procedures applicable to the manufacturing and examination activities.
1.4.3 Conclusions The team determined that Holtec personnel were familiar with the specified design, designated fabrication techniques, testing requirements, and quality control associated with the fabrication of the HI-STAR ATB 1T packaging that met packaging SAR design commitments and requirements documented in the CoC.
1.5 Assembly and Testing 1.5.1 Inspection Scope The team observed activities affecting safety aspects of the packaging such as welding, assembly, and nondestructive examination (NDE) of the CBA to verify that Holtec performed these tasks in accordance with approved methods, procedures, and specifications. The team reviewed the fabrication process through observations, examinations of records, and personnel interviews in the areas of fabrication, assembly, inspection, and testing, along with control of measuring & test equipment. The team witnessed an in-process visual examination of the weld repairs. The team reviewed and observed the following activities:
Gas Metal Arc Welding, metal active gas, CBA Weld 5-2.1 FAB Note SFN 2404115H-1, dated 2/27/2024, Ultrasonic Test (UT) inspection of Weld 5.2 (including Map of welds 5-2.1 thru 5-2.4 rejectable indications)
Ultrasonic Examination Report, UT 2404115H-1 Weld 5-2 Corners inside and out, revision 0, dated February 26, 2024 Repair Traveler, PWRPL 2404115H-1-1-A, Weld 5-2 Indications, Sequence 30, visual and penetrant test of reworked areas prior to welding
8 Visual and Liquid Penetrant Examinations, Report MTR 2404115H-10, Weld 5-2.1 thru 5-2.4 Excavations Holtec UT 2004-09, Ultrasonic Angle Beam Technique Card, revision 0 Welding Procedure Specifications (WPS) and Procedure Qualification Records (PQR) according to Swedish requirements for ISO 15641 WPS 536 SKB, Gas Metal Arc Welding - Metal Active Gas, revision 0, dated June 14, 2023 PQR 1750 SKB, Gas Metal Arc Welding - Metal Active Gas, revision 0, dated June 20, 2023 WPS 537 SKB, Gas Tungsten Arc Welding - Tungsten Inert Gas, revision 0, dated June 14, 2023 PQR 1751 SKB Gas Metal Arc Welding - Metal Active Gas, revision 0, dated June 20, 2023 WPS 544 SKB, Low Power Density Laser Beam Welding (LLBW)- American Society of Mechanical Engineers (ASME) Boiler and Pressure Vessel Code (B&PVC),Section IX, revision 0, dated October 3, 2023 PQR 1785 SKB Low Power Density Laser Beam Welding (LLBW) - ASME B&PVC,Section IX, revision 0, dated October 3, 2023 The team also reviewed the following procedures:
HQP-10.0, Control of Inspection Activities, revision 9 HQP-11.0, Test Control, revision 25 HQP-12.0, Control of Measuring and Test Equipment, revision 29, HSP-1105, Liquid Penetrant Examination (Solvent Removable Visible Dye),
revision 10 HSP-1104, Visual Weld Examination, revision 9 HSP-2000, Ultrasonic Testing of Welds and Steel Forgings in accordance with International Standard Organization 17640, revision 2 HSP-100902, Control of Welding Activities, revision 0 HSP-101201, Control of Measuring and Test Equipment, revision 7 HSP-101401, Inspection, Test, and Operating Status, revision 2 The team reviewed the control of measuring and test equipment (M&TE) program to evaluate how the fabricator identified, specified, and controlled tools and equipment in accordance with their standard procedures. The team selected a sample of the M&TE used during the welding of the CBA. The sample included a review of travelers that identified the use of specific M&TE that the team selected such as a light meter, digital thermometer, and a laser welding machine. The team reviewed the calibration records to verify calibration dates, testing standards, and traceability of the associated M&TE.
1.5.2 Observation and Findings The team assessed that Holtec established appropriate means to control the HI-STAR ATB 1T CBA fabrication activities and special processes. The team noted that Holtec implemented their NQAM, QA implementing procedures, and special processes with qualified personnel, using approved procedures for assembly, welding, and testing.
9 The team noted that Holtec personnel performed the weld repairs of the HI-STAR ATB 1T CBA in accordance with the applicable drawings using qualified procedures and qualified welding personnel. The team also noted that welds were inspected by qualified personnel in accordance with the applicable drawing requirements. Further, inspection and examination results of weld 5-2s excavated areas were documented in a repair traveler and examination reports in accordance with quality procedures. The team noted, areas of rejection that would require additional rework.
No findings were identified.
1.5.3 Conclusions The team determined that materials, components, and other equipment received by the fabricator met transportation packaging design procurement specifications, and the procurement specifications conform to the design commitments and requirements contained in the SARP and CoC.
1.6 Procurement Control 1.6.1 Inspection Scope The team reviewed processes and procedures that addressed procurement, including receipt inspection, traceability of material, and commercial grade dedication (CGD), as applicable. The team reviewed selected drawings and records and interviewed personnel to verify that procurement specifications for materials, fabrication, and inspection met design commitments and requirements contained in the SARP and CoC.
The team also reviewed the following implementing procedures and procurement documents:
HQP 4.0, Procurement Document Control, revision 0, HQP 5.0, Instructions, Procedures, and Drawings, revision 0, HSP 100401, Processing of Purchase Orders, revision 6, HSP 100402, Purchase Specification, Revision 4, and HSP 100701, Receipt Inspection, Revision 9.
The team reviewed a sample of POs, receipt inspection records and commercial grade dedication packages specific to ITS Category A components.
The team reviewed HI-STAR ATB-1T packaging containment boundary components bill of material, drawings, and purchase specifications to verify that Holtec invoked the material specification requirements of ASME Section II SA-508 Grade 4N, Class 2.
Further, the team reviewed HI-STAR ATB-1T containment side walls, end walls, base plate, and cover lid POs, receipt inspection reports and material test reports to verify that Holtec procured the containment components and met the material specification requirements of ASME Section II, SA 50 Grade 4N, Class 2. The team also reviewed Holtec procurement control measures for the use of the International Laboratory Accreditation Cooperation (ILAC) accreditation process in lieu of performing commercial-grade surveys for the procurement of calibration and testing services as part of the commercial-grade dedication process.
10 The following is a list of procurement documents reviewed for the HI-STAR ATB 1T:
Drawings Drawing No. 9786 HI-STAR ATB-1T Cask for Project 2404, revision 10, and Drawing No. 12182, Bill of Material ITS, revision 1 Purchase Orders (PO)
PO No. 129513 for ITS-A carbon steel forge plates SA-582 Gr.4N, Class 2, revision 1,
PO No. 20127416 for procurement of ITS-A weld wire, revision 1, PO No. 133511 for ITS-A lifting trunnion sleeve, hollow shaft P/N 12182-1023, ASME SA 182 Gr. FXM19, revision 0, PO No. 133533 for ITS-A, closure lid lift lugs, impact absorbers I through VI, left-hand, and right-hand end locking wedges, left-hand, and right-hand side locking wedges, lifting trunnion solid shaft revision 0, and PO 136892 for calibration services for tensile tester and extensometer to PS-501, revision 0.
Purchase Specifications (PS)
PS-501, Purchase Specifications for Calibration of ITS and Safety-Related M&TE, revision 5, PS-746, Welding Material Specification for Section III, GMAW, Using ER120S-G, revision 0, PS-747, Welding Material Specification for Section III, GTAW using ER120S-G, revision 0, PS-2404-0006, Purchase Specification for Fabrication to HI STAR ATB-1T Cask, revision 4, PS-2404-0018, Purchase Specification for ASME SA 508 Grade 4N, Class 2 Forgings, revision 1, PS-2404-0102, Purchase Specification for Elastomeric Seals (NITS), revision 1, and PS-2404-0111, Purchase Specification for SA-182, Grade FXM-19 Forgings, revision 0.
Material Inspection Certification (MIC)
MIC C-35667 for Plate 3-1/2x61x139, material ASME Section II SA 508 Gr. 4N Class 2, traceable to Heat #221535, Job# 22\\3034A inspected and accepted on March 9, 2023, MIC C-35672 for plate 6-1/4x100x 140 material SA 508 Gr. 4N Class 2, traceable to Heat# 221529 LBC 22\\303\\1B inspected and accepted on March 9, 2023, MIC C-35668 for plate 6-1/4 x 58 x 136-3/4 material SA 508 Gr. 4N Cl. 2, traceable to Heat# 221529 inspected and accepted on March 9, 2023, MIC C-35669 for plate 6-1/4 x 62 x 100 material SA 508 Grade 4N Cl. 2, traceable to Heat# 221535, inspected and accepted on March 9, 2023,
11 MIC WC-261 for ESAB weld wire 0.045 Ø, 550 lbs. pack, ER120S-1, ASME SFA 5.28, traceable to heat/lot# 674366 inspected and accepted on October 27, 2023, MIC WC-262 for ESAB weld wire 3/36 x 36 ER120S-1, ASME SFA 5.28, traceable to heat/lot# 674366, inspected and accepted on December 12, 2023, and MIC I-210 for 8 Lifting Trunnion Solid Shafts material ASME SB-637 Gr. UNS N07718, traceable to Heat# 609326, inspected and accepted on December 28, 2023.
Dedication Reports Quality Plan - 132708A, Vendor Parker O-Ring and Seals, revision 1, Dedication Report and Quality Plan for Material or Items QP 12143-B, for Project No. 2370, O-Rings and Seals from PO No. 126279, dated January 20, 2022, and Dedication Report and Quality Plan for Material or Items QP 12902, for ITS-A, calibration of Power Sensors s/n 970357, and 3047798 on PO 20125220, dated April 29, 2022.
1.6.2 Observation and Findings Overall, the team assessed that Holtec had adequate control of the procurement process for the ITS components selected and reviewed. The team determined that Holtec procured ITS components consistent with design requirements and their QA implementing procedures. The team noted that Holtec maintain adequate controls of material traceability, procurement, and receipt inspections, as applicable. The team assessed that the POs were adequate and specified the applicable criteria and requirements including Part 21. The material ordered and received at the HMD facility met the design requirements, and the critical characteristics for dedicated material. The team noted that Holtec provided layers of traceability as shown in the commercial-grade dedication reports, quality plans, purchase specifications, material test and examination reports, and a final receipt inspection report.
The team noted Holtec verified and maintained the traceability throughout the procurement and receipt process. The team also noted that Holtec purchased and applied controls over vendors and sub-contractors currently on the Holtecs approved vendors list (AVL). The team confirmed that the POs adequately imposed the applicable technical, regulatory, and quality requirements. Additionally, the team noted that Holtec implementation of the CGD process for calibration services using ILAC process invoked the provisions of NEI-14-05A revision 2.
No findings were identified.
1.6.3 Conclusions The team determined that materials, components, and other equipment received by the Holtec met the procurement specifications, and the specifications conform to the design commitments and requirements contained in the SARP and CoC. This included the use of the CGD process to procure commercial items and calibration services using NRC endorsed guidance documents.
1.7 Nonconformance and Corrective Actions
12 1.7.1 Inspection Scope The team reviewed a sample of nonconformance records and QIs to verify that Holtec effectively implemented their nonconformance control and corrective action programs in accordance with the requirements of 10 CFR Part 71. The team verified that Holtec completed corrective actions for identified deficiencies and nonconformances in a technically sound and timely manner. The team reviewed the following quality standard procedures related to the fabricators programs:
HQP 15.0, Control of Nonconforming Conditions, revision 3 HQP 16.0, Corrective Action, revision 24 HSP 101502, Control of Nonconforming Conditions, revision 8 HSP 101503, Manufacturing Condition Control, revision 9 HSP 101601, Corrective Action, revision 4 The inspectors reviewed nonconformance reports (NCRs) and QIs from the start of fabrication activities, which included Holtecs deposition of NCRs related to the fabrication activities for HI-STAR ATB 1T. The team also discussed the NCRs and QIs with Holtec personnel to gain an understanding of any technical justification or repairs.
1.7.2 Observation and Findings Overall, the team assessed that Holtec had adequate nonconformance and corrective action programs controls in place to resolve deficiencies if identified. The team assessed that Holtec appropriately identified issues and implemented corrective actions in a time frame commensurate with their safety significance.
No findings were identified.
1.7.3 Conclusions The team concluded that Holtec effectively implemented its nonconformance and corrective action control programs and has adequate procedures in place to ensure compliance with applicable regulations and quality assurance requirements.
1.8 Personnel Training and Oversight 1.8.1 Inspection Scope The team reviewed selected records and procedures, interviewed selected personnel, and observed selected activities affecting the safety aspects of the packaging to verify that Holtec properly trained and qualified individuals performing activities affecting quality and that the Management and quality assurance staff provided appropriate oversight. The team also reviewed procedures and documents regarding training, qualification, and certification of personnel involved in quality activities. The team reviewed the records of two selected quality inspectors and two welders that performed NDE and welding, respectively. The team reviewed the following quality standard procedures related to training and qualifications:
13 HSP-100203, Training Program, revision 2 HSP-100901, Written Practice for Qualification of NDE Personnel, revision 6 HSP-100903, Control and Qualification of NDE Personnel, revision 0 HSP-100904, Procedure for Training and Qualification of Visual Examination Personnel, revision 0 HSP-101001, Qualification of Inspection Personnel, revision 2 Welder Performance Qualifications (WPQ)
WPQ welder identification/stamp number 902, LLBW WPQ welder identification/stamp number 1113, GTAW 1.8.2 Observation and Findings The team assessed that welder performance qualifications and welder continuity conformed to Section IX of the American Society of Mechanical Engineers (ASME)
Boiler and Pressure Vessel Code. For the welding qualification records reviewed, the team noted that the fabricator had qualified welders for each applicable process, and that welders maintained their welding continuity for the welding processes observed.
The team also noted that personnel performing NDE had qualified in accordance with the American Society for Nondestructive Testing Recommended Practice No. SNT-TC1A, which includes the required training, experience, medical testing, and education.
No findings were identified.
1.8.3 Conclusions The team determined that Holtec properly trained and qualified individuals performing activities affecting quality. The team also determined that Holtec Management and quality assurance staff provided appropriate oversight.
1.9 Audits 1.9.1 Inspection Scope The team reviewed Holtecs audit program to verify that Holtec scheduled, planned, and performed audits in accordance with their QAP including associated implementing procedures. The team reviewed the following documents as a part of the review for performing internal and external audits.
HQP-18.0, Audits, revision 0 HSP-101801, Certification of Audit Personnel, revision 1 HSP-101802, Audits, revision 7 HSP-101803, Internal QA Surveillance and Document Reviews, revision 0 The team reviewed the internal audit results to determine if Holtec identified deficiencies and addressed the deficiencies within their corrective action program. The team also reviewed the external audits of suppliers and vendors for ITS materials and services identified on Holtecs AVL. The team selected a sample of internal and external audits.
14 This sample also included a review of the qualifications, training records, and certifications of Holtecs lead auditors and auditors for internal and external audits. The team focused on activities related to the fabrication of the Holtec ATB 1T. The team also reviewed three Nuclear Industry Assessment Committee (NIAC) audit reports that Holtec assessed to take credit for as external audits of suppliers.
1.9.2 Observation and Findings The team confirmed that Holtec performs internal audits on a yearly basis and that Holtec audits all eighteen QAP elements. The team noted that Holtec develops audit plans and schedule audits in accordance with approved quality procedures. The audit plans identify the organization being audited, audit scope, requirements, audit team members, activities for audit, applicable documents, and audit checklists. The team noted that Holtec provided objective evidence, documentation, and examined to the depth necessary. The team noted that Holtec lead auditors issued and signed all audit reports. The team assessed that Holtec scheduled and performed internal audits and internal surveillances in accordance with their implementing procedures.
Additionally, the team noted that the auditors identified QIs during the audit and that Holtec captured all the issues on their QI reports. The team noted that Holtec had closed and provided evidence, which included, when necessary, a root cause analysis and appropriate corrective actions taken to resolve QIs in a timely manner. This included a performance verification of adequate implementation of the corrective actions taken on previous internal audit QIs by the auditors.
As far as external audits, the team determined that the NIAC audit package to be thorough with the use of the NIAC checklists and detailed documentation. The team noted that Holtec followed its procedures by performing an audit review checklist to accept the audit as its own and assessed them to be very thorough with the use of checklists and documented evidence. The team assessed that the NIAC auditor and lead auditor had completed the required training and attained the applicable qualifications to perform their duties as an auditor and lead auditor.
No findings were identified.
1.9.3 Conclusions The team determined that Holtec performed audits as scheduled of their QAP elements and activities affecting the safety aspects of the transportation packaging and resolved deficiencies if identified in a timely manner.
2.0 Entrance and Exit Meeting On April 8, 2024, the NRC inspection team discussed the scope of the inspection during an entrance meeting with Mark Solar, Vice President of Quality, and other Holtec representatives. On April 10, 2024, the NRC inspection team discussed the preliminary results and observations during an onsite exit meeting with Holtec representatives.
Section1 of the attachment to this report shows the attendance for the entrance and exit meetings.
Attachment ATTACHMENT 1.
ENTRANCE/EXIT MEETING ATTENDEES AND INDIVIDUALS INTERVIEWED Name Title Affiliation Entrance Exit Marlone Davis Team Leader NRC X
X Earl Love Senior Safety Inspector NRC X
X Raju Patel Safety Inspector NRC X
X Daneira Melendez-Colon Project Manager NRC X
X Mark Soler Vice President Quality Holtec X
X Brock Peltier Corporate Quality Manager Holtec X
X Jeffrey Surmacz Quality Manager HMD X
X Rick Rothrauff Director of Manufacturing HMD X
X Anthony Conti Product Line Manager HMD X
X Nazar Yanis Project Manager Holtec X
Vaughn Curcio Director of Quality Manufacturing HMD X
INSPECTION PROCEDURES USED IP 86001 Design, Fabrication, Testing, and Maintenance of Transportation Packagings NUREG/CR6407 Classification of Transportation Packaging and Dry Spent Fuel Storage System Components According to Importance to Safety NUREG/CR6314 Quality Assurance Inspections for Shipping and Storage Containers LIST OF ITEMS OPENED, CLOSED, AND DISCUSSED Item Number Status Type Description None None None None LIST OF ACRONYMS USED 10 CFR Title 10 of the Code of Federal Regulations ADAMS Agencywide Documents Access and Management System ASME American Society of Mechanical Engineers AVL Approved Vendors List CAP Corrective Action Program CBA Containment Boundary Assembly CGD Commercial Grade Dedication CoC Certificate of Compliance ILAC International Laboratory Accreditation Cooperation IMC Inspection Manual Chapter
2 IP Inspection Procedure ITS Important to Safety M&TE Measuring and Test Equipment NCR Nonconformance Report NDE Nondestructive Examination NIAC Nuclear Industry Assessment Committee NRC U.S. Nuclear Regulatory Commission NQAM Nuclear Quality Assurance Manual PDR Public Document Room PO Purchase Order QA Quality Assurance QAP Quality Assurance Program QIs Quality Issues WPQ Welder Performance Qualification WPS Welding Procedure Specification SAR Safety Analysis Report SARP Safety Analysis Report for Packaging SSC Structure, System, and Component DOCUMENTS REVIEWED Certificate holder documents reviewed during the inspection were specifically identified in the Report Details above.