ML20014E726

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Regulatory Update NOC 012020
ML20014E726
Person / Time
Issue date: 01/29/2019
From: Kerri Kavanagh
NRC/NRR/DRO/IQVB
To:
Kavanagh K
References
Download: ML20014E726 (13)


Text

NRC Regulatory Update Nuclear Oversight Conference Meeting St. Petersburg, FL January 29, 2019 Kerri Kavanagh, Branch Chief Quality Assurance and Vendor Inspection Branch, Office of Nuclear Reactor Regulation

An Introduction 2

One year ago Two QA/vendor inspection branches in the Office of New Reactors (NRO) (QVIB 1 and 2) 15 personnel Today One QA/vendor inspection branch in the Office of Nuclear Reactor Regulation (NRR) (IQVB) 15 personnel - a few new faces Same mission and focus

IQVB Current Initiatives/Focus 3

7th NRC Vendor Oversight Workshop, June 18, 2020 NRC Regulatory Information Conference (RIC)

Session on Worldwide Uses of Equipment Qualification and Commercial-Grade Dedication, March 11, 2020 Safety Conscience Work Environment in the Nuclear Supply Chain Safeguard Information Program inspections Commercial Calibration and Testing Services Monitoring of Counterfeit, Fraudulent, and Suspect Items (CFSI)

Licensing Activities and Inspections Part 21 and Operational Experience

2020 Vendor Oversight Workshop 4

On June 18, 2020, the NRC will hold its seventh Vendor Oversight Workshop in conjunction with annual Nuclear Procurement Issues Corporation (NUPIC)

Vendor Conference in Baltimore, Maryland The NRC anticipates the workshop will have several hundred participant's both from domestic and international nuclear utilities and vendors Topics of the workshop are being developed

Safety Conscious Work Environment (SCWE) and NRC Vendor Inspection Program 5

NRC is enhancing its Inspection Manual Chapter (IMC), Inspection Procedures and staff guidance documents to include guidance for SCWE assessments/observations To bring the Vendor Inspection Program (VIP) in compliance with the current NRR SCWE mindset for operating reactors Provides the NRC a measure of the safety culture health of the nuclear supply chain Previously, SCWE assessments/observations have been performed at vendor facilities, but no documented guidance or expectations existed for IQVB staff Revising IMC 0617, Quality Assurance and Vendor Inspection Reports, to include guidance for documenting SCWE observations/assessments of a vendors/applicants SCWE program The SCWE guidance does not change past work

Safeguards Information (SGI) Program Inspections of Design Certificate Applicants/Vendors 6

Title 10 Code of Federal Regulations (CFR) Part 73.21 (General) and Part 73.22 (Specific) 2007 Order EA-07-231: Issued to individual vendors/applicants 2008 rulemaking: Additional changes in later years Currently, NRR/IQVB conducts inspections of vendors or applicants programs for protecting SGI 3 year periodicity of SGI inspections Inspection Procedure 81811, Protection of Safeguards Information by Design Certification Applicants and Vendors SGI inspections are typically performed as part of a routine NRC inspection

Provisional Recognition of ISO/IEC No.17025:2017 7

On October 1, 2018, the Nuclear Energy Institute (NEI) requested the NRC to recognize the 2017 Edition of the International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025, General Requirements for the Competence of Testing and Calibration Laboratories, for use during 3-year transition period that is set to expire on November 30, 2020 NRC response to NEI concluded that ISO/IEC 17025:2017 maintains the same technical and quality requirements as ISO/IEC 17025:2015. This was based on an independent review of ISO/IEC 17025:2017, and a gap analysis done by both the NUPIC and NEI The NRC staff confirmed that the applicable critical characteristics for commercial calibration and testing services continue to be properly controlled and verified in ISO/IEC 17025:2017, as part of the ILAC accreditation process NRC staff is anticipating that NEI will submit for NRC staff review, a revision of NEI 14-05A for the staffs endorsement of ISO/IEC 17025:2017

Monitoring of Counterfeit, Fraudulent, Suspect Item (CFSI) Issues 8

Remain proactive and ahead of events or threats NRC is engaged with other Government agencies to gain knowledge and experience NRC has a formal agency-wide strategy to monitor, screen and evaluate CFSI NRCs Operating Experience Program updated to include CFSI as a Technical Review Group Generic communications related to CFSI include:

Information Notice (IN) 2008-04, Counterfeit Parts Supplied to Nuclear Power Plants

IN 2012-22, Counterfeit, Fraudulent, Suspect Items (CFSI) Training Offerings

IN 2013-02, Issues Potentially Affecting Nuclear Facility Fire Safety

IN 2013-15, Willful Misconduct/Record Falsification and Nuclear Safety Culture

IN 2018-11, Kobe Steel Quality Assurance Record Falsification

Regulatory Issue Summary 2015-08, Oversight of Counterfeit, Fraudulent, and Suspect Items in the Nuclear Industry

Licensing and Inspections 9

IQVB conducts licensing reviews of licensees, applicants, and some vendors quality assurance programs

Four operating reactor QAPD changes under review

Five advanced reactors/moly-99 QAPD under review

One construction permit transfer QAPD under review IQVB conducts 20 vendor inspections a fiscal year

Plan on observing two NUPIC audits

Usually observe one foreign Regulator vendor inspection as part of MDEP VICWG

Majority of inspections will be related to operating reactor suppliers

Issued yearly Vendor Times newsletter (ML19324F291)

IQVB participates in NQA-1 and ASME Section III standards development meetings - supports endorsement by NRC

Vendor Inspection Findings FY2019 10 FY2019 - 7 NONs issued FY2019 - Issues of Significance HydroAire Third party oversight L&S Machine Engineering evaluation by customer Curtiss Wright Enertech Inadequate audits/oversight Fisher Controls Environmental qualification of pressure transducers

Part 21 and operational experience (OpE) 11 Benefits of evaluating OpE reported to the NRC 10 CFR Part 21 was designed to implement Section 206 of the Energy Reorganization Act of 1974 One of a few regulations with reporting requirements Recognition of OpE as a potential contributor to safety was identified as a TMI Action Item:

Provide administrative procedures for evaluating operating, design and construction experience and for ensuring that applicable important to industry experiences will be provided in a timely manner to those designing and constructing the plant. (I.C.5)

OpE is tracked and trended by the NRC staff Focus on highly safety significant items or services Easily accessible at https://www.nrc.gov/reading-rm/doc-collections/event-status/part21/

For More Information 12 The Quality Assurance for New Reactors Website offers a variety of information including:

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

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