Section 180-13-021 - QUALITY ASSURANCE REQUIREMENTSThis 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" includes all 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 satisfying the quality assurance requirements that apply to its use of a packaging for the shipment of licensed material subject to this section.
021.01PROGRAM ESTABLISHMENT. Unless otherwise authorized by the Department, each licensee must establish, maintain, and execute a quality assurance program satisfying each of the applicable criteria of 10 CFR 71.101 through 71.137 and satisfying any specific provisions applicable to the licensee's activities including procurement of packaging. The licensee must execute the applicable criteria in a graded approach to an extent that is equivalent with the quality assurance requirement's importance to safety.021.02PROGRAM APPROVAL. Before the use of any package for the shipment of licensed material subject to this section, each licensee must obtain Departmental approval of its quality assurance program. Each licensee must 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: ATTN: Nebraska Department of Health and Human Services, Office of Radiological Health, 301 Centennial Mall South, P.O. Box 95026, Lincoln, NE 68509-5026021.03MATERIAL AND COMPONENT IDENTIFICATION. The licensee must identify the material and components to be covered by the quality assurance program.021.04PROCEDURES. Each licensee must document the quality assurance program by written procedures or instructions and must carry out the program according to those procedures throughout the period during which packaging is used.021.05WRITTEN RECORDS. The licensee must maintain sufficient written records to demonstrate compliance with the quality assurance program. Records of quality assurance pertaining to the use of a package for shipment of radioactive material must be maintained for a period of three years after shipment.021.06RADIOGRAPHY CONTAINERS. The licensee must maintain a program for transport container inspection and maintenance limited to radiographic exposure devices, source changer, or packages transporting these devices and meeting the requirements of 180 NAC 5-011 or equivalent Agreement State or NRC requirements.021.07DELEGATION. The licensee must 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 must retain responsibility for the program. The licensee must 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 approval is issued.021.08FUNCTIONS. The quality assurance functions are:(A) Assuring an appropriate quality assurance program is established and effectively executed; and(B) Verifying, by procedures such as checking, auditing, and inspection, that activities affecting the safety-related functions have been performed correctly.021.09AUTHORITY AND ORGANIZATIONAL FREEDOM. The persons and organizations performing quality assurance functions must have sufficient authority and organizational freedom to:(A) Identify quality problems;(B) Initiate, recommend, or provide solutions; and(C) Verify implementation of solutions.021.10HANDLING, STORAGE, AND SHIPPING CONTROL. The licensee must establish measures to control, according to 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 inert gas atmosphere, and specific moisture content and temperature levels must be specified and provided.021.11INSPECTION, TEST, AND OPERATING STATUS. The licensee must:(A) Establish measures to indicate, by the use of markings such as stamps, tags, labels, routing cards, or other suitable means, the status of inspections and tests performed upon individual items of the packaging. These measures must 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; and(B) Establish measures to identify the operating status of components of the packaging, such as tagging valves and switches, to prevent inadvertent operation.021.12NONCONFORMING MATERIALS, PARTS, OR COMPONENTS. The licensee must establish measures to control materials, parts, or components that do not conform to the licensee's requirements to prevent their inadvertent use or installation. These measures must include, as appropriate, procedures for identification, documentation, segregation, disposition, and notification to affected organization. Nonconforming items must be reviewed and accepted, rejected, repaired, or reworked according to documented procedures.021.13CORRECTIVE ACTIONS. The licensee must establish measures to assure conditions adverse to quality, such as deficiencies, deviations, defective material and equipment, and nonconformances, are prompt identified and corrected. In the case of significant condition adverse to quality, the measures must assure the cause of the condition is determined and corrective action taken to preclude repetition. Identification of the significant condition adverse to quality, cause of the condition, and corrective action taken must be documented and reported to appropriate levels of management.021.14RECORDS. The licensee must maintain sufficient written records to describe the activities affecting quality. These records must include changes to the quality assurance program as required by 180 NAC 13-022. The records must include the instruction, procedures, and drawings to prescribe quality assurance activities and must include closely related specifications such as required qualification of personnel, procedures, and equipment. The records must include the instructions or procedures, which establish a records retention program consistent with applicable regulations and designates factors such as duration, location, and assigned responsibility. The licensee must retain these records for three years beyond the date which the licensee last engage in the activity for which the quality assurance program was developed. If any portion of the written procedures or instruction is superseded, the licensee must retain the superseded material for three years after it is superseded.021.15AUDITS. The licensee must 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 must be performed according to written procedures or checklists by appropriately trained personnel not having direct responsibilities in the areas being audited. Audited results must be documented and reviewed by management having responsibility in the area audited. Follow-up action, including reaudit of deficient areas, must be taken where indicated.021.16COMPLEXITY AND PROPOSED USE OF THE PACKAGE AND ITS COMPONENTS. The licensee must 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 to 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.021.17INDOCTRINATION AND TRAINING. The licensee must provide for indoctrination and training of personnel performing activities affecting quality, as necessary to assure suitable proficiency is achieved and maintained. The licensee must review the status and adequacy of the quality assurance program at established intervals. Management of other organizations participating in the quality assurance program must review regularly the status and adequacy of that part of the quality assurance program they are executing.180 Neb. Admin. Code, ch. 13, § 021
Amended effective 4/20/2021Amended effective 11/2/2022