ML20259A226

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September 2020 NUPIC General Membership Meeting - NRC Update
ML20259A226
Person / Time
Issue date: 09/15/2020
From: Greg Galletti
NRC/NRR/DRO/IQVB
To:
Galletti G
References
Download: ML20259A226 (19)


Text

NRC UPDATE September 15, 2020 NUPIC Conference Webex Nicholas Savwoir and Greg Galletti IQVB/DRO/NRR Quality Assurance and Vendor Inspection Branch, Office of Nuclear Reactor Regulation

TOPICS

  • NRC inspection update
  • Remote Source Verification
  • Virtual workshop and future Townhall meetings Nicholas Savwoir and Greg Galletti IQVB/DRO/NRR Quality Assurance and Vendor Inspection Branch

NRC VENDOR INSPECTIONS &

FINDINGS Inspection Activities (since January 2020 Meeting):

  • Remote Source Verification
  • Internal Database, Criteria, Positivity rate determination
  • Inspections
  • Remote capabilities of vendors and virtual inspections
  • Close previous findings
  • Reduce inspection team sizes and scope
  • Postpone technically focused inspections Nicholas Savwoir and Greg Galletti IQVB/DRO/NRR Quality Assurance and Vendor Inspection Branch

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-Aug NRC-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)

Nicholas Savwoir and Greg Galletti IQVB/DRO/NRR Quality Assurance and Vendor Inspection Branch

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.

Nicholas Savwoir and Greg Galletti IQVB/DRO/NRR Quality Assurance and Vendor Inspection Branch

AUDIT GRACE PERIOD DURING EXIGENT CONDITIONS IMPORTANTLY

  • 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 Nicholas Savwoir and Greg Galletti IQVB/DRO/NRR Quality Assurance and Vendor Inspection Branch

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 SER developed 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 verification Screening Criteria and Process Guidance (ML20139A225, NRC staff completed review ML20153A471) of EPRI TR. SER in process.

Nicholas Savwoir and Greg Galletti IQVB/DRO/NRR Quality Assurance and Vendor Inspection Branch

REMOTE SOURCE VERIFICATION 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.

Nicholas Savwoir and Greg Galletti IQVB/DRO/NRR Quality Assurance and Vendor Inspection Branch

REMOTE SOURCE VERIFICATION 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 verifiers 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.

Nicholas Savwoir and Greg Galletti IQVB/DRO/NRR Quality Assurance and Vendor Inspection Branch

SAFER UPDATE

  • PHX NSRC temporary shutdown
  • Oversight of FLEX Phase 2 vs Phase 3

Nicholas Savwoir and Greg Galletti IQVB/DRO/NRR Quality Assurance and Vendor Inspection Branch

SAFER UPDATE THREE PHASE APPROAC H

PHASE 1:

INSTALLED PHASE 2:

ONSITE-FLEX PHASE 3 (SAFER):

OFFSITE-FLEX Nicholas Savwoir and Greg Galletti IQVB/DRO/NRR Quality Assurance and Vendor Inspection Branch

NRC REGULATORY REQUIREMENTS NEI 12-06 (ML16354B421)

NEI WHITEPAPE R

(ML14259A223)

NRC RG 1.226 (ML19058A012)

NRC Mitigation 10 CFR 50.155 Strategies Order EA-12-049 (Expires Mitigation of Beyond- NRC Staff Assessment September 2022) Design-Basis Events (ML14265A107)

Nicholas Savwoir and Greg Galletti IQVB/DRO/NRR Quality Assurance and Vendor Inspection Branch

APPLICABILITY DIFFERENCES PHASE 2 PHASE 3

  • NEI 12-06 Section 12-Off-Site Programmatic Controls (NOT Resources:

APPENDIX B)

  • National SAFER Response Centers
  • Individual Site Specific Integrated (NSRC): Memphis, TN and Phoenix, Plans AZ Nicholas Savwoir and Greg Galletti IQVB/DRO/NRR Quality Assurance and Vendor Inspection Branch

PHASE 2

  • Individual Strategic Site Specific Plans
  • Overall Integrated Plans (OIPs)
  • Final Integrated Plans (FIPs)
  • NRC Safety Evaluations
  • Phase 2 - FLEX OpE North Anna Farley Watts Barr McGuire Nicholas Savwoir and Greg Galletti IQVB/DRO/NRR Quality Assurance and Vendor Inspection Branch

PHASE 3 (SAFER)

  • Pooled Equipment Inventory Company (PEICo)
  • Equipment Design and Standardized Electrical Fuel Tank Pump Logistics Connections Turbine Generator
  • IQVB SAFER Oversight Inspections:

Standardized Mechanical

  • Alternating SAFER facility Connections Diesel
  • Triennial basis
  • IP 43006, Revision 2 NSRC Pre Staged Equipment Pre Staged Equipment Nicholas Savwoir and Greg Galletti IQVB/DRO/NRR Quality Assurance and Vendor Inspection Branch

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 ILACs 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.

Nicholas Savwoir and Greg Galletti IQVB/DRO/NRR Quality Assurance and Vendor Inspection Branch

VIRTUAL WORKSHOP AND FUTU TOWNHALL MEETINGS

  • Biennial regulatory workshop on vendor oversight as part of vendor outreach and communication strategy.
  • Engage industry on the NRCs 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 Nicholas Savwoir and Greg Galletti IQVB/DRO/NRR Quality Assurance and Vendor Inspection Branch

QUALITY ASSURANCE VENDO INSPECTION BRANCH

QUESTIONS