ML21160A245: Difference between revisions

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{{#Wiki_filter:Regulatory Alternatives for Supplier Oversight During Exigent Conditions Jonathan Ortega-Luciano Quality Assurance and Vendor Inspection Branch, Office of Nuclear Reactor Regulation
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Agenda 2
What caused all this?
Why it wasnt so simple Regulatory requirements NRC/Industry Stakeholder Meetings Audit Extension Remote Source Verification Remote Audit Allowance and Current Status Summary / Questions
 
What caused all of this?
3 On January 31, 2020, the U.S. Department of Health and Human Services declared a public health emergency (PHE) for the United States in response to the Coronavirus (COVID-19).
Domestic and international travel restrictions resulting from the COVID-19 pandemic resulted in licensees confronting significant challenges meeting their regulatory commitment associated with the frequency of performing onsite supplier audits and surveys.
 
Why it wasnt so simple:
4 Regulatory requirements Criterion VII of Appendix B:
Measures shall be established to assure that purchased material, equipment, and services, whether purchased directly or through contractors and subcontractors, conform to the procurement documents. These measures shall include provisions, as appropriate, for source evaluation and selection, objective evidence of quality furnished by the contractor or subcontractor, inspection at the contractor or subcontractor source, and examination of products upon delivery.
 
NRC/Industry Stakeholder Preliminary Meetings 5
NRC staff met with industry stakeholders:
Nuclear Energy Institute (NEI)
EPRI (EPRI)
Licensees Suppliers Public
 
NRC/Industry Stakeholder Preliminary Meetings 6
NRC staff met with industry stakeholders on alternatives / compensatory measures to address extension limit and exceeding audit frequency.
: 1) Procure from alternate source;
: 2) commercial-grade dedication;
: 3) hybrid audit method; and
: 4) provisional procurement authorization in conjunction with the corrective action program (CAP).
Agencywide Document Access and Management System (ADAMS)
Accession No. ML20293A173 Presentations: ML20303A043 and ML20303A041.
 
Audit Extension 7
Overall extension of 25% for the triennial supplier audit and survey frequency (i.e., nine months) during exigent or emergency conditions.
Documented    evaluation
: 1)  Verify suppliers quality assurance program;
: 2)  Receipt inspection / review of operating experience;
: 3)  Review of associated documents;
: 4)  Review of previous performance; and
: 5)  Applicable to domestic / international suppliers.
 
Audit Extension 8
Associated NRC Safety Evaluation Report:
ADAMS Accession No. ML20216A681 Allows other licensees to adopt a similar change to their quality assurance program description (QAPD) without prior NRC approval Four architect engineers / Nuclear Steam Supply System suppliers adopted a similar change to their QAPDs Associated NRC Safety Evaluation Reports:
ADAMS Accession No.: ML20132A321, ML20154K718, ML20140A322, and ML20176A494
 
Remote Source Verification 9
EPRIs Technical Report 3002019436 Remote Source Verification During a Pandemic or Similar State of Emergency: Screening Criteria and Process Guidance NRC  Safety Evaluation Report ADAMS  Accession No. ML20203K876
 
Remote Audit Allowance:
Current Status 10 March 31, 2021, Observation Public Meeting ADAMS    Accession No. ML21092A008 Southern Nuclear license amendment request (LAR)
LAR submitted to the NRC on May 7, 2021, ADAMS Accession No. ML21127A184 Allowance  to perform fully and provisional remote assessments (i.e., audits and commercial-grade surveys)
For times of extenuating circumstances (i.e., pandemics)
 
Remote Audit Allowance:
Audits & Commercial-Grade Surveys 11 Southern Nuclear submittal requested to implement guidance found in the EPRIs Technical Report (TR) 3002020796 Remote Assessment Techniques: Planning and Conducting Audits and Surveys Using Remote Techniques During Exigent Conditions, for performing fully remote and provisional remote assessments.
 
Remote Audit Allowance:
Audits & Commercial-Grade Surveys 12 EPRI TR 3002020796 also includes guidance for conducting vendor assessments utilizing hybrid techniques.
It is the NRC staff position that there are no regulatory restrictions or conditions for when a hybrid assessment of vendors may be utilized No  prior NRC approval required for performance of hybrid assessment.
 
Remote Audit Allowance:
EPRI TR 3002020796 13 Provisional Remote Assessment - team members participating remotely and does not assess all technical and quality requirements of interest.
Fully Remote Assessment - A fully remote assessment is an assessment conducted with all team members participating remotely and assess all applicable technical and quality requirements of interest.
 
Remote Audit Allowance:
EPRI TR 3002020796 14 Table 6-1, Basic comparison of remote assessment types
 
Summary/Questions 15}}

Revision as of 08:04, 8 September 2021

1st Town Hall Meeting - on Vendor Supplier Oversight - Regulatory Alternatives for Supplier Oversight During Exigent Conditions
ML21160A245
Person / Time
Issue date: 06/09/2021
From: Yamir Diaz-Castillo
NRC/NRR/DRO/IQVB
To:
Diaz-Castillo Y
References
Download: ML21160A245 (15)
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