§ 71.101 Quality assurance requirements. ( a ) *Purpose.* This subpart 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 subpart, “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 certificate holder and applicant for a package approval is responsible for satisfying the quality assurance requirements that apply to design, fabrication, testing, and modification of packaging subject to this subpart. 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 subpart.
( b ) *Establishment of program.* Each licensee, certificate holder, and applicant for a CoC shall establish, maintain, and execute a quality assurance program satisfying each of the applicable criteria of §§ 71.101 through 71.137 and satisfying any specific provisions that are applicable to the licensee's activities including procurement of packaging. The licensee, certificate holder, and applicant for a CoC 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.* ( 1 ) Before the use of any package for the shipment of licensed material subject to this subpart, each licensee shall obtain Commission approval of its quality assurance program. Using an appropriate method listed in § 71.1(a), each licensee shall file a description of its quality assurance program, including a discussion of which requirements of this subpart are applicable and how they will be satisfied, by submitting the description to: ATTN: Document Control Desk, Director, Division of Fuel Management, Office of Nuclear Material Safety and Safeguards.
( 2 ) Before the fabrication, testing, or modification of any package for the shipment of licensed material subject to this subpart, each certificate holder, or applicant for a Certificate of Compliance shall obtain Commission approval of its quality assurance program. Each certificate holder or applicant for a CoC shall, in accordance with § 71.1, file a description of its quality assurance program, including a discussion of which requirements of this subpart are applicable and how they will be satisfied.
( d ) *Existing package designs.* The provisions of this paragraph deal with packages that have been approved for use in accordance with this part before January 1, 1979, and which have been designed in accordance with the provisions of this part in effect at the time of application for package approval. Those packages will be accepted as having been designed in accordance with a quality assurance program that satisfies the provisions of paragraph (b) of this section.
( e ) *Existing packages.* The provisions of this paragraph deal with packages that have been approved for use in accordance with this part before January 1, 1979, have been at least partially fabricated before that date, and for which the fabrication is in accordance with the provisions of this part in effect at the time of application for approval of package design. These packages will be accepted as having been fabricated and assembled in accordance with a quality assurance program that satisfies the provisions of paragraph (b) of this section.
( f ) *Previously approved programs.* A Commission-approved quality assurance program that satisfies the applicable criteria of subpart H of this part, Appendix B of part 50 of this chapter, or subpart G of part 72 of this chapter, and that is established, maintained, and executed regarding transport packages, will be accepted as satisfying the requirements of paragraph (b) of this section. Before first use, the licensee, certificate holder, and applicant for a CoC shall notify the NRC, in accordance with § 71.1, of its intent to apply its previously approved subpart H, Appendix B, or subpart G quality assurance program to transportation activities. The licensee, certificate holder, and applicant for a CoC shall identify the program by date of submittal to the Commission, Docket Number, and date of Commission approval.
( g ) *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 § 34.31(b) of this chapter or equivalent Agreement State requirement, is deemed to satisfy the requirements of §§ 71.17(b) and 71.101(b).
[69 FR 3796, Jan. 26, 2004, as amended at 75 FR 73945, Nov. 30, 2010; 79 FR 75741, Dec. 19, 2014; 80 FR 34013, June 12, 2015; 84 FR 65645, Nov. 29, 2019]