FDA審廠管理系統(tǒng)20160504

高級(jí)工程師ISOTC121/SC3成員QQ/WeiXin:54551582Email:怡和嘉業(yè)醫(yī)療科技FDAInspectionManagementSystemFDA審廠管理系統(tǒng)法規(guī)注冊(cè)部陳興文201605準(zhǔn)備工作籌劃Inspection“Do’s”檢查時(shí)“需做的事”Inspection“Don'ts”檢查時(shí)“不可做的事”RolesandResponsibilities角色與職責(zé)FrontRoom—BackRoomACommunicationMethodology前室—后室交流方法FrontRoomOperationalMethods前室運(yùn)作方式BackRoomOperationalMethods后室運(yùn)作方式VISUALMANAGEMENTWALL可視化管理墻Top10StepstowardsasuccessfulFDAassessment成功通過FDA審核的10步Q&AIndex目錄準(zhǔn)備工作籌劃Bepleasant,hospitable,businesslike.Smilewhenintroduced.愉快、熱情、條理清晰。介紹時(shí)面帶微笑。Whenansweringquestions:答復(fù)以下問題時(shí)，要做到：Bedirect,concise,andfocusedwithanswers直接簡(jiǎn)明Staywithinthescopeofthequestion答復(fù)不要超出問題范圍Seekclarificationifneededfromhostand/orInvestigator必要時(shí)，請(qǐng)求接待人員和/或檢查員進(jìn)行解釋Besureofanswers對(duì)答復(fù)〔內(nèi)容〕是確定的Itisokaytosay“Idon?tknow”followedby“Iwillgettheanswer”可以說“不知道”，但接著要說“我去了解一下，稍后答復(fù)您”Inspection“Do’s”檢查時(shí)“需做的事”準(zhǔn)備工作籌劃Behonest.AnswertotheextentofYOURknowledge,notwhatothershavetoldyou.老實(shí)。發(fā)揮你所具備的知識(shí)答復(fù)以下問題，而不是別人告訴你的。AnswerYes/Noquestionswith?Yes?or?No?only.對(duì)是和非問題僅答復(fù)是或不是Becomfortablewithsilence保持安靜-沉靜Answerthequestionbriefly,thenwaittoseeiftheInvestigatorasksformore.簡(jiǎn)要答復(fù)以下問題，然后等檢查員是否問更多Beconfidentinourqualitysystem–butnotoverconfidentorarrogant要對(duì)我們的質(zhì)量體系充滿信心，但不要過于自信或自大Inspection“Do’s”檢查時(shí)“需做的事”準(zhǔn)備工作籌劃Themannerinwhichquestionsareansweredisveryimportant:答復(fù)以下問題的方式很重要Don?tguess不要猜測(cè)Don?tofferunsolicitedcomments,personalviewsoropinions不要主動(dòng)發(fā)表意見，不要摻雜個(gè)人看法或觀點(diǎn)Don?ttrytotelleverythingyouknowaboutasubjectorquestion不要講知道的所有事情Don?tvolunteerextrainformation.不要主動(dòng)提供信息Don?targue不要爭(zhēng)論Don?ttakeadefensivetone不要帶著防御語氣Don?tbreaktheInvestigator?ssilence–“pregnantpause”審核員保持沉默〔“有寓意的暫停”〕的時(shí)候，不要打斷他Inspection“Don'ts”檢查時(shí)“不可做的事”準(zhǔn)備工作籌劃Avoidgeneralities--wordslikenormally,typically,generally,usually.and?mostofthetime?防止模糊的表述，如“通常地”、“一般地”、“經(jīng)常地”和“大多數(shù)情況”Don?tplaceblameonotherfunctionsorsites–weareallXXX不要責(zé)備其他任何部門—XXX公司是個(gè)集體，我們都是其中一員Don?timplythatproblemsaretheresultofalackofresources不要暗示問題是缺乏資源的結(jié)果Don?tstatethataparticulareventisimpossible–theInvestigatormayhaveinformationtothecontrary.不要說某一特殊事件是不可能實(shí)現(xiàn)的—審核員手頭也許有可能的信息Don?ttakebooksofnotesorothernon-essentialpapersorthingsintotheFrontRoom–theInvestigatorwillwanttolookatthem不要將筆記或其他非必要的紙張或物品帶入前室—審核員會(huì)要求進(jìn)行查看

Inspection“Don'ts”檢查時(shí)“不可做的事”準(zhǔn)備工作籌劃PrimaryHosts(FrontRoomPeople)主要人員〔前室人員〕(1)NeedgoodoverallknowledgeofFacility/XXXQualitySystem(ProceduresandInteractions)(1)需要有良好的整體設(shè)施知識(shí)及XXX質(zhì)量體系知識(shí)〔程序文件和相互作用〕(2)NeedinterpretiveknowledgeofFDAQualitySystemRegulation(2)需要有FDA質(zhì)量體系要求的解釋性知識(shí)(3)Needgoodnegotiationandinter-personnelskills(3)需要有良好的談判及人際溝通技能

RolesandResponsibilities角色與職責(zé)準(zhǔn)備工作籌劃BackRoomManagers后室經(jīng)理們(1)NeedgoodoverallknowledgeofFacility/XXXQualitySystem(ProceduresandInteractions)(1)需要有良好的整體設(shè)施知識(shí)及XXX質(zhì)量體系知識(shí)〔程序文件和相互作用〕(2)NeedinterpretiveknowledgeofFDAQualitySystemRegulation(2)需要有FDA質(zhì)量體系要求的解釋性知識(shí)(3)Needgoodtimeandpeoplemanagementskills(3)需要有良好的談判及人際溝通技能(4)Needtobeleaders!(4)需要是領(lǐng)導(dǎo)們RolesandResponsibilities角色與職責(zé)準(zhǔn)備工作籌劃ExpertResponders專業(yè)應(yīng)答人員(1)Person(s)withthebestpracticalknowledgeoftheirfunctionandmodality?spracticesaswellasanunderstandingofFDAQSR(1)具有對(duì)他們職能和形式的最正確實(shí)踐知識(shí)及了解FDAQSR的人員(2)KnowledgeofwhereandhowtofindobjectiveevidenceisCRITICAL(2)具有在哪和如何找到目標(biāo)證據(jù)的認(rèn)知很關(guān)鍵(3)Calmandconfident(3)冷靜自信RolesandResponsibilities角色與職責(zé)FrontRoom前室Who:FDAAuditorFDA審核人員XXX-FDAInterfaceXXXFDA接口PrimaryHost(s)主要應(yīng)審人XXXSubjectMatterExperts(asneeded)XXX主題事實(shí)專家〔根據(jù)需要〕What:Narrowandclarifyquestions縮小并澄清問題SendQuestionstoBackRoom將問題傳至后室InsureResponsesarepresentedinamannerfavorabletoXXX確保以對(duì)XXX有利的方式答復(fù)FrontRoom—BackRoomACommunicationMethodology前室—后室交流方法BackRoom后室Who:BackRoomManager后室經(jīng)理(XXXFDAInterface)(XXXFDA接口)QuestionManagers問題經(jīng)理們ExpertResponders專業(yè)應(yīng)答人員Interpreterifneeded假設(shè)需，詮釋人員What:Prepareanswerstowrittenquestions,review&roleplay針對(duì)書面問題、評(píng)審及角色扮演準(zhǔn)備答案DISCIPLINEISMANDATORY…紀(jì)律是強(qiáng)制性的Theterms:術(shù)語：FRONTROOM&BACKROOMareNOTtobeusedatallduringtheinspectionroom.在檢查房間不要使用術(shù)語前室和后室MandatoryRules強(qiáng)制性規(guī)那么:(1)NOpaperworkflowsintoinspectionroomwithoutBackRoomOkayandFrontRoompreview.未經(jīng)過后室批準(zhǔn)和前室的預(yù)覽，不要將紙張帶入檢查室(2)NooneenterstheFrontRoomwithoutbeinginvitedbyFrontRoomhosts!BringBusinessCard.LeaveCellphoneinBackRoom未經(jīng)前室接待者的允許，不能進(jìn)入前室。進(jìn)入前室時(shí)應(yīng)佩戴工牌，把留在后室。FrontRoomOperationalMethods前室運(yùn)作方式Why???為什么這樣？:(1)ThisinsuresthatthefrontroomhostsunderstandthepaperworkandexplanationthatwillbegiventoFDA這樣做是為確保前室接待員了解將要提供給FDA的文件和解釋(2)KeeptheInvestigatorfocusedononethingatatime.Avoidconfusionandinterruptions-rude這樣做是為確保審核員一次專注于一件事。防止混亂和干擾。MandatoryRules強(qiáng)制性規(guī)那么:(3)OnlytheFDAInterfacewillsendQuestionstothebackroom.僅通過FDA接口向后室傳遞問題.(4)AllintheFrontroomwillremainCoolandCALM.在前室的所有人員需要冷靜沉著FrontRoomOperationalMethods前室運(yùn)作方式Why???為什么這樣？:(3)ThiskeepstheFrontandBackroomsinsynchandpreventsunnecessaryworkonsideissues.這樣做能保證前室和后室獲得的信息同步,并能防止在無關(guān)緊要問題上的做不必要工作(4)Angry,suspiciousornervousInvestigatorsaredangerous.生氣、多疑或緊張的審核員是危險(xiǎn)的MandatoryRules強(qiáng)制性規(guī)那么:(1)NOpaperworkflowsintoinspectionroomwithoutBackRoomOkay.未經(jīng)過后室批準(zhǔn)，不要將紙張帶入檢查室(2)BackRoomDisciplineincludingBoardManagementDisciplineisMandatory!后室規(guī)程，包括“董事會(huì)管理規(guī)程”是強(qiáng)制性的

BackRoomOperationalMethods后室運(yùn)作方式Why???為什么這樣？:(1)ThisinsuresthatthebackroomhostsunderstandthepaperworkandexplanationthatwillbegiventoFDA這樣做是為確保后室接待員了解將要提供給FDA的文件和解釋(2)Withoutthediscipline,itwouldbeimpossibletomanagethequestionsanddocumentationinanorderlyfashion.沒有紀(jì)律，將無法有序地處理問題和記錄MandatoryRules強(qiáng)制性規(guī)那么:(3)TheBackRoomManagerwithinputfromFrontRoomManagerwillselecttheindividualwhowillpresenttheanswersintheFrontRoom.ResponderistoreportbacktoBACKroomIMMEDIATELYafteransweringquestion.接到前室主要應(yīng)審人輸入的后室經(jīng)理選擇去前室答復(fù)以下問題的人員?；貞?yīng)人員答復(fù)以下問題之后應(yīng)立即匯報(bào)給后室

BackRoomOperationalMethods后室運(yùn)作方式Why???為什么這樣？:(3)ItisimportanttomatchpersonalitieswiththeFDAInvestigatortomaintainaconfidentbutnotarrogant“face”totheFDA.向FDA審核人員推薦適宜人格的人員來保持一個(gè)自信但不是自負(fù)的“印象”DONOTMENTIONQUESTIONNUMBER不要提到問題數(shù)字KRETZ QuestionForm問題表8Year年: 2006Month月: 3CONCERNEDPRODUCT:涉及的產(chǎn)品TimeQuestionreceived：接到問題時(shí)間:15:39Question問題#: 13--4-8DATACOLLECTOR資料收集人NancySPOKESPERSON發(fā)言人BernardQ7WeneedthecompletecomplaintfilefortheSampledsetoflistinQ4.BCwillfetchmarkedlist.Pleasemakesurewebringbackoriginallistwithcomplaints.問題7：我們需要完成Q4所列樣本的顧客抱怨文件。BC取標(biāo)記列表。請(qǐng)確保我們?nèi)眍櫩捅г骨鍐卧?。ANSWER回答:DOCUMENTSSUPPLIED提供的文件:DOCUMENTSKEPTSATISFACTORYANSWER:INSPECTORCOMMENTS:檢查評(píng)價(jià)

FDAInspectionStrategy,LSM051409YESNOVISUALMANAGEMENTWALL可視化管理墻INCOMING問題輸入ASSIGNED人員分配READYFORINSPECTIONROOM準(zhǔn)備好進(jìn)入檢查室ININSPECTIONROOM檢查室內(nèi)COMPLETE完成SametimeConnectCopiedtoExcelMacroWorkbook同時(shí)連接復(fù)制到Excel宏工作簿Determine“WHO”will:collectdatarespondtoinvestigator決定由誰收集資料，反響給審核人員Review,Roleplaycompleted&responderisinBackRoom.SendtoInspectionroom后室內(nèi)完成評(píng)審、角色、答復(fù)者。然后送往檢查室AnswertheQuestion答復(fù)以下問題準(zhǔn)備工作籌劃1: Firstimpressionscount;wemustshowwearepreparedforaninspectionbothtechnically(inthedatawepresent)andinouractions(thewaywepresentthedata).1：第一印象很重要：必須展示出我們?cè)诩夹g(shù)上〔我們呈現(xiàn)的數(shù)據(jù)〕和行動(dòng)上〔我們呈現(xiàn)數(shù)據(jù)的方式〕都為檢查做了準(zhǔn)備。

2: Followourownprocedures;thereisnoroomforerrorwiththisrequirement.2：遵循我們自己的規(guī)程：這一要求沒有犯錯(cuò)的空間。

3: Wemustknowourownsurprisesandhavealreadyreactedproperlyandinstitutedpreventiveaction.3：必須知道我們自己的意外情況，并且已經(jīng)采取了適當(dāng)?shù)拇胧?，并設(shè)立了預(yù)防措施。Top10StepstowardsasuccessfulFDAassessment成功通過FDA審核的10步準(zhǔn)備工作籌劃

4: WemustneversurprisetheFDA;sowemusthavereportedissuesofconcerntotheFDApriortotheFDAassessment(e.g.MedicalDeviceReportingmustbedoneinacompliantandtimelymanner).4：我們必須不給FDA意外，因此我們必須在FDA評(píng)估前報(bào)告給FDA關(guān)心的問題?！才e例來說，醫(yī)療器械報(bào)告必須以合規(guī)和及時(shí)的方式完成〕。

5: WemustspeakthelanguageoftheFDA. TheharderwemakeitfortheFDAtounderstandourwayofdoingthings,themoredifficulttheassessmentwillbecome.5：我們必須用FDA方便理解的語言方式表達(dá)。如果我們用FDA難以理解我們做事方式的方法表達(dá)，F(xiàn)DA的審核也會(huì)變得更難。6: Ourrecordsmustbeeasytounderstand. Quitesimply,simpleprocessesarethebestprocesses.6：我們的記錄必須易懂，最簡(jiǎn)單的流程就是最好的流程。Top10StepstowardsasuccessfulFDAassessment成功通過FDA審核的10步準(zhǔn)備工作籌劃7: Ourmanagementmustbecommittedtothequalitysystems;thismeanshavingroutinereviewsofdatawithsubsequentactions.7：我們管理必須致力于符合質(zhì)量體系，這意味著日常的對(duì)在后