Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-50 - Packaging and Transportation of Radioactive Material › Section 3701:1-50-24 - Quality assurance requirements

Current through all regulations passed and filed through July 1, 2024
(A) This rule describes quality assurance
			 requirements applying to design, purchase, fabrication, handling, shipping,
			 storing, cleaning, assembly, inspection, testing, operation, maintenance,
			 repair, and modification of components of packaging that are important to
			 safety. As used in this rule, "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 satisfying the quality assurance requirements
			 that apply to its use of a packaging for the shipment of licensed material
			 subject to this rule.
(B) Each
			 licensee shall establish, maintain, and execute a quality assurance program
			 satisfying each of the applicable criteria of this chapter 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
			 the director's approval of its quality assurance program. Each licensee shall
			 file a description of its quality assurance program, including a discussion of
			 which requirements of this chapter are applicable and how they will be
			 satisfied, by submitting the description to the address in rule
			 3701:1-50-03
			 of the Administrative Code.
(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 paragraph (B) of rule
			 3701:1-48-11
			 of the Administrative Code or equivalent United States nuclear regulatory
			 commission or agreement state requirements, is deemed to satisfy the
			 requirements of paragraph (B) of rule
			 3701:1-50-07
			 of the Administrative Code and paragraph (B) of this rule.
(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.
			 These activities include performing the functions associated with attaining
			 quality objectives and the quality assurance functions.
(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 functions
			 that are important to safety have been correctly performed.