ML18215A387

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Tn Americas, Llc/Oragno, - NRC Form 591S Part 1, Inspection Report 0721004/2018202 and 07100250
ML18215A387
Person / Time
Site: 07201004, 07100250
Issue date: 06/21/2018
From: Jon Woodfield
NRC/NMSS/DSFM/IOB
To: Brownson D
TN Americas LLC
Woodfield J
References
IR 2018202
Download: ML18215A387 (16)
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Text

NRC FORM 691S PART 1 ,,.~-., U.S. NUCLEAR REGULA TORY COMMISSION (10-2013) l~.z,L_\

l~l SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION 10CFR2.201

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1. CERTIFICATE/QUALITY ASSURANCE PROGRAM (OAP) HOLDER: 2. NRG/REGIONAL OFFICE TN Americas, LLC/Orano Headquarters 7135 Minstrel Way, Suite 300 U.S. Nuclear Regulatory Commission Columbia, Maryland 21045 Mail Stop TWFN 4B-34 Washington, DC 20555-000 J REPORT NUMBER(S) 072-I004/2018-202
3. CERTIFICA TE/QAP DOCKET NUMBER(S) 4. INSPECTION LOCATION 5. DATE(S) OF INSPECTION CoC 72-1004 Columbiana Hi Tech, LLC (CHT)

June 18-21, 2018 QAP 71-0250 Kernersville, North Carolina CERTIFICATE/QUALITY ASSURANCE PROGRAM HOLDER:

The Inspection was an examination of the activities conducted under your QAP as they relate to compliance wllh the Nuclear Regulatory Commission (NRC) rules and regulations and the conditions of your QAP Approval and/or Certlflcate(s) of Compliance. The Inspection consisted of selective examinations of procedures and representative records, interviews wilh personnel, and observations by the Inspector. The inspecllon findings are as follows:

01. Based on the Inspection findings , no violations were Identified.

D 2. Previous vlolatlon(s) closed.

[ZJ3. The vlolalions(s), specifically described to you by the Inspector as non-cited violations. are not being cited because they were self-Identified, non-repetitive. and corrective action was or Is being taken. and the remaining criteria In the NRC Enforcement Policy, to exercise discretion. were satisfied. *

- - - - Non-cited vlolallon(s) was/were discussed Involving the following requiremenl(s) and Corrective Actlons(s):

Title 10 CFR 72.150, "Instructions, procedures, and drawings," states, in part, that 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.

(Continued on Next Page)

During this Inspection, certain of your activities, as described below and/or attached, were In violation of NRC requirements and are being ciled In accordance with NRC Enforcement Policy. This form Is a NOTICE OF VIOLATION, which may be subject to posting In accordance with 10 CFR 19.11 .

  • cv10Jat1ons and Corrective Acllons)

Statement of Corrective Actions I hereby state that, within 30 days, the actions described by me to the Inspector will be taken to correct the 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, date when lull compliance will be achieved). I understand that no further written response lo NRC wilt be required, unless specmcally requested .

TITLE PRINTED NAME DATE CERTIFICATE/OAP Douglas Brownson, Director of Quality REPRESENTATIVE Assurance NRC INSPECTOR Jon N. Woodfield BRANCH CHIEF Patricia Silva NRC FORM 691S PART 1 (10-2013)

NRC FORM 591S PART 2 U.S. NUCLEAR REGULATORY COMMISSION (10-2013) 10CFR2.201 SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION

1. CERTIFICATE/QUALITY ASSURANCE PROGRAM (OAP) HOLDER : 2. NRG/REGIONAL OFFICE TN Americas, LLC/Orano Headquarters 7135 Minstrel Way, Suite 300 U. S. Nuclear Regulatory Commission Columbia, Maryland 21045 Mail Stop TWFN 4B-34 Washington, DC 20555-0001 REPORT NUMBER(S) 072-] 004/20] 8-202
3. CERTIFICATE/OAP DOCKET NUMBER(S) 4. INSPECTION LOCATION 5. DATE(S) OF INSPECTION CoC 72-1004 Columbiana Hi Tech, LLC (CHT)

QAP 71-0250 June 18-21, 2018 Kernersville, North Carolina (Continued)

Contrary to the requirements of IO CFR 72.150, during an inspection conducted June 18 - 21 , 2018, the NRC identified the following four examples where TN Americas' fabricator Columbiana Hi Tech (CHT) did not follow prescribed procedures (3) or have adequate procedures (I) for activities affecting quality:

I) The CHT procedure Q-25, "Internal Surveillance," Revision 2, Step 4.3.2.6.c, states, in part, that conditions adverse to quality should be processed in accordance with applicable corrective action procedures. In addition, CHT procedure Q-11 , "Corrective/ Preventive Action Procedure," Revision 3, Step 3.2, states, in part, that it is the responsibility of CHT employees to immediately document in accordance with this procedure any condition adverse to quality. Contrary to the above, the NRC identified during a review of a shop traveler surveillance performed on June 14, 2017, that multiple conditions adverse to quality in the areas of document control and work processes were documented in the report but no corresponding corrective action report (CAR) was issued. This is a violation of IO CFR 72.150 for failure to follow Q-25, Step 4.3.2.6.c.e and Q-11 , Step 3.2.

2) The CHT procedure Q-11 , Step 3.2, states, in part, that it is the responsibility ofCHT employees to immediately document in accordance with this procedure any condition adverse to quality. Contrary to the above, the NRC identified that CHT failed to immediately document the conditions adverse to quality identified in the final Nuclear Industry Assessment Committee (NIAC) audit report of CHT, dated July 12, 2017, and did not document them until September 8, 2017 in CAR 17-041. This is a violation of IO CFR 72.150 for failure to follow Q-11, Step 3 .2.
3) The CHT procedure Q-03 , "Welding Performance Qualification Testing & Records," Revision 2, Step 4.1.6, states, in part, that the welding engineer shall complete the Record of Welder Performance Qualification form or Record of Welding Operator Performance Qualification form, as appropriate, and sign and date the form. Contrary to the above, the NRC identified during a review of welder qualification records that the welding engineer failed to complete the Record of Welder Performance Qualification form for a CHT welder (W-57). This is a violation of IO CFR 72.150 for failure to follow Q-03, Step 4.1.6.
4) The CHT procedure Q-04, "Control of Special Processes & Tests," Revision 11, in Steps 4.2.8 through 4.2.11 provides guidance for the control and storage of new and recycled used weld flux with respect to the weld flux manufacturer's written recommendations. Contrary to the guidance provided in Q-04, Steps 4.2.8 through 4.2.11 , the NRC identified during observation of CHT's actual controls and storage of new and recycled used weld flux that the procedure guidance was inadequate with respect to the weld flux manufacturer's written recommendations. The recommendations were being interpreted by CHT workers and not strictly adhered to in practice. This is a violation of IO CFR 72.150 for failure to have adequate procedures (Q-04, Steps 4.2.8 through 4.2.11) for the control and storage of new and recycled used weld flux in accordance with the weld flux manufacturer's written recommendations.

This violation was entered into CHT's corrective action program as CAR 18-050, dated June 20, 2018; CAR 18-054, dated June 21, 2018; CAR 18-048 dated June 20, 2018; and CAR 18-052, dated June 21 , 2018; respectively for each example. The inspection team evaluated the violation in accordance with Section 2.3 of the NRC Enforcement Policy and dispositioned it as a non-cited Severity Level IV violation.

NRG FORM 591S PART 2 (10-2013)

INSPECTOR NOTES COVER SHEET Licensee/Certificate Holder TN Americas, LLC/Orano (name and address) 7135 Minstrel Way, Suite 300 Columbia, Ma land 21045 Licensee/Certificate Holder Douglas Brownson, Director of Quality Assurance contacts and hone number 41 0-91 0-6963 Office Docket No. 72-1004 Inspection Report No. 72-1004/2018-202 Inspection Date(s) June 18-21, 2018 Inspection Location(s) Columbiana Hi Tech, LLC; Kernersville, North Carolina Inspectors Jon Woodfield, Team Leader, Safety Inspector Earl Love, Senior Safety Inspector Jerem Ta , Safet Ins ector Summary of Findings and This inspection was a routine periodic assessment of TN Actions Americas' (TN) Quality Assurance Program (QAP) implementation at TN's NUHOMS System Dry Shielded Canister steel fabricator Columbiana Hi Tech, LLC (CHT).

The team assessed CHT's management controls, design controls, and fabrication controls for compliance to 10 CFR Parts 21 & 72, and TN 's NRC approved QAP; as related to TN Certificate of Compliance 72-1004 (NUHOMS 61 BTH Type 1).

Overall, the team assessed that TN through CHT was adequately and effectively implementing their NRC approved QAP subject to 10 CFR Part 72 with regard to Quality Assurance, Management Controls, Design Interface Controls, and Fabrication Controls.

One non-cited Severity Level IV violation with four examples of non-compliance was identified by the team and is described in these inspector notes. Contrary to the requirements of 10 CFR 72.150, "Instructions, procedures, and drawings, " there are three examples from the inspection where CHT did not follow its written procedures and one example where CHT did not have adequate procedures in place for quality activities. CHT captured each example of non-compliance with 10 CFR 72 .150 in their corrective action program . There was also one minor violation against regulation 10 CFR 71.9, "Employee protection ,"

paragraph (e)(1) for CHT not posting the current Form 3, "Notice to Employees." CHT also captured this issue in their corrective action ro ram.

Lead Inspector Jon N. Woodfield Signature/Date Inspector Notes Approval Branch Chief Signature/Date Page 1 of 14

Inspection History The NRC conducted the first inspection of TN at CHT at the Kernersville facility (CHT had been previously inspected several times at a prior facility) in October 2015 (Inspection Report 072-1004/2015-204 and ML15349A981 ). The inspection team examined and witnessed selected fabrication, assembly, and test activities and reviewed numerous quality procedures, as well as quality records . Overall, CHT's fabrication activities, and TN's oversight of the fabrication activities, were assessed to be adequate in meeting CHT/TN OAP requirements as well as NRC QA requirements. No violations of Part 72 regulatory requirements were identified.

Inspection Purpose The purpose of the inspection was to assess TN 's compliance with 10 CFR Parts 21 and 72 using CHT as a fabricator and to verify that the storage system for which TN is the holder of Certificate of Compliance (CoC) 1004 could be verified to comply with Part 72 in design, procurement, and fabrication requirements, as applicable. The focus of the inspection was to determine whether TN activities associated with the storage of spent fuel/radioactive materials were in accordance with their NRC approved OAP requirements.

Primary Inspection Procedures/Guidance Documents IP-60852, "ISFSI Component Fabrication by Outside Fabricators" 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: APPLICABLE SECTIONS FROM IP 60852 WERE PERFORMED DURING THE INSPECTION WITH RESULTS DOCUMENTED BELOW UNDER THE BASIC HEADINGS OUTLINED IN NUREG-6314.

4.1 Management Controls 4.1.1 Quality Assurance Policy The team reviewed CHT's corporate Nuclear Quality Assurance Manual (NOAM), Revision 2 dated February 8, 2016, and associated quality procedures; and assessed the effectiveness of the OAP implementation at CHT. The team conducted reviews of CHT's quality program, policies, and procedures, and discussed portions of the reviewed documents with selected personnel to determine whether activities subject to 10 CFR Part 72 were adequately controlled and implemented under TN America 's NRC-approved QA program at CHT. The team reviewed CHT organization charts and interviewed QA personnel to evaluate their organizational independence from cost, schedule, and production activities. The team also reviewed NOAM Section 18 on Audits, since the requirement to regularly assess the status and adequacy of the Page 2 of 14

OAP is provided there. The team assessed a sample of annual management reviews and the internal surveillance program that both implement the Section 18 requirement. The internal surveillance program is controlled by quality Policy/Procedure No. 0-25, "Internal Surveillance,"

Revision 2 and focuses on welding, travelers , and inspection/test performance. The team selected internal surveillances from 2016 and 2017 to review.

The team found that the 2016 and 2017 annual management reviews adequately assessed the OAP to determine if there were any adverse trends. The team noted that these two CHT reports identified the same types of issues as the inspection team identified in their independent nonconformance report (NCR) and corrective action report (CAR) reviews. The main issues were in the areas of dimensional controls, fit-up and welding, machining , and errant cutting operations; and the team determined that actions were being taken by CHT to reduce the occurrence of issues in those areas. The team noted that the 2017 annual management review was not completed in a timely manner and not issued until June 2018. TN had also identified this issue with CHT during a surveillance in May 2018 and it was documented in TN supplier finding report (SFR) 2018-014 and CHT CAR 18-032.

The team found that overall , the CHT internal surveillance program enhanced and supplemented management reviews and the audit program to provide an on-going review of fabrication and supporting administrative processes. However, during a review of a shop traveler surveillance performed on June 14, 2017, the team noted multiple issues in the areas of document control and work processes were documented in the report but no corresponding CAR was issued as required by 0-25, Step 4.3.2.6.c and 0-11 , "Corrective/ Preventive Action Procedure," Revision 3, Step 3.2. As a result, actions to resolve the issues were either not taken or not documented, or both. The team determined the failure to follow the applicable corrective action procedures as required by 0-25 and 0-11 , and document the conditions adverse to quality in a CAR was a violation of 10 CFR 72.150, "Instructions , procedures, and drawings." 10 CFR 72.150, states, in part, that the certificate holder (in this case CHT performing under CoC holder TN) 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 . This is example one of CHT's failure to be in compliance with 10 CFR 72.150.

The team determined this violation to be more than minor because if no CAR was written ,

adequate actions to correct and prevent recurrence of the issue were not assured to be taken.

The team evaluated the violation in accordance with Section 2.3 of the NRC Enforcement Policy and characterized it as a non-cited Severity Level IV violation. CHT entered this issue into their corrective action program (CAP) as CAR 18-050, dated June 20, 2018.

During the review of the 2017 annual management reports and internal surveillances, the team noted it was documented that 1) the cause of a few issues were based at least in part on insufficient time or an attempt to maintain on time delivery, and 2) certain work groups were willing to not follow all processes entirely to keep the work moving forward (schedule pressure).

To determine what actions were taken in response , if any, and if there was an ongoing issue in producing product on time over completing the work per the process, the team interviewed CHT personnel that included the President and Chief Operating Officer and Vice President (VP) of Page 3 of 14

Environmental, Health, Safety, and Quality (EHS&Q). The team determined from interviews and observing current work activities in the field that this was not an ongoing issue and was mainly isolated to one project. The team also determined that CHT had added a Project Management team that should relieve Manufacturing Engineers of some responsibilities that will then allow fabrication activities to begin earlier in the process so more time in product schedules is available for actual production.

Overall implementation of CHT's OAP was assessed to be adequate, except in the area of internal surveillance issue resolution . One Severity Level IV non-cited violation (NCV) was identified with the first example of non-compliance for failure to follow procedures and document conditions adverse to quality identified during an internal surveillance.

4.1.2 Nonconformance and Corrective Action Controls The team reviewed CHT's non-conformance program to assess the effectiveness of measures established to control materials, parts, components, and services that have been identified by CHT as not conforming to specified requirements. The team also reviewed CHT's CAP to assess the effectiveness of the measures established to identify and correct issues, and if required, prevent recurrence. The team reviewed the following CHT quality procedures:

  • Q-05, Control of Nonconforming Items, Revision 6
  • Q-11, Corrective I Preventive Action Procedure, Revision 3 The team assessed that the quality procedures provided adequate guidance for the processing of nonconforming items and corrective actions.

The team reviewed a selection of both NCRs and CARs issued since the previous inspection in 2015 for fabrication of the TN NU HOMS dry storage canisters (DSCs). The team assessed that for the 8 NCRs reviewed , they had been appropriately dispositioned and contained adequate justification for those with a use-as-is or repair disposition. In addition, TN assessed and approved each NCR dispositioned as use-as-is or repair as required. At the time of the inspection, a number of nonconforming components had not yet been dispositioned but they were in CHT's Greensboro facility so their segregation could not be verified . The team verified specifically for NCR 18-090 that was closed during the on-site inspection, the NCR and rework traveler .were completed and closed out appropriately, and it was documented on the main traveler that the NCR was closed and work could proceed.

The team assessed that for the 12 CARs reviewed, they had been appropriately documented and the corrective actions taken were adequate. However, the team noted that a number of CARs documented corrective actions that were not taken in a timely manner and the response to each of these CARs was outside the required 30 day due date without a corresponding request for time extension. TN identified this issue during a CHT surveillance in May 2018 and it was documented in TN SFR 2018-016 and CHT CAR 18-046. CHT stated they plan to Page 4 of 14

institute a corrective action review board, or similar, in the near future to assist in tracking, adequacy reviews, and follow-up of CAR responses and actions.

In addition , the team noted during the review of CAR 17-041 that it was originated September 8, 2017 in response to the findings and observations identified during the triennial Nuclear Industry Assessment Committee (NIAC) audit of CHT performed June 12-16, 2017. Due to the large gap between the time of the NIAC audit and origination of the CAR, the team reviewed the final NIAC audit report and found it was sent to CHT on July 12, 2017 and requested a response within 30 days in accordance with CHT's CAP. Quality procedure Q-11 , Step 3.2 states, in part, that CHT employees immediately identify and document any condition adverse to quality.

Contrary to the above, CHT failed to immediately document the conditions adverse to quality identified in the final 2017 NIAC audit report of CHT, but documented them 2 months later. The team determined that this failure to follow a procedure was example two of a violation of 10 CFR 72.150 requirements. The team determined this violation to be more than minor because if a CAR is not written in a timely manner and the issues corrected, it could lead to a more significant safety issue. The team evaluated the violation in accordance with Section 2.3 of the NRC Enforcement Policy and characterized it as a non-cited Severity Level IV violation. CHT entered this issue into their CAP as CAR 18-054, dated June 21 , 2018.

The team concluded that the quality procedures being implemented at CHT provided adequate guidance for the processing of nonconforming items and corrective actions. Corrective action timeliness was determined by the team to be an area of improvement. This was evidenced by both the finding identified by TN regarding CAR response timeliness , and the second example of non-compliance identified by the NRC regarding CAR origination or documentation of issues timeliness supporting a Severity Level IV NCV.

The team reviewed CHT's procedure Q-07, "Reporting of Defects and Noncompliance in Compliance With 10 CFR Part 21," Revision 4 and determined the procedure adequately implemented the requirements of 10 CFR Part 21. The team asked CHT if any Part 21 Reports had been written for the fabrication work performed for TN and CHT stated that no Part 21 Reports had been written . CHT has only one posting in its fabrication facility and the team verified it was a current copy, which is compliant with Part 21.6, "Posting requirements."

  • Although there was only one posting for such a large facility, no issues were identified by the team regarding 10 CFR Part 21 program controls or implementation at CHT since CHT met the minimum posting requirements. The team did make an observation to CHT during the exit meeting that their Part 21 posting was only in one location and not in the most prominent location where employees could observe it on their way to and from work .

During the verification of the Part 21 posting, the team observed that the NRC Form 3, "Notice to Employees" that was posted at the same location, was dated 5-2012 while the current revision to Form 3 is dated 8-2017. Observing the Form 3 posting was outside the Part 72 inspection scope since the posting is for Part 71. However, CHT is also a Part 71 CoC holder so the team decided to document this violation in these notes.

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Title 10 CFR 71.9, "Employee protection," paragraph (e)(1) states, in part, each licensee, certificate holder, and applicant for a license or Coe must prominently post the current revision of NRC Form 3, "Notice to Employees. " Contrary to the requirements of 10 CFR 71 .9(e)(1), the NRC identified that CHT had not posted the current revision of NRC Form 3. The team determined that this failure to post the current revision of Form 3 was a violation of 10 CFR 71 .9(e)(1 ). The team determined this violation to be a minor violation because there was no safety significance to the out-of-date Form 3. The current revision not posted has no major changes in processes or definitions. This constitutes a violation of minor safety significance that is not subject to formal enforcement action in accordance with Section 2 of the NRC Enforcement Policy. CHT entered this issue into their CAP as CAR 18-053, dated June 21, 2018.

4.1.3 Documentation Controls The team reviewed Section 6, "Document Control," and Section 17, "Quality Assurance Records ," of the TN Americas Quality Assurance Program Description Manual, Revision 15. In addition, the team specifically reviewed the following CHT procedures associated with document controls and records:

  • E-01, Drawing, Specification, Procedure & Customer Contract Review and Control, Revision 9
  • Q- 12, Requirements for Storage & Maintenance of Quality Assurance Records, Revision 5
  • Q-14, Criteria for Preparation of Certificate of Conformance & Customer Specified Data Package, Revision 2
  • Q-27, Control & Distribution of Quality Assurance Manual, Revision 4 CHT uses its shared computer system to ensure that its NQAM and Nuclear QA Procedures are available to all its employees electronically at their computers . CHT demonstrated to the team at a computer screen how all these documents could be accessed electronically. Hard copies of these documents are prepared, reviewed , and approved by authorized personnel and scanned into the shared computer system and secured with a password to prevent editing .

Once the documents are uploaded they are considered controlled documents. The master copy of the NOAM has historically been maintained by the CHT QA manager. That responsibility is to be shifted with CHT's elimination of the QA manager's role and distribution of the QA manager's responsibilities to other QA staff. Per procedure Q-27, the VP of EHS&Q is to review the NOAM annually to assure the NOAM is properly maintained in accordance with procedures.

The review is documented by signature of the VP of EHS&Q in a log maintained with the master copy of the NOAM. The team reviewed the log and verified the annual review was performed and signed off by the VP.

The team verified for the current projects the distribution methods for the 618TH DSC fabrication drawings and fabrication procedure books to various fabrication facility locations in accordance with procedure E-01. The CHT manufacturing engineers and project managers are Page 6 of 14

responsible for review of controlled documents for adequacy, completeness and approval prior to hardcopy distribution. The team verified CHT had the documentation (Drawing Control Cards and Procedure Book Control Sheets in the Master Work Order File) per E-01 for the current projects showing that drawing and procedure hard copy revisions had been distributed to the designated facility locations and the previous drawing revisions removed and destroyed. The team specifically checked the current DSC fabrication drawing revisions were in "Controlled Drawing Files" (Binders) and distributed to engineering, project management; and QC, DSC fabrication, machine shop, and fabrication 1 & 2 areas on the fabrication shop floor. The team determined the E-01 procedure gave detailed document distribution instructions and the distribution requirements were being followed.

Q-12 describes the requirements and process for storage, maintenance, and classification (as lifetime or nonpermanent) of QA records. Each quality record is to be numbered and be traceable to.the item(s) or operation(s) to which it applies and accurately reflect the work accomplished or information required . All records are to be initialed or signed with a date by authorized personnel. All records generated as part of the fabrication process are to be forwarded to CHT quality assurance and maintained in a project specific folder. The team verified that as quality records for fabrication of DSCs were being completed, they were maintained by CHT QA in a project folder.

TN specification NUH61BTH-0105, "Procurement Specification for the NUHOMS 61 BTH Type 1 and 2 Dry Shielded Canisters," Revision 7 requires CHT to submit to TN for review and approval a list of Quality Records that CHT will provide in the final document package (FDP) for each DSC it fabricates for TN. The team reviewed CHT's Generic and Specific Final Documentation Package Format which was submitted to TN and approved by TN. The team verified the approval correspondence. Although not shipped yet, the team reviewed a final document package for a completed DSC from each of the two ongoing 61 BTH projects. The team reviewed the common FDP and specific component FDP for the two DSCs and found them compliant with the approved format. In addition to all the material records and fabrication records, the FDP for each DSC contains As-built fabrication drawings showing the exact fabrication drawing revisions that particular DSC was constructed to. The As-built drawings also show reference to NCRs associated with that DSC. The team traced and verified the process of QA personnel preparing mark-up prints for the As-built fabrication drawings. In the individual DSC FDPs, CHT certifies that the DSC was fabricated in accordance with the As-built drawings.

Once the Certificate of Conformance for a DSC has been signed by the CHT VP of EHS&Q or other authorized individual, it is added to the FDP. The required number of sets of QA records are submitted to the customer (TN) electronically. The original hardcopy QA records are then .

sent to storage. QA records in electronic form are stored at two different locations remote from each other to prevent damage to the records simultaneously due to hazards. Quality assurance restricts which CHT personnel have access to the permanent QA records. The team inspected one storage area of DSC original hardcopy quality records and found it adequate since CHT also maintains electronic copies at two different locations.

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The team determined the document control and QA record procedures were adequate and being followed by CHT personnel. No concerns were identified by the team in the documentation control and records management areas.

4.1.4 Audit Program The team reviewed the internal audit program as defined in Q-22, "Audits," Revision 6. 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 who documented the audit results and followed up deficient areas via the corrective action program. The team reviewed four internal audits performed in 2016 as well as the 2016 through 2018 internal audit schedules to verify that they were conducted in accordance with the program as previously defined. In addition, the team reviewed TN's 2016 annual evaluation of CHT and the triennial NIAC audit of CHT performed in 2017 and accepted by TN to determine if TN 's audits were comprehensive and what issues were identified. The team also reviewed a selection of lead auditor training and qualification records to assess whether those leading audits were trained and qualified as required by CHT's approved procedure, Q-08, "Qualification of Audit Personnel," Revision 4.

The team determined that for the internal audit reports and checklists reviewed, the audits were adequate, reviewed a representative sample of CHT's activities in the area being audited, and the audit reports were written in a timely manner. The team noted that the NIAC checklists being used for internal audits was a strength. The team also noted that the 2018 audit plan was current and comprehensive, but audits planned for 2017 were not performed until June 2018.

This issue was also identified by TN during a CHT surveillance in May 2018 and it was documented in TN SFR 2018-015 and CHT CAR 18-031. Further, the team noted that TN also identified during their surveillance that the 2017 audit schedule had not been revised or updated since February 2017. CHT's planned corrective actions included writing a new quality procedure that summarizes quality assurance oversight activities and provides for periodic verbal and written reporting to CHT senior management on the status of scheduled activities.

The team determined the TN audits reviewed, including the NIAC audit that TN accepted and took credit, were comprehensive in nature and identified issues to correct and improve CHT's QAP. The team noted that the NIAC audit identified 9 findings and 3 observations mainly due to procedure compliance and the lack of attention to detail issues that did not rise to the level of a significant condition adverse to quality. The team's review of CAR 17-041 that captured the NIAC audit issues did not identify any concerns with respect to CHT's corrective actions.

Overall, the team assessed that the internal audit program was adequately implemented by performing audits with trained and qualified personnel of all applicable aspects of the QAP, except in the areas of internal audit scheduling and frequency. TN identified in May 2018 that CHT had not established an internal audit schedule since February 2017 and none of the scheduled internal audits had been conducted.

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4.2 Design Control 4.2.1 Design Development The team reviewed Section 3, "Design Control ," of the TN Americas Quality Assurance Program Description Manual, Revision 15; and CHT procedures E-06, "Design Control," Revision 1 and E-01 , "Drawing, Specification, Procedure & Customer Contract Control, " Revision 9 for the quality assurance requirements and procedures for design control and to verify that they were being properly implemented, as applicable.

TN is totally responsible for DSC design development and therefore CHT does not have any design authority or design change authority. CHT is authorized only to develop fabrication drawings and process fabrication NCRs. Therefore, the team addressed design control by reviewing the design control process between the Dry Cask Storage System (DCSS) designer TN and fabricator CHT. The team first reviewed TN specification NUH61 BTH-0105, "Procurement Specification for the NUHOMS 61 BTH Type 1 and 2 Dry Shielded Canisters,"

Revision 7 which was initially sent to CHT to provide the details of the DSCs to fabricate. The specification also contained the minimum fabrication documentation requirements and submittal requirements of those documents for TN review and approval prior to actual fabrication. The actual TN DSC design drawings for the 618TH Type 1 are not part of the specification but were attached to the original TN purchase order and revised purchase orders (as needed) to CHT.

The team reviewed the process for CHT to develop fabrication drawings from TN design drawings and the transmittal and approval of fabrication drawing revisions between CHT and TN . The team specifically reviewed a sampling of CHT fabrication drawings for the TN NUHOMS 618TH Type 1 Dry Shielded Canister main assembly, siphon and vent block, standard 9 tube bundle, and lifting lug assembly.

The team verified that the fabrication drawings developed by CHT had received the proper CHT reviewer and checker/approver signatures at each revision. The team verified that CHT had records of the transmittal of the fabrication drawings to TN's corporate office in Maryland or TN's on site staff for approval prior to issuance for use in fabrication .

The team then reviewed the TN correspondence documentation approving/accepting the CHT fabrication drawings and revisions. In some instances, TN accepted with comments or rejected the fabrication drawing revision with resolution of the reason for rejection required. CHT was then required to submit to TN another revision to the fabrication drawing due to the resolution of the rejection reason.

The team also reviewed how design drawing revisions from TN to CHT were incorporated into the CHT fabrication drawings and how all controlled copies of issued fabrication drawings were tracked and accounted for. When design drawing revisions were received from TN which affected fabrication, fabrication drawings would be pulled back from the shop floor until the fabrication drawing could be revised by procedure and issued back to the shop floor.

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The team reviewed CHT procedures E-06, "Engineering Personnel Qualifications," Revision 0 for the education and training requirements for the CHT engineering staff that are responsible for drafting and checking the CHT fabrication drawings. The team requested that CHT provide the education and training records for the CHT engineering staff that had drafted and checked the latest revisions to the main assembly, siphon and vent block , standard 9 tube bundle , and lifting lug assembly fabrication drawings. The team found all the education and training records for the individuals to be adequate and to meet the applicable requirements.

Based on its review, the team determined that CHT was following its design procedures, as applicable, to ensure that fabrication drawings and any associated specifications were consistent with the TN design drawings, NRC approved licensing drawings, and design requirements/commitments as documented in the CoC for the DCSS. No concerns were identified with the transmittal of TN design drawings to CHT and CHT development, review and approval of fabrication drawings. In addition, there were no concerns with the documentation of TN 's approval back to CHT so the fabrication drawings could be released for construction .

4.2.2 Modifications Modifications to the DSC design drawings could be performed under the 72.48 and design control processes of TN at their offices in Maryland. All CHT would receive from TN is a revised purchase order with any revised DSC design drawings attached. CHT would then review the revised DSC design drawings for any effects on the fabrication drawings. If the CHT fabrication drawings were affected, CHT would remove those drawings from the shop floor until revised fabrication drawings incorporating the changes could go through the approval process and be re-issued back to the shop floor.

4.3 Fabrication Controls 4.3.1 Material Procurement The team reviewed CHT's procedures that address procurement, traceability, and receipt inspection to verify they are being properly implemented at CHT. The team specifically reviewed the following procedures:

  • P-01 , Procurement of Materials, Items or Services, Revision 8
  • Q-02 , Receiving Inspection of Purchased Items & Services, Revision 7
  • Q-09, Inspection, Acceptance Tags and Stamps, Revision 6
  • MC-01 , Control, Identification & Traceability of Materials or Products, Revision 7 The team verified that TN used a graded approached for identifying important to safety (ITS) components during design and applied this graded quality level to component and material procurement documents through CHT. Specifically, the team reviewed procurement, traceability and receipt inspection of canister shell plate (ASME SA-240 Type 304), as well as, Page 10 of 14

weld materials and flux. The team reviewed CHT's process for identification and status of inspection and test activities in order to assure that items are acceptable for use. The team noted that material status is maintained through the use of tags and that travelers and inspection records associated with material use/fabrication are appropriately stamped by the CHT inspector indicating the acceptance of the operation.

The team verified that at receipt inspection, the vendor/supplier certification documents that are supplied with each procured item, as required by the respective purchase orders, are reviewed and all contain reference to the CHT purchase order for that item. In addition, the team verified CHT's implementation of its positive material identification (PMI) program. The program is used to assure, through testing, the reasonable assurance of the quality of material used in production and prevent the use of counterfeit, suspect or fraudulent materials. The team reviewed receiving report records and noted PMI testing was performed in accordance with procedure Q-28, "Positive Material Identification ," Revision 3 on a random sample of metallic components. Results were adequately recorded on each tested components' receipt inspection records.

The team determined that CHT's material traceability, procurement, and receipt Inspection controls were adequate with no concerns.

4.3.2 Fabrication and Assembly Controls The team evaluated control of the fabrication process through observations, examinations, and personnel interviews in the areas of material traceability controls/procurement/records, fabrication, assembly, test and inspection. The team selected a sample of production materials and assessed their compliance to the applicable CoC, TN specifications, and CHT procurement documents. The team examined CHT's production drawings, specifications, Commercial Grade Dedication Records, certified material test reports (CMTRs), receipt inspection records, certificates of conformance, vendor qualifications, and final CHT documentation packages for completed DSC serial numbers (S/Ns) 61 BTH-1-C-2H-022 and 027.

TN Specifications and CHT documents reviewed included :

  • Procurement Specification, EOS01-0105, NUHOMS EOS-37PTH Dry Shielded Canisters, Revision 1 (Information only since this DSC was not in production)
  • Procurement Specification, NUH61BTH-0105, NUHOMS 618TH Type 1 and 2 Dry Shielded Canisters, Revision 7
  • Weld Procedure Specification, WPS 08081-HW, GTAW Semiautomatic, Revision 0
  • Procedure, E-03, Traveler Sequencing and Conduct of Traveler Operations, Revision 2
  • QIP-VT, Visual Examination, Revision 6
  • 61 BTH-VTNB, Supplement to QIP-VT: Acceptance Criteria, Revision 0
  • 61 BTH-PT, Supplement to QIP-PT: Acceptance Criteria, Revision 0 Page 11 of 14
  • 61 BTH-UT (54-UT-113-002), Procedure for Ultrasonic Examinations of NUHOMS 61-BTH Type 1 and Type 2 Dry Shielded Canisters, Revision 2
  • CHT-UT-A, Supplement to CHT 61 BTH-UT Procedure Number 54-UT-113-002:

Acceptance Criteria per ASME Section Ill , Subsection NB, Revision 1

  • QIP-RT, Radiograph Examination, Revision 5
  • CHT-RT-A, Supplement to QIP-RT: Acceptance Criteria, Revision 0
  • Q-03, Welding Performance Qualification Testing & Records, Revision 2
  • Q-04, Control of Special Processes and Tests, Revision 11 The team observed storage of weld filler materials in original containers in a segregated controlled storage area. In addition, submerged-arc welding wire was controlled and stored in accordance with the manufacturer's recommendation to prevent contamination . The team reviewed the manufacturer's (Lincoln Electric Company) CMTRs for traceability and compliance to ASME Section II, ASME Section Ill NB-2000, and CHT purchase order requirements.

Overall, no concerns were identified with the purchase , control, issuance and storage of weld filler material.

The team observed various 61 BTH welding operations including an inner bottom cover to shell weld and a grapple ring to inner bottom cover weld and noted satisfactory compliance to applicable travelers , fabrication drawings, and weld procedure specifications (WPS). Travelers included appropriate process controls including weld maps and weld record sheets. In all cases, weld maps indicated the parts to be joined , weld joint symbols and sizes (as required) and WPS's to be used. Weld record sheets documented the qualified welders , WPS and heat number of the filler mater used .

The team reviewed a sample of welding operator performance qualification and continuity records for compliance to ASME Section IX. During a welder qualification records review, it was noted that a welder (W-57) had an incomplete performance qualification record. However, the team noted completion of the required test coupons to specific welding processes [Gas Tungsten Arc Welding (GTAW), Gas Metal Arc Welding (GMAW), and Flux Core Arc Welding (FCAW)] and that required radiographic testing (RT) examinations had been performed. The welder had completed the performance qualification testing but CHT had failed to finalize and complete the actual record of welder performance qualification. Quality procedure Q-03, Step 4.1.6 states, in part, that the welding engineer shall complete the Record of Welder Performance Qualification form or Record of Welding Operator Performance Qualification form ,

as appropriate, and sign and date the form. Contrary to the above, the welding engineer failed to complete the Record of Welder Performance Qualification form for a welder. The team determined the failure to follow a procedure to document a welder's performance qualification record was example three of a violation of 10 CFR 72.150 requirements . The team determined this violation to be more than minor because if a welder is not qualified to perform ITS welding on a DSC, the welds performed by that welder may be of poor quality which could lead to a significant safety issue. The team evaluated the violation in accordance with Section 2.3 of the NRC Enforcement Policy and characterized it as a non-cited Severity Level IV violation . CHT entered this issue into their CAP as CAR 18-048, dated June 20, 2018.

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The team observed CHT's controls and storage of new and recycled used weld flux. The team determined that CHT's controls and storage requirements for the new and recycled used weld flux was not in accordance with the flux manufacturer's written recommendations. The team determined that procedure Q-04, steps 4.2.8 through 4.2.11 for the control and storage of new and recycled used weld flux, provided inadequate guidance with respect to the flux manufacturer's written recommendations. The steps just made reference to the flux manufacturer's written recommendations which were not being strictly followed. Without the procedure steps specifically stating the manufacturer's recommendations, the team determined the manufacturer's written recommendations were up to interpretation by CHT workers and therefore not being implemented properly. The team determined that this failure to have an adequate procedure to follow the weld flux manufacturer's written guidance for new and recycled used flux control and storage was example four of a violation of 10 CFR 72.150 requirements. The team determined this violation to be more than minor because if new or recycled used weld flux was controlled or stored inadequately, its use during ITS welding on a DSC might result in poor quality welds which could lead to a significant safety issue. The team evaluated the violation in accordance with Section 2.3 of the NRC Enforcement Policy and characterized it as a non-cited Severity Level IV violation. CHT entered this issue into their CAP as CAR 18-052, dated June 21, 2018.

The team noted routine oversight occurs by CHT, TN, and the licensee during key fabrication and functional testing activities. The team noted an adequate level of oversight when it comes to assessing the effectiveness of the control of quality at the CHT facility at intervals consistent with the importance, complexity, and quantity of the DSC fabrication assembly and testing.

Overall implementation of CHT's fabrication and assembly controls was assessed to be adequate, except in the area of welder qualification records and controls for new and recycled used weld flux. Two examples supporting a Severity Level IV non-cited violation were identified with one for not documenting welder qualifications per procedure and the other for not having an adequate procedure for weld flux controls.

4.3.3. Test and Inspection The team reviewed post-helium leak, radiograph, and ultrasonic examination records specific to 618TH shell assembly S/Ns 22 and 27. With respect to shell S/N 22, the team observed that a relevant indication for a slag inclusion was identified for the circumferential weld at the time of inspection and resulted in NCR 17-307 being written . The team reviewed CHT's repair traveler and determined that the weld process and examinations [i.e., visual testing (VT), penetrant testing (PT), ultrasonic testing (UT), and RT] were satisfactory. In addition, a licensee (Xcel) representative performed oversight and witnessed all the required examinations to assure CHT's procedural compliance and final acceptability of the repair.

The team witnessed visual and liquid penetrant examination of the grapple ring to inner bottom cover on Shell Assembly, DSC No. LGS-61 BTH-1-D-2L-054. The team noted the examination was adequately performed in accordance with QIP-PT, Revision 10 and 61 BTH-PT, Revision 0.

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The team assessed that CHT had procedures in place to conduct quality-related activities in accordance with its NOAM and implementing procedures, 10 CFR Part 21, and 10 CFR Part 72 requirements. The team reviewed a sample of welder and nondestructive examination personnel qualification records, certification records (including eye exams), and training records.

The team determined that the individuals reviewed were trained, qualified, and certified, as applicable. Overall, no concerns were identified.

4.3.4 Tools and Equipment The team reviewed selected measuring and test equipment (M&TE) including records and procedures to assure that equipment used in activities affecting quality were properly controlled and calibrated. The team reviewed Q-01, "Control of Measuring and Test Equipment," Revision 17, which prescribes: activities and requirements concerning use of M& TE; that calibration occurs to national standards; procurement of calibration services; maintenance of records of various tools and equipment used; and actions to take when any piece of equipment is found out of calibration.

The team compared a sampling of M& TE used for recent fabrication and testing activities to the applicable requirements of Q-01, and determined overall compliance to the procedural requirements. The M&TE selected consisted of scales, a thickness gauge, a calibration block, and helium leak standards 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, including sub-suppliers of testing services, were current on CHT's Approved Suppliers List.

The team concluded that the M& TE quality procedure being implemented at CHT provided adequate guidance for M&TE calibration and use, and CHT had adequately implemented M&TE calibration, tracking, and use requirements.

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