ML20104C112
| ML20104C112 | |
| Person / Time | |
|---|---|
| Issue date: | 09/25/2019 |
| From: | Earl Love Office of Nuclear Material Safety and Safeguards |
| To: | |
| Love E | |
| Shared Package | |
| ml20101r995 | List: |
| References | |
| Download: ML20104C112 (13) | |
Text
10 CFR PART 71 QUALITY ASSURANCE PROGRAM REQUIREMENTS and INSPECTION PROGRAM Earl Love, Transportation & Storage Safety Inspector Nuclear Materials Safety and Safeguards Division of Fuel Management Inspections and Operations Branch U.S. Nuclear Regulatory Commission 2019 TRTR Conference September 25, 2019
Introduction
- NMSS Regulatory Framework
- NRC Quality Assurance (QA) Program Requirements
- NRC Compliance Assurance Program
- Inspection Scheduling/Findings
- Summary 2
Regulatory Framework US Nuclear Regulatory Commission Quality Assurance Roles and Responsibilities for Radioactive Material Transport Title 10 of the Code of Federal Regulations (10 CFR) Part 71 Packaging and Transportation of Radioactive Material Subpart H Quality Assurance 3
Regulatory Framework
- U. S. Department of Transportation (DOT)
- Regulates all hazardous material transport including Class 7 radioactive materials
- Title 49 Code of Federal Regulations (CFR)
- U. S. Nuclear Regulatory Commission (NRC)
- Through Memorandum of Understanding with DOT, reviews and approves, by issuance of Certificate of Compliance (CoC), Type B and Fissile material packaging designs
- Title 10 CFR Part 71, Packaging and Transportation of Radioactive Material 4
Regulatory Framework General License: NRC-approved package A general License is issued to any licensee of the Commission to transport, deliver to a carrier for transport, licensed material in a package for which a licensee, certificate of compliance, or other approval has been issued by the NRC.
5
NRC QA Program Requirements
- A secondary CoC holder is normally a user-only of that packaging
- QAP Approval holder is responsible to ensure proper implementation of their NRC-approved QA program in working level procedures
- The QAP specifies commitments made by an organization to meet the requirements of 10 CFR Part 71
- The QAP Approval is the document issued by NRC to identify the conditions of QAP applicability to the requirements of 10 CFR Part 71, Subpart H 6
NRC Compliance Assurance Program
- QAP Approval holder responsible to ensure proper implementation of their NRC-approved QA program
- NRC Division of Fuel Management / Inspections &
Operations Branch conducts periodic planned and reactive safety inspections of Packaging Certificate of Compliance holders/CoC Users/QA Program Approval holders
- Inspection guidance contained in NRC Inspection Procedure 86001 and NUREG/CR-6314 7
NRC Compliance Assurance Program
- Scope and extent of inspection dependent upon activities at the inspection site
- Assessment of implementing QA procedures
- Limited-scope inspections (Operations/Maintenance)
- Corporate inspections without fabrication
- Contracted fabrication facilities
- Inspection results documented in publicly available inspection reports
- Noncompliances dispositioned in accordance with NRC Enforcement Policy Manual 8
NRC Compliance Assurance Program Operations (PSAR Chapter 7)
Acceptance Test and Maintenance Controls (PSAR Chapter 8) 9
Inspection Scheduling/Findings
- 1st Time NRC-approved package user/shipper
- QA Program approved by the Commission as satisfying the provisions of 10 CFR 71 Subpart H - 71.17(b)
- Significant Changes to the QA Program
- Submittal in writing before the first use of the package -
71.17(c)(3)
- Request authorization for use of the package under NRC approved package - 71.17(c)(3)(d)
- Event Reports
- 71.95 Reports 10
Inspection Scheduling/Findings
- Three (3) planned and/or reactive RTR inspections over last five (5) years of QA Program Approval holders
- Inspection Observations
- 10 CFR 71.115 "Control of purchased material, equipment, and services Material spare part procurements (e.g., O-ring gaskets, sealing washers, closure nuts, screws, and studs)
Purchasing of testing and calibration services
- 10CFR Part 21 Reporting of Defects and Noncompliance and 71.95 Reporting 11
Summary
- NRC CoC package users must submit QA Program description
- NRC issues QA Program Approval certificates and the holder implements appropriate quality procedures
- NRC conducts routine planned and reactive safety inspections to verify and assess compliance
- Inspections address Management, Operations, and Maintenance Controls, as appropriate
- Nonconformances dispositioned through NRC Enforcement Policy
- QA Program holders should contact regulator when they have questions on regulatory requirements as failure to do so may result in inspection findings 12
Questions??