ML20309A505
| ML20309A505 | |
| Person / Time | |
|---|---|
| Site: | 07109168, 07109204, 07100935, 07109321, 07109320 |
| Issue date: | 11/03/2020 |
| From: | Jeremy Tapp NRC/NMSS/DFM/IOB |
| To: | Byars R Energy Solutions |
| JETapp - NMSS/DFM/IOB - 301.415.8047 | |
| Shared Package | |
| ML20309A502 | List: |
| References | |
| IR 2020201 | |
| Download: ML20309A505 (11) | |
Text
INSPECTOR NOTES COVER SHEET Licensee/Certificate Holder EnergySolutions (name and address) 740 Osborn Road Barnwell, SC 29812 Licensee/Certificate Holder Mr. Richard Byars, Group Director QA contact and phone number 803-758-1808 Docket Nos. 71-0935, 71-9168, 71-9204, 71-9320, 71-9321 Inspection Report No. 71-0935/2020-201 Inspection Dates(s) September 14 - October 2, 2020 Inspection Location(s) 740 Osborn Road Barnwell, SC 29812 (Remote Inspection)
Inspectors Jeremy Tapp, Team Leader, Safety Inspector Jon Woodfield, Safety Inspector Matthew Learn, Safety Inspector Marlone Davis, Senior Safety Inspector Earl Love, Senior Safety Inspector Summary of Findings and The purpose of the inspection was to verify the adequacy of Actions activities related to design, modification, fabrication, assembly, testing, procurement, repair, and maintenance of transportation packaging(s) performed at the Energy Solutions (ES) Barnwell, SC facility. The focus of the inspection was to assess and determine whether ES 10 CFR Part 71 activities are in accordance with commitments and requirements specified in the Certificate of Compliance (CoC), Safety Analysis Report (SAR), NRC-approved Quality Assurance Program (QAP) for Transportation of Radioactive Materials, and 10 CFR Parts 21 and 71 requirements.
The team of inspectors determined that the transportation packaging was safe to use based on a review of selected quality records and other supporting documentation. The team assessed that ES implementation of its NRC-approved QAP was adequate.
The team identified one non-cited violation related to instructions, procedures, and drawings for the ES QAP. ES acknowledged this finding during an exit teleconference on October 2, 2020 and documented this non-cited violation in the corrective action program.
Lead Inspector Signature/Date Digitally signed by JEREMY E.
Jeremy Tapp JEREMY E. TAPP TAPPDate: 2020.11.03 09:40:49 -05'00' Inspector Notes Approval Leira Y. Cuadrado- Digitally signed by Leira Y.
Branch Chief Signature/Date Leira Cuadrado Cuadrado-Caraballo Caraballo Date: 2020.11.03 11:53:33 -05'00' Page 1 of 11
Inspector Notes On July 5, 2019, the U.S. Nuclear Regulatory Commission (NRC) approved the latest submitted Quality Assurance Program (QAP) from EnergySolutions (ES) for radioactive material packages designated under docket number 71-0935. The approval satisfied Title 10 of the Code of Federal Regulations (10 CFR) Part 71 , "Packing and Transportation of Radioactive Material" requirements.
During the week of September 14, 2020, with further review through October 2, a team of NRC inspectors conducted remote inspection activities applicable to the transportation of radioactive material packaging performed at ES' Barnwell, South Carolina facility. The purpose of the inspection was to verify the adequacy of activities related to the design, modification, fabrication, assembly, testing, procurement, repair, and maintenance of transportation of radioactive material packaging associated with ES. The team performed these activities as follows: a review of the QAP implementing procedures and instructions; inspection of selected documents, records, and drawings; personnel training and qualifications; and interviews with personnel responsible for various engineering, maintenance. procurement, and quality program activities of the Certificate of Compliance (CoC) holder, ES. The team focused the review on the following transportation packagings registered to ES:
Model # Package ID# Docket # Certificate #
8-120B USA/9168/B(U)-96 71-9168 9168 10-160B USA/9204/B(U)F-96 71-9204 9204 MIDUS USA/9320/B(U)-96 71-9320 9320 3-60B USA/9321/B(U)-96 71-9321 9321 The team conducted the inspection activity requirements in accordance with NRC Inspection Procedure 86001, "Design, Fabrication, Testing, and Maintenance of Transportation Packagings." The team performed a preliminary exit briefing on September 18, 2020, at the completion of the inspection week. The team conducted the final telephone exit briefing on October 2, 2020. During the telephone exit briefing, the team informed ES that the NRC identified one Severity Level IV violation of NRC requirements associated with 10 CFR 71.111, Instructions, Procedures, and Drawings. Specifically, ES did not perform periodic maintenance activities in accordance with the requirements of ES QAP implementing procedure TR-OP-52.
The NRC identified finding is being treated as a non-cited violation consistent with the NRC Enforcement Policy Section 2.3.2. ES acknowledged the information presented and documented the violation in the corrective action program.
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INSPECTOR NOTES: APPLICABLE SECTIONS FROM IP 86001 WERE PERFORMED DURING THE INSPECTION WITH RESULTS DOCUMENTED BELOW UNDER THE BASIC HEADINGS OUTLINED IN NUREG-6314 1.0 Management Controls Quality Assurance Policy The team reviewed EnergySolutions (ES) Quality Assurance Program (QAP), Revision 6 and implementing procedures and assessed the effectiveness of the Quality Assurance (QA) program implementation at ES. The QAP Revision 6 was submitted to the NRC on June 14th, 2019, and was reviewed and approved by the NRC on July 5, 2019. The QAP has not been revised since it received NRC approval.
The team discussed portions of the reviewed documents with selected ES staff to determine whether activities subject to 10 CFR Part 71 were adequately controlled and implemented under ES NRC approved QA program. Further, the team reviewed the ES quality organization chart and interviewed ES QA personnel to assess their organizational independence from cost, schedule, and production activities.
The team reviewed procedures and documents regarding training, qualification, and certification of personnel involved in quality activities. The team reviewed the qualifications and training for selected Quality Engineers to determine if they met the requirements stated in the QA program.
In addition, the team reviewed training records of a random selection of employees in quality related positions to determine if they received the required QA indoctrination and annual refresher training.
The team determined that quality assurance controls at ES were adequate and in accordance with the NRC approved QAP.
Nonconformance and Corrective Action Controls The team reviewed selected records and interviewed personnel to verify that ES effectively implemented the nonconformance control and corrective action program (CAP). Specifically, the team reviewed ES policies and the following approved implementing procedures that govern the nonconformance and CAP for ES to verify compliance with applicable requirements to 10 CFR Part 71:
ES-AD-PR-006, Reporting of Defects and Noncompliances (10 CFR 21), Revision 6 ES-AD-PR-008, Condition Reports, Revision 12 ES-AD-PR-013, Control of Nonconforming Items, Revision 4 ES-AD-PR-015, Stop Work Order, Revision 4 ES-AD-PR-019, 10 CFR 71 Reporting, Revision 2 Page 3 of 11
The team discussed the nonconformance and CAP controls with the ES staff and reviewed a sample of nonconformance reports (NCRs) and corrective action reports (CARs) for appropriate disposition. The team also determined whether ES completed CARs and NCRs, as appropriate, for identified deficiencies in a technically sound and timely manner.
The team sampled twelve NCRs since 2015, which consisted of a variety of component types and included a mix of use-as-is, repair, and rework component dispositions. The team determined that ES appropriately dispositioned the nonconformances reviewed and closed them in a timely manner commensurate with the safety significance, in accordance with the quality procedure.
The team sampled 12 CARs since 2015, which are written for conditions adverse to quality.
The sample included several apparent cause analyses. The team reviewed corrective actions associated with two NRC identified violations documented in Inspection Report Numbers 71-0935/2016-201 and 71-0935/2015-202. The team found that the corrective actions taken were adequate and completed in a timeframe commensurate with the safety significance of the issue, when possible.
Further, the team reviewed program controls for 10 CFR Part 21, Reporting of Defects and Noncompliances, including ES-AD-PR-006. The team verified that ES procedure adequately implemented the requirements of the regulation. No issues were identified by the team regarding 10 CFR Part 21 program controls or implementation at ES.
Overall, the team concluded that ES had an adequate nonconformance control and CAP in place to identify, track and resolve quality related deficiencies and deviations. No issues of significance were identified.
Documentation Controls The team reviewed the sections of ES-QA-PG-001, Quality Assurance Program, Revision 6 specifically related to document control and quality assurance records. The team also reviewed the following documents/procedures associated with document control and quality records to determine if ES was following its procedures in controlling its documentation and records:
ES-AD-PR-001, Document Preparation, Revision 10 ES-AD-PR-002, Document Control, Revision 4 ES-AD-PR-021, OnBase Electronic Records System, Revision 1 ES-QA-PR-005, Records, Revision 4 ES-QA-PR-028, Certificate of Conformance, Revision 1 ES-QA-PR-031, NRC Certified Components Quality Assurance Records, Revision 4 ES-QA-PR-034, Handling of Electronic QA Records, Revision 1 ES primarily uses an internal electronic Intraweb, which is only accessible by authorized ES personnel, for the dissemination of information and documents. All new and revised documents Page 4 of 11
require an author/originator, reviewer, and approver. Generally, only electronic signatures are applied to documents. ES Document Control is responsible for maintaining the Intrawebs controlled document content and for authorizing and directing the Gatekeeper of the Intraweb.
The Gatekeeper is the ES individual assigned to manage the Intraweb controlled document content by making additions, changes, and deletions. The current revision of any procedure, drawing, or other type document will be on the Intraweb for ES staff to use.
ES document control does issue hard copies of quality documents to some staff. The team reviewed the ES list of individuals with hardcopies of controlled documents. The team reviewed the document control transmittal forms and return receipt updates sent to and returned from hardcopy holders when updates were sent out. Once a year, hardcopy holders are issued a verification form from document control with the current revisions of documents in their possession. They return the verification form to document control after checking the revisions.
The team verified this process was being followed and the verification forms maintained. No concerns were identified.
All quality procedures are required by procedure to be reviewed every two years. ES document control is responsible for tracking biennial review commitment dates and notifying responsible managers of procedure reviews that are coming due. The team selected a sample of procedures to review the biennial review forms and assessed the forms were properly filled out and retained.
ES uses OnBase, an Electronic Document Imaging System, for the generation, distribution, use, maintenance, storage, retention and disposition of electronic records. OnBase is the official records system to be used for archiving all ES Quality Assurance electronic records. Only authorized ES personnel have access to OnBase. Electronic records and associated hardware and software are protected by virus protection software that is updated regularly. Electronic records are stored in an environment controlled for human occupancy. Electronic record files are backed up daily and dual storage is provided at a different location. Types of record media may include paper, electronic (magnetic or optical) or specifically processed media such as radiographs, photographs, negatives, and microforms.
ES-QA-PR-031 provides direction on how long the various Quality Records associated with transportation packagings shall be retained.
Since this was a remote inspection, the team was unable to physically inspect the ES document control center. However, the procedures require that an inspection of the physical condition of records in the document control center records storage area and the offsite storage facility be performed and documented by document control on an annual basis. ES provided the most recent records of these two internal document control inspections for review by the team. No issues were identified on the internal ES inspection reports of these physical areas and the stored records.
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The team reviewed the ES fabrication Certificate of Conformance and fabrication final document package (FDP) specific to MIDUS transportation packaging M-103 and assessed the FDP to be thorough and complete with the required quality records.
The team assessed that adequate document control and records management exists at ES.
Overall, no concerns were identified by the team in the ES documentation control or quality records areas.
Audit Program The team reviewed the ES audit program to determine if ES scheduled, planned, and performed internal and external audits and surveillances in accordance with their approved implementing procedures. The team selected a sample of audits and surveillances from 2015 of the last NRC inspection to March of 2020. The team reviewed the audit results to determine if ES identified deficiencies and whether ES addressed these deficiencies within their corrective action program. The team also evaluated whether ES provided adequate supervision with quality assurance personnel for appropriate oversight of important to safety activities.
Additionally, the team reviewed applicable procedures and records to determine if individuals performing quality related activities established and maintained training qualifications and certifications. The team selected a random sample of audit personnel records including lead auditors. The team reviewed the following ES procedures and standards:
ES-QA-PG-001, Quality Assurance Program, Revision 6 ES-QA-PR-002, Quality Assurance Surveillances, Revision 3 ES-QA-PR-008, Auditor Qualification, Revision 3 ES-QA-PR-018, Quality Assurance Audits, Revision 7 Overall, the team assessed that for the audits and surveillances sampled, ES generally conducted oversight with qualified and certified personnel and scheduled and evaluated applicable functional areas of the quality assurance program. The team assessed that ES appropriately identified issues and implemented corrective actions in a time frame commensurate with their safety significance when auditors identify findings or observations during audits or surveillances.
2.0 Design Controls Design Development The team reviewed the section of ES-QA-PG-001, Quality Assurance Program, Revision 6 specifically related to design control. The team also reviewed the following documents/procedures associated with design control to determine if ES was following the procedures in developing design documents:
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CG-EN-PR-201, Design Control, Revision 1 CG-EN-PR-202, Preparation and Checking of Engineering Documents, Revision 1 CG-EN-PR-203, Calculations, Revision 2 CG-EN-PR-204, Control and Use of Acquired Analytical Software, Revision 1 CG-EN-PR-205, Control and Use of Company Developed Automation Software, Revision 0 CG-EN-PR-206, Quality Level Assessments for 10CFR71/72 SSCs, Revision 0 CG-EN-PR-207, Engineering Personnel Qualifications, Revision 0 ES provided a list of all engineering change notices (ECNs) performed on its four transportation packagings since the last NRC inspection performed in 2016. Only the MIDUS model had design changes made to it since 2016 to add solid contents as an NRC approved content for transportation. Prior to the changes, the MIDUS had only been approved for liquid contents.
The design changes were needed to support the fabrication of six new MIDUS units for a client and their required solid contents specifications. Therefore, the team reviewed this most recently performed MIDUS design change which also required an NRC CoC and Safety Analysis Report (SAR) amendment to add the additional approved content for transport.
The team reviewed the design plan required by procedure to modify the design and fabricate six new MIDUS units for ES client. The team assessed that the plan was thorough by providing a description of the project, listing outputs, listing key personnel, listing key inputs, providing the design phases, and specifying the need for a system design verification. The team also verified that the required NRC-Certified Design form was attached and properly signed off by the appropriate approvers.
The team reviewed several revisions of the Design Release forms for the project where all the quality documents associated with the project were listed with their current revision. Documents listed included specifications, technical reports, calculations, drawings, and SAR page and licensing drawing revisions. The team assessed the design release forms to be very detailed and contain all the proper electronic signatures per procedure. The team also reviewed the System Design Verification (SDV) form for the project where all the ECNs for the project were listed with other revised design documents. An SDV checklist was also properly filled out and the SDV electronically signed. No concerns were identified by the team.
The team reviewed several of the ECNs listed on the SDV and verified that for changes/revisions to drawings due to the various ECNs, the correct ECN was properly incorporated onto the drawing and the drawing revision block properly identified the ECN. In addition, the team reviewed CCA-000012, Fabrication Specification for the MIDUS Transportation Cask, Revision 0, and determined it contained the required signatures and was very detailed with requirements and responsibilities defined.
The team reviewed the ES computer software listing form which lists the programs that have been commercial grade dedicated for use in performing quality related analysis. The list has five programs on it and the team focused on the ANSYS/LS-DYNA (version 19.2) program which had been used to perform analysis on the initial MIDUS design project. It was noted that Page 7 of 11
a prior version of the ANSYS/LS-DYNA software (now retired) had been used during the initial MIDUS design. The team requested the following documentation for the ANSYS/LS-DYNA software which is required by procedure to qualify a commercial grade software program for quality work: Commercial Grade Software Dedication Plan, Software Qualification and Validation Plan, Software Validation Report, and Software Installation and In-use Test Log. The team assessed all the documents to be in accordance with procedure CG-EN-PR-204 with no concerns. The team also reviewed the process for ES to perform reviews of software error reports for any effects on computer analyses previously performed and specifically the software error evaluation documentation for ANSYS/LS-DYNA. The team determined ES was following its procedures with no concerns.
The team reviewed a shielding calculation performed to support the new solid contents for the MIDUS. This calculation used the Monte Carlo N-Particle Transport software which had been qualified for use at ES. The team assessed the calculation to be compliant with CG-EN-PR-203.
The team selected a sample of ES engineering staff names that were involved in some of the engineering documents and drawings reviewed by the team and requested their qualification records. The team reviewed their qualification records for compliance to CG-EN-PR-207 and assessed that all ES engineering personnel selected for review were properly qualified.
The team assessed that overall, ES was effectively implementing its design control procedures as demonstrated through the review of the most recent MIDUS amendment. The team found that all engineering quality documents were developed and processed in accordance with the applicable procedures and received the proper independent verification reviews and approvals.
No concerns were identified by the team in the design control area.
Modifications The team reviewed the latest ES amendment submitted to the NRC for its MIDUS transportation packaging as discussed above. The team reviewed all the procedures associated with performing initial designs and making modifications to designs. The MIDUS amendment to add solid contents was submitted to the NRC previously and received NRC approval. The team also had no concerns during its review of the latest MIDUS amendment and ES processes for performing it.
3.0 Maintenance Controls Maintenance Activities The team reviewed a selection of periodic or annual maintenance activities performed for the 8-120B, 10-160B, and 3-60B packagings through a review of records and interviews with ES personnel. For the 8-120B and 10-160B packagings, the team verified for the maintenance records reviewed that the work was performed in accordance with LG-MN-PR-001, Inspection Page 8 of 11
and Maintenance of NRC Licensed 8-120B & 10-160B Shipping Casks, Revision 6, as applicable. The team also verified that the requirements in LG-MN-PR-001 adequately implements the maintenance requirements in Chapter 8 of the 8-120B SAR. The team did not identify any concerns regarding the maintenance performed for the 8-120B and 10-160B packagings.
The team also reviewed a selection of periodic maintenance records for the 3-60B packaging.
Specifically, the team reviewed TR-OP-52, 3-60B Operations and Maintenance Manual, Revision 0 to determine if the required periodic maintenance was performed for the maintenance activities reviewed from 2019 on cask number 1. The team found that the required maintenance of O-rings and seals was performed, but the periodic inspection and maintenance of fasteners and threaded holes and periodic maintenance of exposed interior and exterior surfaces required by CS-FP-PR-016, 3-60B Shipping Cask: Periodic Inspection and Maintenance of Fasteners & Threaded Holes, Revision 0 and CS-FP-PR-017, 3-60B Shipping Cask: Periodic Maintenance of Exposed Surfaces, Revision 0, respectively, was not performed.
Section 8 of TR-OP-52 states, in part, that maintenance activities are controlled by procedures as shown in Figure 4. Figure 4 shows the periodic, 12-month maintenance activities that includes CS-FP-PR-016 and CS-FP-PR-017.
In addition, Section 8.1.3 of TR-OP-52 for periodic inspection and maintenance of fasteners and threaded holes states, in part, that CS-FP-PR-016 provides step by step instructions in accordance with the SAR, and Section 8.1.4 for periodic maintenance of exposed surfaces states, in part, that CS-FP-PR-017 provides instructions as required by the 3-60B CoC.
Therefore, the team determined that not all periodic maintenance was being performed as stated in Chapter 8 of the SAR and required to be performed by Condition 6(b) of the 3-60B Certificate of Compliance Number 9321, Revision 3, specifically fasteners/threaded holes and exposed surfaces. The team noted that ES performed pre-use inspections of fasteners/threaded holes and exposed surfaces as a part of the performance of CS-FP-PR-007, Receipt of Unloaded 3-60B Shipping Cask and Preparation for Loading, Revision 1, however, the scope of the procedural requirements in CS-FP-PR-007 was not as comprehensive or detailed as those in CS-FP-PR-016 and CS-FP-PR-017. The one applicable item that did not receive either a pre-use or periodic inspection was the nameplate and package markings, but are verified during shipment activities and used during package assembly, respectively. It was determined that these periodic maintenance procedures have not been performed for the two 3-60B packages that have been in use. The 3-60B cask number 1 has been in use since March 2016 and cask number 2 since that time.
Contrary to the above, since March 2016, the team determined that ES failed to follow procedure TR-OP-52 and perform the required periodic maintenance per CS-FP-PR-016 and CS-FP-PR-017 on the 3-60B packages that have been in use. This is a violation of 10 CFR 71.111, Instructions, procedures, and drawings for failure to follow procedures. 10 CFR 71.111 requires, in part, the 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. The team determined Page 9 of 11
that the violation was more than minor because the failure follow procedures to perform all required periodic annual maintenance, if left uncorrected, represents a failure to implement procedures that has the potential to render the quality of the packagings indeterminate. The team evaluated the violation in accordance with Section 2.3 of the NRC Enforcement Policy and characterized the finding as a non-cited Severity Level IV violation. ES identified this issue in condition report ES-COM-CR-2020-245, dated 9/21/2020. As an immediate corrective action, ES took the affected packagings out of service until all required periodic inspections are performed. ES is also planning to provide the necessary information to the users of the 3-60B package since March 2016, so the required 71.95 reports are issued because, as stated above, condition 6(b) of the CoC was not followed for these shipments.
The team reviewed selected drawings and records to verify that for the procurement specifications reviewed for materials, equipment, and services performed and received by ES met design requirements. The team also reviewed the following documents/procedures associated with procurement to determine if ES was following the procedures as required:
ES-QA-PR-003, Supplier Evaluation, Revision 10 ES-AD-PR-018, Receipt Inspection, Revision 4 The team reviewed 4 procurement document packages from approved suppliers for important-to-safety (ITS) category A components that included the purchase of Helicoils, pressure gauges, O-rings, and threaded inserts. For each of the procurement packages reviewed, the team determined that the procurement was made consistent with their importance to safety according to the design requirements; the items were appropriately described consistent with the design documents; the information received from the supplier, including Certificates of Conformance and test reports, was adequate and met the design requirements; and ES receipt inspection form and any applicable Quality Control (QC) checks were performed as required. In addition, the team verified that the suppliers were on the ES Approved Suppliers List (ASL), dated July 13, 2020, as updated.
The team reviewed the external audits and supplier evaluations for the suppliers of the above procurement packages. Each supplier was audited by the Nuclear Industry Assessment Corporation (NIAC) and evaluated and accepted by ES as required for continued placement on the ASL. The team determined that the scope of the NIAC audits were comprehensive and applicable to ES procurement activities. Annual supplier evaluations for each were also performed as required. No concerns were identified regarding the procurement from approved ITS Category A suppliers.
In addition, the team reviewed selected drawings and records to verify that selected commercial grade dedication plans and associated activities performed by ES met design requirements.
The team also reviewed ES-QA-PR-010, Dedication of Commercial Grade Items/Services, Revision 8, to determine if ES was following the procedure as required. The team reviewed the commercial grade dedication documents specific to commercial grade item dedication packages CGI-16-003 for Parker O-rings related to the MIDUS packaging and CGI-18-001 for Parker Stat-Page 10 of 11
O-Seals related to the 8-120B packaging. Specifically, the team reviewed the critical characteristics identified and ES dedication activities performed to verify those critical characteristics were met. The team found the critical characteristics to be appropriate and dedication activities adequate to qualify the procured components for use in ITS Category A applications. No findings of significance were identified in the area of commercial grade dedication.
Tools and Equipment The team reviewed selected measuring and test equipment (M&TE) including performance of interviews of responsible personnel and review of records and procedures to assure that equipment used in activities affecting quality were properly controlled and calibrated. The team reviewed ES-AD-PR-009, Control of Measuring and Test Equipment, Revision 2, which prescribes activities and requirements concerning use of M&TE; calibration occurs to national standards when possible; equipment identification; maintenance of records of various tools and equipment used; and actions to take when M&TE is found out of calibration.
The team compared a sampling of M&TE used for maintenance activities to the applicable requirements of ES-AD-PR-009 and determined overall compliance to the procedural requirements. The M&TE selected consisted of torque wrenches, pressure gauge, temperature fluke, stopwatch, and helium leak standard in which each were found to be in calibration and had current calibration certificates, as applicable. In addition, the team verified that if the M&TE had been sent offsite for calibration that the calibration service providers were current on ES ASL.
The team concluded that the M&TE quality procedure being implemented at ES provided adequate guidance for M&TE calibration and use, and ES adequately implemented M&TE calibration, tracking, and use requirements.
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