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. 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 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 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.

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 powerplant or fuel reprocessing
plant site prior to installation or use of such material and equipment. This documentary evidence shall be
retained at the nuclear powerplant 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]

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 powerplant 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.