Chapter 9. QUALITY ASSURANCE

TM 55-315

CHAPTER 9

QUALITY ASSURANCE

Section I. GENERAL

9-1. Need for a Quality Assurance Program

US Nuclear Regulatory Commission (NRC) regulations require a quality assurance program to be applied to the design,

fabrication, assembly, testing, maintenance, repair, modification, and use of packaging to be used for transporting

radioactive materials (10 CFR 71.37). The quality assurance program must satisfy each of the applicable criteria

specified in 10 CFR 71. 101, Appendix H, "Quality Assurance Criteria for Shipping Packages for Radioactive Material"

(10 CFR 71.37).

9-2. Purpose and Scope

This chapter outlines the quality assurance program requirements for shippers of radioactive materials to ensure that

packaging used will perform satisfactorily in service.

9-3. Quality Assurance Program Defined

As used in this manual, quality assurance comprises all of those planned and systematic actions required to assure that a

system or component will perform satisfactorily in service. Quality assurance includes quality control assurance actions

related to control of the physical characteristics and quality of materials or components to meet predetermined

requirements.

Section II. QUALITY ASSURANCE PROGRAM REQUIREMENTS (10 CFR 71.101, APPENDIX H)

9-4. Quality Assurance Program

a. The authority and duties of persons and organizations performing activities affecting the safety-related functions

of structures, systems, and components shall be clearly established and delineated in writing for both active and quality

assurance functions. The quality assurance functions are:

(1) Assuring that an appropriate quality assurance program is established and effectively executed.

(2) Verifying, by such means as checking, auditing, and inspecting to ascertain that the activities affecting the

safety-related functions have been correctly performed.

b. The persons and organizations performing quality assurance functions shall have enough authority and

organizational freedom to:

(1) Identify quality problems.

(2) Initiate, recommend, or provide solutions.

(3) Verify implementation of solutions.

c. Quality assurance organizations shall report to a sufficiently high management level that the required authority

and organizational freedom is achieved. This includes providing adequate independence from cost and schedule when

confronting with safety considerations.

9-5. Basic Elements of the Quality Assurance Program

a. The quality assurance program shall be documented by written procedures or instructions and shall be carried out

according to those instructions.

b. The 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 shipping of radioactive materials. Activities affecting quality shall

be accomplished under suitably controlled conditions, to include:

(1) Use of appropriate equipment.

(2) Establishment of suitable environmental conditions, such as adequate cleanliness.

9-1