NRC FORM 591S PART 1 ~ (11).2013) f.~. ~

U.S. NUCLEAR REGULATORY COMMISSION

SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION 1DCFR2.201 \~)

1. CERTIFICATE/QUALITY ASSURANCE PROGRAM (CAP) HOLDER 2 NRC/REGIONAL OFFICE

GE Hitachi Nuclear Energy America, LLC (GEH) 3 90 I Castle Hayne Road

Headquarters U.S. Nuclear Regulatory Commission Mail Stop 3WFN 14C-28 Washington, DC 20555-0001

Wilmington, NC 28402

------------ -------- - -------ii REPORT NUMBER(S)

3 CERTIFICATE/OAP DOCKET NUMBER(S) 4 INSPECTION LOCATION 5 OATE(S) OF INSPECTION

71 -01 70 Vallccitos Nuclear Cenlcr, Sunol, CA May 6-10, 2019

CERTIFICATE/QUALITY ASSURANCE PROGRAM HOLDER:

The inspection was an examination of the activities conducted under your OAP as they relate to compliance w,lh the Nuclear Regulatory Commission (NRC) rules and regulations and the conditions of your OAP Approval and/or Certificale(s} of Compliance. The Inspection consisted of 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 vlolelions were .dentmed

Previous violaUon(s) closed.

The violatlons(s}, specifically described to you by the Inspector as non-cited v:olalions, are not being cited because they were self-Identified, non-repeliUve, and corrective action was or is being taken, and the remaining criteria in the NRC Enrorcement Policy, to exercise dlsaellon, were saUsfl8d.

1 Non-died vfolation(s) was/were d,scussed lnvo!vlng the following requlremenl(s) and Corrective Actions(s}:

IO CFR 71 .111, "Instructions, procedures, and drawings," requires, in part, that a certificate holder shall prescribe activities affecting quality by documented instructions, procedures, or drawings of a type appropriate to the circumstances and shall require that these instructions, procedures, and drawings be followed. Contrary to the above, VNC did not follow the requirements prescribed in its procedure for the Model GE 2000 transportation package. Specifically VNC failed to perform the helium leak rate test within the period specified in the Operations and Maintenance Specification No. 22A9380. Additionally, VNC failed to keep a material log book for material traceability documentation of the Important to Safety components used for maintenance activities as required by their Quality Procedure 10.5, "Control of Material Storage," Revision 5.

During this lnspecUon, certain of your actlvtues, as described below and/or attached, were In violaUon of NRC requirements and are being cited In accordance with NRC Enrorcemenl Policy. This ronn Is a NOTICE OF VIOLATION, which may be subject to posting In accordance with 10CFR 19.11 . (Vlolallons and CorracUve Actions}

Statement of Corrective Actions I hereby state that, within 30 days, the actions described by me to the Inspector will be taken lo correct the violations identified. This statement of corrective actions Is made In accordance with the requirements of 10 CFR 2.201 (corrective steps already taken, corrective steps which will be taken, dale when full compllance will be achieved). I understand that no further written response to NRC win be required, unless specifically requested.

ERTIFICATE/QAP Mark Elliott REPRESENTATIVE GEH Services Quality Leader

t-N-R_c_1_Ns_P_e_c_T_o_R-if-c-ar_1_a_P_. R_oq_u_c_-e_ruz _________ -++b-'-.,."9~------------'fi~+__.:f-1 1 BRANCHCHIEF Ghn5-hav1 Avv ua.5 NRC FORM 5915 PART 1 (10,2013)

INSPECTOR NOTES COVER SHEET

Licensee/Certificate Holder Licensee/Certificate Holder contacts and hone number Docket No.

Inspectors

Summary of Findings and Actions

Inspector Notes Approval Branch Chief Si nature/Date

GE-Hitachi Nuclear Ener America , LLC Mark Elliot, GEH Services Quality Leader Phone: 910-465-2085 71-00170 71-00170/2019-201 Ma 6-10, 2019 Vallecitos Nuclear Center 6705 Vallecitos Road Sunol, CA 94586 Carla Roque-Cruz, Team Leader, Safety Inspector Marlene Davis, Senior Safety Inspector Jon Woodfield, Safet Ins ector On May 6-10, 2019, the U.S. Nuclear Regulatory Commission (NRC) performed an announced inspection of GE-Hitachi Nuclear Energy America, LLC (GEH). The purpose of this inspection was to assess compliance of GE-Hitachi Nuclear Energy America , LLC (GEH), at the Vallecitos facility, to the requirements of Title 10 of the Code of Federal Regulations (10 CFR) Parts 21 and 71.

The inspection activities focused on management controls, and maintenance activities. No significant design activities were taking place at GEH Vallecitos related to Certificate of Compliance packagings. The team performed the exit meeting for this inspection on May 9, 2019.

The team identified one violation in the area of Instructions, procedures, and drawings, (10 CFR 71 .111) for GEH. The team dispositioned the violation as a Severity Level IV non-cited violation, which was consistent with Section 2.3.2 of the NRC Enforcement Polic.

Inspector Notes

The Vallecitos Nuclear Center (VNC) is a 1,600-acre nuclear research facility and the site of a former electricity-generating nuclear power plant located in Sunol, California . VNC is privately owned and licensed by the U.S. Nuclear Regulatory Commission (NRC) for commercial nuclear research and development. General Electric Hitachi Nuclear Energy (GEH), an affiliate of the GE Company, owns the facility. On October 10, 2017, the NRC staff reviewed and approved VNC's Quality Assurance Program (QAP) Manual for Radioactive Material Packages No. 0170, Revision 12, after the staff noted that the changes associated with revision 12 were not considered reduction of commitments in the QAP previously approved by the NRC.

From May 6-10, 2019, the NRC conducted an announced Title 10 of the Code of Federal Regulations (10 CFR) Part 71 team inspection at VCN. The purpose of the inspection was to assess GEH's compliance with 10 CFR Parts 21 and 71. The focus of the inspection was to determine whether GEH actions applicable to radioactive material packaging and transportation activities are in accordance with their NRG-approved QA program requirements.

Primary Inspection Procedures/Guidance Documents

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" Regulatory Guide 7.10, "Establishing Quality Assurance Programs for Packaging Used in the Transport of Radioactive Material"

INSPECTOR NOTES: AS DESCRIBED BELOW, THE TEAM PERFORMED AND DOCUMENTED APPLICABLE PORTIONS OF 02.02 THROUGH 02.10 OF INSPECTION PROCEDURE (IP) 86001 USED FOR THIS LIMITED SCOPE INSPECTION

02.02 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 effective.

The NRC team reviewed GEH's QA program manual , "Quality Assurance Program for Shipping Packages for Radioactive Material," Revision 12 and associated quality procedures in order to assess the effectiveness of the QAP implementation at VNC. The team verified that the overall QAP, as written, adequately addresses the applicable QA criteria of 10 CFR Part 71 used for the NRC regulated activities performed at VNC. Additionally, the team discussed portions of the reviewed documents with selected VNC personnel to determine whether activities subject to 10 CFR Part 71 were adequately controlled and implemented in accordance with the QAP. The team reviewed GEH's "Organization" section and organization chart for the QAP and noted that the QA functions and responsibilities have sufficient authority and organizational freedom to identity, evaluate, recommend solutions, implement corrective actions and stop unsatisfactory work related to quality- and safety related activities. The team also noted that the QA is organizationally independent of the operating functions.

The NRC team reviewed GEHNNC Quality Assurance Manual, Revision 77, and noted that implementing procedures are placed and effective for activities in the areas of administration, inspection, control of measuring and test equipment, procurement control, control of

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nonconformances, corrective actions and audits. In addition, the team noted through discussions with GEH and VNC personnel, that the QA personnel from both locations have open communication and interactions routinely. No concerns were identified by the team with the OAP.

02.03 Verify that provisions are in place for reporting defects, which could cause a substantial safety hazard, as required by 10 CFR Part 21

The NRC team reviewed GEH's working instructions Wl-16-108-07, "Reporting of Defects and Noncompliance under 10 CFR Part 21," Revision 5, and Wl-16-108-07-J01, "Part 21 Schedule Requirements," and noted that GEH has a well-defined and effective Part 21 process. The working instructions have clear roles and responsibilities for different staff and processes to identify, review and communicate potential Part 21 issues. The staff also noted that there is a connection between GEH's corrective action program and the identification of Part 21 issues. Further, as part of the corrective action process, the software used to create and manage corrective actions reports includes a section to assess the issues per the requirements in Part 21. During different tours of the facilities, the team noted that the Part 21 required documents are posted in conspicuous locations where the activities subject to Part 21 are conducted. No concerns were identified by the team with GEH's Part 21 program.

02.04 Interview selected personnel and review selected design documentation to determine that adequate design controls are implemented

VNC is one of multiple facilities under the blanket of GEH. Although VNC has a full scope NRC approved Part 71 OAP to perform design activities, VNC stated to the NRC team that currently there are no design activities being performed at the VNC location. The maintenance of the transportation packaging model 2000 (Certificate of Compliance (CoC) 9228) is performed at the VNC facility but the Coe holder is GEH in Wilmington, North Carolina . As a CoC holder, the North Carolina facility also has a full scope NRC approved Part 71 OAP and performs the design activities. Therefore, no design activities were reviewed at VNC and design activities at the North Carolina location will be reviewed during a future inspection.

02.05 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 CoC

The NRC team reviewed selected drawings, maintenance records and interviewed personnel to evaluate how VNC implemented a maintenance control program in accordance with their NRC approved QA Program, CoC conditions, and the requirements of 10 CFR Part 71 for the transportation of radioactive material. The team performed a review of the maintenance activities related to the GE 2000 packaging for a period of five years for model numbers 2001 and 2002. The team evaluated annual maintenance activities conducted at VNC and other various maintenance facilities, as applicable. The evaluation included a review of maintenance requirements identified in the Safety Analysis Report (SAR) and CoC, operations and maintenance specification, completed maintenance records, and personnel qualification training records.

Specifically, the NRC team reviewed Specification No. 22A9380, "Operations and Maintenance of Model 2000 Transport Package," Revisions 8 and 9; Quality procedure (QP) 10.3, "Inspection Reporting ," Revision 7; QP 20.5, "Dye Penetrant Procedure," Revision 6; QP 20.8, "Visual Inspection," Revision 1; Model 2000 Type B Package Annual Quality Inspection Records, dated

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October 2016-July 2017, Serial Number S/N 2002; and CP-20-05, "Qualifications of NOE Examination Personnel," Revision 8. Based on this review of the maintenance records and procedures, the team assessed that VNC used appropriate maintenance materials, tools and equipment to conduct the annual maintenance activities for the GE Model 2000 transportation package. The team verified that the inspections were comprehensive and met acceptance criteria for tests identified in the operations and maintenance specification. The team also verified the results of the visual weld inspection and helium leakage rate testing of the GE 2000 model numbers 2001 and 2002 and noted that VNC appropriately inspected attributes of the cask body, overpack, and cask lid. The team verified that maintenance personnel and technicians recorded the proper information on the applicable forms and data sheets as defined and required in the VNC quality procedures and maintenance specification. The team assessed that the maintenance program and tests satisfied the requirements identified in the GE 2000 SAR and CoC. However, the team discovered examples of VNC personnel failing to follow procedures.

In one case, VNC did not perform the helium leak rate test within the period specified in the Operations and Maintenance Specification No. 22A9380. VNC started the annual maintenance but did not complete the helium leak rate test until seven months after the due date. Further, VNC used a leak testing procedure under development to perform the overdue test. The team noted that this was contrary to the maintenance program in Section 8 of GE 2000 SAR and the operations and maintenance specification procedure. The team assessed that this was a violation of NRC requirements . Specifically, 10 CFR 71.111 , "Instructions, procedures, and drawings," requires, in part, that certificate holders shall prescribe activities affecting quality by documented instructions, procedures, or drawings of a type appropriate to the circumstances and shall require that these instructions, procedures, and drawings be followed. Contrary to the above, between October 2016 and July 2017, VNC did not follow the requirements prescribed in their operations and maintenance specification for the Model GE 2000 transportation package. Specifically, paragraphs 4.9 and 4.10 of the Operations and Maintenance Specification No. 22A9380, states, in part, that an American Society of Nondestructive Testing (ASNT) Level Ill examiner develop the periodic, and maintenance leak testing procedure, with the cask being tested before first use, after the third use, every twelve usages, or at least once within 12-month period prior to subsequent use, whichever comes first. VCN failed to perform this function as required . The team noted that this was one example of VNC failing to follow procedure. The team did verify that although the leak test was late, once performed the results met the acceptance criteria identified in the procedure.

The team discussed this issue with VNC during the on-site inspection week. The team dispositioned the violation using the traditional enforcement process in Section 2.3 of the Enforcement Policy. The team determined the violation was of 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 6.c, in that this affected ITS equipment and could call into the results of the leak rate test. The team determined that the violation was a Severity Level IV violation (i.e., more than minor concern that resulted in no or relatively inappreciable potential safety or security consequence) . The team decided to treat the Severity Level IV violation as a non-cited violation, which was consistent with Section 2.3.2 of the NRC Enforcement Policy. VNC acknowledged the information presented and documented the violation in their corrective action program as condition report (CR) 31712 for resolution.

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02.06 Observe activities affecting safety aspects of the packaging {such as maintenance and/or testing) to verify that they are performed in accordance with approved methods, procedures, and specifications

The NRC team reviewed Section 6, "Document Control ," and Section 17, "Quality Assurance Records," of the VNC QAP manual for Shipping Packages for Radioactive Material, QAP-1 Revision 12. In addition, the team specifically reviewed CP-17-101 , "Product Quality Assurance Records," Revision 8.1; CP-17-104, "Nuclear Material Safeguards Records Retention," Revision 3; Safety Standard 25.1 , "Document Control, " Revision 9; and Wl-17-101-01 , "Processing of Quality Records," Revision 7.0 to verify that document control is being properly implemented.

The NRC team interviewed VNC staff regarding their document control process and noted that all documents at VNC are maintained as on-line electronic files. Following the revision of an on­line document, all affected VNC employees are notified by e-mail. Electronic document copies are considered the controlled copy and any paper copies are designated as non-controlled copies. Each VNC department is responsible for obtaining the appropriate reviews and approvals of their documents prior to final issuance for implementation. As part of the inspection, VNC staff demonstrated how the on-line document revision notification system is used by the staff for document and records control. The system used by VNC is called Training Tracker. GEH staff present during the inspection stated that although Training Tracker is used to notify employees of revisions of controlled copy revisions, the system is still a work in progress and that record keeping requirements such training requirements for workers are tracked by other methods. VNC also stated that all quality records associated with transportation packaging maintenance are not actually completed and put in the records system at VNC. The quality records developed at VNC are sent electronically to GEH in Wilmington , North Carolina for final review and closeout and then placed as permanent, quality records and documents in the system. The team asked if form CP-17-101-F01 , "Record Transmittal Sheet," from procedure CP-17-101 was used to send the VNC quality records to GEH for final processing and VNC stated that the form was not used, and it was an informal process for sending the documents. Since the actual processing of records is performed at GEH in North Carolina, a formal team review of records will be performed during an upcoming inspection of the North Carolina facility. During the inspection, the team noted that Safety Standard 25.1, Revision 9 was missing the required "reviewed" signature for controlled documents. The team pointed out this oversight to VNC during our daily de-brief and VNC created CR 31440 to have the proper review signature added.

The team determined the VNC document and records control process and procedures were adequate and being followed by VNC personnel in their limited role . No concerns were identified by the team in the area of document control.

The NRC team reviewed Section 12.0, "Control of Measuring and Test Equipment," of VNC QAP manual for Shipping Packages for Radioactive Material, QAP-1 Revision 12. In addition , the team specifically reviewed procedures CP-12-101, "Calibration Control Program," Revision 6.0; QP 30.1, "Gage and Instrument Control ," Revision 7; and SD-12-J001 , "Handling and Storage of Measuring & Test Equipment," Revision 0.0 associated with Measuring and Test Equipment (M&TE) to verify that they were being properly implemented. The NRC team noted that VNC does not maintain a master cal ibration list for the limited number of calibrated M& TE used at the site to perform transportation packaging maintenance. The team did verify that per CP-12-101 the GEH facility in Wilmington, North Carolina was maintaining a M& TE Control System that identifies each item of M& TE requiring recalibration and includes the VNC maintenance M& TE. The calibration history and current calibration status

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is maintained for each VNC item in the M&TE Control System. The team requested a list of the calibrated maintenance M& TE used at VNC and requested the current calibration records for a sampling of M&TE equipment. Items selected from the list included: Digital Thermometer, Dial Caliper, Depth Micrometer, Digital Dynamometer, and Torque Wrench.

The NRC team verified that the sampled M& TE was calibrated by outside Certified Laboratories at the required frequency as required by procedure and the laboratories were on the VNC approved suppliers list. The team also verified that the calibration records included the date of calibration, identification number of equipment, and date when the next calibration was required. The team physically inspected the selected M& TE at VNC and found stickers attached to the equipment indicating the serial number of the equipment and the due date of the next cal ibration as required by procedure. The team also noted that some re-calibration dates on the equipment had passed. VNC personnel stated that some maintenance M& TE might not be used for a long time based on the work load for packaging maintenance at VNC. Therefore, some M& TE is placed in long term storage until it is needed and then re-calibrated prior to its next use. The team requested the documentation from the M& TE Control System identifying that the equipment was in long term storage and not needed to be calibrated until prior to its next usage. The team reviewed the documentation provided and determined the VNC has appropriate controls in place to prevent usage of M& TE prior to re-calibration and removal from long term storage.

The NRC team verified that the reviewed procedures contained guidance on addressing M& TE that is found to be out of calibration . Per procedure, all M&TE recalibration records are to be reviewed upon receipt from the calibration laboratory to determine if the calibration of the instrument during its prior use was acceptable. In addition, when M& TE is found to be out of calibration, an evaluation is to be made to document the validity of previous inspections or test results performed with the M& TE. The team reviewed several deviation reports and condition reports associated with the VNC M&TE and found their resolution adequate. Based on its review, the team determined that VNC's M&TE procedures are adequate to ensure that M&TE is being properly identified for calibration and re-calibrated at the required intervals. No concerns were identified in the area of M& TE.

02.07 Review selected drawings and records, and interview selected personnel, to verify that the procurement specifications for materials, equipment, and services received by the QA Program holder meet the design requirements

The NRC team reviewed selected records , documents, and interviewed personnel to evaluate VNC material and fabrication process controls for receipt inspection, and handling and storage of important to safety (ITS) components used in the GE 2000 transportation packaging. The team evaluated how VNC controlled the handling and storage of their spare part inventories including how personnel verify the shelf-life of stored components. The team reviewed implementing QP 10.5, "Control of Material Storage, " Revision 5 and work instruction Wl-10-100-02, "Receiving Inspection - Vallecitos Nuclear Center," Revision 0. The team also observed the spare parts storage area.

The NRC team assessed that VNC had a receipt inspection program to accept spare parts used for maintenance activities. The team verified that ITS components observed in the storage area had part numbers, heat numbers, and other appropriate means to identify the components including expiration dates for shelf-life, as applicable. However, the team did identify that VNC did not establish measures to control the parts and material flow for traceability in accordance with QP 10.5. Specifically, paragraph 5.1 of QP 10.5, states, in part, that a material log book

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will be maintained to record material flow and traceability. The paragraph further states that as a minimum, entries shall include the receiving inspection report, location and complete description of the material. After interviewing VNC personnel, the team noted that VNC did not have a material log book for material traceability documentation of the ITS components used for maintenance activities as required by their procedure. The team captured this issue as another example to the violation of the requirements of 10 CFR 71.111 for failure to follow procedures discussed above. VNC created CR 31461 for failure to keep a material log book and will address this issue.

02.08 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 NRC team reviewed VNCs nonconformance program and corrective action program to assess the effectiveness of controls established for the processing of nonconforming materials, parts, or components , and that personnel completed corrective actions for identified deficiencies in a technically sound and timely manner. The team reviewed VNC's OAP manual for Shipping packages for Radioactive Waste, Revision 12, Section 15 for nonconforming material and Section 16 for corrective actions; CP 50.1, "Nonconformances," Revision 7; CP-16-108, "Corrective Action Program," Revision 11; Wl-16-108-01, "Condition Review Process," and Wl-1620-106-06, "Corrective Action Program Qualifications. "

The NRC team noted that VNC has a system in place for reporting and correcting material nonconformances. The process guides the staff to create deviation reports to assess and disposition nonconforming material. This process includes a review by the Material Review Board (MRB). The level of review by the MRB will vary depending on the disposition of the item(s) and it can escalate from a supervisory review for re-work or scrapping the item to a formal review for repair or use-as-is where a customer representative is required during the review and disposition process. The procedure also addressed segregation of nonconforming material and roles and responsibilities for VNC staff involved in the process. The team reviewed a sample of nonconforming reports and noted that the MRB performed a review in accordance with the disposition for the item. The team also noted that there is a link between programs for those instances where a deviation report and a CR are open to address the nonconforming material/issue. DR 437098797-023 opened for calibration performed by sub-tier supplier that didn't have the required accreditation certifications was one example of a deviation report that was reviewed per the procedure requirements, had a CR opened as a result and the dispositioned, follow-up actions and closure were adequate and performed in a timely manner. All the deviation reports reviewed had been adequately dispositioned and closed in a timely manner.

The NRC team reviewed VNC's corrective action program (CAP) as well to assess the effectiveness of the measures established to identify and correct issues, and if required, prevent recurrence. The team noted that CP-16-108, Revision 11, provided the requirements and responsibilities of the CAP and the related processes of documenting conditions adverse to quality including corrective and preventive actions, review, approval and evaluation of CRs. VNC CAP encompasses condition reporting, investigation, analysis, corrective action, preventive action, trend analysis and reviews. The team noted that the procedure includes a process flowchart to guide all employees through the corrective action process. The team also noted that GEH has trained staff to be part of the MRB and address corrective actions.

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The NRC team reviewed a sample of CRs encompassing opened to address adverse conditions in the areas of staff training, audit findings, engineering and NRC inspection findings. The team verified that the CRs were opened soon after the adverse condition was identified and that VNC performed extend of condition reviews when required by the condition. The team noted that

. assessing the conditions for potential Part 21 implications is also part of the process. The team also noted that a CR can be initiated by any team member at VNC and that the staff uses a corrective action form to document/track corrective actions. This form contains a description of the issue, actions taken, responsible department, root cause, Part 21 potential and actions taken to prevent recurrence. The team reviewed CRs 26142, 26085, 25871, 18596 and 26014 and noted that most of these CRs were adequately documented and provided evidence of corrective actions performed by VNC to address the conditions adverse to quality and close the CRs. The staff found only one example were a CR (18596) was closed to a future action which is not allowed per VNC procedures. The team did verify that the all actions for CR 18596 had been completed.

The NRC team interviewed VNC's QA personnel on the Nonconformances and Corrective Action process and found that they were knowledgeable and understood these processes as described in the QA Manual. No concerns were identified by the team in the processing of nonconformances and CRs by VNC.

02.09 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) team are cognizant and provide appropriate oversight

The NRC team reviewed selected records and procedures and interviewed QA personnel to assess if individuals who perform quality-related activities are properly trained and qualified. The team reviewed CP-20-301 , "Quality and Technical Training;" CP-20-310, "Technical Training and Proficiency;" CP-20-312, "ANSI Qualifications of Inspections, Examination and Testing Personnel; " CP-18-03, "Lead Auditor Certification and Audit Team Training Requirements; " and Wl-1620-106-06, "Corrective Action Program Qualifications."

The NRC team selected a sample of VNC personnel qualification records in the areas of maintenance and audits to assess qualification and certification in accordance with the requirements in the QA manual and procedures. During the inspection the team learned that some training records for VNC employees are kept in hard copies and are still to be added to the Training Tracker system. The team reviewed the latest maintenance training records for the VNC workers that perform transportation packaging maintenance and found them acceptable. All the qualification packages reviewed by the team contained all information required by VNC procedures including education, tests scores, experience and re-certification dates. The team noted that all the qualifications were current and signed in accordance with procedures. The team found one certification package where the experience indicated for the staff did not align with his training. According to the experience the staff had performed non-destructive examination (NOE) that he was not qualified to performed. The team discussed this issue with GEH staff present during the NRC inspection. After talking with the individual GEH staff stated that the information is incorrect, and that the individual did not perform NOE activities. GEH opened CR 31439 to address this issue and the team indicated that it will look for the resolution of this CR during the upcoming inspection at GEH in Wilmington, North Carolina.

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The team assessed that VNC implemented the applicable sections of the QA manual, and applicable procedures for the qualification of personnel , and used the proper forms to document the qualification records. The team assessed that personnel were appropriately qualified according to applicable requirements. No issues or concerns were identified with VNC's program for staff training and qualification.

02.10 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 manner

The NRC team reviewed the internal audit program as described in Section 18, "Audits" of VNC's QA Manual. The review was to verify that the program was comprehensive and that audits were scheduled and conducted periodically in accordance with approved procedures by trained and qualified audit personnel. According to Section 18 all audits are to be performed by trained personnel not having direct responsibilities in the areas being audited. Additionally, audits of safety-related activities are conducted at least on an annual basis. The team also reviewed CP-18-100, "Quality Assurance Internal Audit Requirements," Revision 9.1; CP-18-03, "Lead Auditor Certification and Audit Team Training Requirements, " Revision 6.0; and CP-18-02 , "Supplier Audits and Commercial Grade Surveys," Revision 15.1 and the 2019 schedules for internal and supplier audits.

The NRC team noted that the schedules have the dates of the last audit and the scheduled dates for the upcoming audits. The team reviewed the last GEH internal audit performed by the company Global QA, NQA-2018-12 and VNC internal audit performed by GEH staff, NQA-2018-05, both audits took place in 2018. While reviewing the audit reports the team noted that the all the areas of QA were audited and documented using a checklist. The team also noted that issues found during the audit were entered into VNC's corrective action program for follow-up and closure of these findings. The team also reviewed the qualifications of the lead auditor and auditors and verified that the auditor's qualification packages were complete with information on the auditor's education, training, and experience as required by VNC QA manual and procedures.

The NRC team reviewed the audit report for the audit supplier audit GEH performed at IAI lngenieria SA de CV, IAl-2019-01 in 2019. The scope of the supplier audit was nuclear plant services including modifications, repairs , maintenance, NOE and QC inspection services. The team noted that all applicable areas were audited and that GEH used CP-18-02-F02, "Supplier Audit Report Form" to document the audit. Additionally, the team noted that GEH opened CRs for all the deficiencies identified during the audit. The team also reviewed the certification package for the lead auditor and verified that the lead auditor was trained and certified as a lead auditor in accordance with the QA manual and procedures.

The NRC team determined that the VNC's audits reviewed were comprehensive in nature, performed using a checklist, and conducted by qualified lead auditors. The team also noted that VNC initiated CRs to address and document the issues and findings identified during the audits and that corrective actions were taking in a timely manner. Additionally, the team noted that VNC's scheduling and frequency of audits is adequate and in accordance with its QA program. No concerns were identified in the area of audits.