September 2020 NUPIC General Membership Meeting - NRC ...Nicholas Savwoir and Greg Galletti Quality Assurance and Vendor Inspection Branch IQVB/DRO/NRR QUESTIONS Title September 2020

NRC UPDATESeptember 15, 2020

NUPIC Conference Webex

Nicholas Savwoir and Greg GallettiQuality Assurance and Vendor Inspection Branch, Office of Nuclear Reactor

RegulationIQVB/DRO/NRR

TOPICS• NRC inspection update

• Audit Grace Period During Exigent Conditions

• Remote Source Verification

• FLEX | SAFER

• Update on ILAC

• Virtual workshop and future Townhall meetings

Nicholas Savwoir and Greg GallettiQuality Assurance and Vendor Inspection Branch

IQVB/DRO/NRR

NRC VENDOR INSPECTIONS & FINDINGS

Inspection Activities (since January 2020 Meeting):

• Remote Source Verification • Audit Grace Period During Exigent Conditions• Internal Database, Criteria, Positivity rate determination• Inspections

• Remote inspection: Valcor Engineering (ML20216A590)• Remote capabilities of vendors and virtual inspections• Close previous findings• Reduce inspection team sizes and scope• Postpone technically focused inspections


IQVB/DRO/NRR

AUDIT GRACE PERIOD DURING EXIGENT CONDITIONS

• Licensee and Suppliers challenged to meet triennial schedules for routine audits/surveys due to Covid-19 related travel restrictions and site accessibility issues.

Mar-Apr Apr-Jun Jun-AugNRC-Industry discussions WEC/GEH/S&L Ameren QAPD Submittal And development of basic QAPD submittals to implement revised Principles regarding and SER development approach. Ameren SER extended Grace Period per 50.4(b)(7)(ii). completed per

50.54(a)(4)


IQVB/DRO/NRR

AUDIT GRACE PERIOD DURING EXIGENT CONDITIONS

• 25% grace period (9 months) allotted for triennial audits/surveys. This grace period is for exigent conditions only.

• Use of grace period is allowed for each audit/survey cycle based on documented evaluation of suppliers.

• Verification supplier still implementing and Appendix B compliant program or adequate programmatic controls

• Receipt inspection and industry OE are reviewed • Review previous source verifications, audits, surveys • OE of identical or similar items furnished by same supplier• Results of other source evaluations (ASME, NRC., etc)• If Sign. Contract modification changes scope, controls, or

activities, supplier will provide documented justification for continued control.


IQVB/DRO/NRR

AUDIT GRACE PERIOD DURING EXIGENT CONDITIONSIMPORTANTLY

• Audit schedule clock does NOT need to be reset after use of 25% grace period

• This provision applies to both domestic and international suppliers.• This grace period allowance can be applied to any supplier audit

cycle

This approach has been accepted by the NRC in a SE (Ameren ML20216A681)And can be adopted by other licensees and suppliers without prior NRC Approval


IQVB/DRO/NRR

REMOTE SOURCE VERIFICATION

• Licensee and Suppliers challenged to meet triennial schedules for routine audits/surveys due to Covid-19 related travel restrictions and site accessibility issues.

Mar-Apr Apr-Jun Jun-Sept.

Industry stakeholders (including NRC) Energy Northwest requests NRC issues SERdeveloped EPRI TR 3002019436, approval of Columbia GS QAPD approving CGS QAPD revision"Remote Source Verification During change to allow for remote (ML20181A445, ML20203K876)a Pandemic or Similar State of Emergency: source verificationScreening Criteria and Process Guidance” (ML20139A225, NRC staff completed review ML20153A471) of EPRI TR. SER in process.


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EPRI TR 3002019436 provide guidance to recognize BOTH screening criteria to assess feasibility of performing remote source verification activities AND the limitations of the use of remote techniques.

The EPRI TR provides for a screening of the specific source verification be performed to determine if remote source verification is appropriate for the activities being verified prior to conducting the activity remotely.

The report provides specific screening criteria and guidance:

1) Is it possible to do on-site surveillance?2) Is the activity an assessment?3) Can the activity be surveilled remotely?4) Can progress and results be captured and communicated in real time?5) Can a maintainable record be created for objective evidence?6) Does the initiating entity concur with the use of remote surveillance?

The NRC staff also participated in the development of the EPRI technical report to ensure that the intent of the regulations continued to be met.


IQVB/DRO/NRR


EPRI TR, Section 3.1, identified limitations and identified planning and QA controls the user could implement prior to witnessing the source verification activities to compensate for the limitations,

Such as:

• The ability to review the actual documents and procedures online, as well as preparations, equipment, personnel, and other things going on in the vicinity of the activity.

• The ability to ask questions during the process, request adjustments, and doublecheck measurements.

• The verifier’s field of vision and ability to observe and verify can be adjusted by the frame of the camera or video screen.

• The ability to verify the capabilities of the video equipment and individuals operating the video equipment prior to performance of the remote source verification.


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• PHX NSRC temporary shutdown


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SAFER UPDATE

• Oversight of FLEX Phase 2 vs Phase 3

• NEI FLEX Summit

PHASE 1: INSTALLED

PHASE 2: ONSITE-FLEX

PHASE 3 (SAFER): OFFSITE-FLEX

THREE PHASE APPROACH

____


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SAFER UPDATE

NRC REGULATORY REQUIREMENTS

10 CFR 50.155 Mitigation of Beyond-Design-Basis Events

NRC RG 1.226 (ML19058A012)

NEI 12-06 (ML16354B421)

NRC Mitigation Strategies Order EA-12-049 (Expires September 2022)

NRC Staff Assessment (ML14265A107)

NEI WHITEPAPER (ML14259A223)


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• NEI 12-06 Section 11-“Programmatic Controls” (NOT APPENDIX B)

• Individual Site Specific Integrated Plans

PHASE 2APPLICABILITY DIFFERENCES

• NEI 12-06 Section 12-“Off-Site Resources”:

• National SAFER Response Centers (NSRC): Memphis, TN and Phoenix, AZ

PHASE 3 (SAFER)


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PHASE 2

• Individual Strategic Site Specific Plans• Overall Integrated Plans (OIPs) • Final Integrated Plans (FIPs)

• NRC Safety Evaluations

• EPRI Template

• Phase 2 - FLEX OpE

McGuireNorth Anna

Watts BarrFarley

EPRI Template


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• Pooled Equipment Inventory Company (PEICo)

• Equipment Design and Logistics

• IQVB SAFER Oversight Inspections:

• Alternating SAFER facility • Triennial basis • IP 43006, Revision 2

PHASE 3 (SAFER)


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Standardized Electrical Connections

Standardized Mechanical Connections

NSRC Pre Staged Equipment Pre Staged Equipment

Diesel

Turbine Generator Fuel Tank Pump

UPDATE ON ILAC • As result of the ongoing COVID-19 pandemic, ILAC

extended the transition period for ISO/IEC 17025:2017 from November 30, 2020 to June 1, 2021.

• In light of ILAC’s extension of the transition period, Revision 1 of NEI 14-05A will clarify recognition of June 1, 2021 as an acceptable date for laboratories to transition to ISO/IEC 17025:2017.

• Revision 1 of NEI 14-05A will clarify how these remote assessments still provide the same degree of confidence to determine that the laboratories are adequately implementing the requirements of ISO/IEC 17025.


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VIRTUAL WORKSHOP AND FUTUTOWNHALL MEETINGS

• Biennial regulatory workshop on vendor oversight as part of vendor outreach and communication strategy.

• Engage industry on the NRC’s vendor inspection and quality assurance activities to continue communication between the NRC and the nuclear industry.

• Vendor Oversight virtually on June 23-25, 2020.• Exploring the option of hosting a virtual townhall meeting in

coordination with the biannual workshop


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QUALITY ASSURANCE VENDOINSPECTION BRANCH

• Quality Assurance and Inspection Websitehttps://www.nrc.gov/reactors/new-reactors/oversight/quality-assurance/vendor-oversight/registration.html• Vendor Inspection Program (VIP) Plan

http://www.nrc.gov/reactors/new-reactors/oversight/quality-assurance/vendor-insp/vendor-insp-prog-plan.html

• Vendor Quality Assurance (QA) Inspection Reports for New Reactors

http://www.nrc.gov/reactors/new-reactors/oversight/quality-assurance/vendor-insp/insp-reports.html

• Quality Assurance (QA) Inspections for New Reactor Licensing

http://www.nrc.gov/reactors/new-reactors/oversight/quality-assurance/qual-assure-license.html


IQVB/DRO/NRR

QUESTIONS

Documents

September 2020 NUPIC General Membership Meeting - NRC ...Nicholas Savwoir and Greg Galletti Quality Assurance and Vendor Inspection Branch IQVB/DRO/NRR QUESTIONS Title September 2020