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system, and (3) the operability of the system as a whole and, under conditions as close to design as practical, the performance of the full operational sequence that brings the system into operation for reactor shutdown and for loss-of-coolant accidents, including operation of applicable portions of the protection system and the transfer between normal and emergency power sources.

V. Reactor Containment Criterion 50Containment design basis. The reactor containment structure, including access openings, penetrations, and the containment heat removal system shall be designed so that the containment structure and its internal compartments can accommodate, without exceeding the design leak age rate and with sufficient margin, the calculated pressure and temperature conditions resulting from any loss-of-coolant accident. This margin shall reflect consideration of (1) the effects of potential energy sources which have not been included in the determination of the peak conditions, such as energy in steam generators and as required by $ 50.44 energy from metal-water and other chemical reactions that may result from degradation but not total failure of emergency core cooling functicning, (2) the limited experience and experimental data available for defining accident phenomena and containment responses, and (3) the conservatism of the calculational model and input parameters.

Criterion 51-Fracture prevention of containment pressure boundary. The reactor containment boundary shall be designed with sufficient margin to assure that under operating, maintenance, testing, and postulated accident conditions (1) its ferritic materials behave in a nonbrittle manner and (2) the probability of rapidly propagating fracture is minimized. The design shall reflect consideration of service temperatures and other conditions of the containment boundary material during operation, main tenance, testing, and postulated accident conditions, and the uncertainties in determining (1) material properties, (2) residual, steady state, and transient stresses, and (3) size of flaws.

Criterion 52–Capability for containment leakage rate testing. The reactor contain ment and other equipment which may be subjected to containment test conditions shall be designed so that periodic integrated leakage rate testing can be conducted at containment design pressure.

Criterion 53--Provisions for containment testing and inspection. The reactor contain: ment shall be designed to permit (1) appropriate periodic inspection of all important areas, such as penetrations, (2) an appropriate surveillance program, and (3) periodic testing at containment design pressure of

the leaktightness of penetrations which have resilient seals and expansion bellows.

Criterion 54-Piping systems penetrating containment. Piping systems penetrating primary reactor containment shall be provided with leak detection, isolation, and containment capabilities having redundancy, reliability, and performance capabilities which reflect the importance to safety of isolating these piping systems. Such piping systems shall be designed with a capability to test periodically the operability of the isolation valves and associated apparatus and to determine if valve leakage is within acceptable limits.

Criterion 55-Reactor coolant pressure boundary penetrating containment. Each line that is part of the reactor coolant pressure boundary and that penetrates primary reactor containment shall be provided with containment isolation valves as follows, unless it can be demonstrated that the containment isolation provisions for a specific class of lines, such as instrument lines, are acceptable on some other defined basis:

(1) One locked closed isolation valve inside and one locked closed isolation valve outside containment; or

(2) One automatic isolation valve inside and one locked closed isolation valve outside containment; or

(3) One locked closed isolation valve inside and one automatic isolation valve outside containment. A simple check valve may not be used as the automatic isolation valve outside containment; or

(4) One automatic isolation valve inside and one automatic isolation valve outside containment. A simple check valve may not be used as the automatic isolation valve outside containment. Isolation valves outside containment shall be located as close to containment as practical and upon loss of actuating power, automatic isolation valves shall be designed to take the position that provides greater safety.

Other appropriate requirements to minimize the probability or consequences of an accidental rupture of these lines or of lines connected to them shall be provided as necessary to assure adequate safety. Determination of the appropriateness of these requirements, such as higher quality in design, fabrication, and testing, additional provisions for inservice inspection, protection against more severe natural phenomena, and additional isolation valves and containment, shall include consideration of the population density, use characteristics, and physical characteristics of the site environs.

Criterion 56- Primary containment isolation. Each line that connects directly to the containment atmosphere and penetrates primary reactor containment shall be pro

vided with containment isolation valves as with a capability to permit appropriate perifollows, unless it can be demonstrated that odic inspection and testing of components the containment isolation provisions for a important to safety, (2) with suitable shieldspecific class of lines, such as instrumenting for radiation protection, (3) with approlines, are acceptable on some other defined priate containment, confinement, and filterbasis:

ing systems, (4) with a residual heat remov(1) One locked closed isolation valve inside al capability having reliability

al capability having reliability and testabiand one locked closed isolation valve outside lity that reflects the importance to safety of containment: or

decay heat and other residual heat removal, (2) One automatic isolation valve inside

and (5) to prevent significant reduction in and one locked closed isolation valve outside

fuel storage coolant inventory under accicontainment; or

dent conditions. (3) One locked closed isolation valve inside

Criterion 62Prevention of criticality in and one automatic isolation valve outside

fuel storage and handling. Criticality in the containment. A simple check valve may not

fuel storage and handling system shall be be used as the automatic isolation valve out

prevented by physical systems or processes, side containment; or (4) One automatic isolation valve inside

preferably by use of geometrically safe con

figurations. and one automatic isolation valve outside containment. A simple check valve may not

Criterion 63Monitoring fuel and waste be used as the automatic isolation valve out.

storage. Appropriate systems shall be pro

vided in fuel storage and radioactive waste side containment.

systems and associated handling areas (1) to Isolation valves outside containment shall detect conditions that may result in loss of be located as close to the containment as residual heat removal capability and excespractical and upon loss of actuating power, sive radiation levels and (2) to initiate apautomatic isolation valves shall be designed propriate safety actions. to take the position that provides greater

Criterion 64-Monitoring radioactivity resafety.

leases. Means shall be provided for monitorCriterion 57-Closed system isolation

ing the reactor containment atmosphere, valves. Each line that penetrates primary

spaces containing components for recirculareactor containment and is neither part of

tion of loss-of-coolant accident fluids, effluthe reactor coolant pressure boundary nor

ent discharge paths, and the plant environs connected directly to the containment at

for radioactivity that may be released from mosphere shall have at least one contain

normal operations, including anticipated ment isolation valve which shall be either

operational occurrences, and from postulatautomatic, or locked closed, or capable of

ed accidents. remote manual operation. This valve shall be outside containment and located as close (Sec. 161, as amended, Pub. L. 83-703, 68 to the containment as practical. A simple Stat. 948 (42 U.S.C. 2201); sec. 201, as check valve may not be used as the auto- amended, Pub. L. 93-438, 88 Stat. 1242, Pub. matic isolation valve.

L. 94-79, 89 Stat. 413 (42 U.S.C. 5841)) VI. Fuel and Radioactivity Control

[36 FR 3256, Feb. 20, 1971, as amended at 36

FR 12733, July 7, 1971; 41 FR 6258, Feb. 12, Criterion 60Control of releases of radio- 1976; 43 FR 50163, Oct. 27, 1978) active materials to the environment. The nuclear power unit design shall include

APPENDIX B-QUALITY ASSURANCE CRImeans to control suitably the release of radioactive materials in gaseous and liquid ef

TERIA FOR NUCLEAR POWER PLANTS AND fluents and to handle radioactive solid

FUEL REPROCESSING PLANTS wastes produced during normal reactor operation, including anticipated operational Introduction. Every applicant for a conoccurrences. Sufficient holdup capacity struction permit is required by the provishall be provided for retention of gaseous sions of $ 50.34 to include in its preliminary and liquid effluents containing radioactive safety analysis report a description of the materials, particularly where unfavorable quality assurance program to be applied to site environmental conditions can be expect the design, fabrication, construction, and ed to impose unusual operational limita testing of the structures, systems, and comtions upon the release of such effluents to ponents of the facility. Every applicant for the environment.

an operating license is required to include. Criterion 61-Fuel storage and handling in its final safety analysis report, informaand radioactivity control. The fuel storage tion pertaining to the managerial and adand handling, radioactive waste, and other ministrative controls to be used to assure systems which may contain radioactivity safe operation. Nuclear power plants and shall be designed to assure adequate safety fuel reprocessing plants include structures, under normal and postulated accident con systems, and components that prevent or ditions. These systems shall be designed (1) mitigate the consequences of postulated ac

cidents that could cause undue risk to the health and safety of the public. This appendix establishes quality assurance require. ments 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.

lems; 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.

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 prob

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 regu

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 hold ers of construction permits and operating licenses.

larly 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.

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.

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 con trol 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 crite. ria 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.

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.

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.

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.

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.

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.

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.

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