ML20303A043

Industry'S Presentation for the November 2, 2020 Nrr/Iqvb Public Meeting - Vendor Audit Relief Options

ML20303A043
Person / Time
Site:	Nuclear Energy Institute
Issue date:	11/02/2020
From:	Aughtman A, Yamir Diaz-Castillo, Mayhorn E, Tannenbaum M, Chutima Taylor, Wearne J Electric Power Research Institute, Exelon Corp, NRC/NRR/DRO/IQVB, Nuclear Energy Institute, Nuclear Quality Management Leadership, Nuclear Utilities Procurement Issues Corp
To:
Diaz-Castillo Y
References
Download: ML20303A043 (15)

Text

VENDOR AUDIT RELIEF OPTIONS Amy Aughtman, NQML Vendor Audit Relief Subcommittee Chair Justin Wearne, NEI Earl Mayhorn, NUPI C Steering Committee Cal Taylor, Exelon Marc Tannenbaum, EPRI November 2, 2020

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Background===

• Vendor audits are to be completed on a 36-month frequency

• Most utilities have adopted an NRC-approved SER that allows for a 25% (i.e. 9 months) grace period to complete an audit beyond the 36-month period

• Most vendor audits are coordinated through NUPIC and adhere to NUPIC and EPRI guidance, utilizing a performance-based approach

• Performance-based auditing guidance requires direct observation at the vendor facility

• Common interpretation of Appendix B Criterion VII is that supplier audits must be conducted at the vendor facility

Current Issue

• COVID-19 related travel restrictions, both domestic and international, are precluding the ability of station QA personnel from conducting audits of vendors required by Criteria VII and XVIII of Appendix B and utility QA plans.

• Personnel travel is challenged across state and international lines

• Some suppliers are restricting access to their facility

• One international suppliers 9-mo grace period will expire Jan 2021

• Additional international and domestic suppliers 9-mo grace period will expire Feb 2021

What is being done to mitigate these challenges?

Decision Tree Issue Identified Use of CAP to evaluate supplier Should Tak e Imm ediate Immediate Action Be Yes A ctions as Taken? A ppropriate No Document It Control Room Screen for Condition Operability , Yes Requires Control Functionality and Room Review?

Reportability*

No A ddres s Dis pos ition Meets Operability , No A ppropriately CAP Threshold?

Functionality and A s Non-CAP Item Reportability Yes Inv es tigate P er Signif icance of Is sue Meets and Correct the Yes No SCAQ Threshold Is s ue Utilize VA R Dec ision Tree and U nders tand Cause and P PA Form)

Dev elop CAP R Document QA Marginally Effective program Re view Enter Conditional Reasonable Assurance Rele ase/

Nonconformance Es tablis h P roce ss (U se-A s-Is ) Mitigating Ac tions Imple ment CA PR Track Full A udit

• OP S re vie w sh o u l d b e a f u n ct i o n al i t y Comple tion as a CA o r p ro m pt d e t erm i n at i o n , o r wi t h 18 -

0 3, s i mp l y i n it i a l O PS re vi e w t o i n c lu d e revi e w o f CL B is su e s. T h is s ho u l d n o t re q u i re f u ll Op e rab i l i t y e val u at i o n at t h is p h as e.

Close CR

Basis for Provisional Procurement Authorization Continued use of suppliers that have exceeded the maximum allowed audit or survey time due to extenuating circumstances is allowed if the following conditions are met:

a. A documented evaluation* must be performed to summarize why the audit or survey could not be performed prior to the end of the 25% (9-month) grace period, and to provide the basis for utilizing the supplier after the grace period has expired. While implementing procedures must describe elements to be included in the documented evaluation, the following items should be considered as applicable:

For 10 CFR 50, Appendix B suppliers, verification that the suppliers quality assurance program is still committed to meeting the requirements of 10 CFR 50, Appendix B.

For commercial suppliers who are approved based on commercial grade survey, verification the supplier has maintained adequate documented programmatic controls in place for the activities affecting the critical characteristics of the item/services being procured.

Evaluation of any significant open issues with the NRC, 10 CFR Part 21 Notifications, and any open findings since the previous triennial audits describing impact on the items/services being procured from that supplier.

Review of procurement history since last triennial audit/survey including receipt inspection results to identify any potential issues. The results of the performance history must be included in the evaluation.

The degree of standardization of the items being procured. For instance, suppliers of catalog items which are used across multiple industry with widely accepted good performance histories would be considered good candidates to allow extended use of a supplier after the 25% (9-month) grace period has been exceeded.

• If a licensees initial 25% grace provisions require this evaluation be completed, then the evaluation must be updated to determine if any new information exists that could change the outcome of that evaluation for the purpose of supporting a Provisional Procurement Authorization.

Note: blue font is used on this and the following page to distinguish differences from similar conditions contained in ML20216A681.

Basis for Provisional Procurement Authorization contd

b. If concerns are identified based on the above evaluation, the following mitigating actions may be considered:

Enhanced receiving inspections beyond visual inspections and quality checks.

Based on safety-significance and complexity of item, consider use of remote source verification as approved in ML20181A445.

Identification of any additional requirements/restrictions to be placed on the supplier.

c. For audits/surveys performed after the 25% grace period, the audit/survey shall include a review of activities performed by the supplier since the 36-month audit/survey expiration date.

Example Evaluation within CAP Refer to handout example Evaluation has two parts Part A focuses on Supplier QA program Note: The use of red font in Part A represents information selected to force the example to demonstrate the additional evaluations in Part B.

Part B focuses on technical and quality characteristics of specific item, if needed

Summary Multiple efforts in progress to maintain nuclear supply chain All options to complete audits or secure procurement alternatives would be explored prior to allowing a suppliers audit to expire after grace is exhausted Corrective Action Program option is reserved until all other means are explored Provides formal means of tracking audit completion Visibility with station leadership Utilizes mitigating actions already approved by NRC

Proposed approach for implementation Prior NRC approval not needed for decision tree or use of CAP Procedure changes governing treatment of suppliers on Qualified Supplier List below threshold of QATR program description Supplier status would be treated as conditional with appropriate conditions and mitigating actions specified Further evaluation of specific part or service fits within nonconformance or conditional release process

Preliminary 50.54(a) screening of use of CAP

• Change being evaluated:

• Example Quality Assurance Topical Report (QATR) reviewed - no changes to QATR

• Example procedures reviewed - change procedure provision requiring supplier status be changed to inactive on the Qualified Supplier List (QSL) if the audit has not been completed by the audit expiration date including 25% grace, to a status of conditional if a documented evaluation supports a provisional procurement authorization Question Disposition Exclusion Questions of 50.54(a)(3) Not excluded - requires further review Conflict with Part 50 App B? No Criterion VII - continue to assess effectiveness of control of quality by contractors Criterion XVIII - audits shall be performed in accordance with written procedures Criterion XVI - measures shall be established to assure that conditions adverse to quality such as nonconformances are promptly identified and corrected

Preliminary 50.54(a) screening of use of CAP, contd Question Disposition Conflict with QATR commitment? No; Level of detail that requires removing overdue vendors from QSL is in procedures and not in QATR.

Regulatory guidance does not specify actions for treatment of supplier if audit expires.

Eliminate a function, control or activity from No functions, controls or activities eliminated. NOS still QATR? evaluates effectiveness of vendor QA program in PPA and will perform audit when conditions allow.

Reduce size or scope of organization in QATR? Scope remains static Any other reason change would reduce QA Supplier would not be reapproved on QSL until audit is program commitments? completed. Provisional or conditional use of the supplier will be documented in CAP and evaluated.

Conclusion Prior NRC approval on use of CAP as method of last resort is not needed

Closing NRC feedback Identify any follow-up actions

Acronyms used ATL Audit Team Lead PPA Provisional Procurement Authorization CAP Corrective Action Program QA Quality Assurance CAPR Corrective Action to Prevent QAPD Quality Assurance Program Recurrence Description CGD Commercial Grade Dedication QATR Quality Assurance Topical Report EPRI Electric Power Research Institute QSL Qualified Supplier List NEI Nuclear Energy Institute SCAQ Significant Condition Adverse to Quality NOS Nuclear Oversight SSC Structure, System or Component NQML Nuclear Quality Management SER Safety Evaluation Report Leadership NUPIC Nuclear Utilities Procurement TR Technical Report Issues Corporation