ML24150A140
| ML24150A140 | |
| Person / Time | |
|---|---|
| Site: | 07109279 |
| Issue date: | 05/30/2024 |
| From: | Hector Rodriguez-Luccioni NRC/NMSS/DFM/IOB |
| To: | Princen K US Dept of Energy, Carlsbad Field Office |
| References | |
| Download: ML24150A140 (1) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 205550001 Kenneth E. Princen Department of Energy Carlsbad Field Office Assistant Manager Office of the National TRU Program Waste Certification & Disposal U.S. Department of Energy P. O. Box 3090 Carlsbad, NM 88221
SUBJECT:
NRC FABRICATION INSPECTION REPORT FOR DOE/WIPP FACILITY
Dear Kenneth Princen:
On March 12, 2024, through March 14, 2024, the U.S. Nuclear Regulatory Commission (NRC) staff conducted an announced inspection of the U.S. Department of Energy Waste Isolation Pilot Plant (WIPP) quality assurance (QA) program as applied to the ongoing fabrication of Model No. HalfPACT transportation packaging. The NRC performed the inspection onsite at Holtec Manufacturing Division in East Pittsburgh, PA, which is performing the fabrication work for fabrication contractor Holtec Government Services, LLC. The staff continued the inspection activities with an inoffice review through April 8, 2024, followed by an exit meeting on April 16, 2024. The enclosed report presents the results of this inspection.
Pursuant to the WIPP Land Withdrawal Act, no transuranic waste may be transported to or from WIPP, except in packages that have been determined by the NRC to satisfy its QA requirements. The inspection was performed to assess whether fabrication activities performed under WIPPs QA program for the HalfPACT packaging satisfied NRCs QA requirements under Title 10 of the Code of Federal Regulations (10 CFR) Part 71. The inspection scope included observations of shop fabrication activities, reviews of records, and interviews with personnel.
Based on the inspection results, overall, it was determined that for the HalfPACT packaging fabrication activities reviewed and witnessed, they were performed in a manner that satisfied NRCs QA 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, between 8 a.m. and 4 p.m. eastern time (ET), Monday through Friday, except Federal holidays.
May 30, 2024
K. Princen 2
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. 719279
Enclosure:
NRC Inspection Report Signed by Rodriguez-Luccioni, Hector on 05/30/24
ML24150A140 OFFICE DFM DFM DFM NAME JTapp SFigueroa HRodriguez-Luccioni DATE 5/30/24 5/30/24 5/30/24
Enclosure U.S. NUCLEAR REGULATORY COMMISSION Office of Nuclear Material Safety and Safeguards Division of Fuel Management Docket:
N/A Report.:
N/A Enterprise Identifier: N/A Certificate Holder:
U.S. Department of Energy Facility:
Holtec Manufacturing Division Location:
East Pittsburgh, PA Inspection Dates:
March 12, 2024, through April 16, 2024 Inspection Team:
Jeremy Tapp, Transportation and Storage Safety Inspector, Team Leader Earl Love, Senior Transportation and Storage Safety Inspector Marlone Davis, Senior Transportation and Storage Safety Inspector Gang Zhao, Structural Engineer (Observer)
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
U.S. Department of Energy Waste Isolation Pilot Plant Carlsbad Field Office On March 12, 2024, through March 14, 2024, the U.S. Nuclear Regulatory Commission (NRC) staff conducted an announced inspection of the U.S. Department of Energy (DOE) Waste Isolation Pilot Plant (WIPP) quality assurance (QA) program as applied to the ongoing fabrication of Model No. HalfPACT transportation packaging. The NRC performed the inspection onsite at Holtec Manufacturing Division (HMD) in East Pittsburgh, PA, which is Holtec location performing the fabrication work for fabrication contractor Holtec Government Services, LLC (Holtec). The staff continued the inspection activities with an inoffice review through April 8, 2024, followed by an exit meeting on April 16, 2024.
Pursuant to the WIPP Land Withdrawal Act, no transuranic waste may be transported to or from WIPP, except in packages that have been determined by the NRC to satisfy its QA requirements. The inspection was performed to assess whether fabrication activities performed under WIPPs QA program for the HalfPACT packaging satisfied NRCs QA requirements under Title 10 of the Code of Federal Regulations (10 CFR) Part 71. The inspection scope included observations of shop fabrication activities, reviews of records, and interviews with personnel.
Based on the inspection results, overall, it was determined that for the HalfPACT packaging fabrication activities reviewed and witnessed, they were performed in a manner that satisfied NRCs QA requirements.
Quality Assurance Program The team assessed that the DOE Carlsbad Field Offices (CBFOs) oversight of their contractor, Salado Isolation Mining Contractors (SIMCO), as well as the QA program implementation and oversight by SIMCO on Holtec fabrication controls and implementation of the applicable QA requirements for the procurement and fabrication of HalfPACT packagings was generally adequate and equivalent to NRCs 10 CFR Part 71 QA requirements. (section 1.1) 10 CFR Part 21 The team determined that the provisions of 10 CFR Part 21 were implemented; Holtec personnel were familiar with the reporting requirements of 10 CFR Part 21; and Holtec complied with 10 CFR 21.6, "Posting requirements" at HMD. (section 1.2)
Design Control The team determined, for the items selected for review that the fabrication specifications were consistent with the design commitments and requirements documented in the safety analysis report (SAR) and Certificate of Compliance (CoC). (section 1.3)
3 Fabrication, Maintenance, and Testing The team concluded, for the important to safety (ITS) components selected for observation and review that Holtec performed fabrication and testing in accordance with the HalfPACT SAR, written procedures, and specifications, as applicable.
In addition, Holtec personnel were familiar with the specified design, designated fabrication techniques, testing requirements, and quality control associated with the fabrication of the inner containment vessel (ICV) components that met the HalfPACT SAR design commitments and requirements documented in the CoC. (section 1.4)
Procurement The team determined for the most part that materials, components, and other equipment received by SIMCO and Holtec met design procurement specifications, and the procurement specifications conformed to the design commitments and requirements contained in the SAR and CoC. However, the team observed an instance where the Orings fabricated in 2021 for the HalfPACTs did not meet NRC requirements for design and procurement controls. Corrective actions are planned to be taken by DOE CBFO to correct the observations. (section 1.5)
Nonconformance and Corrective Action The team concluded that Holtec, with SIMCO oversight, effectively implemented its nonconformance program and corrective action program (CAP), has adequate procedures in place to ensure compliance to QA requirements for the HalfPACT packagings, and were equivalent to NRCs 10 CFR Part 71 QA 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 and SIMCO personnel provided appropriate oversight of quality related activities, as applicable. (section 1.7)
Audit Program The team determined in general that SIMCO and Holtec performed internal and external (supplier) audits as scheduled of their QA program requirements for transportation packagings activities based on the audits selected for review. The team also determined that SIMCO and Holtec resolved deficiencies, if identified in the audits, in a timely manner. (section 1.8)
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 verified that the DOE CBFO, which includes WIPP, quality activities related to fabrication of HalfPACT packagings, are being conducted in accordance with the NRC approved HalfPACT CoC and SAR that DOE is the CoC holder. The team focused its review on the extent to which the DOE CBFO implemented its QA program oversight for the procurement and fabrication of HalfPACT packagings through its prime contractor SIMCO. Further, the team verified that SIMCO appropriately implemented its QA program to procure fabrication of HalfPACT packagings, primarily through Holtec, where fabrication was taking place at HMD. The team also reviewed Holtecs QA program implementing procedures to assess the adequacy and effectiveness of QA program implementation at HMD.
The team reviewed the DOE CBFO QA program DOE/CBFO941012, Quality Assurance Program Document, revision 14, and SIMCOs QA program and selected implementing procedures, which consists of the following two program documents that comprise the 10 CFR Part 71 QA program: WP 131, Quality Assurance Program Description, revision 43 and WIPP Procedure (WP) 08PT.03, WIPP 10 CFR Part 71, Subpart H, Quality Assurance Program Plan, revision 15. The team conducted interviews with DOE CBFO, SIMCO, and Holtec personnel about implementation of each organizations QA program, and implementing procedures as applicable, to determine whether each organization adequately controlled and implemented quality activities for HalfPACT packaging fabrication equivalent to 10 CFR Part 71 QA requirements.
Additionally, the team reviewed the SIMCO QA organization to verify it functioned as an independent group. The team reviewed the procurement documents from DOE CBFO through SIMCO to Holtec and interviewed personnel to verify 10 CFR Part 21 responsibility was adequately flowed down to the responsible organization and understood by each participating organization. The team also reviewed the DOE CBFO and SIMCO QA program documents and SIMCOs document TPHP-QGR0001, Q-List and Quality Category Assessments for the TRUPACT-II & HalfPACT Packages, revision 0 to verify that DOE CBFO and SIMCO used a graded approach to quality as documented in the respective QA programs, and SIMCO identified ITS components for the HalfPACT packaging design.
1.1.2 Observation and Findings The team determined that SIMCO has a QA program that provides satisfactory controls equivalent to NRC Part 71 QA requirements for quality activities related to the procurement and fabrication of HalfPACT packagings, as required by DOE CBFO. In addition, the team found that Holtec had a QA program and implementing procedures in place that were effective in conducting quality activities in accordance with their QA
5 manual. The team noted through the review of procurement documents that Holtec held 10 CFR Part 21 responsibility for the fabrication of the HalfPACT packagings.
No findings of significance were identified.
1.1.3 Conclusions The team assessed that the DOE CBFOs oversight of their contractor, SIMCO, as well as the QA program implementation and oversight by SIMCO on Holtec fabrication controls and implementation of the applicable QA requirements for the procurement and fabrication of HalfPACT packagings was generally adequate and equivalent to NRCs 10 CFR Part 71 QA requirements.
1.2 10 CFR Part 21 1.2.1 Inspection Scope The team verified that provisions are in place for reporting defects which could cause a substantial safety hazard, as required by 10 CFR Part 21. The team reviewed the 10 CFR Part 21 procedure Holtec standard procedure (HSP) 101501, Reporting of Defects per 10CFR21 or 10CFR50.55e, revision 2 to verify if provisions were in place for reporting defects that could cause a substantial safety hazard and whether Holtec would complete the required evaluation and notification in a timely manner. The team reviewed Holtecs procedure because Holtec was responsible for Part 21 by contract. The team requested a list of 10 CFR Part 21 evaluations and notifications associated with HalfPACT fabrication activities and interviewed Holtec personnel to verify familiarity with the implementing procedure. The team also verified if Holtec complied with 10 CFR 21.6, Posting requirements at HMD.
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 for the 10 CFR Part 21 postings sampled at HMD that they met the applicable requirements of 10 CFR Part 21.
No findings of significance were identified.
1.2.3 Conclusions The team determined that the provisions of 10 CFR Part 21 were implemented; Holtec personnel were familiar with the reporting requirements of 10 CFR Part 21; and Holtec complied with 10 CFR 21.6, "Posting requirements" at HMD.
6 1.3 Design Control 1.3.1 Inspection Scope The team reviewed selected design documentation to determine that adequate design controls are implemented. Specifically, the team reviewed HalfPACT licensing drawings against the fabrication drawings and specification to verify consistency of critical parameters and material specifications. Specifically, the team focused on design commitments and requirements for ITS components from the HalfPACT SAR to fabrication drawings. The team reviewed the following drawings and specification:
Drawing No. 707SAR, HalfPACT Packaging SAR Drawing, revision 12 TPHP-DWG3400, ICV Body, revision 0 TPHP-DWG3401, ICV Lower Dished Head, revision 0 TPHP-SPC0001, Specification for Fabrication of the TRUPACT-II and HalfPACT Type B Packaging, revision 0 The team also reviewed a sample of quality classification evaluations for the HalfPACT packaging documented in TPHP-QGR0001. The team selected components classified as ITS category B and C to determine if the component was classified in accordance with the guidance in NUREG/CR6407, Classification of Transportation Packaging and Dry Spent Fuel Storage System Components According to Importance to Safety, and the justification provided for the quality classification was appropriate.
1.3.2 Observation and Findings The team did not identify any discrepancies between the fabrication drawings and specification and the SAR licensing drawings. The team noted that SIMCO captured relevant requirements that were applicable to fabrication and that SIMCO fabrication drawings contained the relevant information needed for fabrication. The team also noted that SIMCO had adequate document control for the QA records reviewed.
No findings of significance were identified.
1.3.3 Conclusions The team determined, for the items selected for review that the fabrication specifications were consistent with the design commitments and requirements documented in the SAR and CoC.
1.4 Fabrication, Maintenance, and Testing 1.4.1 Inspection Scope The HalfPACT Type B package, CoC No. 719279, Revision 11, has been developed for the DOE for the transportation of contact-handled transuranic (CHTRU) materials and other authorized payloads. The packaging is comprised of an outer confinement assembly that provides a secondary confinement boundary, and an ICV that provides the containment boundary for CHTRU waste that is shipped within the packagings.
7 The team observed drawings, procedures, and records, and observed selected activities related to the ICV shell, ICV body, and ICV lid assemblies to determine if fabrication, assembly, and testing activities met SAR, Revision 9, dated October 2022, design commitments and requirements documented in CoC 719279. The team selected the ICV because it is an ITS category A assembly.
The team interviewed selected personnel and reviewed the fabrication specification and drawings against the licensing drawings to determine whether DOE CBFO, SIMCO, and Holtec implemented adequate instructions, requirements, and testing and acceptance criteria controls. The team reviewed the following documents:
TPHP-SPC0001, Specification for Fabrication of the TRUPACT-II and HalfPACT Type B Packaging, revision 0 Unit Serial No. 1 Travelers:
o 11089101A34001-A, ICV Body o
11089101A340021-A, Lower Dished Head o
11089101A2001021-A, Z-Flange, revision 0 o
11089101A200102, (Variation Request No. 1929), Z-Flange, revision 1 Unit Serial No. 2, Travelers:
o 11089101A34002-A, ICV Body o
11089101A340032-A, ICV Body Shell o
11089101A32002-A, ICV Lid Assembly HSP 100502, Standard and Project Procedures, revision 4 Nuclear Waste Partnership (NWP) Fabrication Drawings:
o TPHP-DWG3200, ICV Lid, revision 0 o
TPHP-DWG3400, ICV Body, revision 0 TPHP-QGR0001, Q-List and Quality Category Assessments for the TRUPACT-II
& HalfPACT Packages, revision 0 Specifically, the team observed activities such as welding, assembly, and nondestructive examination (NDE) of the ICV 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 reviewed and observed the following shop activities:
Gas tungsten arc welding (GTAW) of lower dished head (weld joint (WJ) 123) and flange (WJ 122) to ICV body shell (unit 2)
Dye penetrant testing (PT) and visual NDE of root pass lower dished head to ICV body shell (unit 2)
Radiographic testing (RT) film review of unit 1, ICV body assembly (WJs 123, 122 and 121 ICV body)
The team also reviewed the control of measuring and test equipment (M&TE) program to evaluate how Holtec 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 assembly and testing of the ICV. 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, welding machines, and a step-wedge film strip. The team
8 reviewed the calibration records to verify calibration dates, testing standards, and traceability of the associated M&TE. The team verified that personnel used M&TE within their rated capacities and sensitivities as documented in calibration records.
The team reviewed the following documents and records specific to welding, testing, NDE, and M&TE:
Welding Procedure Specification (WPS):
o WPS 47HC, manual Gas Tungsten Arc Welding, revision 8, dated October 4, 2018 o
WPS 76HC, semi-auto Gas Metal Arc Welding, revision 4, dated October 22, 2014 o
WPS 227, Machine Submersible Arc Welding, revision 4, dated August 8, 2016 o
Welder Performance Qualification (WPQ):
WPQ welder identification/stamp number 1116, GTAW WPQ welder identification/stamp number 1099, GTAW WPQ welder identification/stamp number 0829, GTAW NDE reports and Nondestructive Testing (NDT) certification records:
o RT report no. 11089101A6, lower dished head to ICV body (WJ 123), dated November 28, 2023 o
PT examination report no.: MTR11089101A22, WJ123 and flange to ICV body WJ 122, dated December 9, 2023 o
RT report no. 11089101A8, lower dished head to ICV body (WJ 123), dated March 5, 2024 o
RT report no. 11089101A-6, flange to ICV body (WJ 122), dated November 28, 2023 o
PT examination report no.: MTR11089101A23, flange to ICV body (WJ 122),
revision 1, dated January 3, 2023 o
RT report no. 11089101A-8, flange to ICV body (WJ 122), dated March 5, 2024 o
RT report no. 11089101A-8, ICV body (WJ 121), dated March 5, 2024 o
RT report no. 11089101A-8, body head filler plate to ICV body (WJ 120), dated March 5, 2024 o
NDT certification record nos.: 4029 and 2863 (PT) and 8121 (RT)
M&TE o
Densitometer, ID no. HD3, calibration due: May 22, 2024 o
Welding Machine, ID no. 111, calibration due: June 8, 2024 o
Light Meter, ID no. LM5, calibration due: January 12, 2025 o
Thermometer, ID no. TC125, calibration due: May 19, 2024 o
Thermocouple, ID no. TC155, calibration due: June 20, 2024 HSPs and Holtec Quality Procedures (HQPs) o HSP503, Visual Weld Examination (AWS D1.6), revision 0, dated February 17, 2023 o
HSP1105, Liquid Penetrant Examination (Solvent Removable Visible Dye),
revision 10, dated October 24, 2023 o
HSP1111, Procedure for the Fit-up and Alignment of Welded Joints, revision 4, dated April 14, 2022 o
HSP100902, Control of Welding Activities, revision 0, dated January 10, 2018 o
HSP101201, Control of Measuring and Test Equipment, revision 7, dated April 8, 2022
9 o
HSP101401, Inspection, Test, and Operating Status, revision 2, dated August 31, 2023 o
HQP10.0, Control of Inspection Activities, revision 9, dated January 18, 2018 o
HQP11.0, Test Control, revision 25, dated January 18, 2018 o
HQP12.0, Control of Measuring and Test Equipment, revision 29, dated January 18, 2018 1.4.2 Observation and Findings The team assessed that Holtec established appropriate means to control ICV fabrication activities and special processes for those activities observed. The team noted that Holtec implemented their QA manual, quality procedures, and special processes with qualified personnel, using approved procedures for assembly, welding, and testing. The team determined that Holtec provided the appropriate information on shop travelers in accordance with approved procedures, and the travelers identified applicable drawings, material specifications, work instructions, and procedures applicable to the manufacturing activity.
The team observed ICV welds were made in accordance with the applicable drawings using qualified procedures and qualified welding personnel and that welds were inspected by qualified personnel in accordance with the applicable drawing requirements. Further, welds were visually inspected in the completed condition for acceptance. The team noted that inspection and test results were documented in applicable fabrication travelers and/or inspection reports in accordance with quality procedures and that test results and inspection reports were traceable to the applicable ICV unit serial number.
The team also assessed Holtec established controls for the most part with M&TE in accordance with their quality standard procedure requirements, industry standards and regulatory requirements.
No findings of significance were identified.
1.4.3 Conclusions The team concluded, for the ITS components selected for observation and review that Holtec performed fabrication and testing in accordance with the HalfPACT SAR, written procedures, and specifications, as applicable.
In addition, Holtec personnel were familiar with the specified design, designated fabrication techniques, testing requirements, and quality control associated with the fabrication of the ICV components that met the HalfPACT SAR design commitments and requirements documented in the CoC.
1.5 Procurement 1.5.1 Inspection Scope The team reviewed processes and procedures that addressed procurement, including receipt inspection, traceability of material, and commercial grade dedication (CGD), as
10 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 SAR and CoC.
The team reviewed SIMCO and Holtec implementing procedures, receipt inspection records, purchase orders (POs), and sampled CGD packages for the ceramic fiber paper, form, and containment seals.
WP 09CN3040, Commercial Grade Item or Service Dedication, revision 8 WP13QA 1003, QA Receipt / Source Inspection, revision 31 WP13QA 3012, Supplier Evaluation / Qualification List, revision 26 WP13QA 3017, Visual and Dimensional Inspection of Type B Packaging Oring Seals, revision13 WP13QA 3019, Main Containment O-ring Batch Test, revision 15 GEN-SPC0002 HQP 4.0, Procurement Document Control, revision 0 HSP 100701, Receipt Inspection, Revision 9 PO - 700753 PO - 700730 PO - 517324 E1806, Supplier Audit E2106, Supplier Audit E2210, Supplier Audit CGD Plan No. 23014, revision 0 1.5.2 Observation and Findings Overall, the team assessed that SIMCO and Holtec had adequate controls of the procurement process for the ITS components selected and reviewed. The team determined for the most part that SIMCO and Holtec procured ITS components consistent with design requirements and their QA program implementing procedures. In general, SIMCO and Holtec purchased and applied controls over subcontractors and vendors currently on their qualified and approved suppliers list, respectively. The team assessed that SIMCO and Holtec had adequate controls over material traceability, procurement, and receipt inspection. Additionally, SIMCO and Holtec verified and maintained the traceability throughout the procurement and receipt process. The material ordered and received met the design requirements, and the items that Holtec dedicated met the critical characteristics upon the receipt and acceptance criteria developed for the ceramic fiber paper and form.
However, the team identified an issue with the procurement of ITS Orings from a subcontractor that was on the qualified suppliers list without a QA program consistent with the applicable provisions of 10 CFR Part 71, subpart H. The team noted in previous audits performed by a contractor that the subcontractor would supply the Orings as commercial grade items with certain restrictions placed within the supplier audit. The team observed that the Orings fabricated in 2021 and shipped to Holtec for installation into the HalfPACTs were procured without performing a CGD plan for the ITS category A Orings. The team noted that this did not meet NRC requirements for design and procurement controls. The team determined that although the fabricated Orings purchased in 2021 did not meet design and procurement controls requirements the
11 Orings had not been installed in any HalfPACTs. By letter dated May 8, 2024, (Agencywide Documents Access and Management System (ADAMS) Accession No. ML24142A512) the DOE CBFO issued a letter to the NRC stating that a corrective action report will be issued to SIMCO requesting development of a corrective action plan to address the above observations.
1.5.3 Conclusions The team determined for the most part that materials, components, and other equipment received by SIMCO and Holtec met design procurement specifications, and the procurement specifications conformed to the design commitments and requirements contained in the SAR and CoC. However, the team observed an instance where the Orings fabricated in 2021 for the HalfPACTs did not meet NRC requirements for design and procurement controls. Corrective actions are planned to be taken by DOE CBFO to correct the observations.
1.6 Nonconformance and Corrective Actions 1.6.1 Inspection Scope The team reviewed selected records and interviewed selected personnel to verify that nonconformance controls are effectively implemented for HalfPACT fabrication, and that corrective actions for identified deficiencies are technically sound and completed in a timely manner. The team reviewed the following procedures related to nonconformances and corrective actions:
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 WP 15PC3041, Approval/Variation Request Processing, revision 15 The team reviewed Holtecs nonconformance program to assess the effectiveness of controls established for the processing of nonconforming materials, parts, and components. Holtec procedure HSP101503 provides instructions for documenting, processing, and reporting of manufacturing conditions. Conditions Reports (CRs) are generated for potentially significant conditions adverse to quality. Nonconformance reports (NCRs) are generated for the most significant issues pertaining to safety significant items. Shop Fabrication Notes (SFNs) are used to document minor manufacturing related conditions. The team reviewed a sample of 12 SFNs and 3 CRs that had been generated as a result of HalfPACT packaging fabrication activities. The review focused on SFNs that were dispositioned as Use-AsIs" to determine if Holtec had justified their dispositions of the SFNs adequately.
The team also reviewed Holtecs CAP and reviewed one quality issue (QI) generated as a result of HalfPACT packaging fabrication activities. The QI was reviewed to determine whether Holtec completed corrective actions for identified deficiencies in a technically sound and timely manner.
12 Further, as a part of the procurement contract with SIMCO, Holtec is required to provide nonconformance reports for review and approval using the approval request/variation request (AR/VR) process. The team verified through a review of a sample of AR/VRs that Holtec provided SFNs to SIMCO as required. In addition, the team reviewed a sample of AR/VRs generated by SIMCO for nonconformances issued by a government furnished equipment vendor for ITS components supplied to Holtec by SIMCO.
1.6.2 Observation and Findings Overall, the team determined that Holtec had adequate nonconformance controls and CAP in place to identify, track, and resolve quality related deficiencies and deviations.
Nonconformances and corrective actions reviewed were appropriately dispositioned and resolved in a timely manner and in accordance with implementing procedures. In addition, SIMCO reviewed and approved contractor nonconformances to ensure appropriate actions were being taken to correct nonconformances during HalfPACT fabrication activities.
No findings of significance were identified.
1.6.3 Conclusions The team concluded that Holtec, with SIMCO oversight, effectively implemented its nonconformance program and CAP and has adequate procedures in place to ensure compliance to QA requirements for the HalfPACT packaging and were equivalent to NRCs 10 CFR Part 71 QA requirements.
1.7 Personnel Training and Quality Assurance Oversight 1.7.1 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.
Specifically, the team reviewed training and qualification records for selected Holtec employees that have performed NDE and welding activities to verify the personnel qualifications were adequate and current. The review also included lead auditors certifications and qualifications.
1.7.2 Observation and Findings The team noted NDE personnel performing visual weld, PT, and RT examinations were qualified in accordance with Holtecs quality procedures. In addition, the team noted that welding personnel were qualified per American Society of Mechanical Engineers, Boiler and Pressure Vessel Code,Section IX, as required by the HalfPACT SAR.
No findings of significance were identified.
13 1.7.3 Conclusions The team determined that Holtec had trained and qualified individuals performing activities affecting quality and that Holtec and SIMCO personnel provided appropriate oversight of quality related activities, as applicable.
1.8 Audit Program 1.8.1 Inspection Scope The team reviewed the audit programs to verify that SIMCO and Holtec scheduled, planned, and performed audits in accordance with their QA programs and associated implementing procedures. The team reviewed the audit results to determine if SIMCO and Holtec identified deficiencies and addressed these deficiencies within their CAP.
The team selected a sample of internal and external audits and interviewed personnel to verify that SIMCO and Holtec effectively implemented their audit program from 2018 to the present. The team reviewed lead auditors certifications and qualifications to conduct audits in accordance with approved procedures. In addition, the team reviewed the last two management reviews of the SIMCO QA program to determine whether SIMCO management performed the reviews as required and if the reviews were an effective tool to use for the overall health of the program. The team also reviewed external audits for suppliers of ITS materials, equipment, and services.
HQP18.0, Audits, revision 0 HSP101801, Certification of Audit Personnel, revision 1 HSP101802, Audits, revision 7 HSP101803, Internal QA Surveillance and Document Reviews, revision 0 WP 08PT.03, NWP 10 CFR Part 71, Subpart H Quality Assurance Program Plan, revision 14 WP 13QA.03, Quality Assurance Independent Assessment Program, revision 32 1.8.2 Observation and Findings Overall, the team assessed that for the audits sampled SIMCO and Holtec generally conducted audits with qualified and certified personnel, scheduled and evaluated applicable elements of their QA programs. The team noted that SIMCO and Holtec identified observations and findings as applicable within the audits and documented issues identified in accordance with the approved quality procedures. Additionally, the team noted that SIMCO and Holtec for the most part addressed the observations and findings identified within their CAP.
No findings of significance were identified.
1.8.3 Conclusions The team determined in general that SIMCO and Holtec performed internal and external (supplier) audits as scheduled of their QA program requirements for transportation packagings activities based on the audits selected for review. The team also determined
14 that SIMCO and Holtec resolved deficiencies, if identified in the audits, in a timely manner.
2.0 Entrance and Exit Meeting On March 12, 2024, the NRC inspection team discussed the scope of the inspection during an entrance meeting with DOE, SIMCO, and Holtec staff. On March 14, 2024, the NRC inspection team discussed the preliminary results and observations during an onsite debrief meeting with DOE, SIMCO, and Holtec staff. The team continued the inspection activities with an inoffice review of additional information related to procurement. The team completed the inspection activities on April 8, 2024, and held an exit meeting on April 16, 2024, with DOE and SIMCO staff. Section 1 of the attachment to this report shows the attendance for the entrance, debrief, and exit meetings.
Attachment ATTACHMENT 1.
ENTRANCE/EXIT MEETING ATTENDEES AND INDIVIDUALS INTERVIEWED Name Title Affiliation Entrance Debrief Exit Jeremy Tapp Inspection Team Leader NRC X
X X
Earl Love Inspector NRC X
X Marlone Davis Inspector NRC X
X X
Gang Zhao Structural Engineer NRC X
X DaBrisha Smith NTP Packaging Manager DOE CBFO X
X Jason Biesecker QA Program Manager DOE X
X Todd Sellmer Manager for Packaging
& Information Systems SIMCO X
Steve McGonagill Cognizant Engineer SIMCO X
X X
Camille Allred Quality Assurance Manager SIMCO X
Veronica Ballew QA Programs Manager SIMCO X
Jason Mayse WIPP QA Programs SIMCO X
X X
Steven Boyd Quality Engineer SIMCO X
X Steve Tanner Quality Engineer SIMCO X
X Mark Soler Vice President Quality Holtec X
X Brock Peltier Corporate Quality Manager Holtec X
X Bronson Resh Project Manager Holtec X
X Trent Tutko Alternate Project Manager Holtec X
X Jeffrey Surmacz Quality Manager Holtec X
X Rick Rothrauff Director of Manufacturing Holtec X
X Jason Reglin Product Lifecycle Manager Holtec X
X Lee Solada Senior Director Manufacturing Holtec X
Vaughn Curcio Director of Quality Manufacturing Holtec X
2.
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 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 AR/VR Approval Request/Variation Request CAP Corrective Action Program CBFO Carlsbad Field Office CGD Commercial Grade Dedication CHTRU Contact-handled Transuranic CoC Certificate of Compliance CR Condition Report DOE U.S. Department of Energy GTAW Gas Tungsten Arc Welding HMD Holtec Manufacturing Division Holtec Holtec Government Services, LLC HQP Holtec Quality Procedure HSP Holtec Standard Procedure ICV Inner Containment Vessel IMC Inspection Manual Chapter IP Inspection Procedure ITS Important to Safety M&TE Measuring and Test Equipment NCR Nonconformance Report NDE Nondestructive Examination NDT Nondestructive Testing NRC U.S. Nuclear Regulatory Commission NWP Nuclear Waste Partnership PDR Public Document Room PO Purchase Order PT Dye Penetrant Testing QA Quality Assurance QI Quality Issue RT Radiographic Testing SAR Safety Analysis Report SFN Shop Fabrication Note SIMCO Salado Isolation Mining Contractors WIPP Waste Isolation Pilot Plant WJ Weld Joint WP WIPP Procedure WPQ Welder Performance Qualification WPS Weld Procedure Specification 5.
DOCUMENTS REVIEWED Documents reviewed during the inspection were specifically identified in the Report Details above.