Part 50 - Domestic Licensing of Production and Utilization Facilities
Appendix B to Part 50 -- Quality Assurance Criteria for Nuclear
Power Plants and Fuel Reprocessing Plants
Introduction.
Every applicant for a construction permit is
required by the provisions of §50.34 to include in its preliminary safety
analysis report a description of the quality assurance program to be applied to
the design, fabrication, construction, and testing of the structures, systems,
and components of the facility. Every applicant for an operating license is
required to include, in its final safety analysis report, information
pertaining to the managerial and administrative controls to be used to assure
safe operation. Every applicant for a combined license under part 52 of this
chapter is required by the provisions of §52.79 of this chapter to include in
its final safety analysis report a description of the quality assurance applied
to the design, and to be applied to the fabrication, construction, and testing
of the structures, systems, and components of the facility and to the
managerial and administrative controls to be used to assure safe operation. For
applications submitted after September 27, 2007, every applicant for an early
site permit under part 52 of this chapter is required by the provisions of
§52.17 of this chapter to include in its site safety analysis report a
description of the quality assurance program applied to site activities related
to the design, fabrication, construction, and testing of the structures,
systems, and components of a facility or facilities that may be constructed on
the site. Every applicant for a design approval or design certification under
part 52 of this chapter is required by the provisions of 10 CFR 52.137 and 52.47,
respectively, to include in its final safety analysis report a description of
the quality assurance program applied to the design of the structures, systems,
and components of the facility. Every applicant for a manufacturing license
under part 52 of this chapter is required by the provisions of 10 CFR 52.157 to
include in its final safety analysis report a description of the quality
assurance program applied to the design, and to be applied to the manufacture
of, the structures, systems, and components of the reactor. Nuclear power
plants and fuel reprocessing plants include structures, systems, and components
that prevent or mitigate the consequences of postulated accidents that could
cause undue risk to the health and safety of the public. This appendix
establishes quality assurance requirements for the design, manufacture,
construction, and operation of those structures, systems, and components. The
pertinent requirements of this appendix apply to all activities affecting the
safety-related functions of those structures, systems, and components; these
activities include designing, purchasing, fabricating, handling, shipping,
storing, cleaning, erecting, installing, inspecting, testing, operating,
maintaining, repairing, refueling, and modifying.
As used in this appendix, “quality assurance” comprises all those planned and
systematic actions necessary to provide adequate confidence that a structure,
system, or component will perform satisfactorily in service. Quality assurance
includes quality control, which comprises those quality assurance actions
related to the physical characteristics of a material, structure, component, or
system which provide a means to control the quality of the material, structure,
component, or system to predetermined requirements.
I. Organization
The applicant1 shall be responsible for the establishment and execution
of the quality assurance program. The applicant may delegate to others, such
as contractors, agents, or consultants, the work of establishing and executing the
quality assurance program, or any part thereof, but shall retain responsibility
for the quality assurance program. 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. These activities include both the performing functions of
attaining quality objectives and the quality assurance functions. The quality
assurance functions are those of (1) assuring that an appropriate quality
assurance program is established and effectively executed; and (2) verifying,
such as by checking, auditing, and inspecting, that activities affecting the
safety-related functions have been correctly performed. The persons and
organizations performing quality assurance functions shall have sufficient
authority and organizational freedom to identify quality problems; to initiate,
recommend, or provide solutions; and to verify implementation of solutions. There
persons and organizations performing quality assurance functions shall report
to a management level so that the required authority and organizational
freedom, including sufficient independence from cost and schedule when opposed
to safety considerations, are provided. Because of the many variables
involved, such as the number of personnel, the type of activity being
performed, and the location or locations where activities are performed, the
organizational structure for executing the quality assurance program may take various
forms, provided that the persons and organizations assigned the quality
assurance functions have the required authority and organizational freedom. Irrespective
of the organizational structure, the individual(s) assigned the responsibility
for assuring effective execution of any portion of the quality assurance
program at any location where activities subject to this appendix are being
performed, shall have direct access to the levels of management necessary to
perform this function.
1 While the term “applicant”
is used in these criteria, the requirements are, of course, applicable after
such a person has received a license to construct and operate a nuclear power
plant or a fuel reprocessing plant or has received an early site permit, design
approval, design certification, or manufacturing license, as applicable. These
criteria will also be used for guidance in evaluating the adequacy of quality
assurance programs in use by holders of construction permits, operating
licenses, early site permits, design approvals, combined licenses, and
manufacturing licenses.
II. Quality Assurance Program
The applicant shall establish at the earliest practicable time, consistent with the
schedule for accomplishing the activities, a quality assurance program which
complies with the requirements of this appendix. This program shall be
documented by written policies, procedures, or instructions and shall be
carried out throughout plant life in accordance with those policies,
procedures, or instructions. The applicant shall identify the structures,
systems, and components to be covered by the quality assurance program and the
major organizations participating in the program, together with the designated
functions of these organizations. The quality assurance program shall provide
control over activities affecting the quality of the identified structures,
systems, and components, to an extent consistent with their importance to
safety. Activities affecting quality shall be accomplished under suitably
controlled conditions. Controlled conditions include the use of appropriate
equipment; suitable environmental conditions for accomplishing the activity,
such as adequate cleanness; and assurance that all prerequisites for the given
activity have been satisfied. The program shall 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. The program shall provide for indoctrination and training of personnel
performing activities affecting quality as necessary to assure that suitable
proficiency is achieved and maintained. The applicant shall regularly review
the status and adequacy of the quality assurance program. Management of other
organizations participating in the quality assurance program shall regularly
review the status and adequacy of that part of the quality assurance program
which they are executing.
III. Design Control
Measures shall be established to assure that applicable regulatory requirements and the
design basis, as defined in §50.2 and as specified in the license application,
for those structures, systems, and components to which this appendix applies
are correctly translated into specifications, drawings, procedures, and instructions.
These measures shall include provisions to assure that appropriate quality
standards are specified and included in design documents and that deviations
from such standards are controlled. Measures shall also be established for the
selection and review for suitability of application of materials, parts,
equipment, and processes that are essential to the safety-related functions of
the structures, systems and components.
Measures shall be established for the identification and control of design interfaces
and for coordination among participating design organizations. These measures
shall include the establishment of procedures among participating design
organizations for the review, approval, release, distribution, and revision of
documents involving design interfaces.
The design control measures shall provide for verifying or checking the adequacy of
design, such as by the performance of design reviews, by the use of alternate
or simplified calculational methods, or by the performance of a suitable
testing program. The verifying or checking process shall be performed by
individuals or groups other than those who performed the original design, but
who may be from the same organization. Where a test program is used to verify
the adequacy of a specific design feature in lieu of other verifying or
checking processes, it shall include suitable qualifications testing of a
prototype unit under the most adverse design conditions. Design control
measures shall be applied to items such as the following: reactor physics,
stress, thermal, hydraulic, and accident analyses; compatibility of materials;
accessibility for inservice inspection, maintenance, and repair; and
delineation of acceptance criteria for inspections and tests.
Design changes, including field changes, shall be subject to design control measures
commensurate with those applied to the original design and be approved by the
organization that performed the original design unless the applicant designates
another responsible organization.
IV. Procurement Document Control
Measures shall be established to assure that applicable regulatory requirements, design
bases, and other requirements which are necessary to assure adequate quality
are suitably included or referenced in the documents for procurement of
material, equipment, and services, whether purchased by the applicant or by its
contractors or subcontractors. To the extent necessary, procurement documents
shall require contractors or subcontractors to provide a quality assurance
program consistent with the pertinent provisions of this appendix.
V. Instructions, Procedures, and Drawings
Activities affecting quality shall be prescribed by documented instructions, procedures,
or drawings, of a type appropriate to the circumstances and shall be accomplished
in accordance with these instructions, procedures, or drawings. Instructions,
procedures, or drawings shall include appropriate quantitative or qualitative
acceptance criteria for determining that important activities have been
satisfactorily accomplished.
VI. Document Control
Measures shall be established to control the issuance of documents, such as
instructions, procedures, and drawings, including changes thereto, which
prescribe all activities affecting quality. These measures shall assure that
documents, including changes, are reviewed for adequacy and approved for
release by authorized personnel and are distributed to and used at the location
where the prescribed activity is performed. Changes to documents shall be
reviewed and approved by the same organizations that performed the original
review and approval unless the applicant designates another responsible
organization.
VII. Control of Purchased Material, Equipment, and Services
Measures shall be established to assure that purchased material, equipment, and
services, whether purchased directly or through contractors and subcontractors,
conform to the procurement documents. These measures shall include provisions,
as appropriate, for source evaluation and selection, objective evidence of quality
furnished by the contractor or subcontractor, inspection at the contractor or
subcontractor source, and examination of products upon delivery. Documentary
evidence that material and equipment conform to the procurement requirements
shall be available at the nuclear power plant or fuel reprocessing plant site
prior to installation or use of such material and equipment. This documentary
evidence shall be retained at the nuclear power plant or fuel reprocessing
plant site and shall be sufficient to identify the specific requirements, such
as codes, standards, or specifications, met by the purchased material and
equipment. The effectiveness of the control of quality by contractors and
subcontractors shall be assessed by the applicant or designee at intervals
consistent with the importance, complexity, and quantity of the product or
services.
VIII. Identification and Control of Materials, Parts, and Components
Measures
shall be established for the identification and control of materials, parts,
and components, including partially fabricated assemblies. These measures
shall assure that identification of the item is maintained by heat number, part
number, serial number, or other appropriate means, either on the item or on
records traceable to the item, as required throughout fabrication, erection,
installation, and use of the item. These identification and control measures
shall be designed to prevent the use of incorrect or defective material, parts,
and components.
IX. Control of Special Processes
Measures shall be established to assure that special processes, including welding, heat
treating, and nondestructive testing, are controlled and accomplished by
qualified personnel using qualified procedures in accordance with applicable
codes, standards, specifications, criteria, and other special requirements.
X. Inspection
A program for inspection of activities affecting quality shall be established and
executed by or for the organization performing the activity to verify
conformance with the documented instructions, procedures, and drawings for
accomplishing the activity. Such inspection shall be performed by individuals
other than those who performed the activity being inspected. Examinations,
measurements, or tests of material or products processed shall be performed for
each work operation where necessary to assure quality. If inspection of
processed material or products is impossible or disadvantageous, indirect
control by monitoring processing methods, equipment, and personnel shall be
provided. Both inspection and process monitoring shall be provided when
control is inadequate without both. If mandatory inspection hold points, which
require witnessing or inspecting by the applicant's designated representative
and beyond which work shall not proceed without the consent of its designated
representative are required, the specific hold points shall be indicated in
appropriate documents.
XI. Test Control
A test program shall be established to assure that all testing required to
demonstrate that structures, systems, and components will perform
satisfactorily in service is identified and performed in accordance with
written test procedures which incorporate the requirements and acceptance
limits contained in applicable design documents. The test program shall
include, as appropriate, proof tests prior to installation, preoperational
tests, and operational tests during nuclear power plant or fuel reprocessing
plant operation, of structures, systems, and components. Test procedures shall
include provisions for assuring that all prerequisites for the given test have
been met, that adequate test instrumentation is available and used, and that
the test is performed under suitable environmental conditions. Test results
shall be documented and evaluated to assure that test requirements have been
satisfied.
XII. Control of Measuring and Test Equipment
Measures shall be established to assure that tools, gages, instruments, and other
measuring and testing devices used in activities affecting quality are properly
controlled, calibrated, and adjusted at specified periods to maintain accuracy
within necessary limits.
XIII. Handling, Storage and Shipping
Measures shall be established to control the handling, storage, shipping, cleaning and
preservation of material and equipment in accordance with work and inspection
instructions to prevent damage or deterioration. When necessary for particular
products, special protective environments, such as inert gas atmosphere,
specific moisture content levels, and temperature levels, shall be specified
and provided.
XIV. Inspection, Test, and Operating Status
Measures shall be established 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 nuclear power plant or fuel
reprocessing plant. These measures shall provide for the identification of
items which have satisfactorily passed required inspections and tests, where
necessary to preclude inadvertent bypassing of such inspections and tests. Measures
shall also be established for indicating the operating status of structures,
systems, and components of the nuclear power plant or fuel reprocessing plant,
such as by tagging valves and switches, to prevent inadvertent operation.
XV. Nonconforming Materials, Parts, or Components
Measures shall be established to control materials, parts, or components which do not
conform to requirements in order to prevent their inadvertent use or
installation. These measures shall include, as appropriate, procedures for
identification, documentation, segregation, disposition, and notification to
affected organizations. Nonconforming items shall be reviewed and accepted,
rejected, repaired or reworked in accordance with documented procedures.
XVI. Corrective Action
Measures shall be established to assure that conditions adverse to quality, such as
failures, malfunctions, deficiencies, deviations, defective material and
equipment, and nonconformances are promptly identified and corrected. In the
case of significant conditions adverse to quality, the measures shall assure
that the cause of the condition is determined and corrective action taken to
preclude repetition. The identification of the significant condition adverse
to quality, the cause of the condition, and the corrective action taken shall
be documented and reported to appropriate levels of management.
XVII. Quality Assurance Records
Sufficient records shall be maintained to furnish evidence of activities affecting quality.
The records shall include at least the following: Operating logs and the
results of reviews, inspections, tests, audits, monitoring of work performance,
and materials analyses. The records shall also include closely-related data
such as qualifications of personnel, procedures, and equipment. Inspection and
test records shall, as a minimum, identify the inspector or data recorder, the
type of observation, the results, the acceptability, and the action taken in
connection with any deficiencies noted. Records shall be identifiable and
retrievable. Consistent with applicable regulatory requirements, the applicant
shall establish requirements concerning record retention, such as duration,
location, and assigned responsibility.
XVIII. Audits
A comprehensive system of planned and periodic audits shall be carried out to
verify compliance with all aspects of the quality assurance program and to
determine the effectiveness of the program. The audits shall be performed in
accordance with the written procedures or check lists by appropriately trained
personnel not having direct responsibilities in the areas being audited. Audit
results shall be documented and reviewed by management having responsibility in
the area audited. Followup action, including reaudit of deficient areas, shall
be taken where indicated.
[35 FR 10499, June 27, 1970, as amended at 36 FR 18301, Sept. 11, 1971; 40 FR
3210D, Jan. 20, 1975; 72 FR 49505, Aug. 28, 2007]