Section 3130. Quality assurance

Article 5. Quality Assurance

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. The licensee, certificate holder, and applicant for a CoC are responsible for the quality assurance requirements as they apply to design, fabrication, testing, and modification of packaging. 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, certificate holder and applicant for a CoC 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, certificate holder, and applicant for 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. Before the use of any package for the shipment of licensed material subject to this rule, each licensee shall obtain NRC approval of its quality assurance program.

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, is deemed to satisfy the requirements of 12VAC5-481-3000 and subsection B of this section.

E. The licensee, certificate holder, and applicant for a CoC shall be responsible for the establishment and execution of the quality assurance program. The licensee, certificate holder, and applicant for a CoC 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.

G. The persons and organizations performing quality assurance functions must have sufficient authority and organizational freedom to:

1. Identify quality problems;

2. Initiate, recommend, or provide solutions; and

3. Verify implementation of solutions.

Historical Notes

Derived from Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

Statutory Authority

§ 32.1-229 of the Code of Virginia.