ML24193A077

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Nice ASME NQA-1 International Working Group (Iwg) - Emea (Europe, Middle East, & Africa) Iwg Trip Report Part 21 Presentation
ML24193A077
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Issue date: 07/09/2024
From: Aaron Armstrong
Office of Nuclear Reactor Regulation
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Download: ML24193A077 (17)
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10 CFR Part 21, Reporting Of Defects and Non compliance ASME NQA-1 EU / EMEA IWG JULY 9, 2024 AARON ARMSTRONG US NUCLEAR REGULATORY COMMISSION (NRC)

Agenda 10 CFR Part 21 Purpose Definitions and Process Part 21 Timeline Part 21 Requirements Regulatory Guide RG 1.234 Evaluating Deviations and Reporting Defects and Noncompliance Questions & Comments 2

10 CFR PART 21 REQUIREMENTS & GUIDANCE

10 CFR Part 21

  • Purpose of the regulation is to notify the Nuclear Regulatory Commission of:

Defects in a basic components relating to substantial safety hazards or, A failure to comply with any applicable rule, regulation, order, or license of the NRC relating to substantial safety hazards.

NRC licensed facilities Suppliers of basic components for NRC licensed facilities 3

10 CFR PART 21 REQUIREMENTS & GUIDANCE

Definitions and Process

- Structure, system, or component or part thereof, that affects a safety function necessary to assure:

1. Integrity of the RCS pressure boundary
2. Capability to shutdown the reactor and maintain in safe shutdown condition, or
3. The capability to prevent or mitigate the consequences of accidents which could result in offsite exposure []

- Items designated and manufactured under:

  • A Commercial-grade item which have successfully completed the dedication process 4

10 CFR PART 21 REQUIREMENTS & GUIDANCE

Part 21 Process

  • Discovery
  • Evaluation
  • Notification 5

10 CFR PART 21 REQUIREMENTS & GUIDANCE

Part 21 Process

  • Discovery -
  • completion of the documentation first identifying the existence of a deviation or failure to comply

[10 CFR 21.3]

- Inputs to Part 21 process could be potential deviations and failures to comply identified through the nonconformance and/or corrective action process that may require evaluation under the Part 21 process 6

10 CFR PART 21 REQUIREMENTS & GUIDANCE

Part 21 Process

  • Deviation -

A departure from the technical requirements included in a procurement document Strong Corrective Action Programs are VITAL for identifying potential deviations 7

10 CFR PART 21 REQUIREMENTS & GUIDANCE

Part 21 Process

  • Evaluation -

- The process within Part 21 program used to determine whether a deviation is a defect

  • Defect -

- Deviation in a basic component delivered to a purchaser, that on a basis of an evaluation could Create a substantial safety hazard, or Violate license technical specification safety limits, etc.

NRC NUREG-0302, contains the criteria to determine the existence of substantial safety hazard (SSH) 8 10 CFR PART 21 REQUIREMENTS & GUIDANCE

Part 21 Process

  • Evaluation -

- Determine, within 60 days of discovery, if deviation could create a SSH [10 CFR 21.21(a)]

- Issue an interim report when the evaluation can not be completed within 60 days of discovery [10 CFR 21.21(a)]

- If the supplier does not have the capability to perform the evaluation, notify all affected purchasers within 5 working days of this determination [10 CFR 21.21(b)]

9 10 CFR PART 21 REQUIREMENTS & GUIDANCE

Part 21 Process

  • Notification - [10 CFR 21.21(d)]

- Inform a director or responsible officer, as soon as practicable and, in all cases, within 5 working days after completion of the evaluation

- Notification to Commission

  • Initial notification by facsimile or telephone within 2 days of informing the responsible officer and written notification within 30 days of informing the responsible officer 10 10 CFR PART 21 REQUIREMENTS & GUIDANCE

Part 21 Process

  • Notification (continued)

- Content of written notification

  • Name and address of entity informing the Commission
  • Identification of the vendor
  • Nature of the defect
  • The SSH that could be or was created by the defect
  • The date that the information of the defect was obtained
  • The number and location of all such basic components in use or supplied to facilities subject to this regulation
  • The corrective action
  • Advice given to purchasers 11 10 CFR PART 21 REQUIREMENTS & GUIDANCE

Part 21 Process Discovery of Deviation Documented in CAP NCR?

Able to perform Evaluation If not, inform customer within 5 days of making determination Is the evaluation going to take more than 60 days?

If yes, make an interim report within 60 days of making determination Has NRC been notified via 50.72 or 50.73?

If NRC already notified, another report (i.e. Part

21) is not required Is the deviation a defect? Can this defect create a Substantial Safety Hazard?

If yes, then the defect has to be reported to NRC Director or Responsible Officer notified 5 days to notify the Director or Responsible Officer Initial Notification by phone/fax to NRC Operation Center 2 days following receipt of information by the director or responsible corporate officer Written notification 21.21(4)(i)-(ix)

Written notification to NRC 30 days following receipt of information by the director or responsible corporate officer 12 10 CFR PART 21 REQUIREMENTS & GUIDANCE

Part 21 Timeline Day 1 Discovery 60 days 5 days 30 days 2 days Evaluation Interim Report Inform Respnsible Officer Initial Notification Written Notification For suppliers: 5 working days to notify customers if not capable of performing evaluation To the NRC 13 10 CFR PART 21 REQUIREMENTS & GUIDANCE

Part 21 Requirements

  • Inspections [10 CFR 21.41]

- Entities subject to Part 21 shall permit the Commission to inspect:

  • Records
  • Premises
  • Activities

Part 21 Requirements

  • Interpretation - Except as specifically authorized by the Commission in writing, no interpretation of the meaning of the regulation in this part by any officer or employee of the Commission other than a written interpretation by the General Counsel will be recognized to be binding upon the Commission. [10 CFR 21.4]

15 10 CFR PART 21 REQUIREMENTS & GUIDANCE

RG 1.234 Evaluating Deviations and Reporting Defects and Noncompliance

  • Provides clarification on Part 21 requirements for reporting and evaluating
  • Efforts made by the staff as part of the Rule Making process to clarify Part 21 requirements are captured here 16 10 CFR PART 21 REQUIREMENTS & GUIDANCE

Questions & Comments Contact Information:

Aaron Armstrong 301-415-8396 Aaaron.Armstrong@nrc.gov 17 10 CFR PART 21 REQUIREMENTS & GUIDANCE

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