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共45页第1页MANAGERIALSYSTEM管理系统zAdministrative/Role&Responsibilities管理的作用和职责YESNOyCurrentorganizationchartsavailableandaccurate?当前可用的、正确的组织结构图yPolicy/procedurethatdefinestheresponsibilityandauthorityofQCunit.规定QC部门的权力和职责的方针或程序yHavetheresponsibilitiesofeachfunctionalgroupandsupervisorbeenclearlyDefined,includingtestingandoperationalrequirements,SOPs,andallotherCriticalfunctions?每一个分工小组和管理者的职责应有明确的规定，包括测试和操作要求、SOPS以及其他的关键要求。yIsanorganizationalstructureinplaceandproperlystaffedtoassureallrequiredTesting/monitoringsupportactivitiesareperformed?是否有适当的组织结构，使员工保证所有要求检验、监测支持活动必须被执行。yIsthespanofcontroladequate?控制范围是否适当、充分？yWhatistheratioofsupervisiontoanalyst?分析员监督比率是多少？yAretherolesandresponsibilitiesforeachpositionclearlydefined?每一个岗位（或职位）的作用与职责是否被明确的规定？yArejobdescriptionsavailable?是否有职位说明？共45页第2页yAresignatureauthority,responsibility,andaccountabilitiesappropriateandclearlydefined?签名权力、责任、适当的问责制是否有明确地规定？yDosystemsexisttoenhancecommunication,understanding,andworkingrelationshipsbetweenLaboratoryandQApersonnel?在实验室与QA之间是否有加强信息沟通、理解以及工作关系的程序？yDoesapersonnelperformanceevaluationsystemexistwhichtracksLaboratoryPersonnelstrengthsandweaknessandestablishescorrectiveactionprocedurestoMitigateanyweakness？是否有人员业绩评估程序，跟踪实验室人员的优势和劣势，建立矫正行动程序，减轻任何弱点？yDoesamastertestingscheduleorsimilardocument(s)exittoinsuresmoothworkflow,andminimizeLaboratorypersonnelovercommitment?是否有用以保证顺利工作流程，最小化实验室人员上面的的承诺的主要试验大纲或类似的文件(s)？yDocurrentCV'sandresumesexistforallpersonnelincludingconsultants?是否有所有员工包括顾问的个人简历？zTraining培训yHavetheeducational,trainingandworkexperiencerequirementsforeachlaboratorypositionbeenclearlydefinedanddotheyreflectcurrentstandardsintheindustry?对于每一个实验室岗位的教育、培训和工作经验强化培训计划需求是否有明确的规定？对于行业中的现行标准，他们是否可以反映？yAretrainingrequirementsclearlydocumentedinaSOP.(IncludingManagers,Supervisors,AnalystsandTemporarystaff)?培训需求在SOP中是否有明确的规定（包括经理、管理者、分析员以及临时员工）？yHasatrainingcurriculumbeendevelopedforeachpositionwhichclearlyidentifiesallrequiredSOPsandPolicies,safety,cGMPsaswellasallotherinternalandexternalcoursesorprograms?(Databaseorhardcopy?)每个位置需要的SOPS、策略、安全、cGMPs以及所有其他的内部和外部的课程或者方案(数据库或硬拷贝)的培训课程是否被开发？共45页第3页yIsjob-specifictrainingidentified?仅限于工作的培训鉴定了吗？yDoeseachemployeehaveatrainingfile?每位员工是否都有培训文件（资料）？yArethetraininghistoriesforeachindividualcurrent?(Databaseorhardcopy?)当前的每位员工是否都有培训历史？（数据库或硬拷贝?）yHavealllaboratorypersonnelbeenproperlytrained?所有试验人员是否得到适当的培训？yIsthistrainingdocumentedandwheredothesedocumentsreside?是否有培训记录，并存档？yHowisSOPtrainingconducted?如何实施SOP培训？yAremetricsusedtodetermineacceptability?是否有可接受的标准？yIstherealaboratorycertificationprogram?是否有实验室认证程序？yHasanindividualbeendesignatedasthetrainingcoordinatorormanager?是否有固定的培训协调员或经理？yIsthereevidenceorrmanagementsupportfortrainingandtrainingprograms?是否有培训和管理培训方案的程序文件？yDoesaformaltrainingbudgetexist?是否有一个正式的培训（经费）预算？yDovendor-trainingrecordsexist?是否有供应商培训记录？共45页第4页yIsthereevidencethatnewlyhiredemployeesareevaluatedforskilllevelandcompetency是否有证据表明新聘用的员工是经过技术水平和能力的评估？yIsthereaformaltrainingscheduleinplaceandisbeingexecuted?是否有一个正式的培训计划并正在执行？yIsthereevidenceofemployeere-training?是否有员工再培训的证据？yIsthereapositiveattitudewithrespecttotrainingonthepartofManagementandLaboratorypersonnel?关于对实验室的管理和人员培训这部分是否有一个积极的态度？zChangeControl变更控制yIsthereacurrentChangeControlsystemandwrittenprocedureforauthorization,documentationandimplementationofchangesthatmayhavearegulatoryorqualityimpact?是否有经批准的日常变更控制系统和诉讼的书面程序？是否有变更执行后的监管或对质量的可能影响？yWhoisresponsibleforadministrationandapprovalofChangeControlsystem?谁负责管理变更控制系统？谁负责审批变更控制系统？yIsthereatrackingsystemforchanges?是否有变更跟踪系统？yDoestheChangeControlsystemincludemechanismsforplannedchangesto:变更控制系统是否包括对计划的变更机制：StandardOperatingProcedures?标准操作规程（SOP）？Formulation?处方？ManufacturingProcess共45页第5页生产过程？MajorEquipment?主要设备BatchSize?批量？ProductionSite?生产地点？RawMaterialorPackagingMaterialSupplier/Process?原（辅）料和包装材料的供应商及生产过程？TestingMethods?测试方法？ProductSpecifications?产品规格？RawandPackagingMaterialSpecification?原（辅）料和包装材料明细表？ChangesinRegulatoryRequirements?变化的监管要求？DefiningMajorandMinorChanges?定义主要和次要的变化？yHowareunplannedchangesmade?无计划的变更是如何发生的？yWhoapprovesthosechanges?谁批准这些变更？zCommunications/Reports共45页第6页通信/报告yDoesthelabconductstatisticalqualitycontrol?实验室是否进行统计质量控制？yHowisthisinformationcommunicated?此信息是如何传达的？yArelabOOSresultstrended?实验室OOS结果的趋势如何？yIsthereasystemtoinformQAofnegativetrends?这个系统在通知QA的过程中是否有消极的趋势？yIsmanagementnotifiedinatimelymannerofalllaboratoryrejectionsandnegativetrends?在拒绝了所有实验室和消极的趋势后，是否及时的通知了管理人员？yIstheinformationonOOS,lotrejections,etc.suppliedinatimelyfashionforAnnualProductReviews?在年度产品回顾中，是否有OOS的信息，包括供应商？yArelaboratoryoperationsauditedroutinely?是否有实验室操作常规审计？yWhatisthefrequency?频率是什么？yAretheresultsdocumented?结果是否记录？yArecorrectiveactionsdoneinatimelymanner?是否及时纠正？yWhoreceivescopiesoftheauditreports,responses?审计报告的副本给谁？是否有反馈？yIsthereaself-auditprograminplace?共45页第7页是否有一个适当的自审程序？yDocumented?记录？yFollow-uponCorrectiveActions?对纠正措施的落实？yAreinternalauditreportsreviewswithanalyst?是否有内审报告回顾与分析？yAretheresystemsforperiodicreviewoftestingprogramsandQAsystemstoremaincurrentwithindust