淺談計算機(jī)設(shè)備驗證課件

設(shè)備驗證2008年11月2023/12/51Validation驗證“Establishingdocumentedevidencewhichprovidesahighdegreeofassurancethataspecificprocesswillconsistentlyproduceaproductmeetingitspredeterminedspecificationsandqualityattributes”. 建立一個文件化的證據(jù),以提供一個高水準(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)計基礎(chǔ)文件設(shè)計&安裝-Mechanical機(jī)械A(chǔ)irunit空調(diào)Electrical電設(shè)計&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計算機(jī)工程師.Mech.C.機(jī)械工程師ACSC./SystemOwner計算機(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項目層面參數(shù)一覽表Systemlist系統(tǒng)清單Blockdiagram設(shè)計結(jié)構(gòu)圖紙概括的系統(tǒng)描述PFD流程圖Criticalityanalysis重要項分析MasterValidationPlan驗證主計劃Traceabilitymatrix矩陣圖Goodfordesign用于設(shè)計2023/12/55Design-Basicdocuments基礎(chǔ)設(shè)計文件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報警項目清單Goodforconstruction用于制造Traceabilitymatrix矩陣圖2023/12/56Design&Installation-ACS/Software

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

設(shè)計及安裝－硬件Detailedsystemdescription詳細(xì)的系統(tǒng)描述Parameterlist參數(shù)清單Alarmlist報警清單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&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

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

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

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

現(xiàn)場安裝確認(rèn)Traceabilitymatrix矩陣圖Systeminstallation系統(tǒng)安裝Designdocuments設(shè)計文件IOtestprotocolIO測試方案Tightnesstestprotocols嚴(yán)密的測試方案FieldinstallationverificationReport現(xiàn)場安裝確認(rèn)報告System系統(tǒng)FieldInstallationVerification現(xiàn)場安裝確認(rèn)2023/12/513Approval1

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

測試－SAT軟件Traceabilitymatrix矩陣圖Applicationsoftware應(yīng)用軟件TestdocumentsSATSAT測試文件SATprocedures程序SATprotocols方案SiteAcceptanceTest工廠測試SoftwareSATreport軟件SAT報告Software軟件2023/12/515Testing-SATequipment

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

批準(zhǔn)2023/12/517Systems1System=1PIDExample如: 1airhandlingunit一個空調(diào)單元 1cleansteamgenerator一個清潔蒸汽發(fā)生器 3holdingtanks三個儲罐Asystemisacompositionofcomponentsthatlogicallycohereinordertofulfilaparticularfunctionality一個系統(tǒng)是由多個單元組成的復(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項目文件必須有追溯性

DesigndocumentsmustbetraceabletoURS設(shè)計文件對應(yīng)于URSTestingmustbetraceabletodesignspecificationandURS測試對應(yīng)于設(shè)計標(biāo)準(zhǔn)和URSURSprojectlevelURS項目層面URSsystemlevelURS系統(tǒng)層面DesignDocuments設(shè)計文件Tests測試Useofatraceabilitymatrixistherecommendedmethod推薦用追溯性的矩陣圖2023/12/519Criticality

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