ML19176A216

IR 071-0938/2019-201, February 25-28, 2019, at Federal Way, Washington, NRC Form 591S, Safety Inspection Report and Compliance Inspection, Inspector Notes and Cover Sheet

ML19176A216
Person / Time
Site:	07109341, 07109295, 07109184, 07109305, 07109287, 07109328, 07100938
Issue date:	06/18/2019
From:	Jon Woodfield NRC/NMSS/DSFM/IOB
To:	Lloyd C Orano Federal Services
Woodfield J
References
IR 2019201
Download: ML19176A216 (14)

Text

NRC FORM 591S PART 1 U.S. NUCLEAR REGULATORY COMMISSION

( 10-2013)

IOCFR 2 201 SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION 1 CERTIFICATE/QUALITY ASSURANCE PROGRAM (QAP) HOLDER 2 NRC/REGIONAL OF FIC E Orano Federal Services LLC (OFS) Headquarters 7135 Minstrel Way. Suite 300 U. S. Nuclear Regulatory Commission Columbia, Maryland 21045 Mail Stop TWFN 4B-34 Washington. DC 20555 -000 I REPOR T NUMBER($) 071-0938/2019-20 I 3 CERTIFICATE/OAP DOCKET NUMBER(S) 4. INSPECTION LOCATION 5 DATE (S) OF INSPECTION CoCs 71 -9184 , 71 -9287, 71-9295, 71 -9305, 505 South 336th Street, Suite 400 February 25-28, 2019 71-9328, 71 -9341 QAP 71-0938 Federal Way. Washington 9,8003 Exit Meeting May 23, 2019 CERTIFICATE/QUALITY ASSURANCE PROGRAM HOLDER:

The inspection was an examination of the activities conducted under your QAP as they relale to compliance with the Nuclear Regulatory Commission (NRC) rules and regulations and the conditions of your QAP Approval and/or Certificate(s) of Compliance. The inspection consisted of selective examinations of procedures and representative records . interviews with personnel. and observations by lhe inspector. The inspection findings are as follows :

D Based on the inspection findings . no violations were identified .

0 2. Previous violation(s) closed 0 3. The violations(s) . specifically described to you by the inspector as non-cited violations . are not being cited because they were sell-idenlified .

non-repetitive. and corrective action was or is being taken . and the remaining criteria in tile NRC Enforcement Policy. to exercise discretion. were satisfied .

- -- - Non-cited violation(s) was/were discussed involving the following requirement(s) and Corrective Actions(s):

Title 10 CPR 71. 11 I, Instructions. procedures, and drawings," states. in part. that the certificate holder shal I 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 cited 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 .

(Violations and Corrective Actions)

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

CERTIFICATE/OAP Chris Lloyd , OFS Senior Manager, REPRESENTATIVE Environmental Safety. Health. and Quality NRC INSPECTOR Jon N. Woodfield BRANCH CHIEF Christian Araguas NRC FORM 59 1S PART 1 (10-2013)

NRC FORM 591S PART 2 U.S. NUCLEAR REGULATORY COMMISSION (10-2013) 10 CFR 2.201 SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION

1. CERTIFICATE/QUALITY ASSURANCE PROGRAM (OAP) HOLDER: 2. NRG/REGIONAL OFFICE Orano Federal Services LLC (OFS) Headquarters 7135 Minstrel Way, Suite 300 U.S. Nuclear Regulatory Commission Columbia, Maryland 21045 Mail Stop TWFN 4B-34 Washington, DC 20555-000 I REPORT NUMBER(S) 07]-0938/20] 9-20]

3. CERTIFICATE/OAP DOCKET NUMBER(S) 4. INSPECTION LOCATION 5. DATE(S) OF INSPECTION CoCs 71-9184, 71-9287, 71-9295, 71-9305, 505 South 336th Street, Suite 400 February 25-28, 2019 71-9328, 71-9341 QAP 71-0938 Federal Way, Washington 98003 Exit Meeting May 23, 2019 (Continued)

Contrary to the requirements of IO CFR 71.111, during an inspection conducted February 25 - 28, 2019, the NRC identified the following two examples where OFS failed to follow procedures.

For the first example, OFS Procedure FS-QA-PRC-16.1 "Corrective Action Program," Revision 13, Step 4.2 states, in part, that corrective action reports (CAR) Significance Level 2 is less severe, requiring an Apparent Cause Analysis (ACA). Contrary to this requirement, OFS failed to perform an ACA for CAR 2018-850. This is a violation of IO CFR 71.111 for failure to follow procedures. The team determined this violation was more than minor because the CAR identified there were issues of personnel failing to perform their duties as required by the procurement and design documentation and their respective quality procedures, but no corrective actions nor actions to prevent recurrence were taken regarding these issues. The only corrective actions taken were to perform the required dimensional inspections and analysis supporting the use-as-is determination, and prepare new bolts and washers as required. This issue was entered into OFS' corrective action program as CAR 2019-652.

For the second example, OFS Procedure FS-QA-PRC-7.3 "Supplier Audits," Paragraph 5.2.3 states, in part, that documentation examined or activities witnessed during the (supplier) assessment shall be recorded on the (audit) checklist to the extent necessary to substantiate the conclusions being drawn. Further, Paragraph 5.2.7 of FS-QA-PRC-7.3, states, in part, that findings are instances of deviation from requirements and shall be identified as "Unsatisfactory" in the checklist.

Contrary to these requirements, OFS supplier audit report, FS-SE-2018-018 for Rainier Rubber, dated August I, 2018, was missing objective evidence on its checklist to support the conclusion of qualifying Rainier as an Important-to-Safety Category A supplier. There was no documentation of objective evidence to support the checklist conclusions in accordance with Paragraph 5.2.3 of FS-QA-PRC-7.3. Secondly, the team noted that Rainier's internal audit lead auditor did not comply with NQA-1-2008 standards for qualification as a lead auditor. The OFS audit checklist did not provide a justification to accept the deviation from the requirements ofNQA-1-2008 or if OFS considered the deviation from the requirements as a finding and should have identified it as "Unsatisfactory" on the checklist in accordance with Paragraph 5.2.7 of FS-QA-PRC-7.3 . These two incidences of not providing documentation is a violation of IO CFR 71.111 for failure to follow procedures. Based on review of the documentation provided in the Rainier Rubber supplier audit, the team assessed that OFS did not perform an adequate supplier audit to qualify Rainier as an Important-to-Safety Category A supplier for inclusion on the OFS approved suppliers list. This issue was entered into OFS' corrective action program as CAR 2019-807.

The inspection team dispositioned the two examples of procedural violations in accordance with Section 2.3 of the NRC Enforcement Policy. The team characterized the violation as a non-cited Severity Level IV violation since it was more than minor and OFS entered the issues in their corrective action program.

NRG FORM 591S PART 2 (10-2013)

INSPECTOR NOTES COVER SHEET Licensee/Certificate Holder CoC Holder Location: Contact Location:

(name and address) Orano Federal Services LLC Orano Federal Services LLC (OFS) 7135 Minstrel Way, Suite 300 505 South 335th Street, Suite 400 Columbia, Maryland 21045 Federal Wa , Washin ton 98003 Licensee/Certificate Holder Chris Lloyd, OFS Senior Manager, Environmental Safety, contacts and hone number Health , and Qualit Phone: 410-910-6870 Office Docket No. 071-0938 Inspection Report No. 71-0938/2019-201 Inspection Date( s) February 25-28, 2019, Final exit meeting May 23, 2019 by phone Inspection Location( s) Orano Federal Services LLC, Federal Way, Washington Inspectors Jon Woodfield, Team Leader, Safety Inspector Marlene Davis, Senior Safety Inspector Jerem Ta , Safet Ins ector Summary of Findings and This inspection was a routine periodic assessment of Orano Actions Federal Services' Quality Assurance Program (OAP) implementation at their office in Federal Way, Washington.

The team assessed OFS' management, design, fabrication, and maintenance controls, as applicable; for compliance to 10CFR Part 71, 10CFR Part 21, and OFS' NRC approved OAP; as related to OFS CoC's 71-9184 (PAS-1), 71-9287 (Eagle), 71-9295 (Mixed Oxide Fresh Fuel), 71-9305 (TRUPACT-111), 71-9328 (TN-55), and 71-9341 (BEA Research Reactor).

Overall, the team assessed that OFS was adequately and effectively implementing their NRC approved OAP regarding Quality Assurance, Management Controls, Design Controls, and Fabrication & Maintenance Interface Controls.

One non-cited Severity Level IV violation with two examples of non-compliance was identified by the team and is described in these inspector notes. Contrary to the requirements of 10 CFR 71.111 , "Instructions, procedures, and drawings," OFS failed in one example to perform an Apparent Cause Analysis per procedure for a corrective action report. In the second example ,

OFS failed to properly document objective evidence and identify findings as unsatisfactory for a supplier audit on the audit checklist in accordance with procedures. OFS captured the two exam les of non-com liance in their corrective action Lead Inspector Jon N. Woodfield Signature/Date Inspector Notes Approval Christian Araguas Branch Chief Signature/Date Page 1 of 12

Inspection History From November 4, through November 6, 2014, the NRC conducted the last team programmatic inspection at Orano Federal Services' (OFS) [Areva Federal Services (AFS) at the time] offices in Federal Way, Washington. The purpose of the routine inspection was to assess the compliance of AFS/OFS to the requirements of 10 CFR Parts 71 and 21. The inspection activities focused on management and design. The inspection consisted of selected examinations of procedures and representative records , observations of activities, and interviews with personnel.

No new violations were identified and previous violations were closed. Details of the inspection can be found in the inspection report and inspector notes (ADAMS ML14353A351 ). Overall, AFS/OFS' implementation of their NRC approved Part 71 Quality Assurance Program (QAP) at their Federal Way, Washington location was assessed to be adequate during the November 2014 inspection.

From February 1, through February 3, 2011, the NRC conducted a team programmatic inspection at AFS/OFS offices in Tacoma, Washington (AFS/OFS offices were in Tacoma at the time). The purpose of the routine inspection was to assess the compliance of AFS/OFS to the requirements of 10 CFR Parts 71 and 21. The inspection activities focused on management and design. The inspection consisted of selected examinations of procedures and representative records, observations of activities, and interviews with personnel.

The inspection team identified one violation of NRC requirements. The NRC identified several completed Nonconformance Report NCR forms that were not completed in accordance with AFS/OFS procedures. Also, several instances were identified on documents where signature authority was delegated but no documented record of such delegation could be provided by AFS/OFS, as required by their procedures. Finally, an AFS/OFS licensing procedure required the performance of a reconciliation of packaging fabrication drawings to the packaging SARP licensing drawings and then documentation of the reconciliation on a form contained in the procedure. The inspection team noted AFS/OFS personnel failed to document the reconciliation of the fabrication drawings and licensing drawings of a Packaging amendment on the required procedure form. These three findings were a violation of 10 CFR 71.111, "Instructions, procedures, and drawings," which states in part that an applicant for a CoC shall prescribe activities affecting quality by documented instructions or procedures of a type appropriate to the circumstances and shall require that these instructions and procedures be followed.

Details of the violation can be found in the inspection report (ADAMS ML110540584) and inspector notes (ADAMS ML110540607). No written response to the violation from AFS/OFS was requested by the inspection team leader. Overall, AFS/OFS' implementation of their NRC approved Part 71 QAP at their Tacoma, Washington location was assessed to be adequate during the February 2011 inspection.

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Inspection Purpose The purpose of the inspection was to assess OFS' compliance with 10 CFR Parts 21 and 71 ,

and to verify that the transportation packagings for which OFS is the holder of the Certificate of Compliance (CoC), can be verified to comply with Part 71 in management, design, procurement, fabrication , and maintenance requirements, as applicable. The focus of the inspection was to determine whether OFS' 10 CFR Part 71 activities were in accordance with their NRC-approved QA program requirements and that the packagings they are responsible for in the transportation of radioactive materials are being properly managed in accordance with the NRC issued CoCs and approved Safety Analysis Reports - Packaging (SARPs).

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: APPLICABLE SECTIONS FROM IP 86001 WERE PERFORMED DURING THE INSPECTION WITH RESULTS DOCUMENTED BELOW UNDER THE BASIC HEADINGS OUTLINED IN NUREG-6314. A SECTION CALLED OTHER ADDRESSES ADDITIONAL SPECIFIC ISSUES REVIEWED BY THE TEAM.

4.1 Management Controls 4.1.1 Quality Assurance Policy The team reviewed OFS document FS-QA-PMD-001 , "Quality Assurance Program Description (QAPD)," Revision 5, and associated changes to FS-QA-PMD-001 performed by OFS under the change provisions of 10 CFR 71 .106. The team conducted reviews of OFS' quality program, policies, and procedures, and discussed portions of the reviewed documents with selected personnel to determine whether activities subject to 10 CFR Part 71 were adequately controlled and implemented. The team reviewed OFS organization charts and interviewed Quality Assurance personnel to evaluate their organizational independence from cost, schedule, and production activities. The team also reviewed the QAPD Section 2, "Quality Assurance Program ," since the requirement that management regularly assess the status and adequacy of the quality assurance program is located there. The team reviewed three management assessments from 2018 that implemented this requirement.

The team verified that the QAPD as written adequately addressed the eighteen Subpart H QA criteria of 10 CFR Part 71. As stated in the Introduction, the QAPD is also written to satisfy 10 CFR Part 50 and 72 QA criteria. The team reviewed the Statement of Quality Policy and Page 3 of 12

Authority, signed by the President and CEO, and noted that the Senior Manager, Environment, Safety, Health & Quality (ESH&Q) is assigned the responsibility for developing, maintaining and verifying implementation of the QAPD consistent with the policy. The team reviewed Section 1, "Organization," and the associated Figure 1-1, "Orano Federal Services Organization and verified appropriate independence of the Senior Manager ESH&Q from cost and scheduling concerns as the Senior Manager ESH&Q reports directly to the President and CEO of OFS.

The team also verified that changes made to the QAPD under 71.106 were performed and documented as required , which did not constitute a reduction in commitments.

The team found that for the three management assessments reviewed , they all adequately assessed the applicable areas reviewed and identified issues that were captured in the corrective action program (CAP) as required. The issues that were found were identified due to a comprehensive and in-depth review that added value to the overall health of the OAP.

Overall implementation of the OFS OAP was assessed to be adequate with no concerns identified.

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

The team reviewed the following OFS quality procedures:

- FS-QA-PRC-15.1 "Control of Nonconforming Items ," Revision 11

- FS-QA-PRC-16.1 "Corrective Action Program ," Revision 13 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 supplier nonconformance reports (SNRs) issued since 2016 for fabrication of BEA Research Reactor (BRR) packagings. The team also reviewed a selection of corrective actions reports (CARs) issued since the last inspection in 2014. The team assessed that for the 5 SNRs reviewed, they had been appropriately dispositioned and closed , as applicable, in accordance with FS-QA-PRC-15.1. The team noted that for SNR number BRR-SNR-005, Revision O that it contained a justification for a use-as-is disposition, but the documented justification lacked in the detail needed to fully understand the reason behind the basis presented . Through discussions with knowledgeable OFS personnel, the team was provided the information supporting the justification and had no additional issues. OFS entered this observation in its CAP as CAR 2019-643, dated February 28, 2019.

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The team assessed that for the approximately 15 CARs reviewed , which included four Significance Level 2 CARs that require an Apparent Cause Analysis (ACA), they had been adequately documented and the corrective actions taken were adequate, except for CAR 2018-850. The team reviewed CAR 2018-850, which was determined by OFS to be a Significance Level 2 CAR for BRR lift adapter dimensions being significantly different from the drawing. No ACA was found in the records provided to the team associated with CAR 2018-850, and after discussing this issue with OFS personnel, no objective evidence of an ACA being performed could be provided for CAR 2018-850.

Quality procedure FS-QA-PRC-16.1, Step 4.2 states, in part, that Significance Level 2 is less severe, requiring an ACA. Contrary to the above, OFS failed to perform an ACA as required by procedure for CAR 2018-850. This was determined to be one example of a violation of 10 CFR 71 .111 , "Instructions, procedures, and drawings," for failure to follow procedures. The team determined this violation was more than minor because the CAR identified there were issues of personnel failing to perform their duties as required by the procurement and design documentation and their respective quality procedures, but no corrective actions nor actions to prevent recurrence were taken regarding these issues. The only corrective actions taken were to perform the required dimensional inspections and analysis supporting the use-as-is determination, and prepare new bolts and washers as required . An adequately performed ACA would have driven OFS to perform adequate corrective actions to prevent recurrence. For this first example of not following procedures, 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 . OFS entered this first example of not following procedures into their CAP as CAR 2019-652.

The team concluded that OFS effectively implemented its nonconformance control and corrective action programs and has adequate procedures in place to ensure compliance with the applicable regulations and QAP requirements, except in the one isolated case discussed above. One Severity Level IV non-cited violation was identified with this as one example for failure to follow procedures to perform an ACA for a Significance Level 2 CAR, which resulted in inadequate corrective actions taken to prevent recurrence.

10 CFR Part 21 Postings and Procedures The team reviewed OFS Procedure FS-QA-PRC-15.2, "Reportability Determinations," Revision 8, to evaluate if provisions were in place for evaluating deviations that could cause a substantial safety hazard and complete the required NRC notification in a timely manner. The team evaluated if OFS posted Part 21 requirements in noticeable areas around the office consistent with the 10 CFR 21.6, "Posting requirements. " The team also requested a list of Part 21 evaluations and notifications associated with OFS transportation packages and interviewed personnel to evaluate if they were familiar with the quality assurance implementing procedure FS-QA-PRC-15.2.

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The team assessed that OFS has adequate provisions in place for evaluating deviations and reporting defects, as required by 10 CFR Part 21 . The team noted that OFS did not make any Part 21 notifications to the NRC within the last five years . However, the team did review an interim report written for the potential use of a software program with deficiencies. The team verified that OFS dispositioned the interim report in accordance with FS-QA-PRC-15.2 and adequately determined that the use of the software program did not meet the Part 21 notification requirements.

4.1.3 Documentation Controls Orano Federal Services LLC is one entity of Orano Inc., whose main United States office is in Charlotte, North Carolina. Some documenUrecord review checks for procedural compliance are performed by the document control group in Charlotte, once documents are put into the corporate electronic document system . However, the team found the OFS office to have its own document control room and document control administrator/manager (DCM) with responsibility for all the documents/records produced in the OFS office.

The team reviewed the document control section of the QAPD, FS-QA-PMD-001, Revision 5 and implementing procedure FS-RM-PRC-001, "Records Management," Revision 15, that address document controls to verify they were being properly implemented.

The team interviewed the OFS DCM and discussed all the requirements of procedure FS-RM-PRC-001. The team reviewed a sample of documents issued and revised by OFS associated with the Model No. 380-B packaging project and had the DCM demonstrate how they were processed to determine if the controls on those documents were adequate and performed in accordance with FS-RM-PRC-001. The team determined that the requirements of the procedure were adequately being followed. As required by the procedure, the team found access control to the document control hard copy area included posting of an approved access list of those individuals allowed unescorted access to the files. Individuals not identified on the access list are not permitted access to the record files without supervision or assistance from an individual permitted access. The team verified that per procedure, copies of OFS staff and staff augmentation employees written signatures and initials were being maintained. The team verified that document records were being submitted to Document Control (DC) using the proper submittal form FS-RM-FRM-002. The DCM described/demonstrated how submitted records are reviewed for legibility, identification , and traceability to the activity to which they applied. Once determined acceptable, documents/records are stamped as reviewed and accepted by records management. Records are assigned an additional unique identification number for tracking purposes in the OFS electronic document database.

Controlled copies of the most current revision of an OFS procedure are available through OFS '

electronic document control system.

The team verified that there was dual storage of electronic documents and that paper copies of records were stored in two-hour rated fireproof file cabinets. When temporary storage of Page 6 of 12

records is required during processing, they are stored in one-hour fire rated file cabinets.

OFS utilizes an electronic records storage system called Documentum and a long-term archiving system for the storage and retrieval of files associated with a record called COLDStor.

The DCM demonstrated to the team how documents are scanned and loaded into the Documentum system and the Documentum security features with restricted access. The DCM demonstrated how OFS staff could perform document searches and then verify and access the latest revision of records in the system without the ability to modify any of the records. The I

manager demonstrated the same types of controls for the COLDStor system . OFS staff can print hard copies of electronic records but are required by the procedure to stamp them as uncontrolled, for information, or as appropriate, but all records are considered uncontrolled unless stamped controlled through document control.

The team determined that OFS quality record controls were adequate and met the requirements stated in FS-RM-PRC-001 and the applicable regulations . Overall, the team assessed that document and records management controls at OFS were adequate.

4.1.4 Audit Program Internal Audits The team reviewed the OFS audit program to evaluate if OFS scheduled, planned, and performed internal audits and surveillances in accordance with their quality assurance implementing procedures FS-QA-PRC-18.1, "Internal Audits ," Revision 5 and FS-QA-PRC-18.2, "Surveillance," Revision 6. The team selected internal audits and surveillances from the last five years, particularly related to transportation activities. The team reviewed the audit results to evaluate if OFS identified deficiencies and addressed the deficiencies within their corrective action program. Additionally, the team interviewed personnel to evaluate how OFS trained and qualified lead auditors to cover all applicable aspects of the QA program.

Overall, the team assessed that for the internal audits sampled , OFS adequately conducted audits with qualified and certified personnel, scheduled and evaluated applicable elements of their QA program. The team assessed that OFS appropriately identified issues and implemented corrective actions in a time frame commensurate with their safety significance and covered all 18 quality criteria for the planned internal audits and surveillances. The team assessed that OFS adequately trained and qualified all personnel as required by procedures and covered all applicable aspects of the QA program.

Procurement/External Audits The team reviewed OFS procurement control, planning, selection, evaluation, documentation, and acceptance of items and services that affected important-to-safety (ITS) activities. The team focused its review on the procurement of items and services associated with two of OFS' transportation packages, the BEA Research Reactor (BRR) and the Model No. 380-B.

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Specifically, the procurement of the containment internal 0-rings used to maintain a leak tight seal to prevent the release of radioactive material. This review included how OFS controlled, verified, and tracked the material from time of design development to purchase and through the installation. The team also reviewed the OFS supplier audit program to determine if OFS scheduled, planned, and performed supplier audits in accordance with their implementing procedures, referenced standards, and guidance documents. This review included how OFS audited the supplier who supplied the 0-rings for the packages. The team reviewed the following quality implementing procedures and documents:

- FS-QA-PRC-7.1, "Control of Purchased Materials, Parts & Components," Revision 3

- FS-QA-PRC-7.2, "Supplier Evaluations," Revision 8

- FS-QA-PRC-7.3, Supplier Audits and Commercial Grade Surveys, Revision 5

- FS-EN-PRC-015, "Classification of Components for 10CFR71 & 10CFR72 Applications,"

Revision 3

- QA-3008391, Approved Supplier List (ASL), Revision 46.

- Purchase Order (PO) 18C3020068, "BEA Research Reactor Package," dated April 30, 2018 *

- PKG-QL-016, "Quality List for the 380-8 Auxiliary Equipment," Revision 0 Generally, the team assessed that OFS had provisions to control material procurement for the BRR and Model No. 380-8 transportation packages. The team assessed and verified that OFS established programs and processes to develop procurement drawings and specifications in accordance with procurement procedures. However, during the review of OFS supplier audit report, FS-SE-2018-018, dated August 1, 2018, the team noted some deficiencies with the report and checklist used to discuss and address all quality criteria required to comply with 10 CFR Part 71 and ASME NQA-1 as applicable for an ITS Category (CAT) A supplier in accordance with OFS' procedures. First, the team noted that the checklist was missing objective evidence to support the conclusion of qualifying the company as an ITS CAT A supplier. Specifically, the team noted that OFS utilized a comprehensive checklist to show how the supplier's quality assurance program complied with ASME NQA-1 standards. However, there was no documentation of objective evidence shown to support the checklist conclusions in accordance with OFS procedure FS-QA-PRC-7.3, paragraph 5.2.3. Secondly, the team noted that the supplier's lead auditors did not comply with NQA-1-2008 standards for qualification of a lead auditor. A review of the OFS checklist did not provide a justification to accept the deviation from the requirements of ASME NQA-1-2008 or if OFS considered this deviation from the requirements as a finding and identified this as "Unsatisfactory" in the checklist in accordance with paragraph 5.2.7 of FS-QA-PRC-7.3. The team assessed that these procedural issues were a second example of violations of NRC regulation 10 CFR Part 71.111, "Instructions, procedures, and drawings."

10 CFR Part 71.111, "Instructions, procedures, and drawings," requires, in part, that the certificate holder shall prescribe activities affecting quality by documented procedures of a type appropriate to the circumstance and shall require that these procedures be followed. Contrary to, as of March 21, 2019, OFS did not follow procedure FS-QA-PRC-7.3, Paragraph 5.2.3.

Specifically, Paragraph 5.2.3 of FS-QA-PRC-7.3, states, in part, that documentation examined Page 8 of 12

or activities witnessed during the assessment shall be recorded on the checklist to the extent necessary to substantiate the conclusions being drawn. Further, Paragraph 5.2. 7 of FS-QA-PRC-7 .3, states, in part, that findings are instances of deviation from requirements and shall be identified as "Unsatisfactory" in the checklist. In this case, the team could not determine if the supplier's OAP met the requirements of 10 CFR Part 71 , Subpart Hand ASME NQA-1. If so, the team would assess that OFS did not perform an adequate supplier audit used to qualify the company as an ITS CAT A supplier on their approved supplier's list. The team also dispositioned this second example of the violation for not following procedures in accordance with Section 2.3 of the NRC Enforcement Policy. The team characterized this as a second example in supporting the non-cited Severity Level IV violation discussed in section 4.1.2 since it was more than minor, and OFS entered the condition into their corrective action program.

OFS captured this second example of not following procedures in their CAP as CAR 2019-807.

4.2 Design Controls 4.2.1 Design Development The team reviewed the OFS procedures specifically related to design development/control and modification activities and held discussions with OFS design, engineering analysis, and licensing management staff. The team focused its review on OFS design activities related to an application request for a new Part 71 transportation packaging called the Model No. 380-8 for which OFS had design authority but was not the actual CoC holder with the NRC.

The team reviewed the design control section of the QAPD, FS-QA-PMD-001 , Revision 5, and specifically reviewed the following OFS procedures associated with design control to verify they were being properly implemented:

- FS-EN-PRC-001 , "Design Control ," Revision 13

- FS-EN-PRC-002, "Calculations ," Revision 18

- FS-EN-PRC-003, "Engineering Drawings," Revision 1O

- FS-EN-PRC-004, "Specifications," Revision 6

- FS-EN-PRC-005, "Design Changes ," Revision 11

- FS-EN-PRC-013, "Use and Management of Engineering Application Software," Revision 9,

- FS-EN-PRC-017, "Procurement and Qualification of Procured Engineering Application Software," Revision 8

- FS-EN-PRC-021 , "Engineering Software Error Reporting and Evaluation," Revision 6

- FS-EN-PRC-022, "Fabrication Readiness Review," Revision 3

- FS-PM-PRC-001, "Development of Project Management Plans," Revision 12 OFS' system for the initiation , review, and approval of design documents is a combination of electronic and hard copy reviews . Design documents can be transmitted electronically during the design process from computer work station to computer work station of initiators, reviewers ,

and approvers. However, the team found most signatures on design documents to be hand Page 9 of 12

written . Document Control is required by procedure to maintain copies of company and staff augmentation employees' written signatures and initials for individual traceability.

The team reviewed OFS procedure FS-PM-PRC-001, "Development of Project Management Plans," and found it acceptable. The team specifically reviewed the Project Management Plan PMP-3007319-003 for the Model No. 380-B Package Development Project and found it to be very detailed with all the proper reviews and written in compliance with the procedure.

The team reviewed various design drawings for the Model No. 380-B packaging and verified that all the required drawing reviews and approvals were performed with the names of the individuals provided . The team requested the check prints for the drawings and verified that the checker had initialed the check prints per procedure FS-EN-PRC-003. Some of the drawings reviewed had been revised by engineering change notices (ECN) or design change notices (DCN). The team requested a sampling of ECN/DCNs and verified that they were written ,

reviewed, approved and processed per procedure FS-EN-PRC-005. OFS demonstrated a tracking database for the Model No. 380-B project where all the design drawings were listed and the associated revisions and ECN/DCNs for each drawing . Additional information was provided for each ECN/DCN such as if it had been incorporated on to the drawing and date of its issue.

The team also reviewed various specifications for the Model No. 380-B project and the associated check prints. The team verified the methods used by the specification checkers to record their comments and provide them to the specification originator were in compliance with procedure FS-EN-PRC-004.

The team reviewed Calculation 3007786-001 , "380-B Thermal Analysis," Revision 1, which performed a safety evaluation of the thermal performance for the Model No. 380-B packaging when loaded with a generic payload . The team determined that the calculation had been performed in compliance with procedure FS-EN-PRC-002, Calculations. The team also verified that the proper calculation design verification checklist form had been used and it was filled out properly and stored in document control. Calculation 3007786-001 utilized a computer analysis software program which led the team to QA requirements for software and the three engineering software procedures listed above. The team also reviewed other Model No. 380-B project calculations that utilized software to perform analysis. Other software programs used on the 380-B project were ANSYS and SCALE. The team reviewed the computer software testing and acceptance reports for the various software programs and verified that they were performed in accordance with the procedures.

The team interviewed the OFS Computer Software Error Report Coordinator to discuss compliance with the requirements of FS-EN-PRC-021 , Engineering Software Error Reporting and Evaluation. The procedure contained detailed requirements for error report tracking. The team reviewed the data base for tracking software vendor error reports and OFS demonstrated how it tracked project calculations that utilized various software so that OFS could evaluate if any software errors affected the previously performed calculations. The controls in place for tracking software errors and identifying any affected calculations were determined to be Page 10 of 12

adequate by the team.

The team reviewed the fabrication and construction readiness review document FRRC-3020093-000 for the Model No. 380-B packaging. The team determined the fabrication readiness review was thorough , contained an extensive review checklist, and contained all the proper reviews and signatures in accordance with procedure FS-EN-PRC-022.

The team chose a sampling of OFS staff names from the design documents reviewed and requested their qualification and training records as design engineers. The team determined from the review of documentation provided that the individuals were qualified and trained in computer software to perform as design engineers and they were also current on the latest revisions to the OFS design control procedures.

The team assessed that OFS was effectively implementing its design control procedures specifically for the Model No. 380-B Project. The team found that specifications, calculations ,

design/licensing/fabrication drawings, and DCNs/ECNs 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.

4.2.2 Modifications Section 4.2.1 provides some discussion of the team 's review of ECN/DCNs for modifications to the Model No. 380-B design. NRC approval is always required prior to implementing a proposed change to or deviation from a Part 71 packaging SARP, especially licensing drawings.

The team verified through sampling that all modifications to licensing drawings contained within the OFS SARPs were sent to the NRC for review and the new licensing drawing revisions incorporated into a revised CoC issued by the NRC for that particular packaging.

4.3 Fabrication Controls and 4.4 Maintenance Controls The team reviewed selected records and interviewed personnel to evaluate the limited fabrication and maintenance activities the corporate office performs for their CoC held transportation packages. The team performed a review of the fabrication and maintenance activities related to the BRR and the Model No. 380-B packages for a period of five years. The team reviewed maintenance requirements identified in the SARPs and CoCs, and discussed personnel qualifications and training with the OFS staff, as applicable. The team also reviewed project plans and other related documents related to fabrication and maintenance since the corporate office does not perform those activities onsite.

Based on a review of the maintenance instructions and specifications developed from the maintenance requirements identified in the SARPs and CoCs, the team assessed that OFS adequately developed these documents in accordance with their quality assurance manual and Page 11 of 12

procedures. The team verified that the maintenance instructions and specifications were comprehensive and met acceptance criteria for tests identified in the SARPs and CoCs.

OTHER ISSUES REVIEWED BY THE INSPECTION TEAM Corrective Action Follow-up to 2018 Inspection Non-Cited Violation The team reviewed the corrective actions taken by OFS associated with the violation of 10 CFR 71 .107, "Package design control, " identified during the November 2018 inspection at Premier Technology, Inc. (PTI) to verify they were adequately completed. (Reference the Inspection Report at ADAMS ML18353A452) Specifically, the violation cited the failure by OFS to correctly translate the BRR package design into specifications and drawings. Specifically, the requirement to perform a liquid dye penetrant (PT) inspection was not correctly translated by OFS from the licensing drawing to the fabrication drawing, which was being used by PTI to perform fabrication activities. Corrective action report 2018-9897, dated November 8, 2018, documented the corrective actions taken by OFS for this violation. The team determined that OFS performed engineering change notices as appropriate for each of the drawing revisions needed to correct the incorrect requirements and revise the drawings accordingly. These actions were also performed in a timely manner.

The team determined the corrective actions in response to the non-cited violation from the 2018 inspection at PTI were adequate and the violation is considered closed.

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