Quality Assurance Criteria for Nuclear Power Plants and Fuel
Reprocessing Plants
Current copies of this document are available from the US
Government Printing Office.
__________________________________________________________
[Code of Federal Regulations]
[Title 10, Volume 1, Parts 1 to 50]
[Revised as of January 1, 1999]
From the U.S. Government Printing Office via GPO Access
[CITE: 10CFR50]
TITLE 10--ENERGY
CHAPTER I--NUCLEAR REGULATORY COMMISSION
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 Sec. 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. 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, 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 therefor.
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 (a) assuring that
an appropriate quality assurance program is established and effectively
executed and (b) verifying, such as by checking, auditing, and
inspection, 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. Such persons and organizations performing quality
assurance functions shall report to a management level such that
this 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
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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 this 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 such levels of management as may be
necessary to perform this function.
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\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. These criteria will also be
used for guidance in evaluating the adequacy of quality assurance
programs in use by holders of construction permits and operating
licenses.
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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 Sec. 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
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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,
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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]
