Section 120.791 - Quality Assurance Requirements(A)Purpose. 105 CMR 120.791 through 120.797 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 105 CMR 120.791 through 120.797, "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 requirements that apply to its use of a packaging for the shipment of licensed material subject to 105 CMR 120.791 through 120.797.(B)Establishment of Program. Each licensee shall establish, maintain, and execute a quality assurance program satisfying each of the applicable criteria of 105 CMR 120.791 through 120.797 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)Approval of Program. Before the use of any package for the shipment of licensed material subject to 105 CMR 120.791 through 120.797, each licensee shall obtain Agency approval of its quality assurance program. Using an appropriate method listed in 105 CMR 120.013, each licensee shall file a description of its quality assurance program, including a discussion of which requirements of 105 CMR 120.791 through 120.797 are applicable and how they will be satisfied, by submitting the description to the Agency.(D)Radiography Containers. 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 10 CFR 34.31(b) or equivalent Agreement State requirement, is deemed to satisfy the requirements of 105 CMR 120.777(B) and 120.791(B).Amended by Mass Register Issue 1307, eff. 2/26/2016.Amended by Mass Register Issue 1373, eff. 9/7/2018.Amended by Mass Register Issue 1480, eff. 10/14/2022.