淺談?dòng)?jì)算機(jī)設(shè)備驗(yàn)證課件

設(shè)備驗(yàn)證2008年11月2023/12/51Validation驗(yàn)證“Establishingdocumentedevidencewhichprovidesahighdegreeofassurancethataspecificprocesswillconsistentlyproduceaproductmeetingitspredeterminedspecificationsandqualityattributes”. 建立一個(gè)文件化的證據(jù),以提供一個(gè)高水準(zhǔn)的保證體系,確保生產(chǎn)出的產(chǎn)品始終符合預(yù)定的標(biāo)準(zhǔn)和質(zhì)量要求。

FDAGuidelinesonGeneralPrinciplesofProcessValidation,May1987.Documents文件2023/12/52Operational運(yùn)行確認(rèn)QualificationInstallation安裝確認(rèn)QualificationDesignQualification設(shè)計(jì)確認(rèn)Sequenceofdocuments文件建立次序SpecificationQualification標(biāo)準(zhǔn)確認(rèn)-URS用戶需求

-SpecificationsSystem設(shè)計(jì)基礎(chǔ)文件設(shè)計(jì)&安裝-Mechanical機(jī)械A(chǔ)irunit空調(diào)Electrical電設(shè)計(jì)&安裝Hardware硬件Software軟件IQ安裝確認(rèn)-ACSHardware硬件Software軟件IQ安裝確認(rèn)-Mechanical機(jī)械A(chǔ)irunit空調(diào)Electrical電OQ運(yùn)行確認(rèn)-ACSHardware硬件Software軟件OQ運(yùn)行確認(rèn)-Mechanical機(jī)械A(chǔ)irunit空調(diào)Electrical電PerformanceQualification性能確認(rèn)-SystemSystemOwner系統(tǒng)使用者EngineeringC.工程部ACSC計(jì)算機(jī)工程師.Mech.C.機(jī)械工程師ACSC./SystemOwner計(jì)算機(jī)工程師/系統(tǒng)使用者M(jìn)echanicalC./SystemOwner機(jī)械工程師/系統(tǒng)使用者SystemOwner系統(tǒng)使用者2023/12/53VModelLifeCycle2023/12/54URS-systemlevel用戶需求Specifications標(biāo)準(zhǔn)URS用戶需求projectlevel項(xiàng)目層面參數(shù)一覽表Systemlist系統(tǒng)清單Blockdiagram設(shè)計(jì)結(jié)構(gòu)圖紙概括的系統(tǒng)描述PFD流程圖Criticalityanalysis重要項(xiàng)分析MasterValidationPlan驗(yàn)證主計(jì)劃Traceabilitymatrix矩陣圖Goodfordesign用于設(shè)計(jì)2023/12/55Design-Basicdocuments基礎(chǔ)設(shè)計(jì)文件Detailedsystemdescription詳細(xì)系統(tǒng)描述PIDGeneralsystemdescription概括的系統(tǒng)描述PFD流程圖Roomdatasheets–Parameters參數(shù)一覽表Traceabilitymatrix矩陣圖Instrumentlist儀表清單Equipmentlist設(shè)備清單Parameterlist參數(shù)清單Alarmlist報(bào)警項(xiàng)目清單Goodforconstruction用于制造Traceabilitymatrix矩陣圖2023/12/56Design&Installation-ACS/Software

設(shè)計(jì)及安裝－軟件Detailedsystemdescription詳細(xì)系統(tǒng)描述Parameterlist參數(shù)清單Alarmlist報(bào)警項(xiàng)目清單PIDInstrumentlist儀表清單Equipmentlist設(shè)備清單Traceabilitymatrix矩陣圖Softwaredesignconcept軟件概念設(shè)計(jì)Testplan測(cè)試計(jì)劃TestdocumentsFAT設(shè)備生產(chǎn)廠測(cè)試文件Programreviewreport回顧報(bào)告Applicationsoftware應(yīng)用軟件ReadyforFATTraceabilitymatrix矩陣圖2023/12/57ReadyforFAT進(jìn)入設(shè)備生產(chǎn)廠測(cè)試階段Design&Installation-ACS/Hardware

設(shè)計(jì)及安裝－硬件Detailedsystemdescription詳細(xì)的系統(tǒng)描述Parameterlist參數(shù)清單Alarmlist報(bào)警清單PIDInstrumentlist儀表清單Equipmentlist設(shè)備清單Traceabilitymatrix矩陣圖Hardwaredesignconcept硬件概念設(shè)計(jì)I/OlistI/O清單Addresslist地址清單DatasheetsInstruments儀表一覽表PLCconfigurationPLC配置Electricaldrawings電氣圖Controlpanels控制面板Instruments儀表Traceabilitymatrix矩陣圖2023/12/58Design&Installation–Mechanical

設(shè)計(jì)&安裝－機(jī)械部分Detailedsystemdescription詳細(xì)的系統(tǒng)描述Parameterlist參數(shù)清單Alarmlist報(bào)警清單PIDInstrumentlist儀表清單Equipmentlist設(shè)備清單Traceabilitymatrix矩陣圖Powerdistribution電路分配Airducting空調(diào)管路Piping管道Airductinglayout空調(diào)管路圖Electricallayout電氣圖Equipmentlayout設(shè)備圖Pipinglayout管道圖DatasheetsEquipment設(shè)備一覽表Equipment設(shè)備ReadyforSAT進(jìn)入SATReadyforFAT進(jìn)入FAT2023/12/59Testing-FATsoftware

測(cè)試－FAT軟件部分Traceabilitymatrix矩陣圖Applicationsoftware應(yīng)用軟件FAT測(cè)試文件FATprocedures程序FATprotocols方‘案FactoryAcceptanceTest設(shè)備生產(chǎn)廠測(cè)試SoftwareFATreport軟件部分測(cè)試報(bào)告Software軟件2023/12/510Testing-FAThardware

測(cè)試－FAT硬件部分Traceabilitymatrix矩陣圖Electricalpanels儀表板TestdocumentsFAT測(cè)試文件FATprocedures程序FATprotocols方案FactoryAcceptanceTest設(shè)備生產(chǎn)廠測(cè)試hardwareFATreport硬件的FAT報(bào)告Hardware硬件Instruments儀表Calibrationcertificates校驗(yàn)證書2023/12/511Testing-FATEquipment

測(cè)試－FAT設(shè)備部分Traceabilitymatrix矩陣圖Equipment設(shè)備TestdocumentsFAT測(cè)試文件FATprocedures程序FATprotocols方案FactoryAcceptanceTest設(shè)備生產(chǎn)廠測(cè)試EquipmentFATreport設(shè)備的FAT報(bào)告Equipment設(shè)備Certificates合格證書2023/12/512Fieldinstallationverification

現(xiàn)場(chǎng)安裝確認(rèn)Traceabilitymatrix矩陣圖Systeminstallation系統(tǒng)安裝Designdocuments設(shè)計(jì)文件IOtestprotocolIO測(cè)試方案Tightnesstestprotocols嚴(yán)密的測(cè)試方案FieldinstallationverificationReport現(xiàn)場(chǎng)安裝確認(rèn)報(bào)告System系統(tǒng)FieldInstallationVerification現(xiàn)場(chǎng)安裝確認(rèn)2023/12/513Approval1

批準(zhǔn)SoftwareFATreport軟件的FAT報(bào)告HardwareFATreport硬件的FAT報(bào)告EquipmentFATreport設(shè)備FAT報(bào)告Fieldinstallationverificationreport現(xiàn)場(chǎng)安裝報(bào)告Approved批準(zhǔn)ReadyforSAT進(jìn)入SAT2023/12/514Testing-SATsoftware

測(cè)試－SAT軟件Traceabilitymatrix矩陣圖Applicationsoftware應(yīng)用軟件TestdocumentsSATSAT測(cè)試文件SATprocedures程序SATprotocols方案SiteAcceptanceTest工廠測(cè)試SoftwareSATreport軟件SAT報(bào)告Software軟件2023/12/515Testing-SATequipment

測(cè)試－SAT設(shè)備部分Traceabilitymatrix矩陣圖Equipment設(shè)備TestdocumentsSATSAT測(cè)試文件SATprocedures程序SATprotocols方案SiteAcceptanceTest工廠測(cè)試EquipmentSATreport設(shè)備SAT報(bào)告Equipment設(shè)備Certificates合格證書2023/12/516Approval2SoftwareSATreport軟件SAT報(bào)告EquipmentSATreport設(shè)備SAT報(bào)告ReadyforPerformancetesting進(jìn)入性能測(cè)試Approved

批準(zhǔn)2023/12/517Systems1System=1PIDExample如: 1airhandlingunit一個(gè)空調(diào)單元 1cleansteamgenerator一個(gè)清潔蒸汽發(fā)生器 3holdingtanks三個(gè)儲(chǔ)罐Asystemisacompositionofcomponentsthatlogicallycohereinordertofulfilaparticularfunctionality一個(gè)系統(tǒng)是由多個(gè)單元組成的復(fù)合體，各單元組合在一起而完成特定的功能2023/12/518Traceability

追溯性Projectdocumentsmustbetraceabletorequirements項(xiàng)目文件必須有追溯性

DesigndocumentsmustbetraceabletoURS設(shè)計(jì)文件對(duì)應(yīng)于URSTestingmustbetraceabletodesignspecificationandURS測(cè)試對(duì)應(yīng)于設(shè)計(jì)標(biāo)準(zhǔn)和URSURSprojectlevelURS項(xiàng)目層面URSsystemlevelURS系統(tǒng)層面DesignDocuments設(shè)計(jì)文件Tests測(cè)試Useofatraceabilitymatrixistherecommendedmethod推薦用追溯性的矩陣圖2023/12/519Criticality

關(guān)鍵CriticalityAnalysisisessentialtogoodproject重要性分析是一個(gè)好項(xiàng)目成功的關(guān)鍵intendedtofocuseffortonmostcriticalareasfor