ML23012A331: Difference between revisions
StriderTol (talk | contribs) (StriderTol Bot insert) |
StriderTol (talk | contribs) (StriderTol Bot change) |
||
Line 16: | Line 16: | ||
=Text= | =Text= | ||
{{#Wiki_filter:UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 205550001 | {{#Wiki_filter:UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 205550001 Brad Greene Vice President of Quality NAC International, Inc. | ||
3930 East Jones Bridge Rd., Suite 200 Peachtree Corners, GA 30092 | 3930 East Jones Bridge Rd., Suite 200 Peachtree Corners, GA 30092 | ||
Line 23: | Line 23: | ||
==Dear Brad Greene:== | ==Dear Brad Greene:== | ||
On August 9, 2022, through August 11, 2022, the U.S. Nuclear Regulatory Commission (NRC) conducted an announced onsite team inspection at Joseph Oat Corporation (JOC) in Camden, New Jersey. JOC is under contract with N.A.C. International, Incorporated (NAC) to fabricate components associated with the Optimal Modular Universal Shipping Cask (OPTIMUS), Version L Certificate of Compliance (CoC) Number (No.) 9390. The inspection team continued the inspection activities with an in-office review while the team waited for NAC to complete a root cause analysis for a failure to notify the NRC in advance of starting fabrication activities on the first OPTIMUS-L package for use in the United States. The enclosed report presents the results of this inspection. The team discussed the preliminary results of this inspection with you and other NAC representatives on August 11, 2022, and November 17, 2022, and completed the inspection activities on November 27, 2022. | On August 9, 2022, through August 11, 2022, the U.S. Nuclear Regulatory Commission (NRC) conducted an announced onsite team inspection at Joseph Oat Corporation (JOC) in Camden, New Jersey. JOC is under contract with N.A.C. International, Incorporated (NAC) to fabricate components associated with the Optimal Modular Universal Shipping Cask (OPTIMUS), Version L Certificate of Compliance (CoC) Number (No.) 9390. The inspection team continued the inspection activities with an in-office review while the team waited for NAC to complete a root cause analysis for a failure to notify the NRC in advance of starting fabrication activities on the first OPTIMUS-L package for use in the United States. The enclosed report presents the results of this inspection. The team discussed the preliminary results of this inspection with you and other NAC representatives on August 11, 2022, and November 17, 2022, and completed the inspection activities on November 27, 2022. | ||
The purpose of the inspection was to verify and assess the adequacy of activities related to the design, fabrication, assembly, testing, procurement, repair, and any modification and maintenance for transportation packaging of radioactive material to determine if NAC and its contractor 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 purpose of the inspection was to verify and assess the adequacy of activities related to the design, fabrication, assembly, testing, procurement, repair, and any modification and maintenance for transportation packaging of radioactive material to determine if NAC and its contractor 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 that the transportation packaging is safe to use and in accordance with the commitments and requirements specified in the safety analysis report for packaging, and NACs NRC-approved quality assurance program requirements. | The inspection scope included observations of fabrication activities, documentation reviews, and interviews with personnel to determine that the transportation packaging is safe to use and in accordance with the commitments and requirements specified in the safety analysis report for packaging, and NACs NRC-approved quality assurance program requirements. | ||
Based on the results of this inspection, the NRC inspection team determined that two Severity Level IV violations of NRC requirements occurred. The NRC is treating these violations as Non-Cited Violations (NCVs), which is consistent with section 2.3.2 of the Enforcement Policy. The NRC inspection team describe these NCVs in the enclosed inspection report. | Based on the results of this inspection, the NRC inspection team determined that two Severity Level IV violations of NRC requirements occurred. The NRC is treating these violations as Non-Cited Violations (NCVs), which is consistent with section 2.3.2 of the Enforcement Policy. The NRC inspection team describe these NCVs in the enclosed inspection report.January 19, 2023 B. Greene 2 If you contest these violations, you should provide a response within 30 days of the date of this inspection report, with the basis for your denial, to the Nuclear Regulatory Commission, ATTN: | ||
B. Greene | |||
Document Control Desk, Washington DC 205550001, with copies to: (1) the Director, Office of Nuclear Materials Safety and Safeguards; and (2) the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, DC 205550001. | Document Control Desk, Washington DC 205550001, with copies to: (1) the Director, Office of Nuclear Materials Safety and Safeguards; and (2) the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, DC 205550001. | ||
This letter, its enclosure, and your response (if any) will be made available for public inspection and copying at http://www.nrc.gov/reading-rm/adams.html and at the NRC Public Document Room in accordance with 10 CFR 2.390, Public Inspections, Exemptions, Requests for Withholding. | This letter, its enclosure, and your response (if any) will be made available for public inspection and copying at http://www.nrc.gov/reading-rm/adams.html and at the NRC Public Document Room in accordance with 10 CFR 2.390, Public Inspections, Exemptions, Requests for Withholding. | ||
Sincerely, | Sincerely, Aida Rivera-Varona, Chief Inspection and Oversight Branch Division of Fuel Management Office of Nuclear Material Safety and Safeguards Docket No. 719390 | ||
==Enclosure:== | ==Enclosure:== | ||
NRC Inspection Report No. | |||
719390/2022201 Signed by Rivera-Varona, Aida on 01/19/23 | |||
ML23012A331 C = COVER E = COVER & ENCLOSUREN = NO COPY *via email OFFICE DFM DFM DFM NAME MDavis WWheatley ARivera-Varona DATE 1/9/2023 1/17/2023 1/19/2023 U.S. NUCLEAR REGULATORY COMMISSION Office of Nuclear Material Safety and Safeguards Division of Fuel Management | |||
719390/2022201 | |||
Docket: 719390 | |||
Report.: 719390/2022201 | |||
Enterprise Identifier: I2022201-0034 | |||
Certificate Holder: NAC International, Incorporated | |||
Facility: Joseph Oat Corporation | |||
Location: Camden, New Jersey | |||
Inspection Dates: August 9, 2022, through November 27, 2022 | |||
Inspection Team: Marlone Davis, Senior Transportation and Storage Safety Inspector, Team Leader Earl Love, Senior Transportation and Storage Safety Inspector | |||
Approved By: Aida Rivera-Varona, Branch Chief Inspection and Oversight Branch Division of Fuel Management Office of Nuclear Material Safety and Safeguards | |||
Enclosure U.S. NUCLEAR REGULATORY COMMISSION Office of Nuclear Material Safety and Safeguards Division of Fuel Management | |||
EXECUTIVE | |||
==SUMMARY== | ==SUMMARY== | ||
NAC International, Inc. | |||
NRC Inspection Report 719390/2022201 | |||
On August 9, 2022, through August 11, 2022, the U.S. Nuclear Regulatory Commission (NRC) conducted an announced onsite team inspection at Joseph Oat Corporation (JOC) in Camden, New Jersey. JOC is under contract with NAC International, Inc. (NAC) to fabricate components associated with the Optimal Modular Universal Shipping Cask (OPTIMUS), Version L transportation packaging certificate of compliance (CoC) docket number (No.) 71-9390. The inspection team continued the inspection activities with an in-office review while the team waited for NAC to complete a root cause analysis for a failure to notify the NRC in advance of starting fabrication activities on the first OPTIMUS-L transportation package for use in the United States. | |||
The team discussed the preliminary results of this inspection on August 11, 2022, and November 17, 2022, and completed the inspection activities on November 27, 2022. | The team discussed the preliminary results of this inspection on August 11, 2022, and November 17, 2022, and completed the inspection activities on November 27, 2022. | ||
The purpose of the inspection was to verify and assess the adequacy of activities related to the design, fabrication, assembly, testing, procurement, repair, and any modification and maintenance for transportation packaging of radioactive material to determine if NAC and its contractor 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 purpose of the inspection was to verify and assess the adequacy of activities related to the design, fabrication, assembly, testing, procurement, repair, and any modification and maintenance for transportation packaging of radioactive material to determine if NAC and its contractor 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. | ||
Fabrication The team determined, for the items selected for observation and review that the fabricator conducted fabrication and test activities consistent with fabrication specification that met the SAR and the transportation packaging CoC No. 9390. However, the team noted that NAC did not notify the NRC, in accordance with 10 CFR 71.1, 45 days in advance of starting fabrication of the first packaging under a CoC. Specifically, NAC failed to notify the NRC 45 days prior to starting fabrication of the OPTIMUS-L CoC No. 9390 as required in 10 CFR 71.93(c). (section 1.4) | Quality Assurance Program | ||
Assembly and Testing The team determined, for the items selected for observation and review that the fabricator performed fabrication assembly and testing in accordance with approved methods, procedures, and specifications except when the team identified one Severity Level IV violation of 10 CFR 72.125, Control of measuring and test equipment because a step-wedge film strip used to interpret film was past the 12 month calibration period required by a quality standard procedure. (section 1.5) | |||
Procurement The team determined that materials, components, and other equipment received by the fabricator met the procurement specifications, and the specifications conform to the design commitments and requirements contained in the SAR and CoC. (section 1.6) | The team determined that JOC (fabricator) conducted quality related activities on the transportation packaging in accordance with the CoC, as well as their Quality Assurance Manual (QAM), and had effective implementing procedures in place. (section 1.1) | ||
Non-Conformance and Corrective Action The team determined that the fabricator effectively implemented nonconformance and corrective action control programs and has adequate procedures in place to ensure compliance with the applicable regulations and quality assurance requirements. (section 1.7) | |||
Personnel Training and Quality Assurance Oversight The team determined that the fabricator properly trained and qualified individuals performing activities affecting quality and Management and quality assurance staff provided appropriate oversight. (section 1.8) | 10 CFR Part 21 | ||
Audit Program The team determined that NAC and the fabricator performed audits as scheduled of their QA programs and activities affecting the safety aspects of the transportation packaging and resolved deficiencies if identified in a timely manner. (section 1.9) 3 | |||
The team determined that the fabricator conducted fabrication activities under a quality assurance (QA) program that had provisions in place for reporting defects which could cause a substantial safety hazard, as required by 10 CFR Part 21. The team noted that the fabricator's personnel were familiar with the reporting requirements of 10 CFR Part 21 and the fabricator complied with 10 CFR 21.6, "Posting requirements." (section 1.2) | |||
Design Control | |||
The team determined that for the items selected for review that NAC implemented adequate design control measures. The procurement/fabrication specification was consistent with the design commitments and requirements documented in the SAR and the transportation packaging CoC No. 9390. (section 1.3) | |||
2 Fabrication | |||
The team determined, for the items selected for observation and review that the fabricator conducted fabrication and test activities consistent with fabrication specification that met the SAR and the transportation packaging CoC No. 9390. However, the team noted that NAC did not notify the NRC, in accordance with 10 CFR 71.1, 45 days in advance of starting fabrication of the first packaging under a CoC. Specifically, NAC failed to notify the NRC 45 days prior to starting fabrication of the OPTIMUS-L CoC No. 9390 as required in 10 CFR 71.93(c). (section 1.4) | |||
Assembly and Testing | |||
The team determined, for the items selected for observation and review that the fabricator performed fabrication assembly and testing in accordance with approved methods, procedures, and specifications except when the team identified one Severity Level IV violation of 10 CFR 72.125, Control of measuring and test equipment because a step-wedge film strip used to interpret film was past the 12 month calibration period required by a quality standard procedure. (section 1.5) | |||
Procurement | |||
The team determined that materials, components, and other equipment received by the fabricator met the procurement specifications, and the specifications conform to the design commitments and requirements contained in the SAR and CoC. (section 1.6) | |||
Non-Conformance and Corrective Action | |||
The team determined that the fabricator effectively implemented nonconformance and corrective action control programs and has adequate procedures in place to ensure compliance with the applicable regulations and quality assurance requirements. (section 1.7) | |||
Personnel Training and Quality Assurance Oversight | |||
The team determined that the fabricator properly trained and qualified individuals performing activities affecting quality and Management and quality assurance staff provided appropriate oversight. (section 1.8) | |||
Audit Program | |||
The team determined that NAC and the fabricator performed audits as scheduled of their QA programs and activities affecting the safety aspects of the transportation packaging and resolved deficiencies if identified in a timely manner. (section 1.9) | |||
3 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 NRC inspection team reviewed the fabricators QAM and associated implementing procedures to verify that the fabricator was conducting fabrication, assembly, testing, repair, and procurement activities in accordance with the SAR and transportation packaging CoC No. 9390. The team reviewed the fabricators QAM, JOC QAM, Revision 33 and applicable implementing standard procedures (SPs). This review also included SP-1548, QA Manual and Procedure Revisions, Revision 5. | |||
1.1.2 Observation and Findings | |||
The team assessed that the fabricator has an adequate QA program that included applicable implementing procedures in place to conduct effective quality activities in accordance with the transportation packaging SAR, CoC, and 10 CFR Parts 21 and 71 requirements. The team also verified that the fabricator clearly defined and documented the quality program authorities and responsibilities and that the quality assurance organization functioned as an independent group as described in fabricators QAM. | |||
No findings were identified. | No findings were identified. | ||
CFR Part 21. The team noted that the 10 CFR Part 21 posting at the fabricators facility met the applicable requirements of 10 CFR Part 21. | 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 QAM, and had effective implementing procedures in place. | |||
1.2 10 CFR Part 21 | |||
1.2.1 Inspection Scope | |||
The team reviewed the 10 CFR Part 21 standard procedures, SP-1552, Reporting Defects and Noncompliances (10CFR21), Revision 7 and SP-1552-1, Procedure for Passing Down 10CFR21 To Suppliers, Revision 0 to verify if provisions were in place for reporting defects that could cause a substantial safety hazard and to complete the required notification in a timely manner. The team requested a list of 10 CFR Part 21 evaluations and notifications associated with the fabrication activities and interviewed personnel to verify if they were familiar with the implementing procedure. The team also verified if the fabricator complied with 10 CFR 21.6, Posting requirements. | |||
1.2.2 Observation and Findings | |||
The team assessed that the fabricator has provisions in place for evaluating deviations and reporting defects that could cause a substantial safety hazard, as required by 10 | |||
4 CFR Part 21. The team noted that the 10 CFR Part 21 posting at the fabricators facility met the applicable requirements of 10 CFR Part 21. | |||
No findings were identified. | 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 | 1.2.3 Conclusions | ||
NAC Specification Document No. 70000.14-S-04, Procurement/Fabrication Specification, OPTIMUS-L Outer Packaging Revision 1 SP-1510, Document Control, Revision 6 In addition, the team evaluated the design controls that were in place for the transmittal and handling of engineering/design drawings received from NAC and how the fabricator used the engineering drawing in fabrication, as applicable. This evaluation included the process for distributing controlled engineering and fabrication drawings. | |||
1.3.2 Observation and Findings Based on the teams review, there were no unexplained discrepancies between the design and fabrication activities including the engineering and fabrication drawings. | 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 NAC and the fabricator 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 specification were consistent with the design. Specifically, the team focused on the translation of design commitments and requirements for the important-to-safety (ITS) category A, B, and C components of the OPTIMUS-L and design specifications, including associated licensing drawings, 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: | |||
NAC Specification Document No. 70000.14-S-04, Procurement/Fabrication Specification, OPTIMUS-L Outer Packaging Revision 1 SP-1510, Document Control, Revision 6 | |||
In addition, the team evaluated the design controls that were in place for the transmittal and handling of engineering/design drawings received from NAC and how the fabricator used the engineering drawing in fabrication, as applicable. This evaluation included the process for distributing controlled engineering and fabrication drawings. | |||
1.3.2 Observation and Findings | |||
Based on the teams review, there were no unexplained discrepancies between the design and fabrication activities including the engineering and fabrication drawings. | |||
The team noted that the fabricator captured all requirements reviewed from the purchase order (PO) and procurement/fabrication specification associated with the design and fabrication of the OPTIMUS-L. The team also discovered that the fabricator did not provide any design engineering services. | The team noted that the fabricator captured all requirements reviewed from the purchase order (PO) and procurement/fabrication specification associated with the design and fabrication of the OPTIMUS-L. The team also discovered that the fabricator did not provide any design engineering services. | ||
No findings were identified. | No findings were identified. | ||
1.3.3 Conclusions The team determined that for the items selected for review that NAC implemented adequate design control measures and interfaced with the fabricator to provide adequate design control. The procurement/fabrication specification was consistent with the design commitments and requirements documented in the SAR and the transportation packaging CoC No. 9390. | 5 1.3.3 Conclusions | ||
1.4 | |||
The team determined that for the items selected for review that NAC implemented adequate design control measures and interfaced with the fabricator to provide adequate design control. The procurement/fabrication specification was consistent with the design commitments and requirements documented in the SAR and the transportation packaging CoC No. 9390. | |||
1.4 Fabrication | |||
1.4.1 Inspection Scope | |||
The team reviewed selected drawings, procedures, and records, and observed selected activities related to the OPTIMUS-L cask containment vessel (CCV) to determine if the fabrication, testing, and maintenance activities met SAR design commitments and requirements documented in the CoC. The team selected the CCV because it was an ITS category A component. The team reviewed the following documents: | |||
Welding Procedure Specification No. PS 8303, Revision 32 Traveler ITP-2753-2-Main Procedure No. QC-2744-10, Liquid Penetrate Examination Solvent Removable, Revision 1 Drawing Nos.: D12929.01, CCV Assembly, Revision 0 and D12929.03, CCV Body Weldment, Revision 0. | Welding Procedure Specification No. PS 8303, Revision 32 Traveler ITP-2753-2-Main Procedure No. QC-2744-10, Liquid Penetrate Examination Solvent Removable, Revision 1 Drawing Nos.: D12929.01, CCV Assembly, Revision 0 and D12929.03, CCV Body Weldment, Revision 0. | ||
NAC Procurement/Fabrication Specification No. 70000.14-S-04, Revision 1 1.4.2 Observation and Findings Based on the sample selected, the team assessed that the fabricator established appropriate means to control the OPTIMUS-L CCV fabrication activities and special processes that met the SAR design commitments and requirements documented in the CoC. The team examined NACs 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 activity. However, the team noted that NAC did not notify the NRC, in accordance with 10 CFR 71.1, 45 days in advance of starting fabrication of the first packaging for use in the United States under the CoC Docket No. | NAC Procurement/Fabrication Specification No. 70000.14-S-04, Revision 1 | ||
1.4.2 Observation and Findings | |||
Based on the sample selected, the team assessed that the fabricator established appropriate means to control the OPTIMUS-L CCV fabrication activities and special processes that met the SAR design commitments and requirements documented in the CoC. The team examined NACs 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 activity. However, the team noted that NAC did not notify the NRC, in accordance with 10 CFR 71.1, 45 days in advance of starting fabrication of the first packaging for use in the United States under the CoC Docket No. | |||
71-9390. NAC placed the fabrication order of the first packaging for use in the United States in August 2021 and completed fabrication activities on July 2022 prior to notifying the NRC. | 71-9390. NAC placed the fabrication order of the first packaging for use in the United States in August 2021 and completed fabrication activities on July 2022 prior to notifying the NRC. | ||
The team determined this was a violation of 10 CFR 71.93(c), Inspection and tests, which requires, in part, that the certificate holder shall notify NRC, in accordance with 10 CFR 71.1, 45 days in advance of starting fabrication of the first packaging under a CoC. | The team determined this was a violation of 10 CFR 71.93(c), Inspection and tests, which requires, in part, that the certificate holder shall notify NRC, in accordance with 10 CFR 71.1, 45 days in advance of starting fabrication of the first packaging under a CoC. | ||
This paragraph applies to any packaging used for the shipment of licensed material which either (1) A decay heat load in excess of 5 kW; or A maximum normal operating pressure in excess of 103kPa (15-pound force/per square inch). | This paragraph applies to any packaging used for the shipment of licensed material which either (1) A decay heat load in excess of 5 kW; or A maximum normal operating pressure in excess of 103kPa (15-pound force/per square inch). | ||
Contrary to the above, prior to July 2022, the certificate holder (NAC) did not notify the NRC, in accordance with 10 CFR 71.1, 45 days in advance of starting fabrication of the first packaging under a CoC. Specifically, NAC missed opportunities to notify the NRC of fabrication activities prior to completion of the first packaging for use in the United States under the CoC Docket No. 71-9390. This paragraph applies to the OPTIMUS-L transportation packaging because it has a maximum normal operating pressure more than 103kPa. NAC self-identified the violation and performed a root cause analysis to determine the cause of the violation. | 6 Contrary to the above, prior to July 2022, the certificate holder (NAC) did not notify the NRC, in accordance with 10 CFR 71.1, 45 days in advance of starting fabrication of the first packaging under a CoC. Specifically, NAC missed opportunities to notify the NRC of fabrication activities prior to completion of the first packaging for use in the United States under the CoC Docket No. 71-9390. This paragraph applies to the OPTIMUS-L transportation packaging because it has a maximum normal operating pressure more than 103kPa. NAC self-identified the violation and performed a root cause analysis to determine the cause of the violation. | ||
The team assessed the significance of the violation using the NRC Enforcement Policy and Enforcement Manual. The team dispositioned the violation using the traditional enforcement process in section 2.3 of the Enforcement Policy. The team determined that the violation impacted the ability of the NRC to perform its regulatory oversight function because NAC did not comply with notification requirements. The team determined that the violation was of more-than-minor safety significance because NAC knew of the information and did not recognize that this information required notification to the NRC which did not allow NRC to conduct inspection activities of a new fabricator. The team characterized the violation as a Severity Level IV violation in accordance with the NRCs Enforcement Policy, section 6.9. NAC entered the issue into its corrective action program (CAP) under corrective action report (CAR) No. 22-03. Because this violation was of low safety significance and was entered into NACs CAP, and the issue was not repetitive or willful, it is being treated as a non-cited violation (NCV), consistent with section 2.3.2.a of the Enforcement Policy. (71-9390/2022-201-01) 1.4.3 Conclusions The team determined that the offsite fabricator's personnel were familiar with the specified design, designated fabrication techniques, testing requirements, and quality control associated with the fabrication of the OPTIMUS-L packaging that met packaging SAR design commitments and requirements documented in the CoC. However, NAC failed to notify the NRC 45 days prior to starting fabrication of the OPTIMUS-L CoC Docket No. 71-9390 as required in 10 CFR 71.93(c). | |||
1.5 | The team assessed the significance of the violation using the NRC Enforcement Policy and Enforcement Manual. The team dispositioned the violation using the traditional enforcement process in section 2.3 of the Enforcement Policy. The team determined that the violation impacted the ability of the NRC to perform its regulatory oversight function because NAC did not comply with notification requirements. The team determined that the violation was of more-than-minor safety significance because NAC knew of the information and did not recognize that this information required notification to the NRC which did not allow NRC to conduct inspection activities of a new fabricator. The team characterized the violation as a Severity Level IV violation in accordance with the NRCs Enforcement Policy, section 6.9. NAC entered the issue into its corrective action program (CAP) under corrective action report (CAR) No. 22-03. Because this violation was of low safety significance and was entered into NACs CAP, and the issue was not repetitive or willful, it is being treated as a non-cited violation (NCV), consistent with section 2.3.2.a of the Enforcement Policy. (71-9390/2022-201-01) | ||
Gas Tungsten Arc Welding of a flange to shell root pass on the CCV Liquid Penetration and Visual NDE of the CCV root pass Radiography of the CCV Shell The team reviewed the following quality standard procedures: | |||
7 | 1.4.3 Conclusions | ||
The team determined that the offsite fabricator's personnel were familiar with the specified design, designated fabrication techniques, testing requirements, and quality control associated with the fabrication of the OPTIMUS-L packaging that met packaging SAR design commitments and requirements documented in the CoC. However, NAC failed to notify the NRC 45 days prior to starting fabrication of the OPTIMUS-L CoC Docket No. 71-9390 as required in 10 CFR 71.93(c). | |||
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 CCV to verify that the fabricator 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 activities: | |||
Gas Tungsten Arc Welding of a flange to shell root pass on the CCV Liquid Penetration and Visual NDE of the CCV root pass Radiography of the CCV Shell | |||
The team reviewed the following quality standard procedures: | |||
7 SP-1515, Welding, Revision 1 SP-1516, Nondestructive Examination, Revision 1 SP-1580, Procedure for Documenting Inspection and Testing, Revision 0 | |||
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 QAM, implementing standard procedures, and regulatory requirements. Specifically, the team reviewed the following quality standard procedures: | |||
SP-1501, Procedure for Calibration and Periodic Checks of ID Micrometers (3 Point) and Tube ID Gages, Revision 4 SP-1504, Calibration of Welding Machine Meters, Revision 8 SP-1508, Calibration of Densitometer and Step-Wedge Film Strips, Revision 3 SP-1509, Storage Location of Calibrated Equipment, Revision 2 SP-1519, Calibration of Standards and Miscellaneous Items, Revision 23 | |||
The team selected a sample of the M&TE used during the assembly and testing of the OPTIMUS-L packaging. The sample included a review of travelers that identified the use of specific M&TE that the team selected such as a light meter, temperature gun, welding machine #257, and a step-wedge film strip. 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 the fabricator established appropriate means to control OPTIMUS-L CCV Base and Lid fabrication activities and special processes for the most part. The team noted that the fabricator implemented their QA manual, standard procedures, and special processes with qualified personnel, using approved procedures for assembly, welding, and testing. | |||
The team also assessed that the fabricator provided the appropriate information on shop travelers in accordance with approved procedures. The team verified that personnel used M&TE within their rated capacities and sensitivities as documented in calibration records. The team also assessed that the fabricator established controls for the most part with M&TE in accordance with their quality standard procedure requirements, industry standards and regulatory requirements except in one instance. | The team also assessed that the fabricator provided the appropriate information on shop travelers in accordance with approved procedures. The team verified that personnel used M&TE within their rated capacities and sensitivities as documented in calibration records. The team also assessed that the fabricator established controls for the most part with M&TE in accordance with their quality standard procedure requirements, industry standards and regulatory requirements except in one instance. | ||
The team observed that the calibration step-wedge film strip was past the 12-month calibration / replacement period as required in section 2.3 of SP-1508, revision 3. The step-wedge film strip had a date of 12-21-2020 but a QC inspector arranged for the replacement to occur on 12-21-2022. The team noted that the fabricator used this step-wedge film strip to interpret radiographs of the CCV Shell while it was outside its calibration period. However, there was no nonconformance report or corrective action report to identify this issue. | The team observed that the calibration step-wedge film strip was past the 12-month calibration / replacement period as required in section 2.3 of SP-1508, revision 3. The step-wedge film strip had a date of 12-21-2020 but a QC inspector arranged for the replacement to occur on 12-21-2022. The team noted that the fabricator used this step-wedge film strip to interpret radiographs of the CCV Shell while it was outside its calibration period. However, there was no nonconformance report or corrective action report to identify this issue. | ||
devices used in activities affecting quality are properly controlled, calibrated, and adjusted at specified times to maintain accuracy within necessary limits. | The team determined this was a violation of 10 CFR 71.125, Control of measuring and test equipment, which requires, in part, that the certificate holder shall establish measures to assure that tools, gauges, instruments, and other measuring and testing | ||
8 devices used in activities affecting quality are properly controlled, calibrated, and adjusted at specified times to maintain accuracy within necessary limits. | |||
Contrary to the above, prior to the certificate holder (NAC) did not establish measures to assure that tools, gauges, instruments, and other measuring and testing devices used in activities affecting quality are properly controlled, calibrated, and adjusted at specified times to maintain accuracy within necessary limits. Specifically, NAC oversight of fabrication activities at JOC did not establish measures to assure that the step-wedge film strip used in interpreting film of the CCV shell weld was within the 12-month calibration / replacement period as required in section 2.3 of SP-1508, revision 3 to maintain accuracy within the necessary limits. At the time when the team discovered this issue, the step-wedge film strip had not been retested and called into question the results of previous tests including radiograph of the CCV shell weld. | Contrary to the above, prior to the certificate holder (NAC) did not establish measures to assure that tools, gauges, instruments, and other measuring and testing devices used in activities affecting quality are properly controlled, calibrated, and adjusted at specified times to maintain accuracy within necessary limits. Specifically, NAC oversight of fabrication activities at JOC did not establish measures to assure that the step-wedge film strip used in interpreting film of the CCV shell weld was within the 12-month calibration / replacement period as required in section 2.3 of SP-1508, revision 3 to maintain accuracy within the necessary limits. At the time when the team discovered this issue, the step-wedge film strip had not been retested and called into question the results of previous tests including radiograph of the CCV shell weld. | ||
The team assessed the significance of the violation using the NRC Enforcement Policy and Enforcement Manual. The team dispositioned the violation using the traditional enforcement process in section 2.3 of the Enforcement Policy. The team determined that the violation was of more-than-minor safety significance because it was similar to examples contained in Inspection Manual chapter 0617, Vendor and Quality Assurance Implementation Inspection Reports, appendix E, Minor Examples of Vendor and QA Implementation Findings, Examples 13.b, 13.c. and 13.d. The team characterized the violation as a Severity Level IV violation in accordance with the NRCs Enforcement Policy. JOC entered the issue into its CAP under CAR No. 414. The team assessed that because this violation was of low safety significance and was entered into the fabricators CAP, and the issue was not repetitive or willful, it is being treated as an NCV, consistent with section 2.3.2.a of the Enforcement Policy. (71-9390/2022-201-02) 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 packaging SAR and CoC. | |||
1.6 | The team assessed the significance of the violation using the NRC Enforcement Policy and Enforcement Manual. The team dispositioned the violation using the traditional enforcement process in section 2.3 of the Enforcement Policy. The team determined that the violation was of more-than-minor safety significance because it was similar to examples contained in Inspection Manual chapter 0617, Vendor and Quality Assurance Implementation Inspection Reports, appendix E, Minor Examples of Vendor and QA Implementation Findings, Examples 13.b, 13.c. and 13.d. The team characterized the violation as a Severity Level IV violation in accordance with the NRCs Enforcement Policy. JOC entered the issue into its CAP under CAR No. 414. The team assessed that because this violation was of low safety significance and was entered into the fabricators CAP, and the issue was not repetitive or willful, it is being treated as an NCV, consistent with section 2.3.2.a of the Enforcement Policy. (71-9390/2022-201-02) | ||
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 packaging SAR and CoC. | |||
1.6 Procurement Control | |||
1.6.1 Inspection Scope | |||
The inspectors reviewed the fabricator's processes that addressed procurement, including receipt inspection, traceability of material, and commercial grade dedication. | |||
The team reviewed selected drawings and records and interviewed selected personnel to verify that NACs procurement specification for materials, fabrication, and inspection performed at the fabricators facility met design commitments and requirements contained in the packaging SAR and CoC No. 9390. The team reviewed procedures, sampled POs, receipt inspection records and commercial grade dedication reports specific to ITS Category A components that make up containment of the OPTIMUS-L. | The team reviewed selected drawings and records and interviewed selected personnel to verify that NACs procurement specification for materials, fabrication, and inspection performed at the fabricators facility met design commitments and requirements contained in the packaging SAR and CoC No. 9390. The team reviewed procedures, sampled POs, receipt inspection records and commercial grade dedication reports specific to ITS Category A components that make up containment of the OPTIMUS-L. | ||
The following is a list of procurement documents reviewed for the CCV Base Plate and CVV Lid: | The following is a list of procurement documents reviewed for the CCV Base Plate and CVV Lid: | ||
CCV Base Plate and Shell PO No. 071230, CCV Base Plate and Shell, dated 03/11/2022 JOC ASME Upgrade CoC No. J-2753-2, dated 05/9/22 and 5/11/2022 Laboratory Test Reports, dated 04/29/2022 JOC Reports of Ultrasonic Examination, dated 04/30/2022 Material Supplier Metallurgical Test Report, dated 07/07/20 (Base Plate) | 9 CCV Base Plate and Shell PO No. 071230, CCV Base Plate and Shell, dated 03/11/2022 JOC ASME Upgrade CoC No. J-2753-2, dated 05/9/22 and 5/11/2022 Laboratory Test Reports, dated 04/29/2022 JOC Reports of Ultrasonic Examination, dated 04/30/2022 Material Supplier Metallurgical Test Report, dated 07/07/20 (Base Plate) | ||
Material Supplier Certified Material Test Report (CMTR), dated 10/31/2021 (Shell) | Material Supplier Certified Material Test Report (CMTR), dated 10/31/2021 (Shell) | ||
CCV Lid PO 071227, CCV Lid, dated 03/11/2022, JOC ASME Upgrade CoC No. J-2753-2, dated 05/9/22 Laboratory Test Report, JOC acceptance dated 05/09/2022 JOC Reports of Ultrasonic Examination, dated 04/28/2022 Material Supplier Certificate of Compliance, dated 04/13/2022 Material Supplier CMTR, dated 04/13/2022 PO 071246, dated 05/03/2022, CCV: Lid and Port Cover Inner O-rings The team also reviewed the following implementing procedures and procurement documents: | |||
SP-1512, Purchasing, Revision 3 SP-1526, Customer Supplied Items, Revision 1 SP-1529, Receiving Inspection, Revision 7 SP-1533, Receiving Inspection of Plate, Revision 2 SP-1534, Receiving Inspection of Flanges, Revision 3 SP-1552-1, Procedure for Passing Down 10CFR21 to Suppliers, Revision 0 SP-1568, Commercial Grade Dedication Procedure, Revision 5 SP-1570, Guidelines for Commercial Grade Dedication, Revision 0 1.6.2 Observation and Findings Overall, the team assessed that the fabricator had adequate control of the procurement process for the ITS components selected and reviewed. The team determined that the fabricator procured ITS components consistent with design requirements and their QA implementing procedures. The fabricators material traceability, procurement, and receipt inspection controls were adequate. 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 fabricators facility met the design requirements, the critical characteristics for dedicated material. Additionally, the fabricator verified and maintained the traceability throughout the procurement and receipt process. The team also determined that the fabricator purchased and applied controls over sub-contractors and vendors currently on the JOCs approved suppliers list. | CCV Lid PO 071227, CCV Lid, dated 03/11/2022, JOC ASME Upgrade CoC No. J-2753-2, dated 05/9/22 Laboratory Test Report, JOC acceptance dated 05/09/2022 JOC Reports of Ultrasonic Examination, dated 04/28/2022 Material Supplier Certificate of Compliance, dated 04/13/2022 Material Supplier CMTR, dated 04/13/2022 PO 071246, dated 05/03/2022, CCV: Lid and Port Cover Inner O-rings | ||
The team also reviewed the following implementing procedures and procurement documents: | |||
SP-1512, Purchasing, Revision 3 SP-1526, Customer Supplied Items, Revision 1 SP-1529, Receiving Inspection, Revision 7 SP-1533, Receiving Inspection of Plate, Revision 2 SP-1534, Receiving Inspection of Flanges, Revision 3 SP-1552-1, Procedure for Passing Down 10CFR21 to Suppliers, Revision 0 SP-1568, Commercial Grade Dedication Procedure, Revision 5 SP-1570, Guidelines for Commercial Grade Dedication, Revision 0 | |||
1.6.2 Observation and Findings | |||
Overall, the team assessed that the fabricator had adequate control of the procurement process for the ITS components selected and reviewed. The team determined that the fabricator procured ITS components consistent with design requirements and their QA implementing procedures. The fabricators material traceability, procurement, and receipt inspection controls were adequate. 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 fabricators facility met the design requirements, the critical characteristics for dedicated material. Additionally, the fabricator verified and maintained the traceability throughout the procurement and receipt process. The team also determined that the fabricator purchased and applied controls over sub-contractors and vendors currently on the JOCs approved suppliers list. | |||
No findings were identified. | No findings were identified. | ||
1.6.3 Conclusions The team determined that materials, components, and other equipment received by the fabricator met the procurement specifications, and the specifications conform to the design commitments and requirements contained in the packaging SAR and CoC. | 10 1.6.3 Conclusions | ||
1.7 | |||
SP-1527, Nonconformances, Revision 10 SP-1528, Corrective / Preventive Action, Revision 9 The inspectors reviewed nonconformance reports (NCRs) and CARs from the start of fabrication activities, which included NACs deposition of any fabricators NCRs and CARs, and NACs CARs related to the fabrication activities at the fabricators facility. The team also discussed the NCRs and CARs with both the NAC and the fabricators personnel. | The team determined that materials, components, and other equipment received by the fabricator met the procurement specifications, and the specifications conform to the design commitments and requirements contained in the packaging SAR and CoC. | ||
1.7.2 Observation and Findings Overall, the team assessed that the fabricator had adequate nonconformance and CAP programs in place to resolve deficiencies if identified. The team assessed that NAC and the fabricator appropriately identified issues and implemented corrective actions in a time frame commensurate with their safety significance. | |||
1.7 Nonconformance and Corrective Actions | |||
1.7.1 Inspection Scope | |||
The team reviewed a sample of nonconformance records and CARs to verify that the fabricator and NAC effectively implemented nonconformance control and corrective CAPs in accordance with the requirements of 10 CFR Part 71. The team verified that the fabricator and NAC 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: | |||
SP-1527, Nonconformances, Revision 10 SP-1528, Corrective / Preventive Action, Revision 9 | |||
The inspectors reviewed nonconformance reports (NCRs) and CARs from the start of fabrication activities, which included NACs deposition of any fabricators NCRs and CARs, and NACs CARs related to the fabrication activities at the fabricators facility. The team also discussed the NCRs and CARs with both the NAC and the fabricators personnel. | |||
1.7.2 Observation and Findings | |||
Overall, the team assessed that the fabricator had adequate nonconformance and CAP programs in place to resolve deficiencies if identified. The team assessed that NAC and the fabricator appropriately identified issues and implemented corrective actions in a time frame commensurate with their safety significance. | |||
No findings were identified. | No findings were identified. | ||
welders that performed NDE and welding, respectively. The team reviewed the following quality standard procedures related to the fabricators training and qualifications: | 1.7.3 Conclusions | ||
SP-1520, Welder Qualification and Continuity Records, Revision 1 SP-1522, Welder Performance Qualifications, Revision 1 SP-1556, Training Personnel in Quality Areas, Revision 2 SP-1562, Training and Qualification of Inspection Personnel, Revision 11 SP-1579, Requirements for Qualification and Certification of Nondestructive Examination Personnel (SNT-TC-1A) Revision 30 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) | |||
The team concluded that the fabricator 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 the fabricator properly trained and qualified individuals performing activities affecting quality and that the Management and quality assurance staff provided appropriate oversight. The team reviewed the records of two selected quality inspectors and two | |||
11 welders that performed NDE and welding, respectively. The team reviewed the following quality standard procedures related to the fabricators training and qualifications: | |||
SP-1520, Welder Qualification and Continuity Records, Revision 1 SP-1522, Welder Performance Qualifications, Revision 1 SP-1556, Training Personnel in Quality Areas, Revision 2 SP-1562, Training and Qualification of Inspection Personnel, Revision 11 SP-1579, Requirements for Qualification and Certification of Nondestructive Examination Personnel (SNT-TC-1A) Revision 30 | |||
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. | 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. | 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. | No findings were identified. | ||
1.8.3 Conclusions The team determined that the fabricator properly trained and qualified individuals performing activities affecting quality and Management and quality assurance staff provided appropriate oversight. | |||
1.9 | 1.8.3 Conclusions | ||
The team determined that the fabricator properly trained and qualified individuals performing activities affecting quality and Management and quality assurance staff provided appropriate oversight. | |||
1.9 Audits | |||
1.9.1 Inspection Scope | |||
The team reviewed both audit programs to verify that if both entities scheduled, planned, and performed audits in accordance with their QA program. The team focused on the audits or surveillances NAC performed of the fabricator to place them on their qualified vendors list (QVL). The team reviewed the audit results to determine if NAC identified deficiencies and the fabricator addressed these deficiencies within their CAP. The team also evaluated whether NAC and the fabricator provided adequate supervision with QA personnel for appropriate oversight during fabrication activities. | |||
The team also reviewed the external audits of the fabricators suppliers of ITS materials, equipment, and services. The team selected a sample of internal and external audits from the time NAC placed the fabricator on their QVL to the present. This sample also included a review of lead auditor and auditor certifications and qualifications. The team focused on activities related to the fabrication of the OPTIMUS-L. | The team also reviewed the external audits of the fabricators suppliers of ITS materials, equipment, and services. The team selected a sample of internal and external audits from the time NAC placed the fabricator on their QVL to the present. This sample also included a review of lead auditor and auditor certifications and qualifications. The team focused on activities related to the fabrication of the OPTIMUS-L. | ||
assess if it was an effective tool to use for the overall health of their program. The team reviewed the following quality standard procedures: | In addition, the team reviewed the last two management reviews of the fabricators QA program to determine whether the fabricator performed the reviews per procedures and | ||
SP-1543, Management Review, Revision 3 SP-1544, Evaluation of Nuclear Industry Assessment Committee (NIAC) Reports, Revision 2 SP-1567, Performance and Documentation of Audits, Revision 10 SP-1560, Training and Qualification of Auditors, Revision 7 1.9.2 Observation and Findings The team assessed that for the audits and surveillances sampled that NAC and the fabricator generally conducted oversight with qualified and certified personnel, scheduled and evaluated the applicable quality of both QA programs associated with fabrication activities. The team assessed that, in most case that NAC and the fabricator appropriately identified issues and implemented corrective actions in a time frame commensurate with their safety significance if identified during the audits. | |||
12 assess if it was an effective tool to use for the overall health of their program. The team reviewed the following quality standard procedures: | |||
SP-1543, Management Review, Revision 3 SP-1544, Evaluation of Nuclear Industry Assessment Committee (NIAC) Reports, Revision 2 SP-1567, Performance and Documentation of Audits, Revision 10 SP-1560, Training and Qualification of Auditors, Revision 7 | |||
1.9.2 Observation and Findings | |||
The team assessed that for the audits and surveillances sampled that NAC and the fabricator generally conducted oversight with qualified and certified personnel, scheduled and evaluated the applicable quality of both QA programs associated with fabrication activities. The team assessed that, in most case that NAC and the fabricator appropriately identified issues and implemented corrective actions in a time frame commensurate with their safety significance if identified during the audits. | |||
No findings were identified. | No findings were identified. | ||
ATTACHMENT | 1.9.3 Conclusions | ||
: 1. | |||
The team determined that NAC and the fabricator performed audits as scheduled of their QA programs and activities affecting the safety aspects of the transportation packaging and resolved deficiencies if identified in a timely manner. | |||
: 2. | 2.0 Entrance and Exit Meeting | ||
: 3. | |||
: 4. | On August 9, 2022, the NRC inspection team discussed the scope of the inspection during an entrance meeting with you and other members of NAC and the JOC staff. On August 11, 2022, the NRC inspection team discussed the preliminary results and observations during an onsite debrief meeting with you and JOC staff. The team continued the inspection activities with an in-office review while the team waited for NAC to provide additional information. Once the team received the additional information and completed their review, the team discussed the preliminary results of the inspection with you and other NAC representatives on November 17, 2022. The team completed the inspection activities on November 27, 2022. Section1 of the attachment to this report shows the attendance for the entrance and exit meetings. | ||
: 5. | |||
13 ATTACHMENT | |||
: 1. ENTRANCE/EXIT MEETING ATTENDEES AND INDIVIDUALS INTERVIEWED | |||
Name Title Affiliation Entrance Debrief Debrief Exit Marlone Davis Team Leader NRC/DFM X X X X Earl Love Senior Safety NRC/DFM X Inspector Samuel Moore Director of Quality JOC X X X Brad Greene Vice President (VP) NAC X X X X of Quality George Carver VP, Engineering & NAC X X Support Services Mike McMahon VP, Transportation NAC X X | |||
& Strategic Projects Doug Jacobs VP, Storage NAC X Projects John Edwards Director, Fabrication NAC X X X | |||
& Construction Jeff England Director, NAC Transportation Projects Heath Baldner Director, Licensing NAC X Calvin Barnett Manager, Quality NAC X Control | |||
: 2. INSPECTION PROCEDURES (IP) and GUIDANCE DOCUMENTS USED | |||
IP 86001 Design, Fabrication, Testing, and Maintenance of Transportation Packagings NUREG/CR6314 Quality Assurance Inspections for Shipping and Storage Containers NUREG/CR6407 Classification of Transportation Packaging and Dry Spent Fuel Storage System Components According to Importance to Safety | |||
: 3. LIST OF ITEMS OPENED, CLOSED, AND DISCUSSED | |||
Item Number Status Type Description | |||
719390/2022201-01 Closed NCV Failure to Notify Prior to Fabrication 719390/2022201-02 Closed NCV Failure to Establish Control of Measuring and Test Equipment | |||
Attachment | |||
: 4. LIST OF ACRONYMS USED | |||
ADAMS Agencywide Documents Access and Management System ASME American Society of Mechanical Engineers CAP Corrective Action Program CAR Corrective Action Report CCV Cask Containment Vessel CFR Code of Federal Regulations CoC Certificate of Compliance IMC Inspection Manual Chapter IP Inspection Procedure ITS Important to Safety JOC Joseph Oat Corporation M&TE Measuring and Test Equipment NAC NAC International, Incorporate NCR Nonconformance Report NCV Non-Cited Violation NDE Nondestructive Examination NEI Nuclear Energy Institute NRC Nuclear Regulatory Commission PO Purchase Order QA Quality Assurance QAM Quality Assurance Manual QVL Qualified Vendors List SAR Safety Analysis Report VP Vice President WPS Weld Procedure Specification | |||
: 5. DOCUMENTS REVIEWED | |||
Certificate holder and fabricator documents reviewed during the inspection were specifically identified in the Report Details above. | |||
2}} | 2}} |
Latest revision as of 12:40, 15 November 2024
ML23012A331 | |
Person / Time | |
---|---|
Site: | OPTIMUS-L |
Issue date: | 01/19/2023 |
From: | Rivera-Verona A NRC/NMSS/DFM/IOB |
To: | Greene B NAC International |
References | |
IR 2022201 | |
Download: ML23012A331 (18) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 205550001 Brad Greene Vice President of Quality NAC International, Inc.
3930 East Jones Bridge Rd., Suite 200 Peachtree Corners, GA 30092
SUBJECT:
NAC INTERNATIONAL, INC. - U.S. NUCLEAR REGULATORY COMMISSION INSPECTION REPORT NO. 719390/2022201
Dear Brad Greene:
On August 9, 2022, through August 11, 2022, the U.S. Nuclear Regulatory Commission (NRC) conducted an announced onsite team inspection at Joseph Oat Corporation (JOC) in Camden, New Jersey. JOC is under contract with N.A.C. International, Incorporated (NAC) to fabricate components associated with the Optimal Modular Universal Shipping Cask (OPTIMUS), Version L Certificate of Compliance (CoC) Number (No.) 9390. The inspection team continued the inspection activities with an in-office review while the team waited for NAC to complete a root cause analysis for a failure to notify the NRC in advance of starting fabrication activities on the first OPTIMUS-L package for use in the United States. The enclosed report presents the results of this inspection. The team discussed the preliminary results of this inspection with you and other NAC representatives on August 11, 2022, and November 17, 2022, and completed the inspection activities on November 27, 2022.
The purpose of the inspection was to verify and assess the adequacy of activities related to the design, fabrication, assembly, testing, procurement, repair, and any modification and maintenance for transportation packaging of radioactive material to determine if NAC and its contractor 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 that the transportation packaging is safe to use and in accordance with the commitments and requirements specified in the safety analysis report for packaging, and NACs NRC-approved quality assurance program requirements.
Based on the results of this inspection, the NRC inspection team determined that two Severity Level IV violations of NRC requirements occurred. The NRC is treating these violations as Non-Cited Violations (NCVs), which is consistent with section 2.3.2 of the Enforcement Policy. The NRC inspection team describe these NCVs in the enclosed inspection report.January 19, 2023 B. Greene 2 If you contest these violations, you should provide a response within 30 days of the date of this inspection report, with the basis for your denial, to the Nuclear Regulatory Commission, ATTN:
Document Control Desk, Washington DC 205550001, with copies to: (1) the Director, Office of Nuclear Materials Safety and Safeguards; and (2) the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, DC 205550001.
This letter, its enclosure, and your response (if any) will be made available for public inspection and copying at http://www.nrc.gov/reading-rm/adams.html and at the NRC Public Document Room in accordance with 10 CFR 2.390, Public Inspections, Exemptions, Requests for Withholding.
Sincerely, Aida Rivera-Varona, Chief Inspection and Oversight Branch Division of Fuel Management Office of Nuclear Material Safety and Safeguards Docket No. 719390
Enclosure:
NRC Inspection Report No.
719390/2022201 Signed by Rivera-Varona, Aida on 01/19/23
ML23012A331 C = COVER E = COVER & ENCLOSUREN = NO COPY *via email OFFICE DFM DFM DFM NAME MDavis WWheatley ARivera-Varona DATE 1/9/2023 1/17/2023 1/19/2023 U.S. NUCLEAR REGULATORY COMMISSION Office of Nuclear Material Safety and Safeguards Division of Fuel Management
Docket: 719390
Report.: 719390/2022201
Enterprise Identifier: I2022201-0034
Certificate Holder: NAC International, Incorporated
Facility: Joseph Oat Corporation
Location: Camden, New Jersey
Inspection Dates: August 9, 2022, through November 27, 2022
Inspection Team: Marlone Davis, Senior Transportation and Storage Safety Inspector, Team Leader Earl Love, Senior Transportation and Storage Safety Inspector
Approved By: Aida Rivera-Varona, Branch Chief Inspection and Oversight Branch Division of Fuel Management Office of Nuclear Material Safety and Safeguards
Enclosure U.S. NUCLEAR REGULATORY COMMISSION Office of Nuclear Material Safety and Safeguards Division of Fuel Management
EXECUTIVE
SUMMARY
NAC International, Inc.
NRC Inspection Report 719390/2022201
On August 9, 2022, through August 11, 2022, the U.S. Nuclear Regulatory Commission (NRC) conducted an announced onsite team inspection at Joseph Oat Corporation (JOC) in Camden, New Jersey. JOC is under contract with NAC International, Inc. (NAC) to fabricate components associated with the Optimal Modular Universal Shipping Cask (OPTIMUS), Version L transportation packaging certificate of compliance (CoC) docket number (No.) 71-9390. The inspection team continued the inspection activities with an in-office review while the team waited for NAC to complete a root cause analysis for a failure to notify the NRC in advance of starting fabrication activities on the first OPTIMUS-L transportation package for use in the United States.
The team discussed the preliminary results of this inspection on August 11, 2022, and November 17, 2022, and completed the inspection activities on November 27, 2022.
The purpose of the inspection was to verify and assess the adequacy of activities related to the design, fabrication, assembly, testing, procurement, repair, and any modification and maintenance for transportation packaging of radioactive material to determine if NAC and its contractor 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.
Quality Assurance Program
The team determined that JOC (fabricator) conducted quality related activities on the transportation packaging in accordance with the CoC, as well as their Quality Assurance Manual (QAM), and had effective implementing procedures in place. (section 1.1)
The team determined that the fabricator conducted fabrication activities under a quality assurance (QA) program that had provisions in place for reporting defects which could cause a substantial safety hazard, as required by 10 CFR Part 21. The team noted that the fabricator's personnel were familiar with the reporting requirements of 10 CFR Part 21 and the fabricator complied with 10 CFR 21.6, "Posting requirements." (section 1.2)
Design Control
The team determined that for the items selected for review that NAC implemented adequate design control measures. The procurement/fabrication specification was consistent with the design commitments and requirements documented in the SAR and the transportation packaging CoC No. 9390. (section 1.3)
2 Fabrication
The team determined, for the items selected for observation and review that the fabricator conducted fabrication and test activities consistent with fabrication specification that met the SAR and the transportation packaging CoC No. 9390. However, the team noted that NAC did not notify the NRC, in accordance with 10 CFR 71.1, 45 days in advance of starting fabrication of the first packaging under a CoC. Specifically, NAC failed to notify the NRC 45 days prior to starting fabrication of the OPTIMUS-L CoC No. 9390 as required in 10 CFR 71.93(c). (section 1.4)
Assembly and Testing
The team determined, for the items selected for observation and review that the fabricator performed fabrication assembly and testing in accordance with approved methods, procedures, and specifications except when the team identified one Severity Level IV violation of 10 CFR 72.125, Control of measuring and test equipment because a step-wedge film strip used to interpret film was past the 12 month calibration period required by a quality standard procedure. (section 1.5)
Procurement
The team determined that materials, components, and other equipment received by the fabricator met the procurement specifications, and the specifications conform to the design commitments and requirements contained in the SAR and CoC. (section 1.6)
Non-Conformance and Corrective Action
The team determined that the fabricator effectively implemented nonconformance and corrective action control programs and has adequate procedures in place to ensure compliance with the applicable regulations and quality assurance requirements. (section 1.7)
Personnel Training and Quality Assurance Oversight
The team determined that the fabricator properly trained and qualified individuals performing activities affecting quality and Management and quality assurance staff provided appropriate oversight. (section 1.8)
Audit Program
The team determined that NAC and the fabricator performed audits as scheduled of their QA programs and activities affecting the safety aspects of the transportation packaging and resolved deficiencies if identified in a timely manner. (section 1.9)
3 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 NRC inspection team reviewed the fabricators QAM and associated implementing procedures to verify that the fabricator was conducting fabrication, assembly, testing, repair, and procurement activities in accordance with the SAR and transportation packaging CoC No. 9390. The team reviewed the fabricators QAM, JOC QAM, Revision 33 and applicable implementing standard procedures (SPs). This review also included SP-1548, QA Manual and Procedure Revisions, Revision 5.
1.1.2 Observation and Findings
The team assessed that the fabricator has an adequate QA program that included applicable implementing procedures in place to conduct effective quality activities in accordance with the transportation packaging SAR, CoC, and 10 CFR Parts 21 and 71 requirements. The team also verified that the fabricator clearly defined and documented the quality program authorities and responsibilities and that the quality assurance organization functioned as an independent group as described in fabricators QAM.
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 QAM, and had effective implementing procedures in place.
1.2 10 CFR Part 21
1.2.1 Inspection Scope
The team reviewed the 10 CFR Part 21 standard procedures, SP-1552, Reporting Defects and Noncompliances (10CFR21), Revision 7 and SP-1552-1, Procedure for Passing Down 10CFR21 To Suppliers, Revision 0 to verify if provisions were in place for reporting defects that could cause a substantial safety hazard and to complete the required notification in a timely manner. The team requested a list of 10 CFR Part 21 evaluations and notifications associated with the fabrication activities and interviewed personnel to verify if they were familiar with the implementing procedure. The team also verified if the fabricator complied with 10 CFR 21.6, Posting requirements.
1.2.2 Observation and Findings
The team assessed that the fabricator has provisions in place for evaluating deviations and reporting defects that could cause a substantial safety hazard, as required by 10
4 CFR Part 21. The team noted that the 10 CFR Part 21 posting at the fabricators 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 NAC and the fabricator 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 specification were consistent with the design. Specifically, the team focused on the translation of design commitments and requirements for the important-to-safety (ITS) category A, B, and C components of the OPTIMUS-L and design specifications, including associated licensing drawings, 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:
NAC Specification Document No. 70000.14-S-04, Procurement/Fabrication Specification, OPTIMUS-L Outer Packaging Revision 1 SP-1510, Document Control, Revision 6
In addition, the team evaluated the design controls that were in place for the transmittal and handling of engineering/design drawings received from NAC and how the fabricator used the engineering drawing in fabrication, as applicable. This evaluation included the process for distributing controlled engineering and fabrication drawings.
1.3.2 Observation and Findings
Based on the teams review, there were no unexplained discrepancies between the design and fabrication activities including the engineering and fabrication drawings.
The team noted that the fabricator captured all requirements reviewed from the purchase order (PO) and procurement/fabrication specification associated with the design and fabrication of the OPTIMUS-L. The team also discovered that the fabricator did not provide any design engineering services.
No findings were identified.
5 1.3.3 Conclusions
The team determined that for the items selected for review that NAC implemented adequate design control measures and interfaced with the fabricator to provide adequate design control. The procurement/fabrication specification was consistent with the design commitments and requirements documented in the SAR and the transportation packaging CoC No. 9390.
1.4 Fabrication
1.4.1 Inspection Scope
The team reviewed selected drawings, procedures, and records, and observed selected activities related to the OPTIMUS-L cask containment vessel (CCV) to determine if the fabrication, testing, and maintenance activities met SAR design commitments and requirements documented in the CoC. The team selected the CCV because it was an ITS category A component. The team reviewed the following documents:
Welding Procedure Specification No. PS 8303, Revision 32 Traveler ITP-2753-2-Main Procedure No. QC-2744-10, Liquid Penetrate Examination Solvent Removable, Revision 1 Drawing Nos.: D12929.01, CCV Assembly, Revision 0 and D12929.03, CCV Body Weldment, Revision 0.
NAC Procurement/Fabrication Specification No. 70000.14-S-04, Revision 1
1.4.2 Observation and Findings
Based on the sample selected, the team assessed that the fabricator established appropriate means to control the OPTIMUS-L CCV fabrication activities and special processes that met the SAR design commitments and requirements documented in the CoC. The team examined NACs 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 activity. However, the team noted that NAC did not notify the NRC, in accordance with 10 CFR 71.1, 45 days in advance of starting fabrication of the first packaging for use in the United States under the CoC Docket No.
71-9390. NAC placed the fabrication order of the first packaging for use in the United States in August 2021 and completed fabrication activities on July 2022 prior to notifying the NRC.
The team determined this was a violation of 10 CFR 71.93(c), Inspection and tests, which requires, in part, that the certificate holder shall notify NRC, in accordance with 10 CFR 71.1, 45 days in advance of starting fabrication of the first packaging under a CoC.
This paragraph applies to any packaging used for the shipment of licensed material which either (1) A decay heat load in excess of 5 kW; or A maximum normal operating pressure in excess of 103kPa (15-pound force/per square inch).
6 Contrary to the above, prior to July 2022, the certificate holder (NAC) did not notify the NRC, in accordance with 10 CFR 71.1, 45 days in advance of starting fabrication of the first packaging under a CoC. Specifically, NAC missed opportunities to notify the NRC of fabrication activities prior to completion of the first packaging for use in the United States under the CoC Docket No. 71-9390. This paragraph applies to the OPTIMUS-L transportation packaging because it has a maximum normal operating pressure more than 103kPa. NAC self-identified the violation and performed a root cause analysis to determine the cause of the violation.
The team assessed the significance of the violation using the NRC Enforcement Policy and Enforcement Manual. The team dispositioned the violation using the traditional enforcement process in section 2.3 of the Enforcement Policy. The team determined that the violation impacted the ability of the NRC to perform its regulatory oversight function because NAC did not comply with notification requirements. The team determined that the violation was of more-than-minor safety significance because NAC knew of the information and did not recognize that this information required notification to the NRC which did not allow NRC to conduct inspection activities of a new fabricator. The team characterized the violation as a Severity Level IV violation in accordance with the NRCs Enforcement Policy, section 6.9. NAC entered the issue into its corrective action program (CAP) under corrective action report (CAR) No. 22-03. Because this violation was of low safety significance and was entered into NACs CAP, and the issue was not repetitive or willful, it is being treated as a non-cited violation (NCV), consistent with section 2.3.2.a of the Enforcement Policy. (71-9390/2022-201-01)
1.4.3 Conclusions
The team determined that the offsite fabricator's personnel were familiar with the specified design, designated fabrication techniques, testing requirements, and quality control associated with the fabrication of the OPTIMUS-L packaging that met packaging SAR design commitments and requirements documented in the CoC. However, NAC failed to notify the NRC 45 days prior to starting fabrication of the OPTIMUS-L CoC Docket No. 71-9390 as required in 10 CFR 71.93(c).
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 CCV to verify that the fabricator 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 activities:
Gas Tungsten Arc Welding of a flange to shell root pass on the CCV Liquid Penetration and Visual NDE of the CCV root pass Radiography of the CCV Shell
The team reviewed the following quality standard procedures:
7 SP-1515, Welding, Revision 1 SP-1516, Nondestructive Examination, Revision 1 SP-1580, Procedure for Documenting Inspection and Testing, Revision 0
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 QAM, implementing standard procedures, and regulatory requirements. Specifically, the team reviewed the following quality standard procedures:
SP-1501, Procedure for Calibration and Periodic Checks of ID Micrometers (3 Point) and Tube ID Gages, Revision 4 SP-1504, Calibration of Welding Machine Meters, Revision 8 SP-1508, Calibration of Densitometer and Step-Wedge Film Strips, Revision 3 SP-1509, Storage Location of Calibrated Equipment, Revision 2 SP-1519, Calibration of Standards and Miscellaneous Items, Revision 23
The team selected a sample of the M&TE used during the assembly and testing of the OPTIMUS-L packaging. The sample included a review of travelers that identified the use of specific M&TE that the team selected such as a light meter, temperature gun, welding machine #257, and a step-wedge film strip. 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 the fabricator established appropriate means to control OPTIMUS-L CCV Base and Lid fabrication activities and special processes for the most part. The team noted that the fabricator implemented their QA manual, standard procedures, and special processes with qualified personnel, using approved procedures for assembly, welding, and testing.
The team also assessed that the fabricator provided the appropriate information on shop travelers in accordance with approved procedures. The team verified that personnel used M&TE within their rated capacities and sensitivities as documented in calibration records. The team also assessed that the fabricator established controls for the most part with M&TE in accordance with their quality standard procedure requirements, industry standards and regulatory requirements except in one instance.
The team observed that the calibration step-wedge film strip was past the 12-month calibration / replacement period as required in section 2.3 of SP-1508, revision 3. The step-wedge film strip had a date of 12-21-2020 but a QC inspector arranged for the replacement to occur on 12-21-2022. The team noted that the fabricator used this step-wedge film strip to interpret radiographs of the CCV Shell while it was outside its calibration period. However, there was no nonconformance report or corrective action report to identify this issue.
The team determined this was a violation of 10 CFR 71.125, Control of measuring and test equipment, which requires, in part, that the certificate holder shall establish measures to assure that tools, gauges, instruments, and other measuring and testing
8 devices used in activities affecting quality are properly controlled, calibrated, and adjusted at specified times to maintain accuracy within necessary limits.
Contrary to the above, prior to the certificate holder (NAC) did not establish measures to assure that tools, gauges, instruments, and other measuring and testing devices used in activities affecting quality are properly controlled, calibrated, and adjusted at specified times to maintain accuracy within necessary limits. Specifically, NAC oversight of fabrication activities at JOC did not establish measures to assure that the step-wedge film strip used in interpreting film of the CCV shell weld was within the 12-month calibration / replacement period as required in section 2.3 of SP-1508, revision 3 to maintain accuracy within the necessary limits. At the time when the team discovered this issue, the step-wedge film strip had not been retested and called into question the results of previous tests including radiograph of the CCV shell weld.
The team assessed the significance of the violation using the NRC Enforcement Policy and Enforcement Manual. The team dispositioned the violation using the traditional enforcement process in section 2.3 of the Enforcement Policy. The team determined that the violation was of more-than-minor safety significance because it was similar to examples contained in Inspection Manual chapter 0617, Vendor and Quality Assurance Implementation Inspection Reports, appendix E, Minor Examples of Vendor and QA Implementation Findings, Examples 13.b, 13.c. and 13.d. The team characterized the violation as a Severity Level IV violation in accordance with the NRCs Enforcement Policy. JOC entered the issue into its CAP under CAR No. 414. The team assessed that because this violation was of low safety significance and was entered into the fabricators CAP, and the issue was not repetitive or willful, it is being treated as an NCV, consistent with section 2.3.2.a of the Enforcement Policy. (71-9390/2022-201-02)
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 packaging SAR and CoC.
1.6 Procurement Control
1.6.1 Inspection Scope
The inspectors reviewed the fabricator's processes that addressed procurement, including receipt inspection, traceability of material, and commercial grade dedication.
The team reviewed selected drawings and records and interviewed selected personnel to verify that NACs procurement specification for materials, fabrication, and inspection performed at the fabricators facility met design commitments and requirements contained in the packaging SAR and CoC No. 9390. The team reviewed procedures, sampled POs, receipt inspection records and commercial grade dedication reports specific to ITS Category A components that make up containment of the OPTIMUS-L.
The following is a list of procurement documents reviewed for the CCV Base Plate and CVV Lid:
9 CCV Base Plate and Shell PO No. 071230, CCV Base Plate and Shell, dated 03/11/2022 JOC ASME Upgrade CoC No. J-2753-2, dated 05/9/22 and 5/11/2022 Laboratory Test Reports, dated 04/29/2022 JOC Reports of Ultrasonic Examination, dated 04/30/2022 Material Supplier Metallurgical Test Report, dated 07/07/20 (Base Plate)
Material Supplier Certified Material Test Report (CMTR), dated 10/31/2021 (Shell)
CCV Lid PO 071227, CCV Lid, dated 03/11/2022, JOC ASME Upgrade CoC No. J-2753-2, dated 05/9/22 Laboratory Test Report, JOC acceptance dated 05/09/2022 JOC Reports of Ultrasonic Examination, dated 04/28/2022 Material Supplier Certificate of Compliance, dated 04/13/2022 Material Supplier CMTR, dated 04/13/2022 PO 071246, dated 05/03/2022, CCV: Lid and Port Cover Inner O-rings
The team also reviewed the following implementing procedures and procurement documents:
SP-1512, Purchasing, Revision 3 SP-1526, Customer Supplied Items, Revision 1 SP-1529, Receiving Inspection, Revision 7 SP-1533, Receiving Inspection of Plate, Revision 2 SP-1534, Receiving Inspection of Flanges, Revision 3 SP-1552-1, Procedure for Passing Down 10CFR21 to Suppliers, Revision 0 SP-1568, Commercial Grade Dedication Procedure, Revision 5 SP-1570, Guidelines for Commercial Grade Dedication, Revision 0
1.6.2 Observation and Findings
Overall, the team assessed that the fabricator had adequate control of the procurement process for the ITS components selected and reviewed. The team determined that the fabricator procured ITS components consistent with design requirements and their QA implementing procedures. The fabricators material traceability, procurement, and receipt inspection controls were adequate. 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 fabricators facility met the design requirements, the critical characteristics for dedicated material. Additionally, the fabricator verified and maintained the traceability throughout the procurement and receipt process. The team also determined that the fabricator purchased and applied controls over sub-contractors and vendors currently on the JOCs approved suppliers list.
No findings were identified.
10 1.6.3 Conclusions
The team determined that materials, components, and other equipment received by the fabricator met the procurement specifications, and the specifications conform to the design commitments and requirements contained in the packaging SAR and CoC.
1.7 Nonconformance and Corrective Actions
1.7.1 Inspection Scope
The team reviewed a sample of nonconformance records and CARs to verify that the fabricator and NAC effectively implemented nonconformance control and corrective CAPs in accordance with the requirements of 10 CFR Part 71. The team verified that the fabricator and NAC 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:
SP-1527, Nonconformances, Revision 10 SP-1528, Corrective / Preventive Action, Revision 9
The inspectors reviewed nonconformance reports (NCRs) and CARs from the start of fabrication activities, which included NACs deposition of any fabricators NCRs and CARs, and NACs CARs related to the fabrication activities at the fabricators facility. The team also discussed the NCRs and CARs with both the NAC and the fabricators personnel.
1.7.2 Observation and Findings
Overall, the team assessed that the fabricator had adequate nonconformance and CAP programs in place to resolve deficiencies if identified. The team assessed that NAC and the fabricator 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 the fabricator 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 the fabricator properly trained and qualified individuals performing activities affecting quality and that the Management and quality assurance staff provided appropriate oversight. The team reviewed the records of two selected quality inspectors and two
11 welders that performed NDE and welding, respectively. The team reviewed the following quality standard procedures related to the fabricators training and qualifications:
SP-1520, Welder Qualification and Continuity Records, Revision 1 SP-1522, Welder Performance Qualifications, Revision 1 SP-1556, Training Personnel in Quality Areas, Revision 2 SP-1562, Training and Qualification of Inspection Personnel, Revision 11 SP-1579, Requirements for Qualification and Certification of Nondestructive Examination Personnel (SNT-TC-1A) Revision 30
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 the fabricator properly trained and qualified individuals performing activities affecting quality and Management and quality assurance staff provided appropriate oversight.
1.9 Audits
1.9.1 Inspection Scope
The team reviewed both audit programs to verify that if both entities scheduled, planned, and performed audits in accordance with their QA program. The team focused on the audits or surveillances NAC performed of the fabricator to place them on their qualified vendors list (QVL). The team reviewed the audit results to determine if NAC identified deficiencies and the fabricator addressed these deficiencies within their CAP. The team also evaluated whether NAC and the fabricator provided adequate supervision with QA personnel for appropriate oversight during fabrication activities.
The team also reviewed the external audits of the fabricators suppliers of ITS materials, equipment, and services. The team selected a sample of internal and external audits from the time NAC placed the fabricator on their QVL to the present. This sample also included a review of lead auditor and auditor certifications and qualifications. The team focused on activities related to the fabrication of the OPTIMUS-L.
In addition, the team reviewed the last two management reviews of the fabricators QA program to determine whether the fabricator performed the reviews per procedures and
12 assess if it was an effective tool to use for the overall health of their program. The team reviewed the following quality standard procedures:
SP-1543, Management Review, Revision 3 SP-1544, Evaluation of Nuclear Industry Assessment Committee (NIAC) Reports, Revision 2 SP-1567, Performance and Documentation of Audits, Revision 10 SP-1560, Training and Qualification of Auditors, Revision 7
1.9.2 Observation and Findings
The team assessed that for the audits and surveillances sampled that NAC and the fabricator generally conducted oversight with qualified and certified personnel, scheduled and evaluated the applicable quality of both QA programs associated with fabrication activities. The team assessed that, in most case that NAC and the fabricator appropriately identified issues and implemented corrective actions in a time frame commensurate with their safety significance if identified during the audits.
No findings were identified.
1.9.3 Conclusions
The team determined that NAC and the fabricator performed audits as scheduled of their QA programs 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 August 9, 2022, the NRC inspection team discussed the scope of the inspection during an entrance meeting with you and other members of NAC and the JOC staff. On August 11, 2022, the NRC inspection team discussed the preliminary results and observations during an onsite debrief meeting with you and JOC staff. The team continued the inspection activities with an in-office review while the team waited for NAC to provide additional information. Once the team received the additional information and completed their review, the team discussed the preliminary results of the inspection with you and other NAC representatives on November 17, 2022. The team completed the inspection activities on November 27, 2022. Section1 of the attachment to this report shows the attendance for the entrance and exit meetings.
13 ATTACHMENT
- 1. ENTRANCE/EXIT MEETING ATTENDEES AND INDIVIDUALS INTERVIEWED
Name Title Affiliation Entrance Debrief Debrief Exit Marlone Davis Team Leader NRC/DFM X X X X Earl Love Senior Safety NRC/DFM X Inspector Samuel Moore Director of Quality JOC X X X Brad Greene Vice President (VP) NAC X X X X of Quality George Carver VP, Engineering & NAC X X Support Services Mike McMahon VP, Transportation NAC X X
& Strategic Projects Doug Jacobs VP, Storage NAC X Projects John Edwards Director, Fabrication NAC X X X
& Construction Jeff England Director, NAC Transportation Projects Heath Baldner Director, Licensing NAC X Calvin Barnett Manager, Quality NAC X Control
- 2. INSPECTION PROCEDURES (IP) and GUIDANCE DOCUMENTS USED
IP 86001 Design, Fabrication, Testing, and Maintenance of Transportation Packagings NUREG/CR6314 Quality Assurance Inspections for Shipping and Storage Containers NUREG/CR6407 Classification of Transportation Packaging and Dry Spent Fuel Storage System Components According to Importance to Safety
- 3. LIST OF ITEMS OPENED, CLOSED, AND DISCUSSED
Item Number Status Type Description
719390/2022201-01 Closed NCV Failure to Notify Prior to Fabrication 719390/2022201-02 Closed NCV Failure to Establish Control of Measuring and Test Equipment
Attachment
- 4. LIST OF ACRONYMS USED
ADAMS Agencywide Documents Access and Management System ASME American Society of Mechanical Engineers CAP Corrective Action Program CAR Corrective Action Report CCV Cask Containment Vessel CFR Code of Federal Regulations CoC Certificate of Compliance IMC Inspection Manual Chapter IP Inspection Procedure ITS Important to Safety JOC Joseph Oat Corporation M&TE Measuring and Test Equipment NAC NAC International, Incorporate NCR Nonconformance Report NCV Non-Cited Violation NDE Nondestructive Examination NEI Nuclear Energy Institute NRC Nuclear Regulatory Commission PO Purchase Order QA Quality Assurance QAM Quality Assurance Manual QVL Qualified Vendors List SAR Safety Analysis Report VP Vice President WPS Weld Procedure Specification
- 5. DOCUMENTS REVIEWED
Certificate holder and fabricator documents reviewed during the inspection were specifically identified in the Report Details above.
2