U.S. NUCLEAR REGULATORY COMMISSION 10 CFR PART 71 … · Quality Assurance Findings 71.105 Quality...

U.S. NUCLEAR REGULATORY COMMISSION 10 CFR PART 71

QUALITY ASSURANCE AND INSPECTION EXPERIENCE FOR

RADIOACTIVE MATERIAL TRANSPORT

Earl C. Love, Senior Transportation & Storage Safety Inspector U. S. Nuclear Regulatory Commission Division of Spent Fuel Management

Presentation Outline

• Regulatory Framework

• NRC Quality Assurance (QA) Program Requirements

• Quality Assurance Program Implementation Expectations

• NRC Compliance/Inspection Program

• Summary

Date 2

Regulatory Framework

• The NRC staff anticipates receiving approximately 50-70 licensing activities per year for transportation packages.

• Currently ninety (90) CoC/QA Program Approval holders; some with multiple transportation packaging CoCs, some with just one CoC, and some in process of obtaining their first CoC.– Designers/fabricators of radiography cameras – Fuel fabricators for new fuel or powder– Designers/users for medical isotopes– Designers/users for commercial purposes– Dry cask storage vendors for dual-purpose designs

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Regulatory Framework

• Two general exceptions to the imposition of NRC’s QAprogram requirements for radioactive material transport:

1) U.S. DOE

2) Within and between U.S. Agreement States

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October 18, 2016 NRC/FCMA 5

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Regulatory Framework

• Previously, all changes made to Quality Assurance Program Approvals had to be prior reviewed and approved by the NRC before they could be implemented.

• The new regulations in 10 CFR 71 .106 allow changes to quality assurance programs that do not reduce commitments.

• NRC approval must occur before implementing changes quality assurance programs that reduce commitments.

• There is no longer an expiration date for Quality Assurance Program Approval.

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NRC QA Program Requirements

• 10 CFR 71.37 requires Certificate of Compliance applicant to submit a QA program description for review and approval by NRC.

• NRC issues QA Program Approval certificate.

• QA Program Approval holder expected to implement NRC QA requirements in working level procedures.

• NRC routinely performs safety and quality assurance inspections on average of once every five (5) years of transportation package vendors, users, and fabricators.

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Quality Assurance Program Implementation Expectations

• An acceptable QA program submittal is one that lies between two extremes:

1) One that addresses each of the 18 criteria stated in Section H of Part 71, as applicable to the user’s activities.

2) One that provides a description of how each of the applicable criteria will be implemented.

• In developing their QA program, users can refer to general guidance provided by NRC in Regulatory Guide 7.10, “Establishing Quality Assurance Programs for Packaging Used in the Transport of Radioactive Material.”

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NRC Compliance/Inspection Program

• NRC has developed a program and procedures for these reactive and planned inspections and is responsible for their implementation.

• Inspections are conducted by trained and qualified safety inspectors well versed in assessing QA program implementation adequacy.

• Inspection teams usually consist of two to three safety inspectors and are sometimes augmented by NRC technical staff if there is a specific, complex, technical issue that needs to be looked at during an inspection.

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NRC Compliance/Inspection Program

• Scope and extent of inspection dependent upon activities at the inspection site:

Full-scope inspections Corporate inspections without fabrication Contracted fabrication facilities

• Inspection guidance contained in NRC Inspection Procedure 86001, “Design, Fabrication, Testing, and Maintenance of Transportation Packagings”

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NRC Compliance/Inspection Program

• Inspections are typically conducted over a three to five day period and involve in-depth review of QA program documents, interviews with personnel, and observation of field activities.

• Inspection results are communicated verbally at the end of the inspection and subsequently documented in a written report.

• QA program nonconformances to NRC requirements are dispositioned according to their severity and in accordance with NRC written policy.

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NRC Compliance/Inspection Program

• For severe nonconformances, monetary fines may be imposed, and in some cases, the user’s QA Program Approval may be suspended or terminated.

• Suspension or termination of NRC’s approval of the user’s QA program effectively precludes the conduct of NRC-licensed activities involving the transport, design or fabrication of radioactive material packagings.

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NRC Compliance/Inspection Program

• Thirty-three (33) performance based inspections over last four (4) years of CoC/QA Program Approval and Certificate of Compliance holders.

• Eleven (11) planned inspections in FY2018

• International Inspections performed in Canada, France, India, Japan, and United Kingdom.

• Of the 33 inspections, twenty-three (23) violations were identified:- 15 Severity Level IV Notice of Violations - 9 Noncited Violations

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NRC Compliance/Inspection Program

Common 10 CFR 71 Subpart HQuality Assurance Findings

71.105 Quality assurance program. 71.107 Package design control. 71.111 Instructions, procedures, and drawings. 71.115 Control of purchased material, equipment, and services. 71.133 Corrective action. 71.135 Quality assurance records.

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NRC Compliance/Inspection Program

Common Inspection Findings

• Training of personnel performing activities affecting quality• Software validation• Implementation of design changes without NRC approval• Design standards and suitability of applications of ITS-A material• Failure to follow procedures affecting quality activities• Processing and control of nonconforming material• Calibration of equipment • Material control• Nondestructive examinations• Commercial grade dedication• Conformance to procurement documentation• Inadequate corrective actions • Failure to maintain QA recordsOctober 18, 2016 20

Summary

• NRC CoC holders 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, Design, Fabrication, and

Maintenance Controls, as appropriate• Nonconformances dispositioned through NRC Enforcement Policy• CoC/QA Program holders should contact regulator when they have

questions on regulatory requirements as failure to do so may result in inspection findings

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