Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part XIII - Transportation of Radioactive Material › Article 5 - Quality Assurance › Section 12VAC5-481-3130 - Quality assurance

Current through Register Vol. 40, No. 24, July 15, 2024
A. Quality
					 assurance requirements apply to the design, purchase, fabrication, handling,
					 shipping, storing, cleaning, assembly, inspection, testing, operation,
					 maintenance, repair, and modification of components of packaging that are
					 important to safety. Quality assurance comprises all those planned and
					 systematic actions necessary to provide adequate confidence that a system or
					 component will perform satisfactorily in service. Quality assurance includes
					 quality control, which comprises those quality assurance actions related to
					 control of the physical characteristics and quality of the material or
					 component to predetermined requirements. Each licensee is responsible for the
					 quality assurance provision that applies to its use of packaging for the
					 shipment of licensed material subject to this chapter.
B. Each licensee shall establish, maintain,
					 and execute a quality assurance program satisfying each of that applicable
					 criteria of this section, 10 CFR Part 71 Subpart H and satisfying any specific
					 provisions that are applicable to the licensee's activities including
					 procurement of packaging. The licensee shall execute the applicable criteria in
					 a graded approach to an extent that is commensurate with the quality assurance
					 requirement's importance to safety.
C. Before the use of any package for the
					 shipment of licensed material subject to this rule, each licensee shall obtain
					 approval of its quality assurance program. Using an appropriate method, each
					 licensee shall file a description of its quality assurance program, including a
					 discussion of which requirements of this section are applicable and how they
					 will be satisfied by submitting the description to the agency.
D. A program for transport container
					 inspection and maintenance limited to radiographic exposure devices, source
					 changers, or packages transporting these devices and meeting the requirements
					 of
					 12VAC5-481-1270
					 or equivalent NRC or agreement state requirement, is deemed to satisfy the
					 requirements of
					 12VAC5-481-3000
					 and subsection B of this section.
E. The licensee shall be responsible for the
					 establishment and execution of the quality assurance program. The licensee may
					 delegate to others, such as contractors, agents, or consultants, the work of
					 establishing and executing the quality assurance program, or any part of the
					 quality assurance program, but shall retain responsibility for the program. The
					 licensee shall clearly establish and delineate, in writing, the authority and
					 duties of persons and organizations performing activities affecting the
					 safety-related functions of structures, systems, and components. These
					 activities include performing the functions associated with attaining quality
					 objectives and the quality assurance functions. While the term licensee is used
					 in these criteria, the requirements are applicable to whatever design,
					 fabrication, assembly, and testing of the package is accomplished with respect
					 to a package before the time a package is issued.
F. The quality assurance functions are:
1. Assuring that an appropriate quality
					 assurance program is established and effectively executed; and
2. Verifying, by procedures such as checking,
					 auditing, and inspection, that activities affecting the safety-related
					 functions have been performed correctly.