Article 5. Quality Assurance
12VAC5-481-3130. 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. 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.
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.
H. Changes to the quality assurance program.
1. Each quality assurance program approval holder shall submit a description of a proposed change to its agency approved quality assurance program that will reduce commitments in the program description as approved by the agency. The quality assurance program approval holder shall not implement the change before receiving approval.
The description of a proposed change to the agency approved quality assurance program must identify the change, the reason for the change, and the basis for concluding that the revised program incorporating the change continues to satisfy the applicable requirements of this section.
2. Each quality assurance program approval holder may change a previously approved quality assurance program without prior agency approval if the change does not reduce the commitments in the quality assurance program previously approved by the agency. Changes to the quality assurance program that do not reduce the commitments shall be submitted to the agency every 24 months. In addition to quality assurance program changes involving administrative improvements and clarifications, spelling corrections, and nonsubstantive changes to punctuation or editorial items, the following changes are not considered reductions in commitment:
a. The use of a quality assurance standard approved by the agency that is more recent than the quality assurance standard in the licensee's current quality assurance program at the time of the change;
b. The use of generic organizational position titles that clearly denote the position function, supplemented as necessary by descriptive text, rather than specific titles, provided that there is no substantive change to either the functions of the position or reporting requirements;
c. The use of generic organization charts to indicate functional relationships, authorities, and responsibilities, or alternatively, the use of descriptive text, provided that there is no substantive change to the functional relationships, authorities, or responsibilities;
d. The elimination of quality assurance program information that duplicates language in quality assurance regulatory guides and quality assurance standards to which the quality assurance program approval holder has committed to on record; and
e. Organizational revisions that ensure that persons and organizations performing quality assurance functions continue to have the requisite authority and organizational freedom, including independence from cost and schedule when opposed to safety considerations.
3. Each quality assurance program approval holder shall maintain records of quality assurance program changes.
I. The licensee shall maintain sufficient written records to describe the activities affecting quality. These records must include the changes to the quality assurance program as required by subsection H of this section, the instructions, procedures, and drawings required by this section to prescribe quality assurance activities, and closely related specifications such as required qualifications of personnel, procedures, and equipment. The records must include the instructions or procedures that establish a records retention program that is consistent with applicable regulations and designates factors such as duration, location, and assigned responsibility. The licensee shall retain these records for three years beyond the date when the licensee last engaged in the activity for which the quality assurance program was developed. If any portion of the quality assurance program, written procedures or instructions is superseded, the licensee shall retain the superseded material for three years after it is superseded.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 34, Issue 2, eff. October 18, 2017; Volume 34, Issue 14, eff. April 5, 2018.