Current through Register Vol. 49, No. 13, September 23, 2024
Subpart
1.
Program requirement.
A. A licensee who uses a general license
under part 4731.0406, 4731.0409, 4731.0410, or 4731.0411, must establish,
maintain, and execute a quality assurance program satisfying each of the
applicable criteria of this part.
B. As used in this subpart, "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 to predetermined
requirements.
C. Before the use of
any package for the shipment of licensed material subject to this part, a
licensee must obtain the commissioner's approval of its quality assurance
program. The licensee must file a description of its quality assurance program,
including a discussion of which requirements of this part are applicable and
how they will be satisfied.
D. 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 part 4731.4090, subpart 2, items A to
C, or an equivalent requirement of the NRC or an agreement state, is deemed to
satisfy the requirements of subpart 1 and part 4731.0406, subpart 2.
Subp. 2.
Quality assurance
organization.
A. A licensee is
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. These activities include performing the
functions associated with attaining quality objectives and the quality
assurance functions.
B. The quality
assurance functions are:
(1) assuring that an
appropriate quality assurance program is established and effectively executed;
and
(2) verifying, by procedures
such as checking, auditing, and inspection, that activities affecting the
functions important to safety have been correctly performed.
Subp. 3.
Quality
assurance program.
A. The licensee must
document the quality assurance program by written procedures or instructions
and carry out the program according to those procedures throughout the period
during which the packaging is used. The licensee must 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.
B. The
licensee, through its quality assurance program, must 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
ensure conformance to the approved design of each individual package used for
the shipment of radioactive material. The licensee must ensure 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 must 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.
C. 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:
(1) the impact of malfunction
or failure of the item to safety;
(2) the design and fabrication complexity or
uniqueness of the item;
(3) the
need for special controls and surveillance over processes and
equipment;
(4) the degree to which
functional compliance can be demonstrated by inspection or test; and
(5) the quality history and degree of
standardization of the item.
D. The licensee must provide for the
indoctrination and training of personnel who perform activities that affect
quality, as necessary to ensure that 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 shall review regularly the
status and adequacy of that part of the quality assurance program that a
participating organization is executing.
Subp. 4.
Changes to quality assurance
program.
A. A quality assurance program
approval holder must submit a description of a proposed change to its
commissioner-approved quality assurance program that will reduce commitments in
the program description as approved by the commissioner. The quality assurance
program approval holder shall not implement the change before receiving
commissioner approval. The description of a proposed change to the commissioner
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 this part.
B. Each quality assurance program
approval holder may change a previously approved quality assurance program
without prior approval from the commissioner, if the change does not reduce the
commitments in the quality assurance program previously approved by the
commissioner. Changes to the quality assurance program that do not reduce the
commitments must be submitted to the commissioner every 24 months. In addition
to quality assurance program changes involving administrative improvements and
clarifications, spelling corrections, and nonsubstantive changes to punctuation
or editorial items, the following changes are not considered reductions in
commitment:
(1) the use of a quality
assurance standard approved by the commissioner that is more recent than the
quality assurance standard in the certificate holders or applicants current
quality assurance program at the time of the change;
(2) 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;
(3) 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;
(4) the elimination of quality assurance
program information that duplicates language in quality assurance regulatory
guides and quality assurance standards which the quality assurance program
approval holder has committed to on record; and
(5) organizational revisions that ensure
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.
C. Each
quality assurance program approval holder must maintain records of quality
assurance program changes.
Subp.
5.
Handling, 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.
Subp. 6.
Inspection, test, and
operating status.
A. The licensee must
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.
B. The licensee must establish measures to
identify the operating status of components of the packaging, such as tagging
valves and switches, to prevent inadvertent operation.
Subp. 7.
Nonconforming materials,
parts, or components.
The licensee must establish measures to control materials,
parts, or components that do not conform to the licensees requirements to
prevent inadvertent use or installation. These measures must include, as
appropriate, procedures for identification, documentation, segregation,
disposition, and notification to affected organizations. Nonconforming items
must be reviewed and accepted, rejected, repaired, or reworked according to
documented procedures.
Subp.
8.
Corrective action.
The licensee must establish measures to ensure 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 that is adverse to quality,
the measures must ensure that the cause of the condition is determined and
corrective action is taken to preclude repetition. The identification of the
significant condition that is adverse to quality, the cause of the condition,
and the corrective action taken must be documented and reported to appropriate
levels of management.
Subp.
9.
Quality assurance records.
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 subpart 4, and closely related
specifications, such as required qualifications of personnel, procedures, and
equipment. The records must include the instructions or procedures that
establish a records retention program that is consistent with applicable
regulations and that designates factors such as duration, location, and
assigned responsibility for the records. The licensee must retain these records
for three years beyond the date when the licensee last engages 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 must retain the superseded material for three years.
Subp. 10.
Audits.
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 determine the effectiveness of the program. The audits
must be performed according to written procedures or checklists by
appropriately trained personnel who do not have 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.
Statutory Authority: MS s
144.1202;
144.1203
