GRADED APPROACH TO ESTABLISH QA REQUIREMENTS FOR TYPE B AND FISSILE MATERIAL TRANSPORTATION PACKAGINGS

The essence of the graded approach is the establishment of applicable quality assurance (QA) requirements to an extent consistent with the importance to safety of an item, component, system, or activity. The genesis of the graded approach is a study conducted by the U.S. Nuclear Regulatory Commission (NRC) for the U.S. Congress in 1987 to assess the effectiveness of QA activities. That study demonstrated the need to improve the application of QA requirements for the nuclear industry in general. The conclusion of the study indicated that a graded approach for establishing QA requirements is the most viable method to satisfy federal safety standards that result in protecting public health and safety. The application of QA requirements for Type B and fissile material transportation packagings is not based solely on importance to safety or safetyrelated considerations. The operability of items, components, systems, and activities is considered to be equally important. The nuclear industry, along with regulatory agencies, recognizes the significance of operability considerations, as well as the evaluation of each item, component, system, or activity for safety-related considerations. The graded approach for QA requirements for Type B and fissile material transportation packagings is based on Title 10, Part 71 of the U.S. Code of Federal Regulations (CFR), “Packaging and Transportation of Radioactive Material.” Guidance for implementation of the QA requirements specified in §71 is provided in NRC Regulatory Guide 7.10, “Establishing Quality Assurance Programs for Packaging Used in Transport of Radioactive Material,” and ASME NQA-1, “Quality Assurance Requirements for Nuclear Facility Applications.” The graded approach for QA requirements is based on criteria for containment, shielding, and subcriticality specified in 10 CFR Part 71.