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Archived Web Page: Draft Regulatory Document RD-364Joint Canada - United States Guide for Approval of Type B(U) and Fissile Material Transportation Packages

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In this section, the applicant should describe the Quality Assurance (QA) program as required in 10 CFR 71.37 or Paragraph 310 of TS-R-1 as referenced in Paragraph 13(a) of the PTNS Regulations. The applicant should demonstrate that effective and adequate QA programs are specified and established for those aspects of the design, manufacture, testing, documentation, use, maintenance, and inspection of packages, transport, and storage in transit for which the applicant is responsible.

IAEA Safety Series No. 113 Quality Assurance for the Safe Transport of Radioactive Material [8] provides guidance on the minimum requirements for an acceptable QA program. For package designers, the following program elements are required:

  1. QA programs;
  2. Organization;
  3. Document control;
  4. Design control;
  5. Procurement control;
  6. Non-conformance control;
  7. Corrective actions;
  8. Records;
  9. Staff and training; and
  10. Audits.

Packages originally certified in Canada must meet the CNSC QA requirements described below, while packages originally certified in the United States. must meet the NRC QA requirements shown below.

Validation requests should reference the applicable QA program approved with the original certification. Additional information may be requested to determine if the referenced QA program is sufficient for package validation purposes.

9.1 U.S. QA Program Requirements

For U.S. packages, before the design, fabrication, testing, modification, or use of any package, the applicant shall obtain NRC approval of its QA program. The applicant should file a description of its QA program, including a discussion of which requirements of 10 CFR 71, Subpart H are applicable and how they will be satisfied. A previously approved QA program that satisfies the applicable criteria is acceptable. A QA program that NRC approves under Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants, to 10 CFR Part 50, Domestic Licensing of Production and Utilization Facilities, or Subpart G of Part 72, Quality Assurance, is equivalent to a QA program that the staff approves under 10 CFR Part 71. The NRC has also endorsed the use of ANSI/ASME NQA-1-1983, Quality Assurance Program Requirements for Nuclear Power Facilities [4] as a standard that, when properly applied and supplemented (as necessary) to meet all applicable criteria, should result in the development of a QA program that is acceptable to the NRC staff.

Applicants should be aware that the QA regulations in 10 CFR Part 71 include requirements that other standards may not fully address. In general, programs based on standards NQA-1 [4], IAEA Safety Series No. 113 [8], or ISO 9000:2005 Quality Management Systems [10] will require supplementation to address all Subpart H regulations. The only exception is the 1983 revision of NQA-1, which the NRC has endorsed in its entirety. Without supplementation, the NRC may require the QA program user to submit additional information regarding how the applicable Subpart H regulations will be met.

Subpart H of 10 CFR Part 71 establishes QA requirements that apply to designing, purchasing, fabricating, handling, shipping, storing, cleaning, assembling, inspecting, testing, operating, maintaining, repairing, and modifying packaging components that are important to safety. To meet those requirements, licensees should control the quality of each of the above activities using a graded approach; that is, the QA effort that a licensee expends on an activity should be consistent with the importance to safety of the associated structures, systems, and components (SSCs). SSCs important to safety mean the features of a Type B or fissile material package are intended to:

  1. Maintain the conditions required to safely transport the package contents;
  2. Prevent damage to the package during transport; or
  3. Provide reasonable assurance that the radioactive contents can be received, handled, transported, and retrieved without undue risk to the health and safety of the public or the environment.

NUREG/CR-64074, Classification of Transportation Packaging and Dry Spent Fuel Storage System Components According to Importance to Safety [16], provides a graded approach for classification of components used in transportation packaging according to importance to safety.

For U.S. packages, the QA program description should address the following elements from Subpart H of 10 CFR Part 71:

  1. QA organization;
  2. QA program;
  3. Package design control;
  4. Procurement document control;
  5. Instructions, procedures, and drawings;
  6. Document control;
  7. Control of purchased material, equipment, and services;
  8. Identification and control of materials, parts, and components;
  9. Control of special processes;
  10. Internal inspection;
  11. Test control;
  12. Control of measuring and test equipment;
  13. Handling, storage, and shipping control;
  14. Inspection, test, and operating status;
  15. Nonconforming materials, parts, or components;
  16. Corrective action;
  17. Quality assurance records; and
  18. Audits.

9.2 Canadian QA Program Requirements

For Canadian packages, the applicant should include a copy of the quality assurance program that meets the requirements of Paragraph 310 of TS-R-1 as referenced in Paragraph 13(a) of the PTNS Regulations. IAEA Safety Series 113, or standards from the Canadian Standards Association (CSA), or the International Organization for Standardization (ISO) may be followed in establishment of the program. A previously approved quality assurance program that satisfies the applicable criteria is acceptable.

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