La. Admin. Code tit. 33 § XV-1520

Current through Register Vol. 50, No. 11, November 20, 2024

Section XV-1520 - Quality Assurance

A. Quality Assurance Requirements

1. This Section 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 Section, "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 in accordance with 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 Section.

2. Each licensee shall establish, maintain, and execute a quality assurance program that satisfies each of the applicable criteria of this Section and that satisfies 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.

3. Before using any package for the shipment of licensed material subject to this Section, each licensee shall obtain department approval of its quality assurance program. Using an appropriate method listed in 10 CFR 71.1(a), 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 Office of Environmental Compliance.

4. 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 LAC 33:XV.547.B or equivalent NRC or other agreement state requirement, is deemed to satisfy the requirements of LAC 33:XV.1508 and LAC 33:XV.1520.A.

B. Quality Assurance Organization

1. 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.

2. The quality assurance functions consist of assuring that an appropriate quality assurance program is established and effectively executed, and verifying, by procedures such as checking, auditing, and inspection, that activities affecting the functions that are important to safety have been correctly performed.

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

a. identify problems with quality;

b. initiate, recommend, or provide solutions; and

c. verify implementation of solutions.

4. The persons and organizations performing quality assurance functions shall report to a management level that assures that the required authority and organizational freedom, including sufficient independence from cost and schedule factors, when opposed to safety considerations, are provided.

5. Because of the many variables involved, such as the number of personnel, the type of activity being performed, and the location(s) where activities are performed, the organizational structure for executing the quality assurance program may take various forms, provided that persons and organizations assigned the quality assurance functions have the required authority and organizational freedom.

6. Irrespective of the organizational structure, any individual assigned the responsibility for assuring effective execution of any portion of the quality assurance program, at any location where activities subject to this Section are being performed, shall have direct access to the levels of management necessary to perform this function.

C. Quality Assurance Program

1. The licensee shall establish, at the earliest practicable time consistent with the schedule for accomplishing the activities, a quality assurance program that complies with the requirements of this Section. The licensee shall document the quality assurance program by written procedures or instructions and shall carry out the program in accordance with those procedures throughout the period during which the packaging is used. The licensee shall identify the material and components to be covered by the quality assurance program, the major organizations participating in the program, and the designated functions of these organizations.

2. The licensee, through its quality assurance program, shall provide control over activities affecting the quality of the identified materials and components to an extent consistent with their importance to safety, and as necessary to assure conformance to the approved design of each individual package used for the shipment of radioactive material. The licensee shall assure that activities affecting quality are accomplished under suitably controlled conditions. Controlled conditions include the use of appropriate equipment; suitable environmental conditions for accomplishing the activity, such as adequate cleanliness; and assurance that all prerequisites for the given activity have been satisfied. The licensee shall take into account the need for special controls, processes, test equipment, tools, and skills to attain the required quality, and the need for verification of quality by inspection and test.

3. The licensee shall base the requirements and procedures of its quality assurance program on the following considerations concerning the complexity and proposed use of the package and its components:

a. the impact of malfunction or failure of the item on safety;

b. the design and fabrication complexity or uniqueness of the item;

c. the need for special controls and surveillance over processes and equipment;

d. the degree to which functional compliance can be demonstrated by inspection or test; and

e. the quality history and degree of standardization of the item.

4. The licensee shall provide for indoctrination and training of personnel performing activities affecting quality, as necessary to assure that suitable proficiency is achieved and maintained. The licensee shall review the status and adequacy of the quality assurance program at established intervals. Management of other organizations participating in the quality assurance program shall review regularly the status and adequacy of that part of the quality assurance program they are executing.

D. Handling, Storage, and Shipping Control. The licensee shall establish measures to control, in accordance with instructions, the handling, storage, shipping, cleaning, and preservation of materials and equipment to be used in packaging to prevent damage or deterioration. When necessary for particular products, special protective environments, such as an inert gas atmosphere and specific moisture content and temperature levels, shall be specified and provided.

E. Inspection, Test, and Operating Status

1. The licensee shall establish measures to indicate, by the use of markings such as stamps, tags, labels, or routing cards, or by other suitable means, the status of inspections and tests performed upon individual items of the packaging. These measures shall provide for the identification of items that have satisfactorily passed required inspections and tests, where necessary, to preclude inadvertent bypassing of the inspections and tests.

2. The licensee shall establish measures to identify the operating status of components of the packaging, such as tagging valves and switches, to prevent inadvertent operation.

F. Nonconforming Materials, Parts, or Components. The licensee shall establish measures to control materials, parts, or components that do not conform to the licensee's requirements in order to prevent their inadvertent use or installation. These measures shall include, as appropriate, procedures for identification, documentation, segregation, disposition, and notification to affected organizations. Nonconforming items shall be reviewed and accepted, rejected, repaired, or reworked in accordance with documented procedures.

G. Corrective Action. The licensee shall establish measures to assure that conditions adverse to quality, such as deficiencies, deviations, defective material and equipment, and nonconformances, are promptly identified and corrected. In the case of a significant condition adverse to quality, the measures shall assure that the cause of the condition is determined and corrective action is taken to preclude repetition. The identification of the significant condition adverse to quality, the cause of the condition, and the corrective action taken shall be documented and reported to appropriate levels of management.

H. Quality Assurance Records. The licensee shall maintain sufficient written records to describe the activities affecting quality. These records shall include changes to the quality assurance program as required by Subsection J of this Section, the instructions, procedures, and drawings required by 10 CFR 71.111 to prescribe quality assurance activities and shall include closely related specifications such as required qualifications of personnel, procedures, and equipment. The records shall include 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.

I. Audits. The licensee shall carry out a comprehensive system of planned and periodic audits to verify compliance with all aspects of the quality assurance program and to determine the effectiveness of the program. The audits shall be performed in accordance with written procedures or checklists by appropriately trained personnel not having direct responsibilities in the areas being audited. Audited results shall be documented and reviewed by management having responsibility in the area audited. Follow-up action, including re-audit of deficient areas, shall be taken where indicated.

J. Changes to Quality Assurance Program

1. Each licensee shall submit, in accordance with 10 CFR 71.1(a), a description of a proposed change to its department-approved quality assurance program that will reduce commitments in the program description as approved by the department. The licensee shall not implement the change before receiving department approval.

a. The description of a proposed change to the department-approved quality assurance program shall 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.

b. Reserved

2. Each licensee may change a previously approved quality assurance program without prior department approval, if the change does not reduce the commitments in the quality assurance program previously approved by the department. Changes to the quality assurance program that do not reduce the commitments shall be submitted to the department every 24 months, in accordance with 10 CFR 71.1(a). In addition to quality assurance program changes involving administrative improvements and clarifications, spelling corrections, and non-substantive 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 department that is more recent than the quality assurance standard in the licensees 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 responsibilities;

c. the use of generic organizational 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 licensee 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 sufficient independence from cost and schedule when opposed to safety considerations.

3. Each licensee shall maintain records of quality assurance program changes.

La. Admin. Code tit. 33, § XV-1520

Promulgated by the Department of Environmental Quality, Office of the Secretary, Legal Affairs Division, LR 34:2112 (October 2008), repromulgated LR 34:2393 (November 2008), Amended by the Office of the Secretary, Legal Affairs and Criminal Investigations Division, LR 451184 (9/1/2019), Amended LR 471868 (12/1/2021).

AUTHORITY NOTE: Promulgated in accordance with R.S. 30:2104.B and 2113.