計算機(jī)系統(tǒng)驗證方案

1、ComputerisedSystemValidation計算機(jī)系統(tǒng)驗證Dept.部門：EffectiveDate生效日期：Year/Month/月ConfidentialLevelQA/質(zhì)量保證部機(jī)密等級：Date/日Top-secret絕密Confidential機(jī)密Cryptical秘密DistributionList?:分發(fā)清單：QA部、QC?、OSP體制劑部、Lo.物控部、EN工程部、TD技術(shù)部、EQ設(shè)備部Objective目的TestandassessmentshouldbetakenforURS,design,purchase,installation,function,aswel

2、lasprocessadaptabilityofcomputerizedandPLCcontrolsystemrelatedtoGMPincompliancewiththisSOPsoastoensurethatcomputerizedandPLCarefitfordesignrequirementandstatedtechnicalcriteriaandareabletoworkstablyforalongtime.測試、評估采取的URS設(shè)計、采購、安裝、功能以及計算機(jī)限制和PLC限制系統(tǒng)符合GMP以保證計算機(jī)和PLC符合設(shè)計要求和工藝要求并且能夠穩(wěn)定工作很長時間.2Scope范圍Role責(zé)

3、任人Draft起草人Review審核人Review審核人Review審核人Review審核人Review審核人Review審核人Approve批準(zhǔn)人Dept.部門QAQCOSPLo.ENTDEQQDName姓名Signature簽名Date日期ThisSOPisfitforthevalidationmanagementofcomputerizedandPLCcontrolsystemrelatedtoGMP,whichapplytomaterialcontrolandmanagement,laboratoryequipmentcontrolandcommunicationmanagement,

4、manufacturingprocesscontrol,andutilitiescontrol.本SOPS用于電腦,PLC限制系統(tǒng)的治理是否符合GMP物料限制和治理,實驗設(shè)備限制和通信治理、生產(chǎn)過程限制、公用設(shè)施的限制的驗證.3Responsibilities責(zé)任QAisresponsiblefordrafting,revising,reviewing,training,implementingandsupervisingthisSOP.QA負(fù)責(zé)起草、修訂、審核、培訓(xùn)、實施和監(jiān)督本SOPThequalitydirectorisresponsibleforapprovingthisSOP.質(zhì)量副

5、總負(fù)責(zé)批準(zhǔn)本SOPRelevantdepartmentsareresponsibleforreviewingandimplementingthisSOP相關(guān)部門負(fù)責(zé)審核和實施本SOP4Definitions定義ComputerizedorPLCcontrolsystem:Itcomposedofhardware,systemsoftware,applications,andrelevantperipheraldevicesisasystemthatcanimplementafunctionandasetoffunctions.無論是計算機(jī)化還是PLC限制系統(tǒng)：都是由硬件、系統(tǒng)軟件、應(yīng)用、及相關(guān)

6、的周邊設(shè)備組成的一個系統(tǒng),可以實現(xiàn)某一功能和一套功能.Sourcecode:Itissourceprogramofcomputerwhoseformat(programlanguage)canbereadbyoperator,beforecomputerexecution,itshouldbetranslatetomachinelanguagewhoseformatcanbeexecutedbycomputer.源代碼：它是計算機(jī)的源程序(程序語言),可以在電腦執(zhí)行前被計算機(jī)識別,它應(yīng)該被翻譯成可以被計算機(jī)識別的機(jī)器語言.5Procedures程序5.1OrganizationofValida

7、tionteamandresponsibility5.1.1驗證機(jī)構(gòu)及責(zé)任5.1.2Validationteamiscomposedofsupplier,QA,EquipmentDepartment,usedepartment.驗證團(tuán)隊由供給商,QA、工程設(shè)備部和使用部門組成.Implementationdepartmentresponsibilityofsystemvalidation系統(tǒng)驗證實施部門的責(zé)任Usedepartment:ResponsibleforprovidingwrittenURS,preparingvalidationprotocolandreport,implement

8、ingapprovedIQandOQprotocol,completingfinalreportandparticipatingvalidationdeviationinvestigationandalterationreview.使用部門：負(fù)責(zé)提供書面的URS準(zhǔn)備驗證方案和報告、實施批準(zhǔn)IQ,OQ協(xié)議,完成最終報告偏差并參與調(diào)查及變更驗證審核.EquipmentDepartment:ResponsibleforcooperatingwithusedepartmenttoprepareURSandvalidationprotocol,receivingsystem,installingsyst

9、emandimplementingIQ,guidingusedepartmentonIQandOQprocessandparticipatingvalidationdeviationinvestigationandalterationreview.設(shè)備部門： 負(fù)責(zé)準(zhǔn)備使用部門的合作協(xié)議,并確認(rèn)你接收系統(tǒng),安裝系統(tǒng),實施IQ,指導(dǎo)使用部門關(guān)于IQ和OQ的驗證過程和參與驗證偏差調(diào)查和變更回憶.QA:Responsibleforreviewingvalidationdraftandfinalreport,implementingvalidationprotocol,participatingvali

10、dationdeviationinvestigationandalterationapprovalandarchivingvalidationprotocolandreport.QA:負(fù)責(zé)審查驗證,也是最后一項報告草案、實施驗證方案,參與調(diào)查及變更驗證偏差的批準(zhǔn)驗證方案和歸檔,并做好報告.5.2Systemclassification系統(tǒng)分級5.2.1Beforevalidation,evaluationandclassificationshouldbecarriedoutforsystemsoastoinsurethatdifferentgradevalidationshouldbeprov

11、idedfordifferenttypecomputerizedandPLCcontrolsystem.Classificationasfollows:在驗證之前,評估和分級應(yīng)當(dāng)進(jìn)行系統(tǒng)分類,以保證不同等級驗證需提供不同類型的計算機(jī)化的,PLC限制系統(tǒng),分類如下:Classification分類Description描述Validationmethod驗證方法Operatingsystem,network網(wǎng)絡(luò)操作系統(tǒng),Establishednetworkandoperatingsystemforcommerce.E.g.DOSWindows95/98NT.已做好網(wǎng)絡(luò)和操作系統(tǒng)例如：DOSWin

12、dows95/98NT.Validatenameandeditionnumber確認(rèn)名稱及版本號Standarddevice,microcontroller,sensitiveequipment標(biāo)準(zhǔn)配置,微控制器,靈敏的電氣設(shè)備Thesesystemisdesignedbynon-consumerfordrivingfirmwarewhichcanbeinstalledinspecialintegratecircuit(IC)forapplication,readonlymemory(ROM),randomaccessmemory(RAM),PLCsometimes,suchasbarcode

13、modem,single-cyclecontroller,fillingdevice,Checkweigher,temperaturecontrolleretc.這些系統(tǒng)是根據(jù)用戶可以安裝在特殊的集成電路(IC)的驅(qū)動固件,只讀存儲器(ROM、隨機(jī)存取存儲器(RAM、PLC,例如條形碼調(diào)制解調(diào)器,single-cycle限制器、 灌裝設(shè)備,重量限制、溫度限制器等來設(shè)計的.Validateconstructionandconfiguration確認(rèn)構(gòu)造及配置StandardpackageReady-madepackageforcommerce,suchasmultiplansoftware,st

14、andardchemicalValidateapplication標(biāo)準(zhǔn)程序包analysissoftwareetc.現(xiàn)成的軟件包,例如多方案軟件,標(biāo)準(zhǔn)化學(xué)分析軟件等.process驗證應(yīng)用過程Configurablepackage可配置的程序包Usersdeveloptheirownapplicationthroughpre-definitesoftwaremodulesanddevelopingapplicationmodulescanbecarriedoutinthissystem,suchasmanmachinedialogueport,managementcontrol,dataacq

15、uisitionsystem,adaptivecontrolsystemforlaboratory,informationmanagementsystemforlaboratory,materialrequirementplanningsystem,dataprocessingsystemforsystem/applicationandproduct,partPLCetc.用戶自己開發(fā)應(yīng)用可通過pre-definite軟件模塊和開展應(yīng)用模塊都可以在這個系統(tǒng)中運行,采用人機(jī)對話端口,治理限制,數(shù)據(jù)采集系統(tǒng),自適應(yīng)限制系統(tǒng),信息治理系統(tǒng),原材料需求方案系統(tǒng)、數(shù)據(jù)處理系統(tǒng)和產(chǎn)品、系統(tǒng)應(yīng)用局部可編程序

16、限制器(PLC)等.AuditsupplierandvalidateapplicationprocessandsomepreestablishedcodeSystemdevelopedwithinfirm公司內(nèi)部系統(tǒng)開發(fā)Modifyingordevelopingsystemincompliancewithrequirementofhimself修改或開發(fā)符合自己要求的系統(tǒng)ImplementallvalidationprocessesofcomputerizedandPLCcontrolsystem實施計算機(jī)及PLC限制系統(tǒng)驗證的全過程5.2.2SomecomputerizedandPLCcon

17、trolsystemwithcomplexconstructionshouldbeclassifiedinaccordancewithdevelopingdegreeofeachmodule.一些計算機(jī)化的和PLC限制系統(tǒng)復(fù)雜程度應(yīng)當(dāng)跟各分類模塊的開發(fā)程度相一致.5.2.3ValidationofcomputerizedandPLCcontrolsystemshouldbecarriedoutnotonlyforuseprocessofsystem,e.g.validationofnewsystemshouldbecarriedoutnotonlyforinitialdefinitionand

18、designingphasebutalsowholelifecycleofsystemdevelopment.計算機(jī)驗證,PLC限制系統(tǒng)不僅表達(dá)在系統(tǒng)使用過程,如新系統(tǒng)的驗證不僅在初始定義和設(shè)計階段進(jìn)行,而且貫穿于全部生命周期體系的開展.5.3Validationimplementation驗證實施5.3.1URSURSshouldbepreparedbysystemuserandprojectexpertdetailedwithfundamentalrequirement,expectationandperformanceindexofnew/changedcomputerizedandPL

19、Ccontrolsystem,whichwillbeusetodeterminesystemdesigningcriteria.Contentasfollow:URS應(yīng)該為系統(tǒng)用戶和工程專家準(zhǔn)備根本要求詳細(xì)的,預(yù)期和新的性能指標(biāo)、更改計算機(jī)化和PLC限制系統(tǒng),可以用來決定系統(tǒng)設(shè)計標(biāo)準(zhǔn).內(nèi)容如下Systemdescription:whattodoaboutsystem,howconnectionandinteractionbetweendifferentmodule,controlmethods(e.g.logiccontrol,separationcontrol,interlockcontro

20、l,alarmcontrol,locationcontrol,temperaturecontrol,pressurecontrol,timecontrol,countingandothermultipolarcontrol),implementingprocess,portsandsafetyrequirementforoperator.系統(tǒng)描述：系統(tǒng)做到什么程度,如何關(guān)聯(lián)不同模塊、限制方法(例如：邏輯限制、別離控制,連鎖限制、報警限制、位置限制,溫度限制,壓力限制、時間限制、計數(shù)和其他多級限制)、實施流程、操作員的端口和平安標(biāo)準(zhǔn).5.3.2.Physicalrequirement:inclu

21、desufficientspace,location,peripheral2environment,etc.物理要求：包括有足夠的空間,位置,周邊環(huán)境等.2.1.1.Documentcriteriaforhardware:includechartpaper,schematicchart,hand3book,sparepartslistetc.硬件的文件標(biāo)準(zhǔn)：包括：圖紙,原理圖,操作指南,備件清單等.5.3.1.Documentcriteriaforsoftware:includeprogramnumberandrevisingnumber,4outputprogramanddetailedex

22、planation,reproductionofsoftwareprovisionandretentioncondition,systemblockdrawingandconfigurationlist.軟件的文件標(biāo)準(zhǔn)：包括程序編號和修改編號,輸出接口程序和詳細(xì)說明、軟件的追加和保存條件、系統(tǒng)分程序圖紙和配置清單5.3.1.Testrequirement:testitemsandrecordrequiredtobecarriedouton5systemdevelopingprocess,includingmoduleseparatedtestandintegratedtest.測試要求：測試工

23、程和記錄必須在系統(tǒng)的開展過程中進(jìn)行,包括模塊測試和集成別離測試.5.3.1.Otherrequirementtosupplier:suchasfinishedsystemvalidation,quality6controlandchangecontrolondevelopingprocess,etc.對供給商的其他要求：如在開展進(jìn)程中完成系統(tǒng)驗證、質(zhì)量限制和變更限制等.5.3.2Systemdesign系統(tǒng)設(shè)計5.3.2.Systemdesignshouldcomposeofsystemconfigurablechartdesign,hardware1design,andsoftwaredes

24、ign.Afterdocumentofsystemdesignreviewedandapprovedbyconsumerwhichshouldbepreparedbysupplier,systemconfigurablechartdesignshouldbecarriedout,includingsystemPID(processandinstrument),I/O(input/output)connectiondiagram,controlelementparetodiagram.系統(tǒng)設(shè)計應(yīng)該由系統(tǒng)配置圖、 硬件設(shè)計和軟件設(shè)計組成.在供給商準(zhǔn)備的系統(tǒng)設(shè)計被用戶評估和檢驗后,可配置的系統(tǒng)圖紙設(shè)

25、計應(yīng)該完成,包括系統(tǒng)PID,I/O(輸入/輸出)連接圖、連接原理帕累托圖.5.3.2.Hardwaredesign:includeallI/O(input/output)connectiontemplateand2type,CPUselection,communicationtemplate,man-machineInterfacecontroller,screenviewerselection,mediumrelay,memory,printer,auxiliarypowerunit,electronicelement/wire/cable,otherelementsetc.硬件設(shè)計：包括所

26、有I/O(輸入/輸出)連接模板和類型,CPU選型,通信模板、人機(jī)界面限制器,屏幕查看選擇、中繼電器、記憶存儲器、打印機(jī)、輔助動力裝置,電子部件/電線/電纜、其他元件等.5.3.2.Software:includesystemsoftware,application,anddata.3軟件：包括系統(tǒng)軟件、應(yīng)用和數(shù)據(jù).5.3.3IQIQshouldbecarriedouttoensurethatsysteminstallationisfitfordesigncriteriaandneededtechnicaldatashouldbecompletelyprovided.Specialcontent

27、asfollow:IQ應(yīng)該保證該系統(tǒng)安裝符合設(shè)計標(biāo)準(zhǔn)和工藝需求,數(shù)據(jù)完全提供.特殊內(nèi)容如下：5.3.3.Documentqualificationshouldconsistofconsumertechnicalguide,SOP,1trainingplan,post-saleserviceagreement,equipmentinventory,securityprogram,hardwarequalification,softwarequalification,sourcecode,instrumentlist,instrumentcalibrationprocedure,PID,contr

28、olloopdiagram,I/O(input/output)devicelistandconnectiondiagram,sparepartslist,andmaintenanceprocedure.文件確認(rèn)應(yīng)該由用戶工藝要求、SOP培訓(xùn)方案,售后效勞協(xié)議、設(shè)備庫存,平安程序、硬件說明,軟件說明,源代碼、儀器清單、儀器校準(zhǔn)程序、PID、限制回路圖,I/O(輸入/輸出設(shè)備清單和連接圖,備件清單和維護(hù)規(guī)程.1.3.3.Installationprocessqualification:qualifythatinstallationisfitfor2requirementPIDandoperatin

29、gmanual.安裝過程說明：安裝符合PID和操作手冊的要求.5.3.3.Circumstanceandutilitiesqualification3事件和實用程序說明(1)Qualifyandrecordcircumstanceofsysteminstallation,suchascleanlevel,radiofrequency/electromagneticinterference,physicalprotection,temperature,humility,sound,lighting,etc.系統(tǒng)安裝環(huán)境的檢驗和記錄：例如潔凈水平、射頻/電磁干擾、物理保護(hù)、溫度、濕度、聲音、照明等

30、.(2)Recordconditionofcriticalutilitiesandqualifythatcriticalnatureofutilitiesshouldbefitforinstructionincludingfirealarmannouncement/prevention,coolingsystem,electricpoweranditsadjustment,continuouspowersupply,wideareanetworkconnection,localareanetworkconnection,disasterrecovery,telephonefigure/anal

31、og,etc.記錄關(guān)鍵設(shè)施以及條件,鑒定的公共設(shè)施應(yīng)該跟說明一致：包括消防報警公告/預(yù)防系統(tǒng)、冷卻系統(tǒng)、電力及調(diào)整,持續(xù)供電、大面積網(wǎng)絡(luò)連接,本地區(qū)域網(wǎng)絡(luò)連接,災(zāi)難恢復(fù)、圖形/模擬等(3)Qualifythatrecordsystemisfitforrequirementofman-machineengineer.條件和記錄系統(tǒng)符合人控機(jī)工程師的要求.5.3.3.Systemtestandqualification4系統(tǒng)測試、條件(1)ThefirststeptodoistoqualifythatreportitemsofFAT(factoryacceptancetest)shouldbeco

32、mpletelysuppliedbysupplierandfitfordesigncriteria.第一步要做的是,報告工程FAT的驗收測試應(yīng)該完全由供給商提供,適用于設(shè)計標(biāo)準(zhǔn).(2)Necessarytestshouldbecarriedoutforsystemonoperationalcircumstance.Essentialcontentasfollow:應(yīng)該對系統(tǒng)運行情況開展必要的測試.根本內(nèi)容如下：5.3.4Allinstrumentsandmetersshouldbecalibratedandonexpiredayofcalibration.Calibrationshouldbe

33、fitfordefinitecriteriaandcorrespondingcertificationshouldbeprovided.所有儀器儀表應(yīng)該被校準(zhǔn)和標(biāo)注過期日,校準(zhǔn)應(yīng)該有明確的標(biāo)準(zhǔn)及應(yīng)提供相應(yīng)的檢查證件.I/O(input/output)signaltestshouldbecarriedoutsoastoensurethatsinglecantransmitfromcontrolsystemtodeviceandreturn.I/O(輸入/輸出)信號試驗應(yīng)保證信號可以在限制系統(tǒng)設(shè)備間進(jìn)行傳輸和反應(yīng).Dataacquisitionandtransmissionandsignalmem

34、orytest數(shù)據(jù)采集,傳送和信號記憶測試Othertests?其他測試OQ(operationqualification)運行確認(rèn)ThepurposeofOQisthatallfunctiontestsshouldbecarriedoutonoperationalcircumstancesoastoensurethatsystemandoperationshouldbefitfordesigncriteria.Contentasfollow;OQ的目的是進(jìn)行所有功能運行情況方面的測試以保證系統(tǒng)和運行符合設(shè)計標(biāo)準(zhǔn),內(nèi)容如下：Testforsystemsecurity:worstc

35、aseofalllogicsystemsshouldbetested,e.g.useauthorityofdifferentpersonsshouldbetestedsoastoidentifythatoperationunauthorizedshouldbeforbidden.測試系統(tǒng)平安： “最壞情況的系統(tǒng)邏輯應(yīng)該進(jìn)行測試,如使用不同權(quán)限以便確認(rèn)未經(jīng)授權(quán)運行是否被禁止.Variousprocessescontrolfunctiontestsrequiredbysystemrequest:“worstcase(e.g.maximumcommunicationload,processofcon

36、siderabledatadocument,etc.)testforallfunctionofsystemanddecisionroutinesshouldbecarriedoutinaccordancewithvariousrequirementsandcriteriasuppliedbysystemdefinition.(Itisimportantthatafunctionaldiagramincludingallbranchroutinesshouldbeprovided.)根據(jù)系統(tǒng)要求進(jìn)行的各種各牛的過程限制功能的測試：“最壞情況(例如最大通信承載、過程相當(dāng)大的數(shù)據(jù)文件等)試驗檢查系統(tǒng)

37、和決策程序的功能,應(yīng)根據(jù)系統(tǒng)不同的要求和標(biāo)準(zhǔn)提供的定義.(提供功能圖表包括所有出現(xiàn)的偏差是非常重要的.)Testforalarmandinterlock:efficacyofcorrespondingprogramshouldbetestedontheconditionofalarmandinterlockforsysteminaccordancewithsystemoperationmanual.檢測報警及連鎖：程序連鎖應(yīng)根據(jù)報警條件及系統(tǒng)連鎖操作手冊進(jìn)行測試.Testfortimerandsequencer:establishtimeandprogramofsystemgenerating

38、correspondingfunctionaccordingtosystemoperationmanualsoastovalidateefficacyofsystemtimingororderingprogram.定時器和定序器測試：根據(jù)系統(tǒng)的操作手冊設(shè)置時間和系統(tǒng)產(chǎn)生相應(yīng)的功能以確認(rèn)系統(tǒng)有效時間或程序命令Testfordatadisposalandmemory測試數(shù)據(jù)處理和記憶(1)Qualifycorrectdatamemory,collectionandsearchofsystemsown.正確的數(shù)據(jù)記憶,準(zhǔn)確的數(shù)據(jù)采集和系統(tǒng)的自我搜索確實認(rèn).(2)Qualifydisposalofda

39、taoutputlength,carryandempty數(shù)據(jù)處理的輸出長度、承載和空載確實認(rèn)(3)Qualifythefunctionofsavingdatatocorrespondingfolder.數(shù)據(jù)保存到相應(yīng)文件夾的功能確認(rèn).Testforshutdown/recovery關(guān)機(jī)/恢復(fù)測試5.3.4.(1)Checkconditionofthedataacquisitionbeforeandaftershutdownsoas6toensurethatdatahavenotbeendamagedorlost.在系統(tǒng)關(guān)閉之前和之后才查數(shù)據(jù)采集的情況,保證數(shù)據(jù)沒有損壞或喪失.(2)Checkt

40、hefunctionofbackuppowersupply,uninterruptiblepowersupply,poweradjusterandpowergenerator.檢查備用電源的供給、不間斷電源供給器、電力調(diào)節(jié)器和電力發(fā)電機(jī)(3)Systembreakdownsorfailuresshouldbemadeinaccordancewithsystemoperationmanualsoastoensurethatback-upsystemshouldbeprovided.系統(tǒng)故障和失敗的時候,能夠根據(jù)系統(tǒng)的操作手冊提供系統(tǒng)備份.Otherfunctiontest其他功能測試Perfor

41、mancequalification(PQ)性能確認(rèn)ThepurposeofPQisthatqualifytheefficacyandstabilityofrunningprocessonoperationalcircumstance.Testitemsshouldbeestablishedinaccordancewithachievingdesiredresultandduplicatequalificationshouldbealsocarriedout.PQ的目的是確認(rèn)系統(tǒng)運行過程中的有效性和穩(wěn)定性方面的情況.測試工程應(yīng)確定跟期望到達(dá)的結(jié)果相一致、二次確認(rèn)也應(yīng)該執(zhí)行.Ifsystemis

42、partofproduction,laboratoryorutilities,PQofsystemshouldbecompletedconformitywithPQofequipment(utilities).如果系統(tǒng)是生產(chǎn),實驗室或公共設(shè)施系統(tǒng)的一局部,系統(tǒng)的PQ必須根據(jù)設(shè)備的PQ進(jìn)行完整性測試.5.3.5.IfamanualsystemisbeingreplacedbycomputerizedandPLCcontrol1system,thetwoshouldberuninparallel.5.3.5當(dāng)一個人工系統(tǒng)被電腦,PLC限制系統(tǒng)取代時,兩者需要平行運行.5.3.6.Re

43、gardingtoproductionequipment,thetestforproductspecification,such5.3.7.asassay,testforpackagingspecification,etc,shouldbecarriedoutsoastoensurethattheallprocesscontrolfunctionsareeffective.Testsshouldbecarriedoutforatleast3consecutivebatchesonthesomeproductioncondition.對于生產(chǎn)設(shè)備,要進(jìn)行產(chǎn)品規(guī)格測試,如化驗、 包裝規(guī)格測試等等,

44、保證所有的過程限制功能都是有效的,應(yīng)當(dāng)在相同的生產(chǎn)的條件下進(jìn)行至少3個連續(xù)批次的測試.Monitoringforequipmentofconsecutiveprocessdisposalshouldbecarriedout,e.g.indexofclean-airsystem,suchasdustparticle,microorganism,temperature,humidity,airflow,pressuredifference,airexchangefrequency,etc,shouldbemonitoredduringaperiod.對設(shè)備的連續(xù)過程進(jìn)行監(jiān)控應(yīng)當(dāng)進(jìn)行,如空氣凈化體系

45、的指標(biāo),例如塵埃粒子、微生物、溫度、濕度、風(fēng)量、壓差、換氣頻率等,應(yīng)在一個周期內(nèi)被監(jiān)控.Validationdeviation偏差驗證5.3.6Thedisposalofsystemvalidationdeviationcanreferto.處置系統(tǒng)偏差驗證可參閱.Changecontrol變更限制5.3.7Changeclassification:changeiscomposedofhardwarechange,softwarechangeandchangeofcriticalparametersindatabase.變更的分類：變更是由硬件變更、軟件變更,和數(shù)據(jù)庫的臨界參數(shù)變更組成.Ifchangeoccurring,changecontrolshouldbecarriedoutsoastoensu