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{{#Wiki_filter:U.S. NUCLEAR REGULATORY COMMISSION Office of Nuclear Material Safety and Safeguards Division of Fuel Management Inspection Report Docket No.: 71-0947 Report No.: 71-0947/2022-201 Enterprise Identifier: I-2022-201-0014 Certificate Holder: Orano-Transport Logistics International, Inc. | {{#Wiki_filter:U.S. NUCLEAR REGULATORY COMMISSION | ||
8161 Maple Lawn Blvd, Suite 480 Fulton, MD 20759 Facility: Container Products Corporation 112 North College Road Wilmington, NC 28406 Inspection Dates: February 22-May 20, 2022 Inspectors: Jeremy Tapp, Transportation and Storage Safety Inspector, Team Leader Jon Woodfield, Transportation and Storage Safety Inspector Aaron Thomlinson, Quality Assurance Engineer Approved by: Hipolito Gonzalez, Acting Chief Inspection and Oversight Branch Division of Fuel Management Office of Nuclear Material Safety and Safeguards Enclosure 1 | Office of Nuclear Material Safety and Safeguards | ||
Division of Fuel Management | |||
Inspection Report | |||
Docket No.: 71-0947 | |||
Report No.: 71-0947/2022-201 | |||
Enterprise Identifier: I-2022-201-0014 | |||
Certificate Holder: Orano-Transport Logistics International, Inc. | |||
8161 Maple Lawn Blvd, Suite 480 | |||
Fulton, MD 20759 | |||
Facility: Container Products | |||
Corporation 112 North | |||
College Road Wilmington, | |||
NC 28406 | |||
Inspection Dates: February 22-May 20, 2022 | |||
Inspectors: Jeremy Tapp, Transportation and Storage Safety Inspector, Team | |||
Leader Jon Woodfield, Transportation and Storage Safety Inspector | |||
Aaron Thomlinson, Quality Assurance Engineer | |||
Approved by: Hipolito Gonzalez, Acting Chief | |||
Inspection and Oversight Branch | |||
Division of Fuel Management | |||
Office of Nuclear Material Safety | |||
and Safeguards | |||
Enclosure 1 | |||
2 EXECUTIVE | 2 | ||
EXECUTIVE SUMMARY | |||
Orano-Transport Logistics International, Inc. | |||
NRC Inspection Report 71-0947/2022-201 | |||
Orano-Transport Logistics International, Inc. | On February 22 through 24, 2022, the U.S. Nuclear Regulatory Commission (NRC) staff | ||
NRC Inspection Report 71-0947/2022-201 On February 22 through 24, 2022, the U.S. Nuclear Regulatory Commission (NRC) staff conducted an announced onsite inspection at the Container Products Corporation (CPC) facility in Wilmington, NC. The CPC is under contract with Orano-Transport Logistics International, Inc. | conducted an announced onsite inspection at the Container Products Corporation (CPC) facility | ||
(TLI) to fabricate important-to-safety (ITS) components of the Versa-Pac transportation packaging under Certificate of Compliance (CoC) 71-9342. | in Wilmington, NC. The CPC is under contract with Orano-Transport Logistics International, Inc. | ||
The purpose of the inspection was to verify and assess the adequacy of TLIs compliance with the NRC requirements for the design, modification, fabrication, assembly, testing, and procurement of Versa-Pac components. TLI is the holder of the CoC and designer of the Versa-Pac transportation packaging. | (TLI) to fabricate important-to-safety (ITS) components of the Versa-Pac transportation | ||
packaging under Certificate of Compliance (CoC) 71-9342. | |||
The purpose of the inspection was to verify and assess the adequacy of TLIs compliance with | |||
the NRC requirements for the design, modification, fabrication, assembly, testing, and | |||
procurement of Versa-Pac components. TLI is the holder of the CoC and designer of the Versa- | |||
Pac transportation packaging. | |||
Management Controls | Management Controls | ||
* The team determined that the quality assurance (QA) controls at CPC were generally adequate. The team concluded that CPC conducts its activities associated with QA organization independence and QA responsibilities in accordance with their Quality Assurance Manual (QAM). (Section 1.1) | * The team determined that the quality assurance (QA) controls at CPC were generally | ||
* The team concluded that CPC has an adequate nonconformance control program in place to ensure compliance with the applicable regulations and quality assurance program (QAP) requirements. (Section 1.2) | adequate. The team concluded that CPC conducts its activities associated with QA | ||
* The team identified CPCs corrective action program (CAP) as an area for improvement as evidenced by the issue identified and described in this report. The team identified one Severity Level IV violation of 10 CFR 71.133, Corrective action for CPCs failure to take adequate corrective actions from an issue identified during the previous inspection to ensure that suppliers on its Qualified Suppliers List (QSL) received a triennial inspection as required by the QAM and that the QSL was maintained current with qualified vendors. | organization independence and QA responsibilities in accordance with their Quality | ||
(Section 1.3) | Assurance Manual (QAM). (Section 1.1) | ||
* The team concluded that CPC was effectively implementing its document and records control program and had adequate procedures in place to ensure compliance with the applicable regulations and QAP requirements. (Section 1.4) | * The team concluded that CPC has an adequate nonconformance control program in | ||
* The team found that for the audits reviewed, CPC conducted the audits with qualified personnel independent of the areas being audited and evaluated the applicable functional areas of the QAP. (Section 1.5) | place to ensure compliance with the applicable regulations and quality assurance | ||
Enclosure 1 | program (QAP) requirements. (Section 1.2) | ||
* The team identified CPCs corrective action program (CAP) as an area for improvement | |||
as evidenced by the issue identified and described in this report. The team identified one | |||
Severity Level IV violation of 10 CFR 71.133, Corrective action for CPCs failure to take | |||
adequate corrective actions from an issue identified during the previous inspection to | |||
ensure that suppliers on its Qualified Suppliers List (QSL) received a triennial inspection | |||
as required by the QAM and that the QSL was maintained current with qualified vendors. | |||
(Section 1.3) | |||
* The team concluded that CPC was effectively implementing its document and records | |||
control program and had adequate procedures in place to ensure compliance with the | |||
applicable regulations and QAP requirements. (Section 1.4) | |||
* The team found that for the audits reviewed, CPC conducted the audits with qualified | |||
personnel independent of the areas being audited and evaluated the applicable | |||
functional areas of the QAP. (Section 1.5) | |||
Enclosure 1 | |||
3 Design Controls | 3 | ||
* The team concluded that CPC was effectively implementing their design control program. (Section 2.1) | Design Controls | ||
Fabrication Controls | * The team concluded that CPC was effectively implementing their design control | ||
* The team determined that the procurement controls were adequate, and CPC was generally effective in implementing their procurement program. (Section 3.1) | program. (Section 2.1) | ||
* CPC's implementation of fabrication controls for fabrication and assembly, including material storage, was assessed to be adequate. (Section 3.2) | Fabrication Controls | ||
* The team assessed that CPC had adequate controls for inspection of the Versa-Pac and it was generally being inspected per approved QA procedures and fabrication specifications by qualified personnel. (Section 3.3) | * The team determined that the procurement controls were adequate, and CPC was | ||
* The team concluded that the measuring and test equipment (M&TE) quality procedure being implemented at CPC provided adequate guidance for M&TE calibration and use, and CPC adequately implemented M&TE calibration, tracking, and use requirements. | generally effective in implementing their procurement program. (Section 3.1) | ||
(Section 3.4) | * CPC's implementation of fabrication controls for fabrication and assembly, including | ||
REPORT DETAILS | material storage, was assessed to be adequate. (Section 3.2) | ||
* The team assessed that CPC had adequate controls for inspection of the Versa-Pac and | |||
it was generally being inspected per approved QA procedures and fabrication | |||
Specifically, the team reviewed the QAP authorities and responsibilities to determine if they were clearly defined and documented, and the quality assurance (QA) organization functioned as an independent group. | specifications by qualified personnel. (Section 3.3) | ||
* The team concluded that the measuring and test equipment (M&TE) quality procedure | |||
Enclosure 1 | being implemented at CPC provided adequate guidance for M&TE calibration and use, | ||
and CPC adequately implemented M&TE calibration, tracking, and use requirements. | |||
(Section 3.4) | |||
REPORT DETAILS | |||
1. Management Controls | |||
1.1 Quality Assurance Policy | |||
a. Inspection Scope | |||
The team reviewed the Container Products Corporation (CPC) Quality Assurance Manual | |||
(QAM), Revision 24 and the associated Quality Control Operating Procedures (QCOPs) | |||
and Department Procedures to assess the effectiveness of the quality assurance program | |||
(QAP) implementation. The team conducted reviews of CPCs quality program, policies, | |||
and procedures, to determine whether activities subject to 10 CFR Part 71 were | |||
adequately controlled and implemented under CPCs QAM. | |||
Specifically, the team reviewed the QAP authorities and responsibilities to determine if they | |||
were clearly defined and documented, and the quality assurance (QA) organization | |||
functioned as an independent group. | |||
b. Observations and Findings | |||
The team assessed that CPC had a QAP and implementing procedures in place that were | |||
generally effective in conducting activities in accordance with their QAM. No issues of | |||
significance were identified. | |||
Enclosure 1 | |||
4 | 4 | ||
c. Conclusions | |||
The team determined that the QA controls at CPC were generally adequate. The team | |||
concluded that CPC conducts its activities associated with QA organization independence | |||
and QA responsibilities in accordance with their QAM. | |||
1.2 Nonconformance Controls | 1.2 Nonconformance Controls | ||
a. Scope | |||
The team reviewed the following Section of the CPC QAM, Revision 24, and QCOPs: | The team reviewed selected records and interviewed personnel to verify that CPC | ||
* QAP-1015, Non-Conforming Items, Revision G | effectively implemented a nonconformance control program in accordance with the | ||
* QCOP-2030, Discrepancy Reports, Revision 8 | requirements of 10 CFR Part 71 and CPCs nonconformance procedures. The team | ||
* QCOP-2050, Supplier Discrepancy Report, Revision 1 | requested the Discrepancy Report (DR), CPCs term for a nonconformance report, logbook | ||
for the current batch of 25 Versa-Pacs being fabricated and found that no DRs had been | |||
written. Therefore, the team assessed CPCs nonconformance controls process. | |||
The team reviewed the following Section of the CPC QAM, Revision 24, and QCOPs: | |||
* QAP-1015, Non-Conforming Items, Revision G | |||
* QCOP-2030, Discrepancy Reports, Revision 8 | |||
* QCOP-2050, Supplier Discrepancy Report, Revision 1 | |||
b. Observations and Findings | |||
The team assessed that CPC had adequate procedures and controls in place for | |||
dispositioning and tracking DRs to closure. No issues of significance were identified. | |||
c. Conclusions | |||
The team concluded that CPC has an adequate nonconformance control program in place | |||
to ensure compliance with the applicable regulations and QAP requirements. | |||
1.3 Corrective Actions Controls | 1.3 Corrective Actions Controls | ||
a. Scope | |||
The team reviewed the following Section of the CPC QAM, Revision 24, and QCOP: | The team reviewed selected records and interviewed personnel to verify that CPC | ||
Enclosure 1 | effectively implemented a CAP in accordance with the requirements of 10 CFR Part 71 and | ||
CPCs corrective action procedures. The team requested the CPC corrective action report | |||
(CAR) logbook for the current batch of 25 Versa-Pacs being fabricated and found that no | |||
CARs had been written. Therefore, the team assessed CPCs CAR control process. | |||
The team reviewed the following Section of the CPC QAM, Revision 24, and QCOP: | |||
Enclosure 1 | |||
5 | 5 | ||
* QAP-1015, Corrective Action, Revision J | * QAP-1015, Corrective Action, Revision J | ||
* QCOP-2031, Corrective Action Report, Revision 0 Additionally, the team included a review of CAR 2019-03 that was opened during the previous 2019 NRC inspection to determine whether the corrective actions taken to address the issues were appropriate and was closed out in a timely manner in accordance with CPC procedures. | * QCOP-2031, Corrective Action Report, Revision 0 | ||
Additionally, the team included a review of CAR 2019-03 that was opened during the | |||
During the review of the corrective actions taken to close CAR 2019-03, dated March 4, 2019, that was opened during the previous 2019 inspection to correct several issues identified by the NRC, the team noted that corrective actions were taken with respect to CPCs failure to perform two supplier audits at the three-year frequency established in CPC procedures to keep the suppliers on CPCs QSL. The CAR stated that the corrective action taken was to update the QSL to address this. For the action to prevent recurrence, the CAR only states to see the revised QSL dated February 6, 2019. The team reviewed the most recent QSL dated April 26, 2021, and the latest supplier audit schedule provided by CPC. The team identified that Airgas Performance Plus Division had not been audited since November 14, 2016, and Branham Corporation had not received an audit since being added to the QSL on August 23, 2018. Both remained on the QSL and the QSL stated that their qualification basis was by audit. | previous 2019 NRC inspection to determine whether the corrective actions taken to | ||
The team determined a violation of 10 CFR 71.133, Corrective action occurred in that CPC took inadequate corrective actions during the previous inspection to ensure that applicable suppliers on its QSL received a triennial audit as required by the CPC QAM Section QAP-1007, and that the QSL was maintained current with qualified vendors. At the time of the inspection, Airgas Performance Plus Division and Branham Corporation had not been audited in the past three years and remained on the QSL. 10 CFR 71.133 Corrective action states, in part, that the certificate holder (CPC represents the Certificate of Compliance (CoC) holder TLI) shall establish measures to assure that conditions adverse to quality, such as deficiencies, deviations, defective material and equipment, and nonconformances, are promptly identified and corrected. In the case of a significant condition adverse to quality, the measures must assure that the cause of the condition is determined and corrective action taken to preclude repetition. | address the issues were appropriate and was closed out in a timely manner in accordance | ||
Contrary to the above, CPC took inadequate corrective action from the 2019 inspection as documented in CAR 2019-03 to preclude repetition of suppliers not being audited triennially in order to keep the supplier on the QSL. Specifically, Airgas Performance Plus Division and Branham Corporation have not been audited in the past three years but remained on the QSL. | with CPC procedures. | ||
Enclosure 1 | b. Observations and Findings | ||
The team assessed that CPC had adequate procedures and controls in place for | |||
identifying and writing CARs, documenting corrective action(s) taken, performing a root | |||
cause evaluation for significant conditions adverse to quality, documenting actions taken to | |||
prevent recurrence, performing CAR closure verification, and tracking CARs to closure. | |||
During the review of the corrective actions taken to close CAR 2019-03, dated March 4, | |||
2019, that was opened during the previous 2019 inspection to correct several issues | |||
identified by the NRC, the team noted that corrective actions were taken with respect to | |||
CPCs failure to perform two supplier audits at the three-year frequency established in CPC | |||
procedures to keep the suppliers on CPCs QSL. The CAR stated that the corrective action | |||
taken was to update the QSL to address this. For the action to prevent recurrence, the | |||
CAR only states to see the revised QSL dated February 6, 2019. The team reviewed the | |||
most recent QSL dated April 26, 2021, and the latest supplier audit schedule provided by | |||
CPC. The team identified that Airgas Performance Plus Division had not been audited | |||
since November 14, 2016, and Branham Corporation had not received an audit since being | |||
added to the QSL on August 23, 2018. Both remained on the QSL and the QSL stated that | |||
their qualification basis was by audit. | |||
The team determined a violation of 10 CFR 71.133, Corrective action occurred in that | |||
CPC took inadequate corrective actions during the previous inspection to ensure that | |||
applicable suppliers on its QSL received a triennial audit as required by the CPC QAM | |||
Section QAP-1007, and that the QSL was maintained current with qualified vendors. At the | |||
time of the inspection, Airgas Performance Plus Division and Branham Corporation had not | |||
been audited in the past three years and remained on the QSL. 10 CFR 71.133 Corrective | |||
action states, in part, that the certificate holder (CPC represents the Certificate of | |||
Compliance (CoC) holder TLI) shall establish measures to assure that conditions adverse | |||
to quality, such as deficiencies, deviations, defective material and equipment, and | |||
nonconformances, are promptly identified and corrected. In the case of a significant | |||
condition adverse to quality, the measures must assure that the cause of the condition is | |||
determined and corrective action taken to preclude repetition. | |||
Contrary to the above, CPC took inadequate corrective action from the 2019 inspection as | |||
documented in CAR 2019-03 to preclude repetition of suppliers not being audited triennially | |||
in order to keep the supplier on the QSL. Specifically, Airgas Performance Plus Division | |||
and Branham Corporation have not been audited in the past three years but remained on | |||
the QSL. | |||
Enclosure 1 | |||
6 The team dispositioned the violation using the traditional enforcement process in Section 2.3 of the Enforcement Policy. The team determined the violation was more-than-minor safety significance in accordance with Inspection Manual Chapter (IMC) 0617, Vendor and Quality Assurance Implementation Inspection Reports, Appendix E, Minor Examples of Vendor and QA Implementation Findings, Example 16.a; because the adverse condition recurred. The team characterized the violation as a Severity Level IV violation in accordance with the NRCs Enforcement Policy, Section 6.8. CPC and TLI entered the issue into their CAPs under CAR # 2022-08 and 1215, respectively. This violation is being cited in the enclosed Notice of Violation (Notice). (71-0947/2022-201-01). | 6 | ||
The team dispositioned the violation using the traditional enforcement process in | |||
Section 2.3 of the Enforcement Policy. The team determined the violation was more-than- | |||
minor safety significance in accordance with Inspection Manual Chapter (IMC) 0617, | |||
Vendor and Quality Assurance Implementation Inspection Reports, Appendix E, Minor | |||
Examples of Vendor and QA Implementation Findings, Example 16.a; because the | |||
adverse condition recurred. The team characterized the violation as a Severity Level IV | |||
violation in accordance with the NRCs Enforcement Policy, Section 6.8. CPC and TLI | |||
entered the issue into their CAPs under CAR # 2022-08 and 1215, respectively. This | |||
violation is being cited in the enclosed Notice of Violation (Notice). (71-0947/2022-201-01). | |||
c. Conclusions | |||
The team identified CPCs CAP as an area for improvement as evidenced by the issue | |||
identified and described above. The team identified one violation of NRC requirements | |||
concerning the failure by CPC to take adequate corrective actions from an issue identified | |||
during the previous inspection to ensure that suppliers on its QSL received a triennial | |||
inspection as required by the QAM and that the QSL was maintained current with qualified | |||
vendors. | |||
1.4 Documentation Controls | 1.4 Documentation Controls | ||
a. Scope | |||
* QAP-1006, Document Control, Revision J | The team reviewed CPCs documentation and records control program and quality | ||
* QAP-1017, Quality Assurance Records, Revision J | procedures to assess the effectiveness of controls established for the approval, issuance, | ||
* 1002, Engineering Department Procedure, Revision 9 The team also interviewed QA personnel regarding document and record controls. The team interviewed the QA Manager regarding responsibilities for 1) controlled quality procedures including access, revisions, and distribution; and 2) final document package development, among the interviews performed. | use, and revisions of quality documents. The team also reviewed a sample of CPC | ||
Enclosure 1 | documents (instructions, procedures, records, drawings, and specifications) to verify how | ||
CPC developed and controlled quality related documents. Specifically, the team reviewed a | |||
sample of controlled QAMs and quality procedures, controlled copy distribution lists, receipt | |||
records of updated quality manuals, and fabrication drawing hard copies distributed to | |||
various CPC departments, among the sample of documents reviewed. The team reviewed | |||
the following Sections of the CPC QAM, Revision 24, and Department Procedure: | |||
* QAP-1006, Document Control, Revision J | |||
* QAP-1017, Quality Assurance Records, Revision J | |||
* 1002, Engineering Department Procedure, Revision 9 | |||
The team also interviewed QA personnel regarding document and record controls. The | |||
team interviewed the QA Manager regarding responsibilities for 1) controlled quality | |||
procedures including access, revisions, and distribution; and 2) final document package | |||
development, among the interviews performed. | |||
Enclosure 1 | |||
7 | 7 | ||
b. Observations and Findings | |||
The team assessed that CPC had adequate and effective controls established by their | |||
implementing procedures for the approval, issuance, use, storage, and revision of quality | |||
documents and records. No issues of significance were identified. | |||
c. Conclusions | |||
The team concluded that CPC was effectively implementing its document and records | |||
control program and had adequate procedures in place to ensure compliance with the | |||
applicable regulations and QAP requirements. | |||
1.5 Audit Program | 1.5 Audit Program | ||
a. Scope | |||
The team reviewed the audit schedule and internal audits performed since the previous 2019 initial inspection to determine if they were performed in accordance with the QAM, if CPC identified deficiencies, and whether CPC addressed these deficiencies within their CAP. The team reviewed the following Sections of the CPC QAM: | The team reviewed selected records and interviewed personnel to verify that CPC | ||
* QAP-1002, Quality Assurance Program, Revision O | effectively implemented an internal audit program in accordance with the QAM and the | ||
* QAP-1018, Audits, Revision K | applicable requirements of 10 CFR Part 71. The team reviewed the qualifications, training | ||
records, and annual evaluations for CPCs Quality Assurance Manager and external | |||
auditor to determine if they met the requirements stated in the QAM. | |||
Enclosure 1 | The team reviewed the audit schedule and internal audits performed since the previous | ||
2019 initial inspection to determine if they were performed in accordance with the QAM, if | |||
CPC identified deficiencies, and whether CPC addressed these deficiencies within their | |||
CAP. The team reviewed the following Sections of the CPC QAM: | |||
* QAP-1002, Quality Assurance Program, Revision O | |||
* QAP-1018, Audits, Revision K | |||
b. Observations and Findings | |||
No issues of significance were identified. | |||
c. Conclusions | |||
The team found that for the audits reviewed, CPC conducted the audits with qualified | |||
personnel independent of the areas being audited and evaluated the applicable functional | |||
areas of the QAP. | |||
Enclosure 1 | |||
8 | 8 | ||
2. Design Controls | |||
2.1 Design Development | |||
The team focused its review on the translation of the TLI design specification and licensing drawings to the CPC fabrication drawings and the controls that were in place. The team reviewed a sampling of CPC fabrication drawings for the Versa-Pac assembly and piece parts. The team verified that the fabrication drawings developed by CPC had received the proper CPC and TLI review and approvals. | a. Scope | ||
The team reviewed the following sections of the CPC QAM, Revision 24, and Department Procedure: | The team reviewed the design control Section of the CPC QAM and applicable | ||
* QAP-1003, Design Control, Revision H | implementing quality procedures to verify that CPC properly implemented their design | ||
* QAP-1005, Instructions, Procedures & Drawings, Revision D | control program. Specifically, the team reviewed the design control process between the | ||
* 1002, Engineering Department Procedure, Revision 9 | CoC holder TLI and the fabricator CPC. | ||
The team focused its review on the translation of the TLI design specification and licensing | |||
drawings to the CPC fabrication drawings and the controls that were in place. The team | |||
Enclosure 1 | reviewed a sampling of CPC fabrication drawings for the Versa-Pac assembly and piece | ||
parts. The team verified that the fabrication drawings developed by CPC had received the | |||
proper CPC and TLI review and approvals. | |||
The team reviewed the following sections of the CPC QAM, Revision 24, and Department | |||
Procedure: | |||
* QAP-1003, Design Control, Revision H | |||
* QAP-1005, Instructions, Procedures & Drawings, Revision D | |||
* 1002, Engineering Department Procedure, Revision 9 | |||
b. Observations and Findings | |||
The team assessed that CPC was following its engineering procedures, as applicable, to | |||
ensure that fabrication drawings and any associated specifications were consistent with the | |||
TLI licensing drawings approved by the NRC, and design requirements/commitments as | |||
documented in the Versa-Pac CoC. The team also determined that the design document | |||
approvals were performed as required. No issues of significance were identified. | |||
c. Conclusions | |||
The team concluded that CPC was effectively implementing their design control program. | |||
Enclosure 1 | |||
9 | 9 | ||
3. Fabrication Controls | |||
3.1 Procurement Controls | |||
* QAP-1004, Procurement Document Control, Revision J | a. Scope | ||
* QAP-1007, Control of Purchased Items & Services, Revision M | The team reviewed CPCs procurement of ITS materials and services, which included the | ||
* QCOP-1001, Material Receipt Inspection, Revision 22 | review of procurement documents, drawings and procedures, and receipt inspection | ||
* 1004, Purchasing Department Procedure, Revision 11 The procedures were reviewed to verify if they were being properly implemented. The team also reviewed CPCs QSL, dated April 26, 2021, to determine if materials and services were being procured from qualified suppliers and the suppliers were being acceptably qualified. | records. The team reviewed the following sections of the CPC QAM, QCOP and | ||
The team selected a sample of qualified suppliers and ITS materials for review. The sample included sheet steel, weld wire, hardware, gasket material, and nondestructive examination (NDE) services. | Department Procedure associated with procurement: | ||
* QAP-1004, Procurement Document Control, Revision J | |||
* QAP-1007, Control of Purchased Items & Services, Revision M | |||
Enclosure 1 | * QCOP-1001, Material Receipt Inspection, Revision 22 | ||
* 1004, Purchasing Department Procedure, Revision 11 | |||
The procedures were reviewed to verify if they were being properly implemented. The team | |||
also reviewed CPCs QSL, dated April 26, 2021, to determine if materials and services | |||
were being procured from qualified suppliers and the suppliers were being acceptably | |||
qualified. | |||
The team selected a sample of qualified suppliers and ITS materials for review. The | |||
sample included sheet steel, weld wire, hardware, gasket material, and nondestructive | |||
examination (NDE) services. | |||
b. Observations and Findings | |||
No issues of significance were identified. | |||
c. Conclusions | |||
The team determined that the procurement controls were adequate, and CPC was | |||
generally effective in implementing their procurement program. | |||
Enclosure 1 | |||
10 3.2 Fabrication and Assembly | 10 | ||
3.2 Fabrication and Assembly | |||
* QAP-1008, Identification and Control of Materials, Parts, and Components, Revision E | a. Scope | ||
* QAP-1013, Handling Storage and Shipping, Revision E | The team reviewed records associated with fabrication of the Versa-Pac packagings as | ||
* QAP-1014, Inspection, Test, and Operating Status, Revision E | well as material storage controls to verify that the fabrication and storage processes were | ||
* QCOP-1010, Shelf Life Verification, Revision 9 | properly controlled and implemented. Although there was no ongoing fabrication or | ||
* QCOP-2003, Tagging Procedure, Revision 5 | assembly activities while the team was onsite, the facility was toured to assess material | ||
* QCOP-2029, Shipping, Handling, and Storage, Revision 4 | storage controls and fabrication controls for those Versa-Pacs on the shop floor at the time | ||
* 1001, Manufacturing Department Procedures, Revision 1 A sample of travelers for Versa-Pacs currently being fabricated and three that were completed were reviewed to verify that fabrication and test activities were accomplished and appropriately documented according to controlled drawings and quality procedures. | of the inspection. The team reviewed the following sections of the CPC QAM, QCOPs and | ||
Department Procedure associated with procurement: | |||
* QAP-1008, Identification and Control of Materials, Parts, and Components, Revision | |||
Enclosure 1 | E | ||
* QAP-1013, Handling Storage and Shipping, Revision E | |||
* QAP-1014, Inspection, Test, and Operating Status, Revision E | |||
* QCOP-1010, Shelf Life Verification, Revision 9 | |||
* QCOP-2003, Tagging Procedure, Revision 5 | |||
* QCOP-2029, Shipping, Handling, and Storage, Revision 4 | |||
* 1001, Manufacturing Department Procedures, Revision 1 | |||
A sample of travelers for Versa-Pacs currently being fabricated and three that were | |||
completed were reviewed to verify that fabrication and test activities were accomplished | |||
and appropriately documented according to controlled drawings and quality procedures. | |||
b. Observations and Findings | |||
No issues of significance were identified. | |||
c. Conclusions | |||
CPC's implementation of fabrication controls for fabrication and assembly, including | |||
material storage, was assessed to be adequate. | |||
Enclosure 1 | |||
11 3.3 Test and Inspection | 11 | ||
3.3 Test and Inspection | |||
* QAP-1009, Control of Special Processes, Revision G | a. Scope | ||
* QAP-1010, Inspection, Revision E | The team reviewed CPC processes and procedures that address inspection of the Versa- | ||
* SSPC-ASME-MT1, Magnetic Particle Inspection Procedure, Revision 2 | Pac packaging. The team focused on the magnetic particle inspection (MT) NDE that was | ||
ongoing during the onsite inspection. The team observed MT being performed on Versa- | |||
Pac welds and interviewed personnel involved in the activity. The team reviewed the | |||
qualifications of the individual performing the MT NDE. The team also reviewed a sample | |||
of completed MT records from previous inspection activities on the Versa-Pacs being | |||
fabricated. The team reviewed the following sections of the CPC QAM and the NDE | |||
service providers procedure: | |||
* QAP-1009, Control of Special Processes, Revision G | |||
* QAP-1010, Inspection, Revision E | |||
* SSPC-ASME-MT1, Magnetic Particle Inspection Procedure, Revision 2 | |||
b. Observations and Findings | |||
No issues of significance were identified. | |||
c. Conclusions | |||
The team assessed that CPC had adequate controls for inspection of the Versa-Pac and it | |||
was generally being inspected per approved QA procedures and fabrication specifications | |||
by qualified personnel. | |||
3.4 Tools and Equipment | 3.4 Tools and Equipment | ||
a. Scope | |||
* QAP-1012, Control of Measuring and Test Equipment, Revision H | The team reviewed selected M&TE and reviewed records and procedures to assure that | ||
* QCOP-2011, Control of Measuring and Test Equipment, Revision 1 Specifically, the team reviewed the calibration records with respect to the light meter used to ensure the flashlight used during the MT inspections observed exceeded the minimum footcandle requirement. | equipment used in activities affecting quality were properly controlled and calibrated. The | ||
Enclosure 1 | team reviewed the following Section of the CPC QAM and QCOP: | ||
* QAP-1012, Control of Measuring and Test Equipment, Revision H | |||
* QCOP-2011, Control of Measuring and Test Equipment, Revision 1 | |||
Specifically, the team reviewed the calibration records with respect to the light meter used | |||
to ensure the flashlight used during the MT inspections observed exceeded the minimum | |||
footcandle requirement. | |||
Enclosure 1 | |||
12 | 12 | ||
b. Observations and Findings | |||
No issues of significance were identified. | |||
c. Conclusions | |||
Enclosure 1 | The team concluded that the M&TE quality procedure being implemented at CPC provided | ||
adequate guidance for M&TE calibration and use, and CPC adequately implemented | |||
M&TE calibration, tracking, and use requirements. | |||
4. Entrance and Exit Meeting | |||
On February 22, 2022, the NRC inspection team discussed the scope of the inspection | |||
during an entrance meeting with Andrew Langston and other members of the TLI and CPC | |||
staff. On February 24, 2022, the NRC inspection team presented the inspection results and | |||
observations during an onsite preliminary exit meeting. On May 20, 2022, the NRC | |||
inspection team conducted a final telephone conference exit with Andrew Langston and | |||
other members of the TLI and CPC staff. Section 1 of the attachment to this report shows | |||
the attendance for the entrance and exit meetings. | |||
Enclosure 1 | |||
13 ATTACHMENT | 13 | ||
ATTACHMENT | |||
1. ENTRANCE/EXIT MEETING ATTENDEES AND INDIVIDUALS INTERVIEWED | |||
Name Title Affiliation Entrance Exit | |||
Jeremy Tapp Inspection Team NRC/DFM X X | |||
Leader | |||
Jon Woodfield Inspector NRC/DFM X X | |||
Aaron QA Engineer NRC/DFM X | |||
Thomlinson | |||
Andrew Langston Director, Engineering TLI X X | |||
and Packaging | |||
Services | |||
Alex Jones Chemical Engineer TLI X X | |||
Tom Barron Designate, QA TLI X | |||
Dwight Campbell President CPC X | |||
Tammy Thurston QA Manager CPC X X | |||
Brian Schave QC Supervisor CPC X | |||
Katie Fletcher Sales CPC X | |||
Alex Thomas Buyer CPC X | |||
Rhonda Hahn Engineering CPC X | |||
2. INSPECTION PROCEDURES USED | |||
IP 86001 Design, Fabrication, Testing, and Maintenance of Transportation | |||
Packagings | |||
NUREG/CR-6407 Classification of Transportation Packaging and Dry Spent Fuel Storage | |||
System Components According to Importance to Safety | |||
NUREG/CR 6314 Quality Assurance Inspections for Shipping and Storage Containers | |||
Enclosure 1 | |||
14 | 14 | ||
3. LIST OF ITEMS OPENED, CLOSED, AND DISCUSSED | |||
Item Number Status Type Description | |||
71-0947/2022-201-01 Opened NOV Inadequate corrective actions to | |||
Enclosure 1}} | prevent recurrence of failure to perform | ||
triennial audits of suppliers | |||
4. LIST OF ACRONYMS USED | |||
ADAMS Agencywide Documents Access and Management System | |||
ASME American Society of Mechanical Engineers | |||
ASTM American Society for Testing and Materials | |||
CAP Corrective Action Program | |||
CAR Corrective Action Report | |||
CFR Code of Federal Regulations | |||
CoC Certificate of Compliance | |||
CPC Container Products Corporation | |||
DR Discrepancy Report | |||
IP Inspection Procedure | |||
ITS Important-to-Safety | |||
M&TE Measuring and Test Equipment | |||
MT Magnetic Particle Inspection | |||
NDE Nondestructive Examination | |||
Notice Notice of Violation | |||
NRC Nuclear Regulatory Commission | |||
QA Quality Assurance | |||
QAM Quality Assurance Manual | |||
QAP Quality Assurance Program | |||
QCOP Quality Control Operating Procedure | |||
QSL Qualified Suppliers List | |||
TLI Orano-Transport Logistics International, Inc. | |||
5. DOCUMENTS REVIEWED | |||
Certificate holder and fabricator documents reviewed during the inspection were specifically | |||
identified in the Report Details above. | |||
Enclosure 1 | |||
}} |
Latest revision as of 09:30, 2 September 2023
ML22151A127 | |
Person / Time | |
---|---|
Site: | 07100947 |
Issue date: | 06/01/2022 |
From: | NRC/NMSS/DFM/IOB |
To: | Orano TLI |
J TAPP NMSS/DFM/IOB 3014158047 | |
Shared Package | |
ML22151A125 | List: |
References | |
IR 2022201 | |
Download: ML22151A127 (14) | |
See also: IR 07100947/2022201
Text
U.S. NUCLEAR REGULATORY COMMISSION
Office of Nuclear Material Safety and Safeguards
Division of Fuel Management
Inspection Report
Docket No.: 71-0947
Report No.: 71-0947/2022-201
Enterprise Identifier: I-2022-201-0014
Certificate Holder: Orano-Transport Logistics International, Inc.
8161 Maple Lawn Blvd, Suite 480
Fulton, MD 20759
Facility: Container Products
Corporation 112 North
College Road Wilmington,
NC 28406
Inspection Dates: February 22-May 20, 2022
Inspectors: Jeremy Tapp, Transportation and Storage Safety Inspector, Team
Leader Jon Woodfield, Transportation and Storage Safety Inspector
Aaron Thomlinson, Quality Assurance Engineer
Approved by: Hipolito Gonzalez, Acting Chief
Inspection and Oversight Branch
Division of Fuel Management
Office of Nuclear Material Safety
and Safeguards
Enclosure 1
2
EXECUTIVE SUMMARY
Orano-Transport Logistics International, Inc.
NRC Inspection Report 71-0947/2022-201
On February 22 through 24, 2022, the U.S. Nuclear Regulatory Commission (NRC) staff
conducted an announced onsite inspection at the Container Products Corporation (CPC) facility
in Wilmington, NC. The CPC is under contract with Orano-Transport Logistics International, Inc.
(TLI) to fabricate important-to-safety (ITS) components of the Versa-Pac transportation
packaging under Certificate of Compliance (CoC) 71-9342.
The purpose of the inspection was to verify and assess the adequacy of TLIs compliance with
the NRC requirements for the design, modification, fabrication, assembly, testing, and
procurement of Versa-Pac components. TLI is the holder of the CoC and designer of the Versa-
Pac transportation packaging.
Management Controls
adequate. The team concluded that CPC conducts its activities associated with QA
organization independence and QA responsibilities in accordance with their Quality
Assurance Manual (QAM). (Section 1.1)
- The team concluded that CPC has an adequate nonconformance control program in
place to ensure compliance with the applicable regulations and quality assurance
program (QAP) requirements. (Section 1.2)
as evidenced by the issue identified and described in this report. The team identified one
Severity Level IV violation of 10 CFR 71.133, Corrective action for CPCs failure to take
adequate corrective actions from an issue identified during the previous inspection to
ensure that suppliers on its Qualified Suppliers List (QSL) received a triennial inspection
as required by the QAM and that the QSL was maintained current with qualified vendors.
(Section 1.3)
- The team concluded that CPC was effectively implementing its document and records
control program and had adequate procedures in place to ensure compliance with the
applicable regulations and QAP requirements. (Section 1.4)
- The team found that for the audits reviewed, CPC conducted the audits with qualified
personnel independent of the areas being audited and evaluated the applicable
functional areas of the QAP. (Section 1.5)
Enclosure 1
3
Design Controls
- The team concluded that CPC was effectively implementing their design control
program. (Section 2.1)
Fabrication Controls
- The team determined that the procurement controls were adequate, and CPC was
generally effective in implementing their procurement program. (Section 3.1)
- CPC's implementation of fabrication controls for fabrication and assembly, including
material storage, was assessed to be adequate. (Section 3.2)
- The team assessed that CPC had adequate controls for inspection of the Versa-Pac and
it was generally being inspected per approved QA procedures and fabrication
specifications by qualified personnel. (Section 3.3)
- The team concluded that the measuring and test equipment (M&TE) quality procedure
being implemented at CPC provided adequate guidance for M&TE calibration and use,
and CPC adequately implemented M&TE calibration, tracking, and use requirements.
(Section 3.4)
REPORT DETAILS
1. Management Controls
1.1 Quality Assurance Policy
a. Inspection Scope
The team reviewed the Container Products Corporation (CPC) Quality Assurance Manual
(QAM), Revision 24 and the associated Quality Control Operating Procedures (QCOPs)
and Department Procedures to assess the effectiveness of the quality assurance program
(QAP) implementation. The team conducted reviews of CPCs quality program, policies,
and procedures, to determine whether activities subject to 10 CFR Part 71 were
adequately controlled and implemented under CPCs QAM.
Specifically, the team reviewed the QAP authorities and responsibilities to determine if they
were clearly defined and documented, and the quality assurance (QA) organization
functioned as an independent group.
b. Observations and Findings
The team assessed that CPC had a QAP and implementing procedures in place that were
generally effective in conducting activities in accordance with their QAM. No issues of
significance were identified.
Enclosure 1
4
c. Conclusions
The team determined that the QA controls at CPC were generally adequate. The team
concluded that CPC conducts its activities associated with QA organization independence
and QA responsibilities in accordance with their QAM.
1.2 Nonconformance Controls
a. Scope
The team reviewed selected records and interviewed personnel to verify that CPC
effectively implemented a nonconformance control program in accordance with the
requirements of 10 CFR Part 71 and CPCs nonconformance procedures. The team
requested the Discrepancy Report (DR), CPCs term for a nonconformance report, logbook
for the current batch of 25 Versa-Pacs being fabricated and found that no DRs had been
written. Therefore, the team assessed CPCs nonconformance controls process.
The team reviewed the following Section of the CPC QAM, Revision 24, and QCOPs:
- QAP-1015, Non-Conforming Items, Revision G
- QCOP-2030, Discrepancy Reports, Revision 8
- QCOP-2050, Supplier Discrepancy Report, Revision 1
b. Observations and Findings
The team assessed that CPC had adequate procedures and controls in place for
dispositioning and tracking DRs to closure. No issues of significance were identified.
c. Conclusions
The team concluded that CPC has an adequate nonconformance control program in place
to ensure compliance with the applicable regulations and QAP requirements.
1.3 Corrective Actions Controls
a. Scope
The team reviewed selected records and interviewed personnel to verify that CPC
effectively implemented a CAP in accordance with the requirements of 10 CFR Part 71 and
CPCs corrective action procedures. The team requested the CPC corrective action report
(CAR) logbook for the current batch of 25 Versa-Pacs being fabricated and found that no
CARs had been written. Therefore, the team assessed CPCs CAR control process.
The team reviewed the following Section of the CPC QAM, Revision 24, and QCOP:
Enclosure 1
5
- QAP-1015, Corrective Action, Revision J
- QCOP-2031, Corrective Action Report, Revision 0
Additionally, the team included a review of CAR 2019-03 that was opened during the
previous 2019 NRC inspection to determine whether the corrective actions taken to
address the issues were appropriate and was closed out in a timely manner in accordance
with CPC procedures.
b. Observations and Findings
The team assessed that CPC had adequate procedures and controls in place for
identifying and writing CARs, documenting corrective action(s) taken, performing a root
cause evaluation for significant conditions adverse to quality, documenting actions taken to
prevent recurrence, performing CAR closure verification, and tracking CARs to closure.
During the review of the corrective actions taken to close CAR 2019-03, dated March 4,
2019, that was opened during the previous 2019 inspection to correct several issues
identified by the NRC, the team noted that corrective actions were taken with respect to
CPCs failure to perform two supplier audits at the three-year frequency established in CPC
procedures to keep the suppliers on CPCs QSL. The CAR stated that the corrective action
taken was to update the QSL to address this. For the action to prevent recurrence, the
CAR only states to see the revised QSL dated February 6, 2019. The team reviewed the
most recent QSL dated April 26, 2021, and the latest supplier audit schedule provided by
CPC. The team identified that Airgas Performance Plus Division had not been audited
since November 14, 2016, and Branham Corporation had not received an audit since being
added to the QSL on August 23, 2018. Both remained on the QSL and the QSL stated that
their qualification basis was by audit.
The team determined a violation of 10 CFR 71.133, Corrective action occurred in that
CPC took inadequate corrective actions during the previous inspection to ensure that
applicable suppliers on its QSL received a triennial audit as required by the CPC QAM
Section QAP-1007, and that the QSL was maintained current with qualified vendors. At the
time of the inspection, Airgas Performance Plus Division and Branham Corporation had not
been audited in the past three years and remained on the QSL. 10 CFR 71.133 Corrective
action states, in part, that the certificate holder (CPC represents the Certificate of
Compliance (CoC) holder TLI) shall establish measures to assure that conditions adverse
to quality, such as deficiencies, deviations, defective material and equipment, and
nonconformances, are promptly identified and corrected. In the case of a significant
condition adverse to quality, the measures must assure that the cause of the condition is
determined and corrective action taken to preclude repetition.
Contrary to the above, CPC took inadequate corrective action from the 2019 inspection as
documented in CAR 2019-03 to preclude repetition of suppliers not being audited triennially
in order to keep the supplier on the QSL. Specifically, Airgas Performance Plus Division
and Branham Corporation have not been audited in the past three years but remained on
the QSL.
Enclosure 1
6
The team dispositioned the violation using the traditional enforcement process in
Section 2.3 of the Enforcement Policy. The team determined the violation was more-than-
minor safety significance in accordance with Inspection Manual Chapter (IMC) 0617,
Vendor and Quality Assurance Implementation Inspection Reports, Appendix E, Minor
Examples of Vendor and QA Implementation Findings, Example 16.a; because the
adverse condition recurred. The team characterized the violation as a Severity Level IV
violation in accordance with the NRCs Enforcement Policy, Section 6.8. CPC and TLI
entered the issue into their CAPs under CAR # 2022-08 and 1215, respectively. This
violation is being cited in the enclosed Notice of Violation (Notice). (71-0947/2022-201-01).
c. Conclusions
The team identified CPCs CAP as an area for improvement as evidenced by the issue
identified and described above. The team identified one violation of NRC requirements
concerning the failure by CPC to take adequate corrective actions from an issue identified
during the previous inspection to ensure that suppliers on its QSL received a triennial
inspection as required by the QAM and that the QSL was maintained current with qualified
vendors.
1.4 Documentation Controls
a. Scope
The team reviewed CPCs documentation and records control program and quality
procedures to assess the effectiveness of controls established for the approval, issuance,
use, and revisions of quality documents. The team also reviewed a sample of CPC
documents (instructions, procedures, records, drawings, and specifications) to verify how
CPC developed and controlled quality related documents. Specifically, the team reviewed a
sample of controlled QAMs and quality procedures, controlled copy distribution lists, receipt
records of updated quality manuals, and fabrication drawing hard copies distributed to
various CPC departments, among the sample of documents reviewed. The team reviewed
the following Sections of the CPC QAM, Revision 24, and Department Procedure:
- QAP-1006, Document Control, Revision J
- QAP-1017, Quality Assurance Records, Revision J
- 1002, Engineering Department Procedure, Revision 9
The team also interviewed QA personnel regarding document and record controls. The
team interviewed the QA Manager regarding responsibilities for 1) controlled quality
procedures including access, revisions, and distribution; and 2) final document package
development, among the interviews performed.
Enclosure 1
7
b. Observations and Findings
The team assessed that CPC had adequate and effective controls established by their
implementing procedures for the approval, issuance, use, storage, and revision of quality
documents and records. No issues of significance were identified.
c. Conclusions
The team concluded that CPC was effectively implementing its document and records
control program and had adequate procedures in place to ensure compliance with the
applicable regulations and QAP requirements.
1.5 Audit Program
a. Scope
The team reviewed selected records and interviewed personnel to verify that CPC
effectively implemented an internal audit program in accordance with the QAM and the
applicable requirements of 10 CFR Part 71. The team reviewed the qualifications, training
records, and annual evaluations for CPCs Quality Assurance Manager and external
auditor to determine if they met the requirements stated in the QAM.
The team reviewed the audit schedule and internal audits performed since the previous
2019 initial inspection to determine if they were performed in accordance with the QAM, if
CPC identified deficiencies, and whether CPC addressed these deficiencies within their
CAP. The team reviewed the following Sections of the CPC QAM:
- QAP-1002, Quality Assurance Program, Revision O
- QAP-1018, Audits, Revision K
b. Observations and Findings
No issues of significance were identified.
c. Conclusions
The team found that for the audits reviewed, CPC conducted the audits with qualified
personnel independent of the areas being audited and evaluated the applicable functional
areas of the QAP.
Enclosure 1
8
2. Design Controls
2.1 Design Development
a. Scope
The team reviewed the design control Section of the CPC QAM and applicable
implementing quality procedures to verify that CPC properly implemented their design
control program. Specifically, the team reviewed the design control process between the
CoC holder TLI and the fabricator CPC.
The team focused its review on the translation of the TLI design specification and licensing
drawings to the CPC fabrication drawings and the controls that were in place. The team
reviewed a sampling of CPC fabrication drawings for the Versa-Pac assembly and piece
parts. The team verified that the fabrication drawings developed by CPC had received the
proper CPC and TLI review and approvals.
The team reviewed the following sections of the CPC QAM, Revision 24, and Department
Procedure:
- QAP-1003, Design Control, Revision H
- QAP-1005, Instructions, Procedures & Drawings, Revision D
- 1002, Engineering Department Procedure, Revision 9
b. Observations and Findings
The team assessed that CPC was following its engineering procedures, as applicable, to
ensure that fabrication drawings and any associated specifications were consistent with the
TLI licensing drawings approved by the NRC, and design requirements/commitments as
documented in the Versa-Pac CoC. The team also determined that the design document
approvals were performed as required. No issues of significance were identified.
c. Conclusions
The team concluded that CPC was effectively implementing their design control program.
Enclosure 1
9
3. Fabrication Controls
3.1 Procurement Controls
a. Scope
The team reviewed CPCs procurement of ITS materials and services, which included the
review of procurement documents, drawings and procedures, and receipt inspection
records. The team reviewed the following sections of the CPC QAM, QCOP and
Department Procedure associated with procurement:
- QAP-1004, Procurement Document Control, Revision J
- QAP-1007, Control of Purchased Items & Services, Revision M
- QCOP-1001, Material Receipt Inspection, Revision 22
- 1004, Purchasing Department Procedure, Revision 11
The procedures were reviewed to verify if they were being properly implemented. The team
also reviewed CPCs QSL, dated April 26, 2021, to determine if materials and services
were being procured from qualified suppliers and the suppliers were being acceptably
qualified.
The team selected a sample of qualified suppliers and ITS materials for review. The
sample included sheet steel, weld wire, hardware, gasket material, and nondestructive
examination (NDE) services.
b. Observations and Findings
No issues of significance were identified.
c. Conclusions
The team determined that the procurement controls were adequate, and CPC was
generally effective in implementing their procurement program.
Enclosure 1
10
3.2 Fabrication and Assembly
a. Scope
The team reviewed records associated with fabrication of the Versa-Pac packagings as
well as material storage controls to verify that the fabrication and storage processes were
properly controlled and implemented. Although there was no ongoing fabrication or
assembly activities while the team was onsite, the facility was toured to assess material
storage controls and fabrication controls for those Versa-Pacs on the shop floor at the time
of the inspection. The team reviewed the following sections of the CPC QAM, QCOPs and
Department Procedure associated with procurement:
- QAP-1008, Identification and Control of Materials, Parts, and Components, Revision
E
- QAP-1013, Handling Storage and Shipping, Revision E
- QAP-1014, Inspection, Test, and Operating Status, Revision E
- QCOP-1010, Shelf Life Verification, Revision 9
- QCOP-2003, Tagging Procedure, Revision 5
- QCOP-2029, Shipping, Handling, and Storage, Revision 4
- 1001, Manufacturing Department Procedures, Revision 1
A sample of travelers for Versa-Pacs currently being fabricated and three that were
completed were reviewed to verify that fabrication and test activities were accomplished
and appropriately documented according to controlled drawings and quality procedures.
b. Observations and Findings
No issues of significance were identified.
c. Conclusions
CPC's implementation of fabrication controls for fabrication and assembly, including
material storage, was assessed to be adequate.
Enclosure 1
11
3.3 Test and Inspection
a. Scope
The team reviewed CPC processes and procedures that address inspection of the Versa-
Pac packaging. The team focused on the magnetic particle inspection (MT) NDE that was
ongoing during the onsite inspection. The team observed MT being performed on Versa-
Pac welds and interviewed personnel involved in the activity. The team reviewed the
qualifications of the individual performing the MT NDE. The team also reviewed a sample
of completed MT records from previous inspection activities on the Versa-Pacs being
fabricated. The team reviewed the following sections of the CPC QAM and the NDE
service providers procedure:
- QAP-1009, Control of Special Processes, Revision G
- QAP-1010, Inspection, Revision E
- SSPC-ASME-MT1, Magnetic Particle Inspection Procedure, Revision 2
b. Observations and Findings
No issues of significance were identified.
c. Conclusions
The team assessed that CPC had adequate controls for inspection of the Versa-Pac and it
was generally being inspected per approved QA procedures and fabrication specifications
by qualified personnel.
3.4 Tools and Equipment
a. Scope
The team reviewed selected M&TE and reviewed records and procedures to assure that
equipment used in activities affecting quality were properly controlled and calibrated. The
team reviewed the following Section of the CPC QAM and QCOP:
- QAP-1012, Control of Measuring and Test Equipment, Revision H
- QCOP-2011, Control of Measuring and Test Equipment, Revision 1
Specifically, the team reviewed the calibration records with respect to the light meter used
to ensure the flashlight used during the MT inspections observed exceeded the minimum
footcandle requirement.
Enclosure 1
12
b. Observations and Findings
No issues of significance were identified.
c. Conclusions
The team concluded that the M&TE quality procedure being implemented at CPC provided
adequate guidance for M&TE calibration and use, and CPC adequately implemented
M&TE calibration, tracking, and use requirements.
4. Entrance and Exit Meeting
On February 22, 2022, the NRC inspection team discussed the scope of the inspection
during an entrance meeting with Andrew Langston and other members of the TLI and CPC
staff. On February 24, 2022, the NRC inspection team presented the inspection results and
observations during an onsite preliminary exit meeting. On May 20, 2022, the NRC
inspection team conducted a final telephone conference exit with Andrew Langston and
other members of the TLI and CPC staff. Section 1 of the attachment to this report shows
the attendance for the entrance and exit meetings.
Enclosure 1
13
ATTACHMENT
1. ENTRANCE/EXIT MEETING ATTENDEES AND INDIVIDUALS INTERVIEWED
Name Title Affiliation Entrance Exit
Jeremy Tapp Inspection Team NRC/DFM X X
Leader
Jon Woodfield Inspector NRC/DFM X X
Aaron QA Engineer NRC/DFM X
Thomlinson
Andrew Langston Director, Engineering TLI X X
and Packaging
Services
Alex Jones Chemical Engineer TLI X X
Tom Barron Designate, QA TLI X
Dwight Campbell President CPC X
Tammy Thurston QA Manager CPC X X
Brian Schave QC Supervisor CPC X
Katie Fletcher Sales CPC X
Alex Thomas Buyer CPC X
Rhonda Hahn Engineering CPC X
2. INSPECTION PROCEDURES USED
IP 86001 Design, Fabrication, Testing, and Maintenance of Transportation
Packagings
NUREG/CR-6407 Classification of Transportation Packaging and Dry Spent Fuel Storage
System Components According to Importance to Safety
NUREG/CR 6314 Quality Assurance Inspections for Shipping and Storage Containers
Enclosure 1
14
3. LIST OF ITEMS OPENED, CLOSED, AND DISCUSSED
Item Number Status Type Description
71-0947/2022-201-01 Opened NOV Inadequate corrective actions to
prevent recurrence of failure to perform
triennial audits of suppliers
4. LIST OF ACRONYMS USED
ADAMS Agencywide Documents Access and Management System
ASME American Society of Mechanical Engineers
ASTM American Society for Testing and Materials
CAP Corrective Action Program
CAR Corrective Action Report
CFR Code of Federal Regulations
CoC Certificate of Compliance
CPC Container Products Corporation
DR Discrepancy Report
IP Inspection Procedure
ITS Important-to-Safety
M&TE Measuring and Test Equipment
MT Magnetic Particle Inspection
NDE Nondestructive Examination
Notice Notice of Violation
NRC Nuclear Regulatory Commission
QA Quality Assurance
QAM Quality Assurance Manual
QAP Quality Assurance Program
QCOP Quality Control Operating Procedure
QSL Qualified Suppliers List
TLI Orano-Transport Logistics International, Inc.
5. DOCUMENTS REVIEWED
Certificate holder and fabricator documents reviewed during the inspection were specifically
identified in the Report Details above.
Enclosure 1