ML19084A071
| ML19084A071 | |
| Person / Time | |
|---|---|
| Site: | 07109342 |
| Issue date: | 03/25/2019 |
| From: | Carla Roque-Cruz NRC/NMSS/DSFM/IOB |
| To: | Barron T Daher-TLI |
| Roque-Cruz C | |
| Shared Package | |
| ML19084A070 | List: |
| References | |
| IR 2019201 | |
| Download: ML19084A071 (10) | |
Text
INSPECTOR NOTES COVER SHEET Licensee/Certificate Holder Licensee/Certificate Holder contacts Tom Barron, TU Quality Assurance, Director and hone number 270-559-14 73 Docket No. 71-09342 71-09342/2019-201 Februa 4-7, 2019 Container Products Corporation Wilmin ton, NC Inspectors Carla Roque-Cruz, Team Leader, Safety Inspector Jon Woodfield, Safety Inspector Antonio Ri ato, Technical Reviewer Summary of Findings and Actions On February 4-7, 2019, the U.S. Nuclear Regulatory Commission (NRC) performed an announced inspection of Container Products Corporation (CPC).
The team assessed CPC's compliance with Title 10 of the Code of Federal Regulations (10 CFR) Parts 21 and 71. The focus of the inspection was to assess CPC's management controls and fabrication controls for compliance to 10 CFR Parts 21 and 71, and DAHER Transport Logistics International (TU)'s NRC approved Quality Assurance (QA) program; as related to CPC's fabrication activities for Certificate of Compliance (CoC) 71-9342.
Overall, the team assessed that TU through CPC was adequately and effectively implementing their NRC approved QAP subject to 10 CFR Part 71 with regard to Quality Assurance, Management Controls, Design Interface Controls, and Fabrication Controls. The team identified four non-cited Severity Level IV violations. One violation is in the area of package design control ( 10 CFR 71.107) for DAHER-TU. The other three identified violations are in the areas of procedures, instructions and drawings ( 10 CFR 71.111 ); control of purchased material ( 10 CFR 71.115); and audits (10 CFR 71 .137) for CPC. The team also had an observation for TU and CPC related to Part 21 language in their purchase order documents for items that are not Important-to-Safety {ITS)
Category A components.
TU and CPC acknowledged their respective non-cited violations and captured em in th ir corrective action Inspector Notes Approval Branch Chief Si nature/Date
Inspection History Transport Logistics International (TU) Incorporated (Inc.) is a part of the DAHER group, which is a French industrial business (hereafter referred to as TU). On March 12, 2014, the U.S.
Nuclear Regulatory Commission (NRC) approved the TU Quality Assurance Program Description (QAPD) on NRC Form 311. They (TU} are now responsible for the quality assurance (QA) requirements as applicable to design, fabrication, testing, and modifications of the 10 CFR Part 71 packaging and manufacturing of the Versa-Pac (VP) models. Versa-Pac is currently a certified Type A fissile packaging (USA NRC Certificate# USA/9342/AF-96).
From February 4-7, 2019, the NRC conducted a 10 CFR Part 71 team inspection at TLl's VP-55 fabricator, Container Product Corporation (CPC), in Wilmington, NC. This inspection is the first NRC inspection for CPC. At the time of the inspection, fabrication activities were ongoing for five units of the VP-55 packaging. Overall, CPC's fabrication activities, and TU's oversight of the activities were assessed to be adequate. Four violations of NRC requirements were identified in the areas of package design control (10 CFR 71.107) for TU; and procedures, instructions and drawings (10 CFR 71.111 ); control of purchased material (10 CFR71.115); and audits ( 10 CFR 71.137) for CPC. The team also had an observation for TU and CPC related to Part 21 language in their purchase order documents for items that are not Important-to-Safety
- (ITS} Category A components.
Inspection Purpose The purpose of the inspection was to (1) assess TU's compliance with 10 CFR Parts 21 and 71 using CPC as a fabricator, and (2) ensure that the VP-55 transportation packaging system for Certificate of Compliance (CoC) 71-9342 could be verified to comply with Part 71 in design, procurement, and fabrication requirements, as applicable. The focus of the inspection was to determine whether TU and CPC activities associated with the fabrication of transportation packagings for radioactive materials were in accordance with TU's NRC 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 CPC's QA program manual, Revision 22, dated November 6, 2018, and associated quality procedures to assess the effectiveness of the QA program
2 implementation at CPC. The team verified that the overall QA program, as written, adequately addresses the applicable QA criteria of 10 CFR Part 71 used for the activities CPC performs as the VP-55 fabricator. Additionally, the team discussed portions of the reviewed documents with selected CPC personnel to determine whether activities subject to 10 CFR Part 71 were adequately controlled and implemented in accordance with the QA program. The team reviewed CPC's organization chart and noted that the QA Department Manager reports directly to the company President. The QA personnel has no other responsibilities within the project structure, and functions independent of any group or individual directly responsible for the fabrication activities during all stages of manufacturing, as described in QAP-1001, "Quality Organization," Revision E, dated August 17, 2016.
During the inspection, the NRC team also reviewed TLl's QA and fabrication documents, as TLI has the ultimate responsibility for quality of fabrication. The team verified that TLI approved CPC's QA program before it was implemented for the VP-55 fabrication activities. In addition, the team noted through discussions with TLI and CPC personnel, that the QA personnel from both organizations have open communication and interactions as it relates to the fabrication activities. No concerns were identified by the team with CPC's QAP.
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 At the time of the inspection, CPC did not have an established Part 21 program or Part 21 procedures for the NRC team to review. However, the team noted that TLI Purchase Order (PO) 2018-94 to CPC had a Part 21 and Part 71.95 requirement clause and that CPC accepted this PO with this requirement. Since the VP-55 design has no ITS Category A components, TLI erroneously invoked Part 21 requirements in their PO to CPC; and since CPC does not have an established Part 21 program, CPC erroneously accepted the PO with this clause. The team discussed this issue with TLI and CPC personnel and both entities acknowledged the oversight.
TU opened Corrective Action Report (CAR) 1187, dated February 10, 2019, to address the issue. Also, TLI included the following corrective actions in the CAR: a revision to TLl 's Quality Procedure (QP)-4.01, "Procurement Document Control," to provide guidance when Part 21 or Part 71.95 clause may be required for inclusion in a PO; and extent of condition review for the past 12 months to verify no previously issued POs contain this clause, if not applicable for the procurement. Further, TLI issued Revision 2 of PO 2018-94 to correct the wording. A preliminary review of other POs issued to CPC for non-VP 55 fabrication did not contain this clause.
02.04 Interview selected personnel and review selected design documentation to determine that adequate design controls are implemented The NRC team reviewed Sections QAP-1003, "Design Control," Revision G; and QAP-1005, "Instructions, Procedures & Drawings," Revision D of CPC QA manual; and 1002, "Engineering Department Procedure," Revision 9.
TLI is totally responsible for the VP-55 transportation packaging design development and therefore CPC Engineering does not have any design authority or design change authority.
CPC is authorized only to develop VP-55 fabrication drawings and process fabrication Nonconformance Reports (NCRs). The NRC team first reviewed TLl's PO 2018-294, Revision 1 to CPC for the fabrication of the VP-55 Packagings. The PO included references to the packaging licensing drawings, a fabrication specification , and VP-55 components safety
3 classifications. The licensing drawings, specification, and safety classification documents referenced in the PO all included the revision number for these documents also. If a revision to any of these documents was needed, it has to be done through a PO change order to CPC.
The NRC team reviewed TLI specification TR-20000-NQA-003, "55 Gallon Versa-Pac (VP-55)
Product Specification," Revision 3, which was sent to CPC as part of the PO to provide the details of the VP-55 packagings. The specification also contained the minimum fabrication documentation requirements and submittal requirements for TLI review prior to actual fabrication. The actual TLI VP-55 licensing drawings for the VP-55 were referenced in the specification and were also attached to the original and the* revised TLI purchase POs, as needed.
The NRC team reviewed the process for CPC to develop fabrication drawings from the TLI licensing drawings and the process to get these drawings and any later revisions approved by TLI . The team verified that CPC had records of the transmittal of the fabrication drawings to TU's engineering team for approval prior to issuance for use in fabrication. The team also reviewed the TU's documentation approving/accepting the CPC fabrication drawings and revisions. The team reviewed how licensing drawing revisions from TU to CPC were incorporated into the CPC fabrication drawings and how CPC controlled the issuance of fabrication copies and keeps track of them . According to the process when licensing drawing revisions were received from TLI, which affected fabrication, the shop was notified to stop work on the affected assembly or components until the fabrication drawing could be revised and issued back to the shop.
While performing a sample review of the VP-55 licensing drawing requirements translated to the CPC VP-55 fabrication drawings, the NRC team noted that one weld symbol on a licensing drawing was not properly transferred to one of the fabrication drawings. TLI failed to identify the incorrect transfer of a weld symbol from licensing drawing VP-55-LD sheet 2 of 2, Revision 2 to CPC fabrication drawing 31-4502-1-01 sheet 1 of 3, Revision C during its review and approval of the CPC fabrication drawings. The team determined this to be a violation of 10 CFR 71 .107, "Package design control" requirements for fa ilure to correctly translate the package design specifications in the CoC into the fabrication drawings. The regulation in 10 CFR 71.107 states, in part, that the certificate holder (TLI} shall establish measures to assure that applicable regulatory requirements and the package design, as specified in the CoC, are correctly translated into specifications, drawings, procedures, and instructions. Contrary to this requirement, TLI failed to identify the incorrect transfer of a weld symbol from licensing drawing to the fabrication drawing. 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. TU opened CAR 1188, dated February 11, 2019, to address this issue.
During the review of CPC Engineering Department Procedure 1002, Revision 9, the NRC team determined that CPC was following all the procedure requirements associated with design control except for the action of rubber stamping revised manufacturing drawings with the words, "Revised-Discard All Previous Revisions" before re-distributing the drawing to various CPC departments, such as manufacturing and QA/Quality Control (QC). The team determined this to be one example of failure to comply with the requirements in 10 CFR 71 .111 , "Instructions, procedures, and drawings". The regulation in 10 CFR 71.111 states in part, that the certificate holder (CPC represents the CoC holder TLI) shall prescribe activities affecting quality by documented instructions, procedures, or drawings of a type appropriated to the circumstances and shall require that these instructions, and procedures, and drawings be followed . Contrary to
4 this requirement, CPC failed to stamp VP-55 fabrication drawing revisions prior to releasing them for use in accordance with paragraph 9.5 of CPC Engineering Department Procedure 1002, Revision 9. The team determined that the violation was more than minor because this is one of several examples where CPC failed to follow its procedures. The team evaluated all the examples, which contributed to the violation in accordance with Section 2.3 of the NRC Enforcement Policy and characterized all the individual examples of CPC's failure to follow procedures as one Non-cited Severity Level IV Violation. CPC opened CAR 2019-03, dated March 1, 2019, to address this issue.
Based on its review, the NRC team determined that CPC was following its engineering procedures, as applicable. No concerns, except for the transfer of the weld symbol from the licensing drawing to the fabrication drawing noted above, were identified.
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 Sections QAP-1006, "Document Control ," Revision J; QAP-1017, "Quality Assurance Records," Revision Hof the CPC QA manual; Quality Control Operating Procedure (QCOP)-3001 , "Certificate of Compliance", Revision 5; and 1002, "Engineering Department Procedure," Revision 9. The CPC VP-55 fabrication drawings are maintained by CPC as controlled documents. Control and distribution of the fabrication drawings is done by the CPC engineering department in accordance with procedure 1002. Changes to the fabrication drawings are authorized by the CPC Engineering Department Manager using the CPC Engineering Change Notice (ECN) process. The NRC team reviewed TU specification TR-20000-NQA-003, "55 Gallon Versa-Pac (VP-55) Product Specification," Revision 3, which was sent to CPC as part of the PO. TR-20000-NQA-003 provides a list of all the VP-55 quality records, which are required to be in the final document package (FOP) for each VP-55 fabricated . It also provides requirements for the CoC, which CPC is to provide with each VP-55 produced . The CPC QA manger is responsible for putting together the FDPs and signing the CPC CoCs. Other controlled documents maintained by CPC are the QA manual, Quality Control Plan that contains the QCOPs, and Department Procedures. Hard copies of the above manuals/procedures are furnished to CPC Department Managers and other personnel as required and are marked as controlled copies. Any additional copies made are marked as uncontrolled documents. The CPC QA Department maintains a distribution list to ensure all copies are current. The team reviewed the CPC controlled copy distribution lists and sampled CPC department controlled hard copies and found all the revisions current. Electronic backup of all QA records are maintained, including fabrication drawings, so files can be retrieved and duplicated if any hard copies are inadvertently damaged or destroyed. Access to the records is limited to authorized personnel. The team interviewed the QA manager as all the quality records are funneled through her to develop the FDPs and she is responsible for the master copy/electronic copy of the manuals other than department procedures. The team determined CPC's process to be adequate.
At the time of the inspection, TU had received one FOP for the first VP-55 completed by CPC.
The team reviewed the FOP and found it complete and in accordance with the TU specification requirements. Once TU receives the FDPs, as the holder of the VP-55 NRG CoC, they will be responsible for the quality records for as long as required by regulations. Procedures do not require them to maintain records beyond five years.
5 The NRC team determined the CPC document control and QA record procedures were adequate and being followed by CPC personnel. No concerns were identified in the area of document control.
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 QAP-1012, "Control of Measuring and Test Equipment,"
Revision G of the CPC QA manual and procedure QCOP-2011, "Control of Measuring and Test Equipment," Revision 0. The team verified that CPC QA department keeps a Measuring and Test Equipment (M&TE) Master Equipment List (MEL) that identifies each M&TE requiring recalibration and that the calibration history and current calibration status is maintained for each item on the MEL. The team also reviewed the FOP for the first VP-55 fabricated by CPC, which contained all the calibration records for the M&TE used during fabrication. The team verified that all the M&TE used during fabrication was on the MEL, all the historic records were maintained and that the M& TE was calibrated by outside Certified Laboratories at the required frequency per the procedures. The team also verified that the calibration records included the date of calibration, identification number of equipment, and date when the next calibration is required. The team sampled M&TE in the shop and found stickers attached to the equipment indicating the serial number of the equipment and the due date of the next calibration as required by the procedure.
According to CPC procedures, all M&TE recalibration records are to be reviewed upon receipt from the calibration laboratory to determine if the accuracy/tolerance.of the instrument during its use prior to the recalibration was acceptable. The review is to be noted on the record with the reviewer's initials and date of the review. The reviewer is also to place a sticker on the equipment with its serial number and the due date of the next calibration. 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 NRC team found that some calibration records had been initialed and dated by a reviewer while several others had no initials indicating prior review. In addition, some M&TE was found to be out of calibration and the team found no evaluation associated with this item and the M&TE was still in service. This out of calibration M&TE was not associated with the fabrication of the first VP-55 package.
The NRC team determined this to be another example where CPC failed to comply with the requirements of 10 CFR 71 .111 . Contrary to the requirement, CPC failed to initial and date the review of calibration records when received and to perform evaluations for M&TE found out of calibration in accordance with paragraphs 1.6 and 1.5 of QA manual Section QAP-1012 and CPC procedure QCOP-2011, respectively. The team evaluated the violation in accordance with Section 2.3 of the NRC Enforcement Policy and characterized all the individual examples of CPC's failure to follow procedures as one Non~cited Severity Level IV Violation . To address this issue, CPC opened CAR 2019-03, dated March 1, 2019.
Based on its review, the NRC team determined that overall CPC was following its M&TE procedures to ensure that M&TE was being properly identified for calibration and re-calibrated at the required intervals. Although a concern, the calibration records without reviewer initials were found to be in calibration.
6 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 Sections QAP-1004, "Procurement Document Control," Revision I; and QAP-1007, "Control of Purchased Items & Services," Revision M of CPC's QA manual; and CPC procedures QCOP-1001, "Material Receipt Inspection," Revision 18; QCOP-1010, "Shelf Life Verification," Revision 7; and QCOP-2030, "Discrepancy Report," Revision 7. The team also reviewed the drawings, specifications, POs, receiving inspection reports, receiving travelers, CoC, and certified material test reports, as applicable, for the VP-55 project. The team interviewed CPC personnel in charge of procurement and examined the computer systems used to stored PO information. In addition, random POs from CPC PO database were selected by the team to confirm that they came from CPC's approved suppliers list (ASL). At the time of the inspection, there was one completed VP-55 package and components for four VP-55 packages segregated on the shop floor. The team determined that the PO documents available were traceable to the components segregated on the shop floor for the VP-55.
However, the team noted that three components from the Versa Pac VP-55 had procurement issues: 1) sheet metal, 2) gaskets, and 3) the outer drum of the VP-55 used for handling.
The NRC team found that the CPC PO for sheet metal from one of CPC's approved suppliers, Jemison Metals, had specifically requested that the sheet metal be mercury contamination free.
- The specification material documentation that came with the sheet metal did not indicate that it was mercury contamination free. The sheet metal was accepted during CPC's receipt inspection. The team determine this was one example where CPC failed to comply with the
- requirements of 10 CFR 71.115, "Control of purchased material, equipment, and services." The regulation in 10 CFP 71.115 states, in part, that the certificate holder (CPC represents the CoC holder TU) shall establish measures to assure that purchased material, equipment, and services, whether purchased directly or through contractors and subcontractors, conform to the procurement documents. Contrary to this requirement, CPC failed to verify that the sheet metal received was mercury contamination free as specified in the procurement documents.
The NRC team reviewed the storage of component parts fabricated by CPC to be used in the assembly of the VP-55 packagings and VP-55 spare parts, such as gaskets procured from vendors. The parts inspected by the team included metal components, gaskets, and pad materials. The team compared the CPC parts drawing for the gaskets to the actual gaskets on the table. The CPC parts drawing required that the gasket material be between 50 and 70 durometer hardness. The team noted that the gaskets were very soft and with no indication as to the actual hardness. The team discussed the procurement of the gaskets with CPC and reviewed the gaskets procurement documentation provided by CPC, which required the 50 to 70 durometer hardness. During discussions with CPC QA and procurement personnel, CPC stated that it did not have any method to verify the durometer hardness of the gaskets received .
The NRC team determined that CPC's receipt inspection of the gaskets was not adequate as it failed to verify that the gaskets received complied with all the specifications for the gaskets ordered. The team determine this was another example where CPC failed to comply with the requirements of 10 CFR 71.115, "Control of purchased material, equipment, and services."
Contrary to the requirement, CPC failed to verify that the VP-55 gaskets received from the gasket supplier conformed to the procurement documents. In addition, the team determined that the issue was more than minor because if the gaskets had been installed with the incorrect hardness they might not have performed their design function as verified during the packaging drop testing.
7 The NRC team found one additional issue with the procurement of a drum used for handling of the VP-55. The barrel used for handling of the VP-55 is characterized by a United Nations (UN) stamp. Review of the PO, the UN stamp on the drum, and the receipt inspection paperwork indicated that a barrel other than the one called for on the drawings had been ordered by CPC's procurement personnel. However, the UN stamp on the barrel itself on the shop floor was verified to be the correct barrel found in the licensing drawings. The drawing called for a drum with a minimum UN rating of UN1A2/Y1.6/130 1A2/X374/S and CPC ordered a drum with a UN rating 1A2/Y1.6/130 1A2/X400/S. The team discussed this issue with CPC personnel in charge of procurement and it appears that although the wrong specification information was used in the CPC PO to the drum supplier, the drum supplier still furnished the correct drum to CPC. The team determined this was another example of failure to comply with the requirements of 10 CFR 71 .115, "Control of purchased material, equipment, and services." Contrary to this requirement, CPC failed to verify that the item specifications were correctly translated to the PO for the steel drum.
The NRC team evaluated the violation in accordance with Section 2.3 of the NRC Enforcement Policy and characterized all the individual examples of failure to comply with the requirements of 10 CFR 71.115 as one Non-cited Severity Level IV Violation. To address this issue, CPC opened CAR 2019-03, dated March 1, 2019.
TU analysis of the VP-55 package determined that there are no ITS Category A components for this package. Therefore, no Commercial Grade Dedication activities are performed by CPC.
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 CPC's 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 requirements for CPC's nonconformance program are contained in Section 1015, "Non-conforming Items," Revision F of the QA manual. This procedure describes the method for reporting and controlling nonconforming items that are under the control of CPC's QAP. This Section also directs the CPC personnel to segregate nonconforming items and states that the disposition of design/functionality aspects of nonconforming items shall be determined by the Engineering Department Manager. To document and track nonconformances, CPC uses QCOP 2030, "Discrepancy Report," Revision 7 and QCOP 2050, "Supplier Discrepancy Report," Revision 1. The NRC team reviewed Discrepancy Report 2018-21 related to the VP-55 project. The disposition for this nonconforming item (weld #7) was to rework the weld and re-inspect it. The discrepancy report package for this nonconformance contained a Discrepancy report memo, the welder performance and inspection report, and the Magnetic Particle Inspection Report. The team was able to verify that the rework was done and the weld re-inspected and NDE done in a timely matter. The team also verified that a logbook to document/track the status of discrepancy reports is maintained in the QA office as required by the QA manual.
The NRC team reviewed CPC's corrective action program to assess the effectiveness of the measures established to identify and correct issues, and if required, prevent recurrence. The team review section 1016, "Corrective Action," Revision H of the CPC QA Manual. The team noted that a corrective action report (CAR) can be initiated by any team member at CPC and
8 that CPC uses a corrective action form to documenUtrack corrective actions. This form contains a description of the issue, actions taken, responsible department, root cause and actions taken to prevent recurrence. The team reviewed CARs 2018-04, 2018-05 and 2018-07, and noted that these CARs were adequately documented and provided evidence of corrective actions performed by CPC to address the conditions adverse to quality.
The NRC team interviewed CPC's QA personnel on the NCR 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 NCRs and CARs by CPC.
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 Section 1001 of the QA manual and procedures QCOP 1111, "Employee Training," Revision 7; and QCOP 3002, "Maintenance of CPC Welder Qualification," Revision 7.
The team also reviewed sampled training and qualification records for CPC welders, QA auditors, and lead auditors.
The NRC team selected two audit personnel records to assess qualification and certification in accordance with the requirements in the QA manual. In addition, the team reviewed a sample of certification and qualification records for welders that fabricated the VP packagings. All of the qualification packages reviewed by the team contained all information required by CPC procedures. The team also noted that all the qualifications were current and that a due date for re-qualification was indicated in the package. The CPC personnel does not perform non-destructive examination (NOE). As such, there were no qualification records for NOE inspectors. All NOE is performed by an outside supplier. The team verified that the supplier for NOE was in CPC's ASL.
The team assessed that CPC implemented the applicable sections of the QA manual, and procedures QCOP 1111 and QCOP 3002 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 CPC NCR and Corrective Action program.
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 1018, "Audits" of CPC'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 1018 all audit personnel are required to document the audit results and follow-up for deficient areas via the corrective action program. In addition, for CPC's internal audit of the QA program, the QA manual states that all elements of the QA program will be evaluated every three years. A staggered approach is used
9 by CPC, internal audits are completed by partial audits that are done on an annual basis covering a portion of the QA program every year. The team reviewed the last internal audit starting with a partial audit on August 2016, followed by another partial audit on October 2017 and completing the cycle with the third partial audit on November 2018. The team noted that the audits were documented using a checklist and that any issues found during the audit were entered into CPC's corrective action program for follow-up and closure of the issues. The team also reviewed the qualifications of the lead auditor and auditor and verified that the auditors' qualification packages were complete with information on the auditors' education, training, and experience as required by CPC QA manual.
During the review of CPC's internal audit documents the NRC team found instances where CPC failed to comply with the requirements of 10 CFR 71.137, "Audits." The regulation in 10 CFR 71 .137 states, in part, that the audits must be performed in accordance with written procedures or checklists by appropriately trained personnel not having direct responsibilities in the areas being audited. Contrary to this requirement, during the last internal audit performed from August 2016 to November 2018 in three separate partial audits, one of the individuals in the audit team, during all three partial audits, had direct responsibilities for some of the areas audited. Therefore, CPC failed to perform independent audits as required by 10 CFR 71.137.
The NRC team evaluated the violation in accordance with Section 2.3 of the NRC Enforcement Policy and characterized CPC's failure to perform independent audits as a Non-cited Severity Level IV Violation. To address this issue, CPC opened CAR 2019-03, dated March 1, 2019.
The NRC team reviewed the audit report for the audit TU performed at CPC on September 26-28, 2016. The results of this audit were four administrative program findings, one observation and 6 recommendations. The inspectors noted that these results were captured in CPC CAR 2016-03 and that actions were taken to address and close these findings. The team also reviewed the reports for three supplier audits CPC performed in order to keep the suppliers in their ASL. While reviewing the current ASL, the team noted that for some suppliers, CPC failed to perform the triennial audit in order to keep the supplier in the ASL as required in QA manual Section QAP 1007, "Control of Purchased Items & Services," Revision M. The team determined this to be another example where CPC failed to comply with the requirements of 10 CFR 71 .111, "Instructions, procedures, and drawings." Contrary to the requirement, CPC failed to perform supplier audits at the frequency established in CPC procedures in order to keep the suppliers in their ASL. The NRC team evaluated the violation in accordance with Section 2.3 of the NRC Enforcement Policy and characterized all the individual examples of CPC's failure to follow procedures as one Non-cited Severity Level IV Violation. To address this issue, CPC opened CAR 2019-03, dated March 1, 2019.
Except for the findings noted above, the team determined that the CPC audits reviewed were comprehensive in nature, performed using a checklist, and conducted by qualified lead auditors.
The team also noted that CPC initiated CARs 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 CPC's scheduling and frequency of audits is adequate and in accordance with CPC's approved QA program .