Appendix B to Part 50 - Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants
10:1.0.1.1.30.0.117.88.24 : Appendix B
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 applicant 1 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. The 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 3210, Jan. 20, 1975; 72 FR 49505, Aug. 28, 2007; 84 FR
63568, Nov. 18, 2019]