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{{#Wiki_filter:Vendor Oversight Townhall 10 CFR Part 21 Discission June 21, 2023 Aaron Armstrong and Dong Park Quality Assurance & Vendor Inspection Branch / Office of Nuclear Reactor Regulation
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10 CFR Part 21.3 Definitions 2
* 10 CFR Part 21.3 provides the definitions used in the regulation.
* This section introduces important terms that should be used when discussing and complying with Part 21.
* One important term is Dedication which is a topic for another time and will not be discussed in this presentation.
* These definitions include the language and provide the concepts necessary in meeting the requirements of Part 21. These definitions should be used and included verbatim in the vendors Part 21 program.
 
Part 21.21 Notification of failure to comply or existence of a defect and its evaluation.
3
* 10 CFR Part 21.21 allows for an interim report to be issued if the evaluation for a substantial safety hazards can not be completed with in 60 days of discovery .
*  (a) Each individual, corporation, partnership, dedicating entity, or other entity subject to the regulations in this part shall adopt appropriate procedures to --
    *  (1) Evaluate deviations and failures to comply to identify defects and failures to comply associated with substantial safety hazards as soon as practicable, and, except as provided in paragraph (a)(2) of this section, in all cases within 60 days of discovery, in order to identify a reportable defect or failure to comply that could create a substantial safety hazard, were it to remain uncorrected, and
    *  (2) Ensure that if an evaluation of an identified deviation or failure to comply potentially associated with a substantial safety hazard cannot be completed within 60 days from discovery of the deviation or failure to comply, an interim report is prepared and submitted to the Commission through a director or responsible officer, or designated person as discussed in § 21.21(d)(5). The interim report should describe the deviation or failure to comply that is being evaluated and should also state when the evaluation will be completed. This interim report must be submitted in writing within 60 days of discovery of the deviation or failure to comply.
 
Vendors capability to perform the Part 21 evaluation to determine if a defect exists 4
* 10 CFR Part 21.21(b) states:
* If the deviation or failure to comply is discovered by a supplier of basic components, or services associated with basic components, and the supplier determines that it does not have the capability to perform the evaluation to determine if a defect exists, then the supplier must inform the purchasers or affected licensees within five working days of this determination so that the purchasers or affected licensees may evaluate the deviation or failure to comply, pursuant to § 21.21(a).
 
NRCs guidance for meeting Part 21 requirements 5
* RG 1.234, Evaluating Deviations And Reporting Defects And Noncompliance Under 10 CFR Part 21, Revision 0 (ML17338A072)
* NEI 14-09, Guidelines for Implementations of 10 CFR Part 21 Reporting of Defects and Noncompliance, Revision 1 (ML16054A825)
* NRC staff has determined that NEI 14-09 provides an adequate basis for complying with the requirements of 10 CFR Part 21 with the following clarifications:
* For design certification rule (DCR) applicants and combined operator license (COL) holders, the DCR applicant is considered the supplier and the COL holder is the purchaser while using the guidance of NEI 14-09.
 
NRCs guidance for meeting Part 21 requirements 6
NEI 14-09, Revision1, Figure A-1, Evaluation and Notification Process Flowchart. A point of clarification on the flow chart is that the Notification Process in dark purple is included in the Evaluation Process (60 days) light purple time requirement.
 
Written report requirements per Part 21.21(d)(4) 7
* What should be included in the reporting to meet Part 21 requirements:
* Part 21.21(d)(4) requires the written report required by this paragraph shall include, but need not be limited to, the following information, to the extent known:
    *  (i) Name and address of the individual or individuals informing the Commission.
    *  (ii) Identification of the facility, the activity, or the basic component supplied for such facility or such activity within the United States which fails to comply or contains a defect.
    *  (iii) Identification of the firm constructing the facility or supplying the basic component which fails to comply or contains a defect.
    *  (iv) Nature of the defect or failure to comply and the safety hazard which is created or could be created by such defect or failure to comply.
    *  (v) The date on which the information of such defect or failure to comply was obtained.
 
Written report requirements per Part 21.21(d)(4) 8
* What should be included in the reporting to meet Part 21.21(d)(4) requirements (continued).
      * (vi) In the case of a basic component which contains a defect or fails to comply, the number and location of these components in use at, supplied for, being supplied for, or may be supplied for, manufactured, or being manufactured for one or more facilities or activities subject to the regulations in this part.
      * (vii) The corrective action which has been, is being, or will be taken; the name of the individual or organization responsible for the action; and the length of time that has been or will be taken to complete the action.
      * (viii) Any advice related to the defect or failure to comply about the facility, activity, or basic component that has been, is being, or will be given to purchasers or licensees
      * (ix) In the case of an early site permit, the entities to whom an early site permit was transferred.
 
How the NRC Receives and Evaluates Part 21 Information 9
* 10 CFR PART 21.21(e) states in part:
* Individuals subject to this part may be required by the Commission to supply additional information related to a defect or failure to comply.
Commission action to obtain additional information may be based on reports of defects from other reporting entities.
* The NRCs Technical Review Group 21 (TRG21) evaluates and provides feedback to the NRCs OpE program. The TRG is composed of members from in the agency and led by a TRG lead who is a subject matter expert in a technical topic. Periodic reviews are performed by search related OpE data streams which include the following:
* Licensee event reports
* Inspection reports and findings
* International reports
* OpE Communications posted on the OpE SharePoint site
* 10 CFR Part 21/50.55(e) notifications
* NRC outreach activities
 
How the NRC Receives and Evaluates Part 21 Information Contd 10
* What if the NRC needs more information?
* All entities covered by this regulation should be aware that the NRC will continue to evaluate notifications made to determine if additional information is required.
* If the Commission determines that additional information is required, the Commission will contact appropriate vendors, licensees, or construction permit holders under § 21.21(e), to obtain adequate information.
* Based on this information, the staff will then determine appropriate regulatory action. Such action may consist of direct contact or generic communication such as an Information Notice.
 
Licensees Use Only Option for Meeting Part 21 11
* NRCs positions on 10 CFR Part 21 reporting requirements in conjunction with 10 CFR 50.72, 10 CFR 50.73 and 10 CFR 73.1200 and 73.1205
* In summary:
* If the evaluation of a deviation in a basic component under the guidance for §§ 50.72 and 50.73 results in a report, the obligations under Part 21 for evaluation and reporting have been met.
* In the event the evaluation of a deviation under the guidance for §§ 50.72 and 50.73 does not result in a report, licensees must ensure that the evaluation also meets Part 21 and its associated guidance to ensure Part 21 reporting is completely satisfied.
 
Available Resources for Part 21 12
* Where can you find information on Part 21
* Code of Federal Regulations website
* https://www.ecfr.gov/current/title-10/chapter-I/part-21?toc=1
* Contains the most up to date information for the regulation
* NRC web page
* https://www.nrc.gov/reactors/new-reactors/how-we-regulate/oversight/quality-assurance/part-21-rulemaking.html
* Regulatory Guide (RG) 1.234, "Evaluating Deviations and Reporting Defects and Noncompliance.
* NEI 14-09, Revision 1: This revision incoperates the guidance of NUREG-0302 Revision 1, "Remarks Presented (Questions/Answers Discussed) at Public Regional Meetings to Discuss Regulations (10 CFR Part 21) For Reporting of Defects and Noncompliance."
* Contact the NRCs Quality Assurance Vendor Inspection Branch
* Aaron Armstrong, aaron.armstrong@nrc.gov
* Dong Park, dong.park@nrc.gov
 
Questions 13}}

Revision as of 02:36, 17 July 2023

Vendor Oversight Townhall - 10 CFR Part 21 Discussion June 21, 2023
ML23165A196
Person / Time
Issue date: 06/14/2023
From: Aaron Armstrong, Dong Park
NRC/NRR/DRO/IQVB
To:
References
Download: ML23165A196 (13)
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