Nebraska Administrative Code › Topic - HEALTH AND HUMAN SERVICES SYSTEM › Title 180 - CONTROL OF RADIATION › Chapter 13 - TRANSPORTATION OF RADIOACTIVE MATERIAL › Section 180-13-021 - QUALITY ASSURANCE REQUIREMENTS

Current through June 17, 2024
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" 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.
021.01
PROGRAM
  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.
021.02
PROGRAM
  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 68509-5026
021.03
MATERIAL AND COMPONENT
  IDENTIFICATION.
The licensee must identify the material and
  components to be covered by the quality assurance program.
021.04
PROCEDURES.
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.
021.05
WRITTEN
  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.
021.06
RADIOGRAPHY 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.
021.07
DELEGATION.
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.
021.08
FUNCTIONS.
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.