ML20140D531

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Discusses Pacific Northwest Natl Lab 961204 Rept PNNL-11419, Rept on Evaluation of Tritium Producing Burnable Absorber Rod Test Assembly. Evaluation of DOE Responses to 970103 RAI Re Quality Assurance,Encl
ML20140D531
Person / Time
Issue date: 04/21/1997
From: Martin T
NRC (Affiliation Not Assigned)
To: Sohinki S
ENERGY, DEPT. OF
References
PROJECT-697 NUDOCS 9704230297
Download: ML20140D531 (14)


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NUCLEAR REGULATORY COMMISSION 2

WASHINGTON, D.C. 30086 4001

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April 21, 1997 Stephen M. Sohinki, Director Office of Comercial Light Water Reactor Production Defense Programs Department of Energy Washington, DC 20585

SUBJECT:

DISCUSSION OF THE DOE QUALITY ASSURANCE PROGRAM FOR TRITIUM-PRODUCING BURNABLE ABSORBER ROD LEAD TEST ASSEMBLIES i

Dear Mr. Sohinki:

j On December 4, 1996, the Department of Energy (DOE) submitted Pacific Northwest National Laboratory (PNNL) report PNNL-11419, " Report on the Evaluation of Tritium Producing Burnable Absorber Rod Lead Test Assembly,"

dated November ~1996, for the staff's review. The purpose of this report was to provide technical information related to the irradiation of tritium-producing burnable absorber rod (TPBAR) lead test assemblies (LTAs) in a comercial light-water reactor (CLWR).

In particular, the report provides a description of the design and fabrication requirements for a TPBAR and an evaluation of the safety issues associated with the anticipated irradiation'of LTAs in a CLWR.

~ Based.on its review of the reoort, the staff forwarded a request for additional.information (RAI) to DOE on January 3,1997. On January 21, and February 14, 1997, DOE provided responses to the staff's RAI.

Both of these responses asserted that the TPBARs did not perform a safety-related function

'and that they were, therefore, considered to be non-safety related. -However, the topical report indicated that PNNL would " voluntarily" apply 10 CFR Part 21 provisions and their QA program to these items which they considered met the requirements of 10 CFR Part 50, Appendix B.

By letter dated February 13, 1997, the staff conveyed to DOE its position that the.TPBARs were

part of a basic component and that as such they were subject to the provisions of 10 CFR Part 21 and the quality assurance requirements of 10 CFR Part 50, Appendix B.

In response to the staff's position regarding the safety ~

classification of the TPBARs, PNNL forwarded a revised response to the staff's RAI on March 7, 1997, which acknowledged that the design and fabrication of TPBARs would be accomplished under a quality assurance program that complies with the requirements of 10 CFR Part 50, Appendix B.

This position was reflected in Revision 1 to PNNL-11419, submitted by letter dated March 17, 1997.

l The staff has reviewed the applicable portions of the report, as revised, (Sections 2.4.1, 2.4.2, and 7). Relative to the quality assurance provisions j

specified_ in the topical report, the staff is continuing to review the

'l adequacy of PNNL's programatic controls in order to establish conformance s

with the requirements of 10 CFR Part 50, Appendix B.

In addition to the

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. program, it is anticipated that on-site inspections at PNNL will be necessary in order to verify the adequate implementation of 10 CFR Part 50, Appendix B requirements related to the design and fabrication of the TPBARs. The staff has also determined that a licensee anticipating irradiation of TPBAR LTAs will need to explicitly identify the programmatic controls and processes that will demonstrate compliance with the requirements of 10 CFR Part 50, Appendix B, prior to installing these assemblies into the core.

Enclosed is an evaluation of DOE's responses to the staff's RAI dated January 3, 1997, regarding quality assurance.

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Thomas M. Martin, Director t

Division of Reactor Program Management Office of Nuclear Reactor Regulation Project No. 697

Enclosure:

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. program, it is anticipated that on-site inspections at PNNL will be necessary in order to verify the adequate implementation of 10 CFR Part 30, Appendix B requirements related to the design and fabrication of the TP3ARs.

The staff has also determined that a licensee anticipating irradiatior, of TPBAR LTAs will need to explicitly identify the programmatic controls and processes that will demonstrate compliance with the requirements of 10 CFR Part 50, Appendix B, prior to installing these assemblies into the core.

Enclosed is an evaluation of DOE's responses to the staff's RAI dated January 3, 1997, regarding quality assurance.

Marylee Slosson for/

Thomas M. Martin, Director Division of Reactor Program Management Office of Nuclear Reactor Regulation Project No. 697

Enclosure:

As stated cc w/

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i DISCUSSION OF THE DOE QA PROGRAM FOR TRITIUM-PRODUCING l

BURNABLE ABSORBER R0D LEAD TEST ASSEMBLIES l

1.0 INTRODUCTION

l l

On December 4, 1996, the Department of Energy (DOE) submitted Pacific Northwest National Laboratory (PNNL) report PNNL-11419, " Report on the l

l Evaluation of Tritium Producing. Burnable Absorber Rod, Lead Test Assembly,"

l dated November 1996, for the staff's review. The purpose of this report was 1

l to provide technical information related to the irradiation of TPBARs in a commercial light water reactor.

In particular, the report provides a i

description of the design and fabrication requirements for a TPBAR and an evaluation of the safety issues associated with the anticipated irradiation of these assemblies in a commercial light water reactor.

Based on a review of the report, the staff forwarded a request for additional information (RAI) to DOE on January 3,1997. On January 21, February 14, and March 7, 1997, DOE provided revised responses to the RAI in order to address i

the staff's concerns related to the safety classification of the TPBAR LTAs.

As a result of these interactions PNNL acknowledged that the design and fabrication of the TPBARs would be accomplished in accordance with a quality assurance program that complies with the requirements of 10 CFR 50, Appendix B.

2.0 BACKGROUND

The staff is in the process of reviewing the report to determine whether unreviewed safety questions are involved in the irrradiation of TPBAR LTAs in CLWRs.

This will determine whether a licensee undertaking such irradiation may proceed under the provisions of 10 CFR 50.59 or must seek prior approval from the NRC.

3.0 EVALUATION The staff has completed its initial review of the quality assurance provisions l

described in Sections 2.4.1, 2.4.2 and 7 of PNNL's Topical Report PNNL-TTQP 503, Revision 1.

As previously stated, subsequent to the staff's review of the topical report, an RAI was forwarded to DOE in order to seek clarification on specific technical issues. The responses provided by DOE on January 21, and February 14, 1997, asserted that the TPBARs did not perform a safety-related function and that they were, therefore, considered to be non-safety related. However, the topical report indicated that PNNL would voluntarily apply 10 CFR Part 21 provisions and their QA program to these items which they considered met the requirements of 10 CFR 50, Appendix B.

By letter dated February 13, 1997, the staff conveyed to DOE its position that the TPBARs were part of a basic component and that as such they were subject to the provisions of 10 CFR Part 21 and the quality assurance requirements of 10 CFR Part 50, l

Appendix B.

In response to the staff's position regarding the safety classification of the TPBARs, PNNL forwarded a revised response to the staff's RAI on March 7, 1997, which stated that, "Due to their association with i

reactor fuel assemblies, the TPBARs are considered to be a part of a basic Enclosure 1

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I component as defined in 10 CFR Part 21.

The TPBAR is important to safe and reliable operation, requiring the design and fabrication of TPBARs to be accomplished under a quality assurance program that complies with the i

requirements of 10 CFR 50, Appendix B.

The appropriate quality assurance and 10 CFR Part 21 requirements have been applied to the individual subcomponents of TPBARs to an extent commensurate with their importance to safety, and i

consistent with provisions of 10 CFR 50, Appendix B, Criterion II, Quality Assurance Program."

The staff has reviewed this response and determined that although PNNL acknowledges that the TPBARs are part of a basic component, the initial question related to identifying the specific components in the TPBAR LTAs that are considered safety-related remains unanswered. Therefore, RAI items 1 and 2 will remain open pending the resolution of this issue through future correspondence with DOE /PNNL.

Item 3 of the RAI requested a consolidated description of the quality assurance program controls that would govern the design fabrication, testing and installation of the LTAs.

1 PNNL's response states that in accordance with Tennessee Valley Authority's Nuclear Quality Assurance Plan (TVA-NQA-PLN89-A), the host utility contractually requires PNNL and Westinghouse to establish, maintain and implement a quality assurance program that meets the requirements of 10 CFR 50, Appendix B.

The response further states that PNNL maintains primary j

l responsibility for the design and fabrication of the TPBARs in accordance with their Project Quality Assurance Plan described in ETD-003, Revision 2.

Corresponding quality assurance program information contained in the revised topical report states that in addition to being the fuel system supplier for the host utility, Westinghouse will qualify PNNL as an approved supplier for the design and fabrication of lead test assemblies in accordance with Westinghouse's Quality Management System (QMS), Revision 1.

This qualification process includes evaluation of the PNNL Project Quality Assurance Plan and its implementation for compliance with 10 CFR 50, Appendix B, and ASME NQA,-l Basic and Supplementary Requirements as delineated in the Westinghouse QMS.

l Based on the review of PNNL's response to RAI Item 3, the staff has determined that inadequate information has been provided to resolve this issue.

l Therefore, this item will remain open pending the staff's evaluation of PNNL's quality assurance program related to the design and fabrication of TPBAR LTAs during a future inspection of PNNL.

l Items 4,12,and 18 of the RAI requested a definition si the contractual relationship among the participants described in Figure 7-1 of the topical l

report and for a description of the methods that will be used by the host utility to provide QA oversight of PNNL, Westinghouse, and sub-suppliers.

Additionally, the staff asked if Appendix B audits, surveillances, and inspections would be conducted by the host utility.

PNNL's response stated that Battelle, as the operator of Pacific Northwest Ll*.

National Laboratory (PNNL), is procuring irradiation and technical support services from the host utility and nuclear computer code modification services from Westinghouse Electric Corporation.

Furthermore, it was stated that the host utility is procuring QA oversight (including qualification of PNNL as a supplier), engineering, and technical support services from Westinghouse and that the host utility has contractually imposed 10 CFR 50, Appendix B and 10 CFR 21 on PNNL and Westinghouse.

The response to the RAI also indicated that TVA, as licensee of the facility, is responsible for ensuring appropriate technical and quality requirements are l

established and complied with prior to insertion of the LTAs into the reactor j

core. These activities.are to be accomplished in accordance with TVA's j

established QA Program.

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The RAI-response stated that the final supplier of the completed LTAs to Watts l

Bar will be Westinghouse who is identified as an approved supplier for TVA.

' Additionally, it was stated that Westinghouse has been contracted by the host utility to proride QA oversight of PNNL in accordance with their Quality Management System (QMS) and that planned Westinghouse oversight activities include the following aspects:

a.

Performance of a supplier qualification audit to evaluate PNNL's compliance with 10 CFR 50, Appendix B and ANSI NQA-1, Basic and Supplementary Requirements ~.

b.

Oversight of PNNL manufacturing operations and PNNL control of l

subcontractor quality processes.

c.

Providing the TVA with a report summarizing the adequacy of the implementation of PNNL's QA program, prior to insertion of the LTAs into the core.

The RAI response further stated that PNNL will furnish Westinghouse with certified subcomponents (TPBARs), and that Westinghouse will complete the fabrication, certification, and delivery of the LTAs to TVA.

TVA's acceptance of the LTAs, as stated, will include receipt inspection in accordance with their established QA Program.

The response provided by PNNL regarding the contractual relationship between the participants described in Figure 7-1 of the topical report and the host utility's QA oversight of PNNL, Westinghouse, and sub-suppliers is acceptable.

Therefore, RAI items 4, 12, and 18 are closed. However, the verification of the implementation of these functions which affect safety-related activities will be evaluated during a future inspection of PNNL.

With respect to RAI Items 5 and 13, the staff requested a current copy of PNNL's quality assurance program that implemented ASME NQA-1, 1989, as well as a description of how TVA's quality requirements which conform to NRC Regulatory Guides which endorsed ANSI N45.2 series standards were transmitted to Westinghouse and PNNL.

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corollaries between ASME NQA-1, 1989 and ANSI N45.2 series standards DOE provided an informational copy of PNNL's Tritium Target Qualification Project (TTQP) Quality Assurance Plan, ETD-003, Revision 2.

In providing this document DOE stated in their letter that "The governing quality assurance requirements for this project are embodied 'i the NRC accepted plans of TVA-Watts Bar and Westinghouse, and therefore we are not requesting NRC review and approval of this plan." The staff acknowledges DOE's statement regarding the preeminence of the governing quality assurance provisions in both TVA's and Westinghouse's QA program descriptions. However, the requirements of 10 CFR 50, Appendix B, Criterion IV, state in part that ".... applicable regulatory requirements, design basis, and other requirements which are necessary to assure adequate quality are suitably included in or referenced in the documents for procurement of material, equipment, and services, whether purchased by the applicant or by its contractor or its subcontractor."

Furthermore, Criterion IV states that " To the extent necessary, procurement documents shall require contractors or subcontractors [ emphasis added] to provide a quality assurance program consistent with the pertinent provisions of this appendix."

Although DOE has specified that NRC review and approval of PNNL's quality assurance plan is not requested, the fact that PNNL is identified as maintaining primary responsibility for the design and fabrication of the TPBARs establishes that the evaluation of their QA program will constitute an integral component in the NRC's review of the TPBAR LTA program for CLWRs.

The staff will continue to evaluate the quality assurance program controls associated with the implementation of 10 CFR 50, Appendix B requirements. RAI Items 5 and 13 remain open pending further staff evaluation.

RAI Item 6 requested a description of PNNL's regulatory compliance and quality assurance prograa which would provide audit and oversight of component and service suppliers utilized by PNNL for design and fabrication of TPBAR LTAs.

In response to this question, PNNL stated that their project quality assurance plan required procurement to include appropriate quality requirements and that it specified that component and service suppliers are subject to PNNL QA oversight. The RAI response stated that suppliers are required to submit quality assurance control plans to PNNL, for review and approval and that their oversight included pre-award surveys, periodic audits, in-process monitoring, source inspections, and receipt inspection of delivered ploducts.

The response provided to RAI Item 6 is acceptable and this issue is considered closed. However, the implementation aspects of PNNL's audit and oversight of component and service suppliers will be evaluated during a future inspection of PNNL.

Item 7 of the RAI requested a description of the quality provisions from PNNL's QA program which were passed on to component and service suppliers utilized by PNNL for the design and fabrication of TPBAR LTAs. Additionally, the staff requested a description of PNNL's methodology for determining the acceptability of suppliers. _

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l-In response to this inquiry PNNL stated that quality requirements are established commensurate with importance to safety of the item or service being provided.

PNNL also stated that procurement for components and services required the submittal of a quality assurance / control plan to PNNL for review and approval and that the acceptability of suppliers was established based upon pre-award surveys, periodic audits, source inspections, in-process monitoring, and receipt inspection of delivered products.

The response provided to RAI. Item 7 is acceptable and this issue is considered closed. However, the implementation aspects of PNNL's translation of quality assurance program requirements to component and service suppliers will be evaluated during a future inspection of PNNL.

Item 8 of the RAI requested clarification regarding the_ treatment of commercial grade items that were not manufactured in accordance with Appendix B quality assurance requirements or the PNNL quality assurance program for use in the TPBARS. The staff also requested a description of the process employed by PNNL to determine the acceptability of those items (i.e. commercial grade t

item dedication).

j PNNL's response reiterated that TVA had contractually imposed compliance with L

10 CFR 50, Appendix B and 10 CFR 21 on PNNL and Westinghouse.

PNNL further stated that components received by PNNL that do not comply with the requirements specified in the procurement documents are considered nonconforming and would be handled in accordance with their corrective action program.

PNNL also stated that they require that failures to comply are identified and corrected and that items are acceptable by appropriate combinations of testing, source inspection, review of supplier quality control l

- plans, review of supplier documentation, and receipt inspection.

In conclusion PNNL stated that the methods used are appropriate to the characteristics to be verified.

Based on the review of PNNL's response to RAI Item 8, the staff has determined that inadequate information has been provided to resolve this issue.

l Specifically, the response failed to address the essential progra:nmatic elements that are necessary for the dedication of commercial grade items including the processes associated with the identification and verification of

" critical characteristics". Therefore, this item will remain open pending the staff's evaluation of future correspondence regarding PNNL's commercial grade item dedication program.

Item 9 of the RAI requested a description of the management assessments and quality assurance audits performed by PNNL's regulatory compliance and QA organizations to verify the effectiveness of the PNNL QA program implementation.

PNNL's response stated that their project quality assurance plan established requirements for periodic audits and management assessments. To date, PNNL stated that they had conducted four management assessments related to.QA plan i

implementation in the areas of overall program adequacy and implementation, training, records, and design.

PNNL further stated that fabrication j

activities have only recently commenced, and that supplier QA oversight 4

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activities are underway.

PNNL also indicated that additional management assessments and QA audits will be performed during the remainder of the project to ensure compliance with the project quality assurance plan, including audits of fabrication activities.

In addition, PNNL stated that the l

host utility requires Westinghouse to perform QA oversight activities and j

provide a report to the utility regarding the adequacy of PNNL's QA program.

L The response provided to RAI Item 9 is acceptable and this issue is considered l

closed. However, the adequacy of PNNL's management assessments and quality assurance audits will be evaluated during a future inspection of PNNL.

l Item 10 of the RAI requested a description of the PNNL verification processes that will be employed to assure that TPBARs conform to design specification requirements.

In response to this item PNNL stated that their project quality assurance plan 4

established requirements for source inspections, receipt inspections, review of supplier documentation, as well as in-process and final acceptance inspections.

PNNL also stated that in-process and final acceptance inspections are specified in their Manufacturing and Quality Plan (MAQP). The MAQP is reviewed and administratively approved by Westinghouse to ensure l

provisions for appropriate criteria are established.

1 I

j' The response provided to RAI Item 10 is acceptable and this issue is considered closed. However, the adequacy of PNNL's verification processes l

that will be employed to assure that TPBARs conform to design specification i

requirements will be evaluated during a future inspection of PNNL.

Item 11 of the RAI requested a description of the process where by design i

information will be controlled and transmitted across the' interfaces between

.PNNL, Westinghouse, host utility organizations, and design services suppliers.

l In response to this item PNNL stated that the control of design information l-within each organization is established by procedures in accordance with each organization's quality program. Transmittal of information between utility, l

Westinghouse and PNNL organizations is via designated organizational points of contact.

Based on the review of PNNL's response to RAI Item 11, the staff has determined that inadequate information has been provided to resolve this l

issue.

Specifically, the response lacks sufficient detail to adequately evaluate the process used to control the transmittal of design information l

between cognizant organizations. Therefore, this item will remain open i

pending the staff's evaluation of future correspondence regarding the l

implementation of PNNL's design control program.

t Item 13 of the RAI stated that a limited number of licensees have committed to NQA-1. Accordingly, the staff requested a description of how the host utility l

quality requirements, which typically conform to NRC Regulatory Guides and endorsed ANSI N45.2 series standards, were transmitted to Westinghouse and PNNL and the method whereby the PNNL quality program was found acceptable by the host licensee.

l In response to this issue PNNL stated that the host utility had transmitted copies of their QA program description as well as the host facility's Final Safety Analysis Report to PNNL.

PNNL's response also stated that the host utility contractually required PNNL and Westinghouse to establish, maintain and implement a quality assurance program that complies with 10 CFR 50, Appendix B.

PNNL stated that.the method of compliance, such as use of ASME NQA-1 versus ANSI N45.2 series standards, was not stipulated by the host

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utility.

Furthermore, PNNL's response stated that ASME NQA-1 is the L

programmatic basis selected by PNNL as a means of meeting the requirements of 10 CFR 830.120 and DOE Order 5700.6C.

PNNL also stated that Westinghouse's QMS meets 10 CFR 50, Appendix B and ASME hQA-1, Basic and Supplementary Requirements and is typically used by Westinghouse as their basis for evaluating qualified suppliers.

L The response further indicated that, the utility procured QA oversight services from Westinghouse to perform a qualification audit of PNNL to evaluate PNNL's compliance to 10 CFR 50, Appendix B and ASME NQA-1, Basic and Supplementary Requirements. Based on satisfactory results, PNNL would be l

1 placed on the Westinghouse qualified supplier's list.

l The response provided to RAI Item 13 is acceptable and this issue is considered closed.

However, the adequacy of PNNL's quality assurance program controls will be evaluated during a future inspection of PNNL.

l Item 14 of the RAI requested the identification of the Westinghouse quality program (such as the NRC-approved Quality Management System) that would be applied to activities associated with the LTAs.

PNNL's response to this issue indicated that Westinghouse will apply their Quality Management System (QMS) and implementing procedures to Westinghouse j

activities associated with the LTAs, including QA oversight.

.The response provided to RAI Item 14 is acceptable and this issue is considered closed.

3 Item 15 of the RAI requested a description-of organization (s) responsible for

-the TPBAR/LTA design. Additionally, the staff requested a description of how design reviews and design verification would be carried out by this organization.

PNNL's response to this issue stated that they were responsible for the design of the TPBARs.

PNNL's response further stated that this responsibility included not only the design of the TPBARS.to make tritium, but also the responsibility to consider the implications to safety when the LTAs are loaded into a reactor core.

PNNL stated that tritium release levels are also considered relative to the limits identified in 10 CFR.

Project procedures control documentation and independent review of analyses and calculations by L'

the PNNL design team.

In addition, PNNL stated that a series of design reviews by independent design review boards Iad been initiated in accordance with a project design review plan. The design review plan as stated by PNNL i

includes phased reviews by personnel with appropriate experience and expertise.

-The response provided to RAI Item 15 is acceptable and this issue is considered closed. However, the adequacy of the implementation of PNNL's design control program will be evaluated during a future inspection of PNNL.

Item 16 of the RAI requested specifics on how nonconforming conditions would be reported by supplier organizations to client organizations. Additionally, l

the' staff requested information on how the client organizations would evaluate l

L those nonconforming conditions.

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In response to this issue PNNL stated-that they address the reporting of L

nonconforming conditions through-a formal mechanism established in the PNNL procurement-quality system.

PNNL also stated that procurement documents l

require that a supplier submit a " Contractor Nonconformance Request" (CNR) documenting any nonconforming condition tendered for acceptance of a variance f

from PNNL specifications. As indicated in PNNL's response the supplier must describe the deficient condition, recommend a disposition and provide a justification.~ PNNL'further stated that the supplier must submit the CNR for PNNL's review and approval and that the recommended supplier disposition may be approved, modified or disapproved by PNNL and PNNL must provide an appropriate technical justification to support the disposition.

During the i

review of the CNR, PNNL stated that they will make a determination regarding the type of verifications that are necessary to assure that CNR disposition has been completed correctly.

PNNL maintained that LTA-related nonconformance

- reports, whether generated by PNNL or a PNNL supplier will be made available to Westinghouse and the host utility as part of the process. Furthermore, PNNL stated that the host utility reserves the right to review and concur in all repair and use-as-is dispositions of nonconformances with the utility requirements.

In conclusion PNNL stated that the reporting and posting requirements of 10 CFR Part 21, as passed to PNNL by the host utility and Westinghouse, will be followed and passed to subvendors as appropriate.

The response provided to RAI Item 16 is acceptable and this issue is considered closed. However, the implementation of PNNL's program controls related to nonconforming conditions reported by supplier organizations to client organizations will be evaluated during a future inspection of PNNL.

Item 17 of the RAI requested a description of the process whereby Westinghouse qualified PNNL as an approved supplier for LTA design and fabrication.

' In response to this issue PNNL stated that Westinghouse had performe'd a

. qualification audit of PNNL in accordance with the Westinghouse QMS. As stated by PNNL the scope of this audit included verifying PNNL's compliance with 10 CFR 50, Appendix B and ASME *:')A-1, Basic and Supplementary

. Requirements.

PNNL indicated that as a result of this audit, Westinghouse placed PNNL on the Westinghouse Qualified Supplier List.

PNNL stated that 1

. their listing on the Westinghouse's Qualified Supplier List was conditional upon: 1) satisfactory corrective action response to identified audit findings; 4

and 2) a follow-up audit to verify PNNL QA program implementation in the manufacturing area.

PNNL's response further stated that no fabrication had occurred at the time of the audit.

PNNL stated that upon satisfactory implementation of corrective actions and closure of any findings resulting from follow-up audits, Westinghouse would update the status of PNNL to g

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l L-implementation of corrective actions and closure of any findings resulting i

from follow-up audits, Westinghouse would update the status of PNNL to

" approved."

The response provided to RAI Item 17 is acceptable ant. this issue is considered closed. However, the staff is currently reviewing the results of L

Westinghouse's audit of PNNL and as previously noted the implementation of l

PNNL's quality assurance program will be evaluated during a future inspection of PNNL.

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- Item 19 of the RAI requested a description of the processes *that will be utilized by Westinghouse (eg. receipt inspection, dimensional and configuration verification, and material verification) to verify that the TPBARs conform to Westinghouse technical requirements prior to assembly in j

LTAs.

In pidition to the responsa provided to RAI item 4, PNNL stated that i

vestinghouse will review FliNL's supporting documentation certifying the TPBAR l

was built in accordance with the design requirements and utility's quality l

requirements.

PNNL stated that they would provide unique TPBAR identification l

for traceability, and perform receipt inspection in accordance with approved l

procedures.

l The response provided to RAI Item 19 in conjunction with the staff's review of l

Section 2.4.1 of the topical report, is acceptable and this issue is j

considered closed.

i i-Item 20 of the RAI requested a description of the processes that will be l

utilized by host utility (e.g., receipt inspection, dimensional and i

configuration verification, and material verification) to confirm that LTAs l

are suitable for installation in the core.

L i

In response-to this issue PNNL stated that Section 6.2 of the topical report, l

discussed existing host utility procedures.for receipt and receipt inspection of fuel and fuel components _will be useu to rcceive the LTAs.

PNNL also stated that this inspection, in combination with utility and Westinghouse assessments of TPBAR design and fabrication activities, and successful completion of a reload safety evaluation, will confirm that the LTAs are suitable for installation in the core.

The response provided to RAI Item 20 in conjunction with the staff's review of Section 2.4.2 of the topical report is acceptable and this issue is considered closed.

Item 21 of the RAI requested clarification as to whether Westinghouse special

- prm:eues (eg. welding) have been re-qualified as necessary to account for differences in TPBAR material from that typically used in LTA assemblies.

In response to this issue PNNL stated that special process procedures l

(including welding) will be developed and qualified by PNNL and are, j

therefore, not conside~ d to be re-qualified Westinghouse special processes.

3 The special process cor' als, however, will be subject to oversight by PNNL

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QA. Special processes will be identified and key parameters defined in the MAQP. The MAQP will be reviewed and administratively approved by Westinghouse.

Based on the review of PNNL's response to RAI Item 21, the staff has determined that inadequate information has been provided to resolve this issue. Therefore, this item will remain open pending the staff's future-evaluation of PNNL's Manufacturing and Quality Plan related to the production-of'TPBARs (refer to staff's safety evaluation related to section 5.3.1.5, Weld Qualification.)

I CONCLUSIONS i

The staff has reviewed the applicable portions of the topical report (Sections i

2.4.1,=2.4.2, and 7).

Relative to the quality assurance provisions specified in the topical report, the staff is continuing to review the adequacy of l

PNNL's programmatic controls in order to establish conformance with the e

l requirements of 10 CFR 50, Appendix B.

In addition to the staff's continuing i

programmatic reviews of the governing quality assurance program, it is anticipated that on-site inspections at PNNL will be necessary in order to verify the adequate implementation of 10 CFR 50, Appendix B requirements l

related to the design and fabrication of the TPBARs. The staff has also determined that licensees who anticipate irradiating TPBAR LTAs will need to explicitly identify the programmatic controls and processes that will demonstrate compliance with the requirements of 10 CFR 50, Appendix B, prior to installing these assemblies into the core.

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Project No. 697 I

DOE Tritium Program I

cc:

Max Clausen Office of Commercial Light-Water Reactor Production.

Tritium Project Office U.S. Department of Energy 1000 Independence Avenue, SW Washington, DC 20585 DP-60 Records Management Office of Commercial Light-Water Reactor Production Tritium Project Office U.S. Department of Energy 1000 Independence Avenue, SW Washington, DC 20585 r

Jerry L. Ethridge, Sr. Program Manager Environmental Technology Division Pacific Northwest National Laboratory Battelle Blvd.

P.O. Box 999 Richland, WA 99352 I

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