| (B) 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.
(C) The licensee, certificate holder, and applicant
for a CoC are responsible for the following:
(i) the quality assurance requirements as they apply
to design, fabrication, testing, and modification of packaging; and
(ii) the quality assurance provision applicable to
its use of a packaging for the shipment of licensed material under
subsections (s) - (bb) and (ee) of this section.
(2) Establishment of program. Each licensee, certificate
holder, and applicant for a CoC shall:
(A) Establish, maintain, and execute a quality assurance
program satisfying each of the applicable criteria of this subsection,
subsections (s) and (t) of this section and Title 10, CFR, §§71.101
through 71.137 and satisfying any specific provisions that are applicable
to the licensee's activities including procurement of packaging; and
(B) Execute the applicable criteria in a graded approach
to an extent that is commensurate with the quality assurance requirement's
importance to safety.
(3) Approval of program. Before the use of any package
for the shipment of licensed material subject to this subsection,
each licensee shall:
(A) obtain department approval of its quality assurance
program; and
(B) file a description of its quality assurance program,
including a discussion of which requirements of this subsection and
subsections (t) and (u) are applicable and how they will be satisfied.
(4) Radiography containers. 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 §289.255(m) of this title, is deemed
to satisfy the requirements of subsection (i)(1)(B) of this section
and paragraph (2) of this subsection.
(t) Quality assurance organization. The licensee, certificate
holder, and applicant for a CoC shall (while the term "licensee" is
used in these criteria, the requirements are applicable to whatever
design, fabricating, assembly, and testing of the package is accomplished
with respect to a package before the time a package approval is issued):
(1) be responsible for the establishment and execution
of the quality assurance program. The licensee, certificate holder,
and applicant for a CoC 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; and
(2) clearly establish and delineate, in writing, the
authority and duties of persons and organizations performing activities
affecting the functions of structures, systems, and components that
are important to safety. These activities include performing the functions
associated with attaining quality objectives and the quality assurance
functions.
(3) establish quality assurance functions as follows:
(A) assuring that 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 functions that are important
to safety have been correctly performed.
(4) assure that persons and organizations performing
quality assurance functions have sufficient authority and organizational
freedom to:
(A) identify quality problems;
(B) initiate, recommend, or provide solutions; and
(C) verify implementation of solutions.
(u) Quality assurance program. A quality assurance
program shall be maintained as follows:
(1) The licensee, certificate holder, and applicant
for a CoC shall:
(A) 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 and Title
10, CFR, §§71.101 through 71.137;
(B) 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; and
(C) 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, certificate holder, and applicant
for a CoC, through its quality assurance program, shall:
(A) 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;
(B) assure that activities affecting quality are accomplished
under suitable controlled conditions which include:
(i) the use of appropriate equipment;
(ii) suitable environmental conditions for accomplishing
the activity, such as adequate cleanliness; and
(iii) all prerequisites for the given activity have
been satisfied; and
(C) 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, certificate holder, and applicant
for a CoC 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
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.
(4) The licensee, certificate holder, and applicant
for a CoC shall provide for indoctrination and training of personnel
performing activities affecting quality, as necessary to assure that
suitable proficiency is achieved and maintained.
(5) The licensee, certificate holder, and applicant
for a CoC 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.
(6) Changes to quality assurance program.
(A) Each quality assurance program approval holder
shall submit, in accordance with §289.201(k) of this title, 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 department. The quality assurance program approval
holder shall not implement the change before receiving agency 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 subsections
(s) - (bb) of this section.
(B) 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 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 §289.201(k) of this title. 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:
(i) the use of a quality assurance standard approved
by the department that is more recent than the quality assurance standard
in the certificate holder's or applicant's current quality assurance
program at the time of the change;
(ii) 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;
Cont'd... |
