ANSI ANS 15.8-1995 Quality assurance program requirements for research reactors《研究性反应堆质量保证程序要求》.pdf

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1、ANSI/ANS-I5.9-1995quality assu rance programrequirements for research reactorsDHAF FIR M Hm$EP 1 zffHAN$IIAN$fo)ct)Fu)FIazazANSUANS-I5. these procedures are accredited by the American NationalStandards Institute, Inc., as meeting the criteria for American National Standards.The consensus committee t

2、hat approved the standard was balanced to ensure thatcompetent, concerned, and varied interests have had an opportunlty to participate.AnAmerican National Standard is intended to aid industry, consumers, governmentalagencies, and general interest groups. Its use is entirely voluntar5l. The existence

3、 ofan American National Standard, in and of itself, does not preclude anyone frommanufacturing, marketing, purchasing, or using products, prooeases, or procedunes notconforming to the standard.By publication of this standard, the American Nuclear Society does not insure anyoneutilizing the standard

4、against Iiability allegedly arising from or after its use. Thecontent of this standard reflects acceptable practice at the time of its approval andpublication. Changes, if any, occurring through developments in the state of the art,may be considered at the time that the standard is subjected to peri

5、odic review. It maybe reaffirmed, revised, or withdrawn at any time in accordance with establishedprocedures. Usen of this standard are cautioned to determine the validity of copies intheir possesson and to establish that they are ofthe latest issue.The American Nuclear Society accepts no responsibi

6、lity for interpretations of thisstandard made by any individual or by any ad hoc group of individuals. Requests forinterpretation should be sent to the Standards Department at Society Headquarbers.Action will be taken to provide appropriate response in accordance with establishedprocedures that ensu

7、re consensus on the interpretation.Comments on this standard are encouraged and should be sent to Society Headquar-ters.Published byAmerican Nuclear Society555 North Kensington Avenue, La Grange Park, trlinois 60526 USACopyright O 1996 by American Nuclear Society.Any part of this standard may be quo

8、ted. Credit lines sbould read Extracted sg;fr;“jri3tri5filffi.T*ar standard Quaritv Assurance Program Requirements forThe first version ofAmerican National Standard QualityAssurance Program Require-ments for Research Reactors, ANSVANS-15.8-1976, was approved August 19, 19?6,and subsequently reafEmed

9、 December 15, 1986. It has been twenty years since thefirst working grcup started development of the standard. During this period of time,significant changes have occurred in the requirements associated with managementof research reactor facilities, particularly in the degree of rigor and documentat

10、ion.This edition of the standard is a complete rewrite and provides the applicable qualityassurance program requirements for all phases of a facilitys life.In the prooess of implementing this standard with respect to the existing and variedpractices in many operating facilities, it is important to r

11、ecognize that:a. Considered use of the standard should assist in implementing regulatory require-ments.?he standard is intended to be a significant aid for existing and new owners oroperators.the standard should be helpful for both the facility undergoing change or mod-ification.d. Each provision of

12、the standard should be used only to the extent appropriate tobindividual facility.e. The standard is not intended to require backfitting.With regard to this particular standard, it must be noted that research reactors havetwo characteristics which affect the type of quality assurance program that sh

13、ould beapplied to them, when compared to power reactors. First, the reliability of most of theparts used in a research reactor is not relevant to the health and safety ofthe publicsince failure of the item generally shuts the system down and little else occurs.Second, the typical research reactor op

14、erates on a limited budget with its continuedexistence dependent upon maintaining a low-cost, reliable operation. Because of theseinherent characteristics, the quality assurance program for research reactors is appliedprilnarily to safety-related and important items, and should be graded app“opriate

15、lyto be economically feasible. It is the intent of this standard to state the requirementsfor such a program.For those not yet exposed to modern quality assurance requirements, it is difficult tograsp the value of adequate documentation. Although documentation is not thePt“litY of a quality assuranc

16、e program, it is one element of an appropriate programfor research reactors. Much of the documentation required by a quality uJ“o*oceprogram already exists for an operating research reactor, and little additionaldocumentation may be needed when the quality assurance program is established.Appropriat

17、e application of a standard is very important, anda careful and conprehen-sive reading of this standard is highly recommended before use. Tilo comments a“epresented as aids to interpretation:(1) It is recognized that it is not necessary to apply the same degree of control toall items in a research r

18、eactor. Where this standard uses words such as “asappropriate“ or “as necessaqt,“ these are to be interpreted as meaning varia-tion in the degree of application.(2) It is not intended that this standard require modification of existing charteror licensing requirements, and should not be so interpret

19、ed.b.-l-The membership of Working Group AIIS-15.8 at the time of the completion of thestandard was:T. R. Schmidt, Chairman, Sandia National Labontories D. E. Hughee, Pennsylwnia Sate UnivetsilyA. Adarns, Jr., US, Nudear Regilatory Commission B. Q. Partain, Ias Alamos National IabontotyT. L. Bauer, U

20、nivenity of Texas, Austin J. Razvi, Genenl AtomiaM. L. Gildner, Oak Ridge National labontoty W. G. Vernetson, Univenity of FloridaThe membership of Subcommittee AIIS-15, Operations of Research Reactors, at thetime of its approval of the standard was:W J. Richards, Chairoan, U.S. hprtment of DefenseA

21、 Adams, Jr., U.S. Nuclear fugulatory CommissianT. L. Bauer, Uniuersity of TqasS. Ii Bhatnagar, U.S. Depa.rtmcnt of EnergjrL. M. Bobek, ll/orcestcr Polytzchnfu InstituteW. J. Brynda, Brakhauen Natinnal LabrotoryA F. DMeglio, Individ.ualP. C. Ernst, Ind.iuid.ualJ. P. Farrar, University of VirginiaD. E

22、. Feltz, Terns A and to control or mitigate theconsequences of such accidents.shall, shoul4 and may. The word “shall“ igused to denote a requirement; the word “should“to denote a recommendation; and the word “may“to denote perm.ission, neither a requirement nora rscommendation.test reacton See resea

23、rch reactor.I Numberg in brackets refer to corresponding numbera inSection 6, References.22. Design, Constrmction, and Modifi-cationsThis section provides requirements for establish-ing, managing, conducting, and assessing theprogram of controls over the design, construction,and modification of a re

24、search reactor facility.This standard recognizes that the deecribedcontrols are integral to the management of aproject or facility and do not necessitate theestablishment ofa separate program. This sectionshould be implemented as applicable to thespecific scope of work activities.2.1 Organization. I

25、t is recognized that formost research reactor facilities, the own-erloperatofs organization is small, with itspersonnel performing multiple functions. Duringthe design, construction, or modification of aresearch reactor, most of the work may be per-formed by outside organizations or supportcontracto

26、rs. The owner/operatots role is thenpriinarily one of providing requiremente andverifying compliance with those requirements.The organizational structure and assignment ofresponsibilities shall be defined and documentedsuch that: (a) quality is achieved and maintainedby those who have been assigned

27、responsibilityfor performing work; and (b) quality achievementis verified by persons not directly performing thework. Persons responsible for ensuring thatappropriate controls have been established, andfor veriffing that activities have been correctlyperfomed, need sufficient authority, access towor

28、k aneas, and freedom to: (a) identify pmb-lems; (b) initiate, recommend, or provide sorrec-tive action; and (c) ensure corrective actionimplementation.2.2 Cluality Assurance Pnogram. A docu-mented quality assurance progtam shall be estab-lished in accordance with the requirrements ofthis standard, o

29、r portions thereof, at the earliesttime consistent with the schedule for accomplish-ing quality-affecting activities. The program shallidentiff the items and activities to which itapplies and the extent ofprogram application foreach it6m and activity. The program shall pnovidefor the appropriate and

30、 necessary indoctrinationand training of personnel who perform activitiesthat affect quality, to ensure that suitable profi-ciency is achieved and maintained.2A Deeign ContnoL The responsible designorganization shall preecribe, develop, document,and preserve the design of the structures, sys-tems, a

31、nd components of the research reactorfacility.2.9.1 Design Requirenents. Applicabledesign inputs, such as design bases, perfomancerequirements, regulatory requirements, codes,and standards, shall be identified and document-ed.2.8.2 Design Pnocess. Design interfacesshall be identified and controlled

32、and the designefforts shall be coordinated amongthe participat-ing organizations. The applicability of standard-ized or previously proven designs, with respect tomeeting pertinent design inputs, shall be verifiedfor each application. Known problems affectingthe standardized or previously pnoven desi

33、gns,and their effects on other features, shall beconsidered. Deviations from the established anddocumented design inputs, including the reasonsfor the changes, shall be documented and con-trolled.The final design shall: (a) be relatable to thedesign input by documentation in sufficient detailto perm

34、it design traceability and verification; and(b) identi (b) identi-fication of assignment ofresponsibility for prepar-ing, reviewing, approving, and issuing documents;and (c) review of documents for adequacy, com-pleteness, and correctness prior to approval andissuance. Major changes to controlled do

35、cumentsshall be reviewed and approved by the sameorganizations that performed the original reviewand approval, unless other organizations arespecifically designated.2.7 Control of Purchased lteme and Senr-ic.es. The pnocurement of items and services shallbe controlled to ensure appropriate procureme

36、ntplanning, source evaluation and selection, evalua-tion of objective evidence of quality furnished bythe supplier, source inspection, audit, and exami-nation of items or senrices for acceptance upondelivery or completion.2.7.1 Supplier Selection. The selection ofsuppliers shail be based on evaluati

37、on of theircapability to provide items or ser:vices in accord-ance with the requirements of the procurementdocuments.42.7.2 lf,orkControl. Thepurchasershallestablish measures to control the supplietsperfomance as appropriate.2.7.9 VeriftcationActivitie.ltresuppli-er shall be responsible for the qual

38、ity of his prod-uct and shall veriff and provide evidence ofth4tquality. Supplier-generated documents shan becontrolled, handled, and approved in accordancewith established methods. Means shail be imple-mented to provide for the acquisition, processing,and recorded evaluation of technical, inspectio

39、n,and test data against acceptance criteria. Basedon the complexity of the product and importanceto safety, the purchaser shall consider indepen-dently veriSing the quality of a suppliers prod-uct through source suneillances, inspections,audits, or review of the supplie/s nonconfor-mances, dispositi

40、ons, waivers, and correctiveactions.2.7.4 Item or Senrice Acceptanoe. Thepurchaser shall establish a system to provideassurances that purchased itms and sendcesconfom to procurement specifications. Purchasermethods used to accept an item or related servicefrom a supplier shall be a supplier Certific

41、ate ofConformance, sounce verification, receiving in-spection, post-installation test, or a combinationthereof. Receiving inspections shall be performedin accordance with established procedures andinstructions; to verif by objective evidence suchfeatures as proper configuration, identification,and c

42、lea“liness, and to determine any shippingdamage, fraud, or counterfeit.2.8 Identification and Contnol of Iteme.When specified by codes, standards, or specifica-tions that include specific identification or trace-ability requirements, the item identification andcontrol process shall be capable of prc

43、vidingidentification and traceability control. Itemsidentification shall be maintained from the initialreceipt or fabrication of the items up to andincluding installation and use. Where physicalidentification on the item is silhsl impractical orinsuf;Ecient, physical separation, proceduralcontrol, o

44、r other appropriate means shall beemployed. Identification markings shall be ap-plied through the use of materials and methodswhich provide clear and legible identification anddonot detrimentally affect the functionor servicelife of the item. Markings shall be transferad toeach part of an identified

45、 item when the item igsubdivided, and shall not be obliterated orhiddenby surface treatment or coatings unless substi-tute means are provided. Where specified, itemshaving limited calendar or operating life shall beidentified and controlled to preclude use of itemswhose shelf life or operating life

46、has expired.2.9 Control of Specid Processes. Special pro-cesses include any in which the results are highlydependent on the control of the process or theskill of the personnel. These are also those pro-cesses in which the specified quahff cannot bereadily determined by inspection or non-destruc-tive

47、 testingofthe product. Special processes shallbe controlled by instructions, procedures, draw-ings, checklists, travelers, or other appropriatemeans. It is the responsibility of the organizationperforming the special pnrcess to adhere to theapproved procedures and processes. The require-ments of app

48、licable codes and standards, includ-ing acceptance criteria for the pnocess, shall bespecified or referenced in the procedures orinstructions that control the process. Recordsshail be maintained as appropriate for the cur-rently qualified personnel, processes, and equip-ment associated with special

49、presses.2.10 Inspectione. Inspections to verifr con-formance of an item or activity to requirementsshall be planned, documented, and peromed.The inspection program shall apply to procure-ment, construction, modification, maintenance,and experiment fabrication. Inspection of itemsin-process or under construction shall be per-formed for work activities where product qualitycannot be determined by inspection of the com-pleted product. The final inspection shall beplanned to arrive at a conclusion regardingconformance of the item to specified require-ments. Completed items shal