IR 07100254/2020201
| ML20077L220 | |
| Person / Time | |
|---|---|
| Site: | 07109294, 07100254, 07109309 |
| Issue date: | 01/27/2020 |
| From: | Marlone Davis NRC Region 1 |
| To: | Robert C Global Nuclear Fuel |
| Davis M | |
| References | |
| IR 2020021 | |
| Download: ML20077L220 (10) | |
Text
NRC FORM 5915 PART 1
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U.S. NUCLEAR REGULATORY COMMISSION SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION
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1. CERTIFICATE/QUALITY ASSURANCE PROGRAM (QAP) HOLDER:
2 NRC/REG10NAL OFFICE Headquarters Global Nuclear Fuel - Americas, LCC (GNF-A)
390 I Castle Hayne Road Wilmington, NC. 28402 U.S. Nuclear Regulatory Commission Mail Stop 3WFN 14C-28
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Washington, DC 20555-0001 REPORT NUMBER(S)
71-0254/2020-201 3. CERTIFICATE/CAP DOCKET NUMBER(S)
71-0254, 71-9294, and 71-9309 4, INSPECTION LOCATION Wilmington, North Carolina CERTIFICATE/QUALITY ASSURANCE PROGRAM HOLDER:
5. DATE(S) OF INSPECTION January 27 - 30, 2020 The inspection was an examination of the activities conducted under your OAP as they relate to compliance with the Nuclear Regulatory Commission (NRC) rules and regulations and the conditions of your OAP Approval and/or Certificate(s) of Compliance. The inspection consisted or selective examinations of procedures and representative records, Interviews with personnel, and observations by the Inspector. The Inspection findings are as follows:
Based on the inspection findings, no violations were Identifie Previous violation(s) close The violations(s), specifically described to you by the Inspector as non-cited violations, are nol being cited because they were self-identified, non-repelilive, and corrective aclion was or Is being taken, and the remaining criteria In the NRC Enforcement Polley, to exercise discretion, were satisfie I Non-cited violation(s) was/were discussed Involving the following requirement(s) and Corrective Actlons(s):
I.
to CFR 71.117, "Identification and control of materials, parts, and components," requires, in part, that the certificate holder shall establish measures for the identification and control of materials, parts, and components.
These measures must assure that identification of the item is maintained by heat number, part number, or other appropriate means, either on the item or on records traceable to the item, as required throughout fabrication, installation, and use of the item. These identification and control measures must be designed to prevent the use of incorrect or defective materials, parts, and components. Contrary to the above, as of January 30, 2020, (Continued on the Next Page)
During lhls inspection, certain of your activities, as described below and/or attached, were In violation of NRC requirements and are being cited in accordance with NRC Enforcement Polley. This form is a NOTICE OF VIOLATION, which may be subject lo posting In accordance with10CFR19.1 (Violations and Corrective Actions)
Statement of Corrective Actions I hereby state that, within 30 days, the actions described by me to the Inspector will be taken to correct the violaUons Identified. This statement or corrective actions Is made In accordance with the requirements of 10 CFR 2.201 (corrective steps already taken, corrective steps which will be taken, date when full compliance will be achieved). I understand thal no further written response to NRC will be required, unless specifically requeste TlnE PRINT£D NAME SIGNATURE OAT£ CERTIFICATE/OAP Mr. Curt Robert
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/2.'3,r REPRESENTATIVE Fuel Quality Leader l.A.l/l.A) I(_/ J71t!tA}
OdD NRC INSPECTOR Martone Davis, Team Leader Sr. Storage and Transportation Safety Inspector Alayna Pearson Inspection and Operation Branch BRANCH CHIEF NRC FORM 591S PART 1 p0,2013)
3/13/2020 Alayna N. Pearson Digitally signed by Alayna N. Pearson Date: 2020.03.13 11:42:26 -04'00'
NRC FORM 5915 PART 2 U.S. NUCLEAR REGULATORY COMMISSION
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°2 201 SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION 1. CERTIFICATE/QUALITY ASSURANCE PROGRAM (QAP) HOLDE Global Nuclear Fuel - Americas, LCC (GNF-A)
3901 Castle Hayne Road Wilmington, NC. 28402
11 2. NRCIREGIONAL OFFICE Headquarters U.S. Nuclear Regulatory Commission Mail Stop 3WFN 14C-28 Washington, DC 20555-0001 4 INSPECTION LOCATION Wilmington, North Carolina 5 DA TE(S) OF INSPECTION January 27 - 30, 2020 REPORT NUMBER($) 71-0254/2020-20 J 3, CERTIFICATE/OAP DOCKET NUMBER(S)
71-0254, 71-9294, and 71-9309 (Continued)
Global Nuclear Fuel - Americas (GNF-A) did not establish measures for the identification and control of materials, parts, and components for their radioactive material transportation packages as required throughout fabrication, installation, and use of the item. Specifically, GNF-A did not establish measures to assure that the identification and control of materials, parts, and components used during the refurbishment of the RAJ-II to prevent the use of incorrect or defective items following receipt of components. The team observed different components mixed in containers with no markings, scrap material mixed with good material, and parts with no traceability to the original receipt documentation. The team assessed and dispositioned the violation in accordance with the NRC Enforcement Policy and Manual. The team characterized the violation as a Severity Level IV non-cited violation (NCV), which was consistent with Section 2.3.2 of the NRC Enforcement Policy. GNF-A documented the NCV in their corrective action program for resolution as condition report number 3361 NRC FORM 5915 PART 2 (10-20131
INSPECTOR NOTES COVER SHEET Licensee/Certificate Holder Global Nuclear Fuel - Americas, LLC (GNF-A)
3901 Castle Hayne Road Wilmington, NC 28402 Licensee/Certificate Holder Contact Mr. Curt Robert Fuel Quality Leader 910-386-6782 Docket No Inspection Report N /2020-201 Inspection Date(s)
January 27 - 30, 2020 Inspection Location(s)
3901 Castle Hayne Road Wilmington, NC 28402 Inspectors Marlone Davis, Team Leader, Senior Storage and Transportation Safety Inspector Earl Love, Senior Storage and Transportation Safety Inspector Jon Woodfield, Storage and Transportation Safety Inspector Summary of Findings and Actions During the week of January 27 through January 30, 2020, the U.S. Nuclear Regulatory Commission (NRC)
conducted a team inspection of the implementation of GNF-As NRC approved Quality Assurance Program for compliance with the requirements of Title 10 of the Code of Federal Regulations Parts 21 and 7 The team discussed the preliminary results of this inspection on January 30, 201 The team identified one violation of NRC requirements because GNF did not establish measures for the identification and control of materials, parts, and components for their radioactive material transportation package models to prevent the use of incorrect or defective item The team dispositioned the violation as a Severity Level IV non-cited violation (NCV), which was consistent with Section 2.3.2 of the NRC Enforcement Polic GNF-A acknowledged the information presented and documented the NCV in their corrective action program for resolution as condition report number 3361 Lead Inspector Signature/Date Marlone Davis Inspector Notes Approval Branch Chief Signature/Date Alayna Pearson Marlone F Davis Digitally signed by Marlone F Davis Date: 2020.03.13 10:25:21 -04'00'
Alayna N. Pearson Digitally signed by Alayna N. Pearson Date: 2020.03.13 11:41:42 -04'00'
Inspector Notes
On January 27 to January 30, 2020, the U.S. Nuclear Regulatory Commission (NRC) performed an inspection at Global Nuclear Fuel - Americas, LLC (GNF-A) located in Wilmington, North Carolina (NC). The last Quality Assurance Program (QAP) implementation inspection occurred in February of 2014 (ML14078A627). During that inspection, the team issued one Notice of Violation (NOV) regarding procedural non-compliance with two example Both examples were in the area of nonconforming material control The purpose of this inspection was to verify and assess GNF-As compliance with the provisions of their approved NRC QAP and applicable Certificate of Compliances (CoC)s for the transportation of radioactive material packages, and the requirements of Title 10 of the Code of Federal Regulations (10 CFR) Parts 21 and 7 Specifically, a team of NRC inspectors evaluated the adequacy of GNF-As activities related to management, design, procurement and maintenance controls of their radioactive material transportation package models known as the New Powder Container (NPC) and RAJ I The team also reviewed and assessed the corrective actions from the previous NOV and applicable 10 CFR 71.95 60-day reports associated with the GNF-As transportation package model The team conducted the inspection in accordance with NRC Inspection Procedure 86001, Design, Fabrication, Testing, and Maintenance of Transportation Packagings and NUREG/CR-6314, Quality Assurance Inspections for Shipping and Storage Container The team reviewed selected procedures, quality assurance records, and interviewed personne The team performed an exit meeting on January 30, 2020, which discussed the preliminary results at the completion of the inspection wee The team identified one violation of NRC requirements because GNF-A did not establish measures for the identification and control of materials, parts, and components for their radioactive material transportation package models to prevent the use of incorrect or defective item The team dispositioned the violation as a Severity Level IV non-cited violation (NCV),
which was consistent with Section 2.3.2 of the NRC Enforcement Polic GNF-A acknowledged the information presented and documented the NCV in their corrective action program for resolution as condition report number 3361 The team described the violation in Section 02.06 of the inspector notes for this repor However, in general, the team assessed that GNF-A effectively implemented their NRC-approved QAP for activities subject to 10 CFR Parts 21 and 71 in the areas of management, design, procurement and maintenance control INSPECTOR NOTES: AS DESCRIBED BELOW, THE TEAM PERFORMED AND DOCUMENTED APPLICABLE PORTIONS OF SECTIONS 02.02 THROUGH 02.10, WHICH ARE THE INSPECTION REQUIREMENTS OF INSPECTION PROCEDURE (IP) 8600.02 Verify that the CoC holder's activities related to transportation packaging are being conducted in accordance with the CoC, as well as the NRC-approved QAP, and that implementing procedures are in place and effectiv Quality Assurance Policy
The NRC inspection team reviewed Global Nuclear Fuels (GNF) quality assurance program and implementing procedures to verify how GNF conducted activities in accordance with their transportation package Certificate of Compliances (CoC)s and their NRC-approved Quality Assurance Program (QAP). The team reviewed GNFs QAP document NEDO-11209-A, GE Hitachi Nuclear Energy Quality Assurance Program Description (QAPD), Revision 14 and various implementing procedure Additionally, the team reviewed GNFs graded approach for identifying Important-to-Safety (ITS) components for their radioactive material transportation package model RAJ II (No. 0034-3649, dated November 2014) and ITS descriptions related to the New Powder Container (NPC), QN-01810, Revision 6, Master Spare Parts List - Nuclear Containers,. The team also reviewed a sample of personnel qualifications and indoctrination training records in accordance with implementing procedure CP-20-100, Conduct of Training, Revision The team assessed that GNF had a program and implementing procedures in place and were effective in conducting activities in accordance with the CoCs as well as the NRC approved QAP for the NPC (CoC No. 71-9294) and RAJ-II (CoC No. 71-9309) radioactive material transportation package model The team verified that the quality assurance program authorities and responsibilities were clearly defined and documented, and the quality assurance organization functioned as an independent grou The team also assessed that GNFs RAJ-II component safety classification and quality classification list for the NPC appropriately identified and classified those components used to maintain and refurbish packaging components in accordance with implementing procedure Documentation Controls
The team reviewed the following procedures and work instructions associated with document control and quality records to determine if GNF was following its procedures in controlling its documentation and records:
- CP-06-100, Document Control Process, Rev. 23, issue date 12/30/2019
CP-06-102, Supporting Document Control Process, Rev. 10, issue date 10/16/2018
CP-06-115, Technical Instruction Document Control Process, Rev. 5, issue date 8/12/2019
CP-06-202, Procedure Distribution by Index, Rev. 5, issue date 9/29/2017
CP-06-205, NED Document Control Process, Rev. 7, issue date 2/15/2018
CP-06-400, Electronic Signatures with Adobe Acrobat, Rev. 1.2, issue date 12/10/2018
CP-06-500, Procedure Use and Adherence, Rev. 2.2, issue date 2/14/2019
CP-17-101, Product Quality Assurance Records, Rev. 8.3, issue date 1/27/2020
WI-06-100-01, Periodic Adequacy Review Process, Rev. 11.1, issue date 12/30/2019
- WI-06-100-04, Controlled Document Obsolescence Process, Rev. 6.1, issue date 10/21/2019
WI-06-100-05, Issuing Authority Responsibilities, Rev. 10.1, issue date 3/27/2019
The team assessed that adequate document control and records management exists at GN The team noted that GNF together with General Electric Hitachi (GEH) have three document control group Each group provides an essential function of document and quality record contro The team assessed that the groups were in full compliance with procedure CP-06-10 All documents and records added to the electronic database system by the three groups are user controlled in that the user of a document is required to verify that they have the latest version before using that documen Since all documents and quality records are electronic, they are automatically remotely backed up by the GEH/GNF Information Technology staff periodicall Overall, there were no concerns identified by the team in the GNF documentation control or quality records area.03 Verify that provisions are in place for reporting defects, which could cause a substantial safety hazard, as required by 10 CFR Part 21
The team reviewed the Part 21 work instruction WI-16-108-07, Reporting of Defects and Noncompliance Under 10 CFR Part 21, Revision 7.2, to evaluate if provisions were in place for evaluating deviations that could cause a substantial safety hazard and if the required notification would be completed in a timely manne The inspectors requested a list of Part 21 evaluations and notifications associated with any of the transportation packages and interviewed personnel to verify if they were familiar with the implementing work instruction WI-16-108-0 The team also reviewed GNF posting of Part 21 requirements in accordance with the 10 CFR 21.6, Posting requirement The team assessed that GNF has provisions in place for evaluating deviations and reporting defects, as required by 10 CFR Part 2 The team noted that GNF did not have any Part 21 reports within the last five year.04 Interview selected personnel and review selected design documentation to determine that adequate design controls are implemente Design and Modification Controls
The team interviewed selected personnel and reviewed selected design documentation to verify and evaluate that GNF implemented adequate design controls associated with their radioactive material transportation package models RAJ II and NP The team reviewed the GNFs procedures specifically related to design development, and control of modification activitie The team also reviewed the qualifications of selected engineering personne The team focused its review on the latest GNFs design activity related to Revision 8 of CoC No. 9294 for the Part 71 NPC transportation packaging mode The team reviewed the following GNF procedures and GEH QAPD sections associated with design control and qualification to verify that GNF implemented the procedures and work instructions properl The procedures and work instructions (WI) are as follows:
- CP-03-100, Design Process, Rev. 5.2, issue date 8//1//2019
CP-03-113, Engineering Change Control, Rev. 2.0, issue date 8/20/2019
CP-23-400, Engineering Computer Projects, Rev. 2.3, issue date 10/4/2019
- CP-23-401, Procured Engineering Computer Projects, Rev. 2.1, issue date10/4/2019
CP-23-402, Acquired Engineering Computer Projects, Rev. 2.1, issue date 10/4/2019
WI-03-100-30, Design Verification, Rev. 3.3, issue date 12/13/2018
WI-03-100-32, Engineering Tests, Rev. 1.0, issue date 4/9/2018
QP-3.0.07, Identification of Quality Categories, Revision 1
QP-2.0.06, Qualification of Engineering Personnel, Revision 3
The team evaluated the revised amendment to the NPC CoC No. 9294 for the addition of approved content to the radioactive material transportation packaging mode The team noted that GNF and GEH no longer use engineering change orders because GNF/GEH perform all engineering electronicall Therefore, the team interviewed the project engineer that performed the amendment at their computer to review the work flow and project documents including electronic reviews and approval The team noted that there is a traveler summary document associated with every quality document which shows the individuals that performed the reviews and approvals and the date when personnel add their electronic signatur The team assessed that all reviewer and approver comments are also addressed electronically and are retrievable in the GEH engineering electronic data base syste The team did note that once engineering approves the documents, engineering personnel releases the document into the quality record/document system for use and view by all GNF/GEH staf The team verified that for the NPC amendment, Safety Analysis Report (SAR) revisions, design basis records (which included calculations), and drawings were independently reviewed and approved electronicall Additionally, the team assessed that NPC change in content amendment had a criticality calculation associated with it that used the Keno computer software analysis progra The team verified that GNF provided quality assurance to the Keno program in accordance with their procedure The team assessed that overall, GNF through GEH engineering was effectively implementing its design control procedures as demonstrated through the review of the NPC amendmen The team found that GNF/GEH developed and processed all engineering quality documents in accordance with applicable procedures and design documents received the proper independent verification reviews and approval The team also found the training and qualification records for the GEH engineering staff that worked on the NPC new contents amendment project were adequate to justify their experience, knowledge, and ability to perform the amendmen Therefore, there were no concerns identified by the team in the design control area as subject to the sample chose.05 Review selected drawings, procedures and records, and observe selected activities being performed to determine that design and maintenance activities meet SARP design requirements documented in the Co Maintenance Activities
The team reviewed selected drawings, procedures and maintenance records for the maintenance and inspection activities for the NPC or RAJ-II transportation radioactive material package The team also reviewed the maintenance requirements and inspection procedures associated with the UX30 overpacks that GNF used to transport radioactive materia Specifically, the team reviewed and observed selected activities pertaining to the handling and storage of empty or loaded RAJ-II and NPC shipping container The activities that the team witnessed were loading of an NPC used to ship a payload of scrap material offsite (s/n: N-0417)
and a pre-loaded and final inspection of an NPC and RAJ-II shipping container, respectivel This included the review of three Inner Containment Canister Assembly (ICCA) test results performed on July 15, 2016 for the NPC and other applicable maintenance on two other NPC in December of 2019 (S/Ns: N-0210 and N-0148). The team also observed the refurbishing operations of the RAJ-II that included weld examinations and visual inspection The team assessed that GNF adequately captured and addressed the maintenance requirements from the SAR during the inspection and maintenance refurbishment proces The team noted that GNF maintained the shipping containers in a protective environment, segregated by type, status (empty, loaded, refurbished, etc.) and adequately identified by the individual container serial number and its present statu The team also noted that GNF sealed loaded containers with non-tamper wire seals and the refurbished containers with non-tamper mylar seal The team determined that GNF adequately implemented operations and documented inspection requirements in accordance with the SAR and inspection procedure The team assessed that GNF's maintenance records of NPC and RAJ-II, all conformed to various GNF operating procedures and refurbishment inspection checklist Additionally, the team noted that GNF routinely inspected and maintained the UX-30 overpacks prior to each us The team noted that GNF electronically recorded, as defined and required by procedure, all weld and other non-weld inspection attributes and that the weld inspector was a qualified SNT-TC-1A, VT-1 examine.06 Observe activities affecting safety aspects of the packaging (such as fabrication, assembly, and testing) to verify that they are performed in accordance with approved methods, procedures, and specifications
Control of Measuring and Test Equipment
The team focused on maintenance and inspection activities since there was no ongoing fabrication for the NPC or RAJ-II transportation radioactive material package The team interviewed personnel and reviewed personnel training and qualification records, and controls for tools and equipment use in the refurbishment and loading (new fuel rods or scrap material)
of RAJ-II and NPC container The team reviewed the control of measuring and test equipment (M&TE) procedure to evaluate how GNF identified, specified, and controlled tools and equipment in accordance with applicable standards and regulatory requirement The team selected a sample of the M&TE used during the refurbishment and loading of the RAJ-II and NPC shipping containe The sample included a review of torque wrenches (W17641 and W17105). The team also reviewed the calibration reports to verify calibration dates, testing standards, and traceability of the associated M&T Overall, the team assessed that GNF established controls of M&TE in accordance with standards and regulatory requirement The team assessed that GNF maintenance and operation personnel provided the appropriate information on checklists and work packages in accordance with approved procedure The team found the M&TE program to be adequate with no concern Maintenance Material Control
The team observed activities at the RAJ-II refurbishing work station to assess how GNF controlled the spare parts used in the RAJ-II refurbishment operation The team reviewed five ITS Category B components (i.e., the lid and clamp bolts, helicoil threaded insert, shock absorbers, and end face component). For the most part, the team noted that GNF maintained material control of spare parts during the receipt of the component from the quality supplie However, the team noted that the material control and traceability of the spare part components in the refurbishment area lacked those same control Specifically, material control and traceability were not appropriately established nor verified to be taken from or tracked back to the supplier material quality release record The team noted that GNF had mixed spare part components at the point of use location following removal of the original lot identification for the spare part The team observed components mixed in containers with no markings, scrap material with good material, helicoil threaded inserts were in multiple containers and in cabinets with no documentation. The team determined that there was no traceability to the original receipt documentation prior to use and installation of the ITS components during the refurbishment operatio The team assessed that this was a violation of NRC requirement Specifically, 10 CFR 71.117, Identification and control of materials, parts, and components, which states, in part, that the certificate holder shall establish measures for the identification and control of materials, parts, and component These measures must assure that identification of the item is maintained by heat number, part number, or other appropriate means, either on the item or on records traceable to the item, as required throughout fabrication, installation, and use of the ite These identification and control measures must be designed to prevent the use of incorrect or defective materials, parts, and component Contrary to, as of January 30, 2020, certificate holder (GNF) did not establish measures to assure that identification of the item is maintained by heat number, part number, or other appropriate means, either on the item or on records traceable to the item, as required throughout fabrication, installation, and use of the ite Specifically, GNF in the process of purchase and after release from supplier quality of ITS components to control for shop use to assure traceabilit The team dispositioned the violation in accordance with the NRC Enforcement Polic The team characterized the violation as a Severity Level IV non-cited violation (NCV). The NRC plans to treat this NRC identified violation as an NCV consistent with section 2.3.2 of the NRC Enforcement Polic GNF acknowledged the information presented and documented the NCV in their corrective action program for resolution as condition report (CR) number 3361 Additionally, GNF evaluated this CR under the quality notice QN-02243, dated 2/13/202.08 Review selected records and interview selected personnel to verify that a nonconformance control program is effectively implemented, and that corrective actions for identified deficiencies are technically sound and completed in a timely manner
The team reviewed selected records and interviewed selected personnel to verify that GNF effectively implemented a nonconformance control program, and that personnel completed corrective actions for identified deficiencies in a technically sound and timely manne Specifically, the team reviewed GNFs quality procedure CP-15-100, Control of Nonconforming Items, Revision 3.2 and work instruction WI-15-100-02, GNFA Nonconforming Material Control, Revision The inspectors reviewed a list of nonconformances, and corrective action reports from the last five year Additionally, the team reviewed and assessed the corrective actions from the previous NOV (ML14078A627) and applicable 10 CFR 71.95 60-day reports associated with the RAJ-II, dated June 26, 201 The team discussed the nonconformance and corrective actions with the GNF staff including the previous notice of violatio Overall, the team assessed that GNF had an adequate nonconformance and corrective action program in place to resolve deficiencie GNF addressed concerns from the previous violation and the corrective actions addressed the deficiencies identified and GNF resolved those items in a timely manne.09 Review selected records and procedures, interview selected personnel, and observe selected activities affecting the safety aspects of the packaging to verify that individuals performing activities affecting quality are properly trained and qualified, and to verify that management and quality assurance (QA) staff are cognizant and provide appropriate oversigh The team reviewed the applicable procedures and records to assess if individuals performed quality-related activities in other sections of this repor The team assessed that GNF implemented procedures for the qualification and certification of personne The team determined that GNF appropriately trained and qualified personnel according to standard requirements as noted in their quality procedure.10 Verify that audits of the QA Program and activities affecting the safety aspects of the packaging are scheduled, have been performed as scheduled, and that identified deficiencies have been satisfactorily resolved in a timely manne The team reviewed the GNF audit program to determine if GNF scheduled, planned, and performed internal audits in accordance with approved implementing procedure Specifically, the team reviewed CP-18-100, Quality Assurance Internal Audit Requirements, Revision and CP-18-03, Lead Auditor Certification and Audit Team Training Requirements, Revision The team selected internal audits from the last five years, particularly related to transportation activitie The team reviewed the audit results to determine if GNF identified deficiencies and addressed the deficiencies with their corrective action progra Overall, the team assessed that for the internal audits sampled GNF generally conducted audits with qualified and certified personnel and scheduled and evaluated applicable elements of their QAP for the transportation functional area.