1、CGMP文件風(fēng)險(xiǎn)分析格式SOP文件題目DocumentTitle風(fēng)險(xiǎn)分析的格式SOPSOP-Formatofriskanalysis文件編號(hào)DocumentCode文件版本號(hào)VersionCode00文件種類CategoryofDocument治理標(biāo)準(zhǔn)Managementstandard發(fā)放部門DepartmentofIssueQAf'人員Person類不Category-姓名/職位Name/Position簽名Signature日期Date編寫人Compiledby審核人Checkedby批準(zhǔn)人Approvedby文件分發(fā)部門/編號(hào)：（）Departmentofdocumentdis

2、tributed/Code:序號(hào)SerialNo.部門名稱DepartmentName份數(shù)Copies負(fù)責(zé)人Manager12345678文件變更歷史：Historyofdocumentchanging:版本號(hào)VersionCode變更日期ChangingDate變更內(nèi)容摘要AbstractofChangingContents002011建立文件Filefoundation1 目的Aim規(guī)范風(fēng)險(xiǎn)分析的格式,和公司內(nèi)部按照FMEA(失敗模式阻礙分析)方法實(shí)施風(fēng)險(xiǎn)分析的方法，最終降低產(chǎn)品的質(zhì)量風(fēng)險(xiǎn)。Tostandardizetheformatofriskanalysisandmethodstoca

3、rryoutriskanalysisaccordingtoFMEA(FailedModeEffectsAnalysis)ininternalenterprise,finallytoreducethequalityriskofproduct.2 范疇Scope在進(jìn)行工藝驗(yàn)證，設(shè)備確認(rèn)時(shí)(包括生產(chǎn)工藝驗(yàn)證、滅菌工藝驗(yàn)證、水制備工藝驗(yàn)證等)時(shí)，應(yīng)按照FMEA方法對(duì)驗(yàn)證的過程進(jìn)行風(fēng)險(xiǎn)分析；在進(jìn)行重大變更時(shí)或引入新的程序時(shí)，應(yīng)按照需要進(jìn)行風(fēng)險(xiǎn)分析。Duringprocessvalidationandequipmentqualification(includingproductionprocessvali

4、dation,sterilisationprocessvalidationandwaterpreparationvalidation,etc.),itsnecessarytodoriskanalysistovalidationprocessonthebasisofFMEA；Whencarryingthroughimportantchangeorinductingnewprocess,useriskanalysiswhenneeded.3 職責(zé)Responsibility3.1 QA部負(fù)責(zé)建立和更新本SOPQADepartmenttakesresponsibilityonestablishing

5、andupdatingthisSOP.3.2 各部門負(fù)責(zé)相應(yīng)范疇內(nèi)的風(fēng)險(xiǎn)分析。Everydepartmenttakechargeofriskanalysisincorrespondingareas.3.3 確認(rèn)/驗(yàn)證委員會(huì)負(fù)責(zé)監(jiān)督驗(yàn)證/確認(rèn)時(shí)本程序的有效實(shí)施。詳細(xì)內(nèi)容請(qǐng)見“確認(rèn)/驗(yàn)證委員會(huì)工作描述”(編碼：)。Qualificationandvalidationcommitteeseestoimplementthisprocessefficientlywhensupervisingvalidationandqualification.Detailedcontentcanbereferredin

6、“Position-relatedjobdescription-Qualification/Validationcommittee”(Code:).4 內(nèi)容Content本SOP的內(nèi)容以FMEA記錄表的形式來(lái)實(shí)施。ContentsofthisSOPareimplementedintheformofFMEArecordtables.本SOP的內(nèi)容需通過確認(rèn)/驗(yàn)證委員會(huì)或變更操縱委員會(huì)通過會(huì)議討論來(lái)進(jìn)行實(shí)施.在討論會(huì)上，必須至少有一位生產(chǎn)技術(shù)部成員，一位質(zhì)量保證部成員和一位設(shè)備部成員參加。ThisSOPshouldbeimplementedafterthediscussioninthemeetin

7、gsofqualificationandvalidationcommitteeorchangingcontrolcommittee,andthereshouldbeamemberofproductiontechnologydepartment,amemberofqualityassurancedepartmentandamemberofequipmentdepartmentpresentatleast.4.1 錯(cuò)誤/關(guān)鍵參數(shù)的收集Collectionofwrongandkeyparameters需要對(duì)所有過程或系統(tǒng)的所有操作/功能參數(shù)進(jìn)行測(cè)定，并將各操作項(xiàng)目/功能清晰的列在FMEA記錄單中。確

8、認(rèn)/驗(yàn)證委員會(huì)或變更操縱委員會(huì)的所有在場(chǎng)成員都必須參與此項(xiàng)工作。錯(cuò)誤/關(guān)鍵參數(shù)收集的基礎(chǔ)是：能夠?qū)е率〉年P(guān)鍵參數(shù)或關(guān)鍵步驟的確認(rèn)。關(guān)于每個(gè)確認(rèn)的參數(shù)/過程(在FMEA記錄單上的參數(shù)處給出)，應(yīng)詳細(xì)評(píng)估其可能帶來(lái)的潛在的失敗的阻礙(在FMEA記錄單上的潛在風(fēng)險(xiǎn)處給出)。Itsnecessarytomensuratealloperationandfunctionparametersinallprocessorsystem,andlisteveryoperationitemandfunctiononFMEArecordtables.Allpresentmembersofqualificationa

9、ndvalidationcommitteeorchangecontrolcommitteemusttakepartinthistask.Thebasisofcollectingwrongandkeyparametersisthatitsqualificationofkeyparametersorkeyprocesswhichmayleadtofailure.Everyconfirmedparameterorprocess(placedatParameterontherecordtables)shouldbegivendetailedevaluationoninfluencebroughtbyp

10、ossibleandpotentialfailure(givenatPotentialRiskonFMEArecordtables).4.2 潛在失敗阻礙的確定Confirmationofinfluencecausedbypotentialfailure可能通過確定合理的失敗緣故來(lái)改善對(duì)失敗所造成的阻礙的描述和評(píng)估。在確定潛在失敗所造成的阻礙和失敗緣故時(shí)，要專門考慮對(duì)產(chǎn)品質(zhì)量造成的阻礙。Itisposibletoimprovethedescribtionandevaluationtotheeffectcausedbyfailurethroughconfirmingreasonablefailu

11、rereason.Whenmakingsurethefluenceofpotentialfailureandfailurecauses,pleasepayparticularattentiontofluenceonproductquality.4.3 潛在失敗/關(guān)鍵參數(shù)的評(píng)估Evaluationonpotentialfailureandkeyparameters按照FMEA方法，在風(fēng)險(xiǎn)評(píng)估過程中，要對(duì)下面三個(gè)因素進(jìn)行評(píng)估：- 風(fēng)險(xiǎn)的發(fā)生頻率可通過“失敗的頻率”要素(F)來(lái)確定。- “失敗的嚴(yán)峻性”必須由確認(rèn)/驗(yàn)證委員會(huì)或變更操縱委員會(huì)來(lái)評(píng)估，它也是風(fēng)險(xiǎn)評(píng)估的一個(gè)要素。- 還要通過評(píng)估“察覺失敗

12、的可能性”這一要素對(duì)風(fēng)險(xiǎn)進(jìn)行評(píng)估。AccordingtoFMEA,intheprocessofriskevaluation,threefactorsbelowshouldbeevaluated:- Riskoccurrencecanbeconfirmedbyfailurefrequencyelement(representedbyF)- Failuregravenessshouldbeevaluatedbyqualificationandvalidationcommitteeorchangecontrolcommittee,anditsalsooneelementofriskevaluatio

13、n.- Riskshouldbeevaluatedfromtheelement-possibilityofawarefailure.以各要素的值為1-5來(lái)表示。F值為1，表示發(fā)生失敗的頻率最小，F(xiàn)值為5,表示發(fā)生失敗的頻率最大。同理，G=1,表示嚴(yán)峻性最小，G=5,表示嚴(yán)峻性最大。依此類推。在必要的情形下，委員會(huì)可對(duì)所有的風(fēng)險(xiǎn)因素分不確定其評(píng)估數(shù)值。為了幸免委員會(huì)成員的意見不統(tǒng)一，建議依舊事先確定評(píng)估等級(jí)標(biāo)準(zhǔn)，以便于風(fēng)險(xiǎn)的評(píng)估。范例格式如下表所述：風(fēng)險(xiǎn)分析參數(shù)：失敗的頻率(F)Riskanalysisparameter:failurefrequency(F)評(píng)估evaluation標(biāo)準(zhǔn)stan

14、dard1專門低Extremelylow2低Low3中等Medium4高High5專門高Extremelyhigh風(fēng)險(xiǎn)分析參數(shù)：失敗的嚴(yán)峻性(G)Riskanalysisparameter:failuregraveness(G)評(píng)估evaluation標(biāo)準(zhǔn)standard1專門低：失敗不阻礙產(chǎn)品的質(zhì)量Extremelylow:Failurehasnoinfluencetoproductquality.2低：失敗不阻礙產(chǎn)品的質(zhì)量或以間接的方式對(duì)產(chǎn)品質(zhì)量有專門小的阻礙Low:Failurehasnoinfluenceorinfluentindirectlytoproductquality3中等：失

15、敗對(duì)產(chǎn)品質(zhì)量有專門小的阻礙或只是間接阻礙。產(chǎn)品質(zhì)量的下降在某種程度上不阻礙產(chǎn)品放行。Medium:Failurehasafractionofinfluencesorjustindirectones.Qualitydeclinedoesntaffectreleasingproducts.4高：失敗直截了當(dāng)阻礙產(chǎn)品質(zhì)量。產(chǎn)品的質(zhì)量下降會(huì)阻礙產(chǎn)品放行。High:Failureaffectsproductqualitydirectly.Qualitydeclinehasimpactonproductrelease.5專門高：對(duì)法規(guī)或指導(dǎo)中涉及的方面應(yīng)進(jìn)行評(píng)估，以達(dá)到所要求的標(biāo)準(zhǔn)。Extremelyhi

16、gh:Itsneededtoevaluatetheaspectsinvolvedinregulationsorguidancetoexpectedstandard.風(fēng)險(xiǎn)因數(shù)：察覺失敗的可能性(P)Riskfactor:possibilityofawarefailure(P)評(píng)估evaluation標(biāo)準(zhǔn)standard5專門低：失敗不可能被察覺，沒有定期的檢查，沒有文件規(guī)定要進(jìn)行符合性研究。Extremelylow:Failurecantbeperceived,withoutregularcheckanddocumentationtodocomplianceresearch.4低：差不多的過程操

17、縱檢查，失敗不易于察覺。設(shè)備和儀器的技術(shù)性檢查僅僅是偶然進(jìn)行。Low:Itneedsbasicprocesscontrolcheckanditsnotpronetofailure.Justoccasionallytechnicalcheckonequipmentandinstruments.3中等：定期進(jìn)行過程操縱檢查或不連續(xù)的監(jiān)測(cè)，失敗易于察覺。Medium:Itneedsregularprocesscontrolcheckorincontinuousmonitoringandfailurecanbeperceived.2高：采取不同的方法進(jìn)行監(jiān)測(cè)，如工藝參數(shù)的監(jiān)測(cè)，有專門大可能確定在后續(xù)的

18、生產(chǎn)過程中發(fā)生的失敗。High:Ittakesvariousmonitoringmethods,suchas:monitoringonprocessparameters;itismorelikelytoconfirmfailureinthefollowingproductprocess.1專門高：100%的監(jiān)測(cè)，并可確定在后續(xù)的生產(chǎn)過程中發(fā)生的明顯失敗。Extremelyhigh:Itneedsfullymonitoringandcanconfirmobviousfailureinthefollowingproductprocess.重要講明：請(qǐng)注意，在此表格中，評(píng)估等級(jí)是從“5”到“1”。I

19、mportantnote:pleasenoticethatevaluatinggradeisfrom5to1.1.4 風(fēng)險(xiǎn)追蹤RiskPursue通過因素的等級(jí)評(píng)估和三個(gè)要素的乘積數(shù)，能夠確定某一個(gè)阻礙因素的風(fēng)險(xiǎn)評(píng)估值。因此，如果顯現(xiàn)下列情形，就必須進(jìn)行風(fēng)險(xiǎn)追蹤：三個(gè)要素的乘積數(shù)大于“24”三個(gè)被評(píng)估的要素中，有一項(xiàng)大于或等于“4”。關(guān)于風(fēng)險(xiǎn)追蹤，至少應(yīng)考慮該項(xiàng)風(fēng)險(xiǎn)參數(shù)是否是與質(zhì)量有關(guān)的。如果有必要進(jìn)行風(fēng)險(xiǎn)追蹤，應(yīng)提出解決的措施或更進(jìn)一步的調(diào)查研究的內(nèi)容，以排除可能發(fā)生的失敗并實(shí)施下一步的研究。Ariskevaluatingvaluecanbeobtainedfromfactorgradeev

20、aluationandproductsofthreeelements.Therefore,riskpursuemustbecarriedthroughifthefollowingcaseshappen:-Theproductofthreeelementsisgreaterthan24;-Oneofthethreeevaluatedelementsisgreaterthanorequalto4.Concerningonriskpursue,itshouldbetakenintoconsiderationthatwhethertheriskparameterisrelatedtoqualityor

21、not.IfriskPursueisnecessary,advancesolvingmeasuresormakefurthertosurveyresearchingcontentstogetridofcontingentfailureandgoonnextresearch.1.5 總結(jié)conclusion風(fēng)險(xiǎn)分析以表格的形式加入在各相應(yīng)的驗(yàn)證文件中，作為文件內(nèi)容的一部分。范例格式如下所示，Riskanalysisisaddedtocorrespondingvalidationdocumentintheformoftablesasapartofthedocument.Formatexamples

22、howsbelow:項(xiàng)目Item潛在的風(fēng)險(xiǎn)/錯(cuò)誤PotentialRisk/Errors失敗的頻率FrequencyofFailure(F)失敗的嚴(yán)峻性GravityofFailure(G)察覺失敗的可能性ProbabilitytodetectFailure(P)風(fēng)險(xiǎn)評(píng)估EvaluationofRisk(FXGXP)風(fēng)險(xiǎn)的追蹤*Pursueof*Risk項(xiàng)目1Item1項(xiàng)目2Item2項(xiàng)目3Item31.6 風(fēng)險(xiǎn)同意評(píng)判Riskacceptevaluation應(yīng)在采取措施后再進(jìn)行風(fēng)險(xiǎn)分析，以確定風(fēng)險(xiǎn)已降低至可同意水平內(nèi)(即三個(gè)要素的乘積數(shù)小于或等于“24”).同時(shí)應(yīng)對(duì)有關(guān)的本來(lái)在可同意水平內(nèi)的

23、風(fēng)險(xiǎn)再進(jìn)行一次風(fēng)險(xiǎn)分析，以確定風(fēng)險(xiǎn)未有增加，仍舊在可同意水平內(nèi).若依舊有風(fēng)險(xiǎn)項(xiàng)目超出操縱范疇，則應(yīng)重點(diǎn)對(duì)該風(fēng)險(xiǎn)進(jìn)行分析，提出新的改進(jìn)操縱措施.直至該風(fēng)險(xiǎn)降低到可同意水平.風(fēng)險(xiǎn)評(píng)估的格式如下所示：Conductriskanalysisafterpursuemeasurestoensureriskhasbeendeclinedtoanacceptablelevel(thatproductofthethreeelementislessthanorequalto24).Atthesametime,conductonemoreriskanalysisonrelatedandessentiallyacce

24、ptablerisktomakesurethatriskdoesntincreaseandstayacceptable.Iftherestillareriskitemsoutofcontrollablerange,focusonanalysisonthisriskandputforwardnewimprovingcontrolmeasureuntilitfallstoanacceptablelevel.Theformatofriskevaluationisasfollowing:項(xiàng)目Item潛在的風(fēng)險(xiǎn)/錯(cuò)誤PotentialRisk/Errors風(fēng)險(xiǎn)的追蹤PursueofRisk失敗的頻率Fr

25、equencyofFailure(F)失敗的嚴(yán)峻性GravityofFailure(G)察覺失敗的可能性ProbabilitytodetectFailure(P)風(fēng)險(xiǎn)評(píng)估EvaluationofRisk(FXGXP)風(fēng)險(xiǎn)同意評(píng)判Riskacceptevaluation項(xiàng)目1Item1項(xiàng)目2Item2項(xiàng)目3Item35 風(fēng)險(xiǎn)分析的記錄Riskanalysisrecord一樣來(lái)講，風(fēng)險(xiǎn)分析的進(jìn)行通常和打算的改進(jìn)措施合并在一起，因此不必要另外編寫一份風(fēng)險(xiǎn)分析文件，只需要在有關(guān)文件中附加風(fēng)險(xiǎn)分析的記錄。如在工藝驗(yàn)證主方案中，風(fēng)險(xiǎn)分析記錄需要按照附錄1中“FEMA記錄表”來(lái)設(shè)計(jì)。Generallyspe

26、aking,riskanalysisusuallycombineswitharrangedimprovingmeasures.Sothere'snoneedtocompileanotherriskanalysisdocumentbutadditionalriskanalysisrecordsinrelateddocuments.Forexample,riskanalysisrecordshouldbedesignedaccordingtoFEMArecordtableinappendix1inprocessvalidationmainprotocol.6 變更操縱程序Changecontrolprocess如果本程序需要變更或進(jìn)行專門的修改，必須按變更操縱程序來(lái)實(shí)行并進(jìn)行記錄。具體操作，請(qǐng)參考變更操縱SOP(編碼：7)。Ifthisprocessneedschangeorspecialmodification,followchangecontrolprocessandmakerecords.Specific