SQP质量验厂要求及标准

SQP质量验厂要求及标准SQPStandardrequirement#SQPREQUIREMENT/CRITERIA/REFERENCESQP要求/标准/参考TotalPossibleScore最高可能得分PointsScored实际得分Yes/No是/否Majororminor主要/轻微FacilitiesandEquipment厂房/设备FE1Isthefacilityclean(internal/external)?Throughoutthecourseoftheassessment,observationofcleanlinessshouldbetaken.Cleanlinessshouldbedefinedasanenvironmentthatreducesand/oreliminatesthepotentialforcontamination.工厂是否干净（评估的整个过程都要观察工厂清洁情况，工厂应该有定义清洁的环境要素并持续改善清洁状况）200FE2Aretherewrittenproceduresaddressingthemaintenanceofthe

facility?

PreventiveMaintenancepoliciesandschedulesshouldbedocumented.Recordsshouldbeavailableforreviewandshouldcontaininformationregardingdailypre-operationequipmentinspection,dailymonitoringofequipmentfunction,dailyhousekeepingactivities,sanitationactivitiesandanyothernecessaryactivitiestomaintainthesafetyandqualityofproduct.有没有书面的厂房/设施维护程序？预防性维护的政策和程序。每日开机检查记录，每日设备功能检查记录，每日打扫卫生记录，以及其他所需的工作来保证产品的安全和质量……200FE3Istherealistofapprovedchemicalsformaintainingthesanitationofthefacility?Chemicalsusedforanyoftheaboveactivitiesshouldbedefinedwithintheapprovedproceduresandpolicies.MaterialSafetyDataSheetsshouldbemaintainedforallchemicals.AnappropriatesampleofchemicalsshouldbeselectedandMSDSrequestedforeach.IfanychemicalsareobservedinusewithoutapprovalorifanyofthechemicalsselecteddonothaveMSDSprovided,theanswerisNO.是否有清洁用化学品清单。这些用来清洁的化学品应该有合适的批准程序批准，有MSDS数据。如果发现任何没有在清单中的化学品，或则没有MSDS，答案就应该是“No”100FE4Isstorageofchemicalsusedinthefacilityadequate?EnsurethatallchemicalsarestoredinamannerconsistentwiththeinstructionspertheirMSDSsheets.Additionally,ensurethatthemethodofstorageisinsuchamannertoeliminateproductcontamination.AnswerisNOifstorageconflictswitheitherrequirementabove.存储化学品的设施是否合适/充足？确保所有化学品都按照其MSDS要求合适存储，避免污染。否则答案为“NO”300FE5Isthefacilityinsatisfactorystructuralcondition?

NoRodentEntryPoints,NobrokenGlassorWindows,Ceilingdoesnotindicatewaterdamageorstructuraldefects.厂房结构是否令人满意，没有虫害入侵点，没有破碎的玻璃或窗户。天花板没有漏水的痕迹。300FE6Iswastematerialhandledappropriately?

Ensure

thedumpsterareasarecleanandwellorganized.Externalwasteisnotexcessive.肥料处理是否合适，垃圾桶附近干净整洁。100FE7Isthedesignofthefacilityadequatetoallowforsmoothflowof

materialsandreducepotentialforcontamination?工厂平面结构设计是否合理，可以是物料流转顺畅，避免潜在的污染风险200FE8Arethereadequateenvironmentalcontrolsforthebuilding?

If

theproductunderassessmentrequiresenvironmentalcontrols,ensurethatthesupplierhascontrolledandverifiedtemperatureatcriticalareas.Ifenvironmentalcontrolisinadequate,theanswerisNO.Ifenvironmentalcontrolisnotapplicabletotheproduction,theanswerisN/A.建筑物是否有合适的环境控制，如果产品有环境控制需求，请确保供应商有控制和确认温度。300FE9Isthelightingadequateforthebuilding?建筑内部照明是否充足100FE10Isthepestcontrolprogramadequate?

Ensurethatacontractexiststhatdocumentsaregularlyscheduledpestcontrolserviceprogram.Thecontractpackageshouldincludeataminimum:a)writtendocumentationregardingtheserviceperformedandtypeofmaterialsused;b)acurrentmapindicatingthelocationsofallrodenttraps;c)copiesofthelicensesandcertificatesofinsuranceforthepestcontrolcompanyandcurrentlicenseforinspectors.Reviewarepresentativesampleofinspectionrecordsfromthelast12months.Ensurethatanypestproblemsnotedhavebeenaddressedandhadbeenaddressedpriortothenextinspection.Ensurethetraps/devicesaretraceableeitherbynumericallabeling,barcodingorothermethod.Ensurethatthepestcontrolinspectorhasinitialedorprovidedsomeotherdocumentationtosupportthatalltrapshadbeenproperlyinspected.Finally,toreceiveaYESforthisquestion,nosignofrodentactivity

wasnotedduringthecourseofthisassessment.虫害控制程序是否合适？确保有外发的定期虫害控制合约，合约至少包括a)服务内容和所有材料b)鼠笼的安放位置图c)虫害防治公司的营业执照，检查12个月的虫害控制记录，鼠笼等设备有编号，可以追溯。鼠笼等设备合适安装并定期检查证据300FE11Arethewashroomsandtoiletscleanandingoodworkingorder?

Clean,stockedwithAntibacterialSoapandsingleusenapkin/towel,runninghotwater.水房和厕所是否良好？干净，有防菌肥皂和一次性纸巾，热水300FE12Isanorganizedsparepartsinventorykeptonhandatthefactory?

Lookforaroomorareaseparatefromproductionthatcontainssparepartsfortheproductionequipment.Doesnotneedtobeallspareparts,butataminimumshouldbecriticalpartsneededtokeeptheequipmentrunning.Factoryshouldhaveinventorylist.备件仓是否组织良好？备件仓需同生产隔离。关键零件必须要备件并有清单控制100TOTALSCOREFORTHISSECTION2500QualitySystem品质系统OrganizationandPersonnel组织和人员QS1IsaTableofOrganization(ToO)availableforreview?Current?

Approved?Controlled?MustbeabletosayYEStothesesubsequentrequirementsinordertoscoreYES.组织架构图？最新，有批准和受控200QS2Isqualityassuranceindependentofmanufacturing?

Ensure

thattheToOdescribesseparationofmanufacturingauthorityandqualityassuranceauthority.有没有独立于生产的品质保证部门。组织架构同应该有体现200QS3Areuptodatebiographies(CVs)availableforsupervisory

personnelshownontheToO?主管以上人员必须要简历保存100QS4Doesthequalitydepartmenthaveadequatecoverageduringall

shifts?

Reviewlast30daysofshiftschedules.Foreveryproductionshift,theremustbedocumentedQCcoveragetoscoreaYES.*Guidance:“DocumentedQCCoverage”maybedemonstratedthroughacombinationofbothofthefollowingpractices:1)Designationof“QualityResponsible”operator(s)duringa2ndor3rdshift.Thisisacceptablesolongasverificationoftrainingmaybeprovidedandconclusiondrawnthatdesignated“QualityResponsible”operatorshavetheeducation,experienceandknowledgetoactintheroleofQC.2)ThevendormusthaveprocedureandrecordstoensurethatQAreviewsandreleasesallbatchespriortoshipment.品质部门是否有足够的人员去覆盖所有的生产班次?检查最近30天的生产安排，每个生产班，都必须有品质文件，“品质文件”是指：1）每班有指定合格的品质负责人，且品质负责人有合适的培训，经验和知识2)供应商必须有程序和记录确保出货前qa检查每批货物。300QS5IsthereawrittenprocedureforgeneralGMPtraining?This

shouldbeaprocedureorotherdocumentsdefiningfrequencyoftraining,generalscopeoftraining,trainingproviderandmethodologyfordeterminingcompetency.GMP培训程序？程序要定义培训频率，培训范围，讲师和培训方法100QS6Aretrainingrecordsavailableforindividualsrandomlyselected?Randomlyselectanappropriatesamplebasedonthesizeofoperationtoverifytrainingrecordsexist.Ifnorecordexistsforsampledemployees,scoreNO.随机检查培训记录100QS7Dotrainingrecordscontainnames(trainer/trainee),datesand

subjectmatter?AlsoensuretherecordsdemonstrateconformancewiththeproceduretoscoreYES.培训记录是否报考名字（讲师和学员），日期和培训主题。200QS8Isthereasufficientmeansforverifyingtraineecomprehension?

Reviewthemethodoftrainingverification.Ensurethatitisappropriatetotheextentofresponsibilityfortheproduct.是否有合适培训效果确认方法200QS9Aresatisfactorytrainingmaterialsavailableforreview?

Slides,

handouts,otherdocumentationtodemonstratetrainingprovidedconformstoprocedure.是否有合适的培训材料，幻灯片，印刷材料100QS10DoGMPtrainingmaterialsadequatelyaddressfacilitysanitation,

personalhygiene,andrecordkeeping?培训材料是否有涵盖厂房清洁卫生，个人卫生和记录保存200QS11Doemployeespracticesanitationandhygieneinthemanufacturingoperations?Duringthewalkthroughofproduction,storage,etc.observeemployeestoensureallsanitationandhygienepoliciesareimplemented.Ifobservationdeterminespoliciesarenotbeingfollowed,mustscoreNO.员工是否按照卫生要求开展工作，在现场走访时观察员工和实施的人身状况300QS12Areonthejob(OTJ)trainingrecordsavailableforindividuals

randomlyselected?

Specificallyverifyanyemployeeobservednotfollowingsanitationandhygiene

policiestodetermineifthey'vebeenprovidedthetraining.随机检查员工在职培训记录，特别检查那个没有按照卫生要求做事的员工200QS13AreOTJtrainingrecordscompleteandadequate?Containsnames(trainer/trainee),datesandsubjectmatter,specificreferencetomachine,process,oractivity.岗位培训记录是否详实，包括姓名（讲师和学员），日期，主题，参考材料和相关活动200QS14AreSOPsavailableforreview?

SOPs

shouldcoverallcriticalprocessesutilizedforthecontrolledmanufactureofproduct(s)includedintheassessmentscopetoscoreYES.有没有SOP（标准作业程序），SOP应该涵盖所有关键受控工序300QS15AreSOPswritten,identifiedandapprovedinasatisfactory

manner?Current?Approved?Controlled?MustbeabletosayYEStothesesubsequentrequirementsinordertoscoreYES.SOP是否文件化，有编号和被批准。最新，有审批和受控300QS16IsdistributionofnewandrevisedSOPsandretrievalofobsolete

SOPsadequate?有没有SOP修改，分发控制程序200QS17DodocumentedINSPECTIONproceduresorinstructionsexist?

Reviewinspectionproceduredocumentation.检查作业指导书，100QS18AreSOPsreviewedperiodicallytoensuretheirapplicabilityto

currentpractices?SOP定期审查100QS19Isthereadocumentedchangecontrolprocedureforplannedand

unplannedchangestoproductionprocesses?有没有文件化的变更控制程序，包括计划内的生产工序变更和非计划的变更300QS20Arechangesrelatingtomanufacturing/packagingprocesses

adequatelyapproved,wherenecessary?ThesechangesshouldbeapprovedbytheresponsiblepartiesidentifiedinthechangecontrolprocedureindicatedabovetoscoreYES.有关生产/包装的变更是否有合适的批准程序。300QS21Arelogbooksavailableforreviewwithrespecttoproduction?生产登记本100QS22Istheuseoflogbooksdetailedinawrittenprocedure?文件化的生产登记本使用说明100QS23Arelogbooksclearwithrespecttoactionstakenbyindividuals?生产登记本记录清晰，可以看清楚没有人的动作

记录。100QS24Dologbooksexhibitgooddocumentationpracticeswithrespectto

changes,legibilityandsequenceofevents?

Nowhiteout,scratchoutmarks,etc.Changestotheserecordsshouldbemadewithasinglecross-outandbeinitialedanddatedtoscoreYES.生产登记本是否更改谨慎，清晰易读100QS25Arelogbooksperiodicallyreviewedtoensuretheiradequacy?生产登记本记录是否定期检查100QS26Isthereanadequatewrittenprogramforthemaintenanceof

productionrecordsforeachfinishedproductmanufactured?是否有合适的文件化程序来维护每批产品的生产记录300QS27Dobatchproductionrecordscontainadequateinformationwith

respecttothepackagingoffinishedproducts?

Ensurepackaginglabels/informationincludeadequateinformationtosupportthatproductionrecordsareaccuratewithrespecttoidentification,quantity,weight,material,etc.批生产记录是否包括关于成品包装的合适信息，标签信息300QS28Dobatchproductionrecordscontaintherequiredinformation

necessarywithrespecttoassuringthequalityoffinishedproducts?Ensureproductionrecordscontainidentificationofthetypeofmaterial,amountofmaterial,andverificationofanycriticalstepsperthespecificationtoscoreYES.批生产记录是否包含原材类型，数量个关键步骤确认规范300QS29Dobatchrecordsexhibitgooddocumentationpracticeswith

respecttochanges,legibilityandadequacyofentries?

Nowhiteout,scratchoutmarksetc.Changestotheserecordsshouldbemadewithasinglecross-outandbeinitialedanddatedtoscoreYES.批生产记录改动谨慎，清晰易读。没有涂鸦，修改有备注时间和签名100QS30ArebatchrecordsreviewedbyQApriortoarchival?批记录在存档前必须有QA检查确认300QS31Areadequaterecordsmaintainedwithrespecttothese

investigations?不良品原因调查是否有记录200QS32Doinvestigationsincludeareviewofproductionandlaboratory

eventswhichmaycontributetoorbethecauseofthefailure?调查是否包括检查生产记录，实验室记录200QS33Ifinvestigationsareinconclusiveandretestingisconducted,isthe

approachtoretestingbasedonsoundrationale?如不良调查得出结论需要从新测试，那么测试方法是有合适300QS34Doallinvestigationsconcludeanactualorprobablecauseforthefailure?是否所有调查都给出实际或可能的原因200QS35Areinvestigationscompletedwithinareasonabletimeframe?失效调查是否在合理的时间内完成300QS36DoesQualityAssuranceadequatelyreviewthefailureinvestigations?品质部门是否合适地审查这些调查300AnnualProductReview/InternalAudits/CorrectiveandPreventativeActions年度产品审核/内审/预防改善QS37IsthereanadequatewrittenprocedureforconductingProduct

Reviews?

Thisshouldcontainfrequency,methodology,responsiblepartiesandrecordkeepingrequirements.是否有合适的程序来主导产品审查，包括审核频率，方法，责任人和记录保持100QS38Isthereanadequatewrittenprocedureforconductinginternal

audits?

Thisshouldcontainfrequency,methodology,responsibleparties,record

keepingrequirements,authority,followuporcorrectiveactionreferencebased

oninternalauditresults.是否有内审程序，包括频率，方法，责任方，记录，拥有者和改善行动跟进200QS39Areinternalauditsbeingconductedaccordingtotheprocedure?内审是否按程序进行200QS40Issupportingdocumentation(schedules,auditreports,CAreports)fortheauditsavailable?

Dothesedocumentsandrecordsdemonstrateconformancetotheprocedure?内审计划，内审报告，内审改善报告，200QS41Areresponsestotheauditfindings/observationsintheformof

correctiveand/orpreventativeactions(CAPA)addressingrootcause?内审负责撰写改善行动的人是否有也谢清楚了不良发生的原因200QS42AreCAPAsbeingcompletedandinstitutedwithinareasonable

timeframe?改善行动是否在合理的时间内完成200QS43DoesQualityAssurancefollow-upanddetermineiftheappropriate

CAPAhasbeencompleted?

Thisshouldbe

documentedviatheCorrectiveActionformorrecordutilizedbythefactoryOR

viaasubsequentinternalauditofthedeficientarea.QA是否跟进并确保执行合适的改善行动300QS44Arecorrectiveactionplansdevelopedanddocumentedbasedon

theresultsoftheweeklyQCmeetings?

Isthere

documentationofcorrectiveactionplansintheQCmeetingnotes?MustseetoscoreaYES.是否在每周的品质会议中开发改善行动记录。200TOTALSCOREFORTHISSECTION8900MaterialSystem&SupplierQualityManagement原材料和供应商品质管理ComponentsHandling/HoldingandDistribution部件/零件的处理与分发MS1Doesthefactoryhaveadocumentedprocesstomakesurethat

incomingrawmaterials,components,and/orsub-assembliesconformtospecifications,qualitystandardsandUSSafetyrequirements?

Verifythatthereisaprocessdocumentedtoensureallincomingrawmaterials,componentsand/orsub-assembliesconformtospecificationsandUSSafetyrequirements.Painttestedforleadcontent,etc.工厂是否有文件化的程序来确保原材料，零件，外发加工品符合产品规范，品质标准和美国安全要求，美国安全标准包括油漆测试，铅含量等300MS2Isthereanadequateprocedureforthereceipt,samplingand

identificationofallrawmaterials?

Ensurethatinspectionproceduresextendtoreceiptandqualificationofrawmaterial.Ensurethatrecordsexisttosupportconformancetoprocedure.Ifnoprocedureorrecordsexist,scoreNO.是否有文件化的检查程序来接受，抽样和标识所有原材料。确保检查程序包括接受和认证原材料。确保所有检查记录按照程序进行300MS3Arethereadequatespecificationsforallcomponentsandrawmaterialsreceived?Identification,type,grade,size,amount,weight,supplier,etc.原材料/零件的产品规格，包括识别，类型，等级，大小，数量，重量，供应商等信息300MS4ArerawmaterialsadequatelyquarantineduntilreleasebyQAto

production?Samplemultiplerawmaterialsandensurearecordexiststotracefromreceipttoqualification.Ifnotrailexists,scoreNO.是否所有原材料在分发给生产部之前都有QA检查记录，抽样300MS5Areallcomponents(rawmaterials,primaryandsecondary

packaging)beingtestedagainstappropriateandestablishedspecifications?所有零件（原材料，主要和次要包装材料）都按照和事的规格测试300MS6Whererawmaterialsarenotfullytestedagainstspecifications,isthereaprogramforqualifyingsuppliers?如果原材料没有合适的测试，有没有供应商认可程序300MS7Wherehistoricaldataisusedtoqualifysuppliers,doeshistorical

dataincludeinformationonallthecharacteristicslistedinthespecification?如果历史数据用来认证供应商，这些历史数据是否包括材料规格书中列出的所有特征。200MS8Doesthehistoricaldatasupporttheuseofreducedtesting?是否有历史数据来支持减少测试的动作200MS9Whereauditsareusedtoqualifysuppliers,areauditreportsadequateandavailableforreview?

Auditreportsshouldcontainnameofsupplierandauditor.Theyshouldcontaininformationregardingtheprocessand/ordepartmentscovered.Theyshouldreferencethemethodologyand/orrequirementsusedtoassessthesupplier.如果用审查来认可供应商，那么是否有审查报告，这些报告包括供应商名字，审核员，他们也应该包括流程，部门。应该有审查方法，要求等200MS10Doesaprogramforperiodicauditingofvendors(materialand

servicesuppliers)exist?是否有对供应商定期审查200MS11IfCertificatesofAnalysisareaccepted,verifythatatleastonone

lotperyeartheitemisfullytested?如果接受分析认证。至少对原材料每年测试一批300MS12Arerawmaterials,in-processmaterialsandfinishedproducts

adequatelystoredandhandledsoastoavoidexposuretophysical,chemicalandmicrobiologicalcontamination?原材料，在制品和成品存储是否良好，避免暴漏在物料理，化学和微生物污染的环境中300MS13IsthereanadequateprogramtoensureFIFO?是否有先进先出控制？100MS14Isthereaformalprogramforthere-qualificationofrawmaterials

storedforlongperiodsoftime?

Iftheproductunderassessmentrequirespotentmaterials,ensurethatthesupplierhaseffectivecontrolofexpiredorlesspotentmaterial.Ensurethatrequalificationprocessisadequatetoensurethepotencyofrawmaterial.Ifre-qualification

isinadequate,theanswerisNO.Ifpotencyisnotapplicabletotheproduction,

theanswerisN/A.有没有正式的材料重新测试程序(材料长时间存放后需要做测试)300MS15Arerawmaterials,in-processandfinishedproductsadequatelydispositionedwhenfailingtomeetestablishedspecifications?

Ensurethataprocessexistsforlabelingand(ifappropriate)quarantineofnonconformingmaterialexists.Ensurethatrecordsexisttodemonstratedispositionofnonconformingmaterial.Ifnoprocessorrecordsexist,scoreNO.对于不良品是否有合适的处理，确保不良品有合适的标识，有相关的记录来追踪不良品处理300MS16Isthereanadequateprogramtoestablishthequalificationsand

reliabilityofsuppliersprovidingrawmaterialsiffulltestingisnotconductedonincomingrawmaterials?

Suppliersmustbequalifiedbasedonsoundreasoning.Whatistheimpacttothefinalproduct?Howdoesthefactorysourcenewsuppliers?ThesequestionsmustbeassessedinordertoscoreaYES.如果不是对原材料进行fulltest,是否建立一个合适的程序300MS17Doesthefactorydocumentandtracktheirsupplierreliability

(performance)?Reviewfactory'ssupplierreliability/performancetrackingdocument.RecordsshouldincludeCompany,item,incomingquantityandrejectedquantity.供应商是否追踪供应商的表现，追踪记录必须报还公司，物料编号，来料允收/退货300MS18Arerawmaterialsstoredinacontrolledareatoavoidtheft,loss,

damage,deterioration?Allrawmaterialshouldbeinanareathatiswithinfactoryperimeter,inasecureareathathasaroofandisnotsubjectedtobadweather,waterontheground,etc.

Rawmaterialsshouldbeplacedonpalletsorstoredonshelving.Thereshould

beassignedpersonneltomonitorthisarea.所有原材料必须放在一个受控的区域，避免被盗，丢失，损坏和变质。须有房顶不受天气影响，材料放在栈板上，有专门的看护人员300MS19Doesfactoryusesubcontractorsbasedonqualificationandverification?

Doesthefactorysubcontactphaseofproductioni.e.printing,embroidery,washing,packaging,etc.工厂是否使用被认真的分包商？300MS20Isproductinventoriedandreconciledwhenreceivedfrom

subcontractor?

DoesthefactorycounttheproductwhenitissenttotheSubConandreceivedfromtheSubConandcomparethenumbersagainsttheirrecordstomakesurethateverythingisaccountedfor?从分包商收回的部件是否点数300MS21Isproductreceivedfromsubcontractorinspected?(Records

mustexisttosupport.)

DoesthefactoryQCTeaminspecttheproductreceivedfromtheSubcontractor?Askforprocessdocumentationandreports.Processdocumentationshouldindicatequantitytobeinspectedandtheprocessbasedontheproductoroperationperformed.Reportsshouldincludethefollowinginformation:Inspectorsname,date,incomingquantity,samplesize,defectsfoundandcorrectiveaction(ifapplicable).BothmustbeavailabletoreceiveaYES.从分包商发回来的物料是否有品质检查-检查记录300MS22Doesevidencesupportsubcontractorhasadocumentedquality

controlprocess?

CanthefactoryprovidedocumentedevidencethattheSubcontractorusesforQC?Lookforprocessflows,DCLorsimilardocumentswithinspectionresultsperformedbySubcontractor,defects,etc.是否有证据证明分包商有自己的品质控制程序。300TOTALSCOREFORTHISSECTION6000ProductionSystemManufacturingControlsPR1Dobatchproductionrecordsforeachformulatedfinishedproduct

containtherequiredinformationregardingtypesandamountsofmaterials?批生产记录是否包含原物料类型，数量信息300PR2Dobatchproductionrecordscontainadequateinstructionswith

respecttothemanufactureoffinishedproducts?批生产记录是否包含成品生产的充足指示200PR3Aretheactionsofindividualsincompliancewithestablished

procedures?员工的作业是否符合已经建立的程序200PR4Arecriticalstepsinthemanufacturingoperationcheckedbya

secondindividual?关键工序的制造操作是否有第二个人检查确认300PR5IsQAinvolvedinmonitoringtheproductionoffinishedproducts?

QAmustbeprovidedthefinishedproducttoconductinspectionactivitiesrequiredbyspecifications.QA是否监测成品的生产，QA必须按照产品规范检查成品300PR6AredocumentedPRODUCTIONproceduresorinstructionspresent

ateachproductionoperation?

Whileontheproductionfloor,lookforproductionproceduresateachoperation/machinery.MustbeavailabletoreceiveaYES.是否每个工位都有生程序或生产指示。在生产车间的每个作业点，机器旁寻找作业程序/指导书100PR7Doesthefactoryperforminlineinspections?

Reviewthefactory'sdocumentedinlineinspectionprocedure.ThedocumentmustexisttoreceiveaYES.工厂是否进行在线检查？查看工厂在线检查程序。300PR8Isthereaformalprogramforensuringthequalificationofall

processingequipmentwithrespecttoinstallation,operationandperformance(IQ/OQ/PQ)?

Ensurethatequipmenthasbeeninstalled,qualifiedandcalibratedadequately.Ensurethatprocessparametershavebeenidentifiedandthatverificationpracticesareineffect.Ensurethatanychangetoequipment(i.e.partreplacement,etc.)havebeeninstalled,qualifiedandcalibratedadequately.Ifrecordscannotsupportthispractice,scoreNO.是否有机器设备安装，操作，运行的认可程序？确保所有机器正确安装，充分认可以及充足的校验。确保有效识别确认生产参数。确保任何针对设备变更（例如更换零件）都得到充分的认证和校验。300PR9Isequipmentproperlyinstalledastoallowforreasonablecleaning,maintenanceandcalibration?设备是否安装合理以便于清洁，保养和校验200PR10Aretherewrittenproceduresforensuringthecleanliness,maintenanceandcalibrationofequipment?是否有针对设备清洁，保养和校验的程序200PR11Isequipment(includingutensils)adequatelylabeledwithrespect

toitsconditionregardingcleanlinessandoperationalcapacity?设备（包括治具）是否标识出设备状态，如清洁和操作能力200PR12Doesequipmentstatuscorrelatetocleaninglogentries?机器状况是否和清洁记录相符合100PR13Iscleanedequipment(includingutensils)adequatelyprotected

fromcontaminationpriortonextuse?

Ensurethatthestorageofequipmentisadequatetoprotectagainstcontaminationthatwouldimpactthequalityoftheproduct.Ifnotstoredadequately,scoreNO.机器（包括治具）是否定期清洁确保下次使用没有污染？确认生产设备存储能防止污染到产品的污染源300PR14Isthehandlingofwastematerials(liquids,dust,solids)adequate?

Ensurethatpaperwaste,productionwasteandliquidwasteareproperlydisposedofanddonotposeacontaminationthreattoproduction.Additionally,ensurethatwastecontainersareemptiedonanongoingbasisandwasteisnotoverflowingontothefloor.废弃物处理（废水，废弃，废渣）是否合适。确保废纸，生产废料和废液合理处理，不会威胁到产品受污染。定期倾倒废弃物。确保他们没有溢出到地板上。100PR15Areretainsamplesofallbatchesproducedmaintainedappropriately?Wheresamplesareretained,ensurethatthestorageareaisconstructedsothatmixupiseliminatedandtheareadoesnotposeaphysical,chemicalormicrobialcontaminationthreattoscoreYES.保留样是否保养合理？样品留置区域构建合理，能有效避免混乱。隔绝物理/化学或微生物污染。100ComplaintHandling/Recall/Re-workPR16Isthereawrittenprocedureforhandlingconsumercomplaintsand

adverseevents?

Proceduremustcontainresponsibleparties,methodologies,timelineforevents,record

keepingrequirementsandreferencetocustomernotificationwhereapplicable.是否有消费者投诉或不良事件处理程序？程序必须报考责任方，方法，完成时间。记录保存，以及通知客户（如适用）300PR17Iseachcomplaint/eventuniquelyidentified?是否每个投诉都有制定的识别码/编号？100PR18Doestheprocedurerequirethatthecomplaintberesolved/investigatedwithinaspecifictimeframe?客户投诉处理程序是否要求投诉必须在制定的事件内处理/调查完成200PR19Canthecompleteness/timelinessoftheinvestigationsbeverifiedbyarandomexaminationofthecomplaintfiles?

Reviewallcomplaintsrelatingtoproductsandrandomlysamplecomplaintsrelatingtoproductssuppliedtoprivatelabelcustomers.Ensurethatcomplaintprocedure

hasbeeneffectivelyfollowed.Ifanycomplaintrecorddemonstratesnon-conformancetoestablishedprocedure,scoreNO.是否可能随机检查投诉文件确认调查是否按时完成？审查所有关于产品的投诉，随机检查DI的主要产品。确保投诉处理程序被正确执行。发现任何不符合，答案是NO。300PR20Areretainsamplesexaminedortested,asnecessary,duringacomplaintinvestigation?如有需要，是否在做投诉调查的时候检查/测试保留样品。200PR21Hastherebeenarecallofanyproductwithinthelastfiveyears

andifso,wastherecallprocedureutilizedeffectively?

Ifnorecall,scoreN/A.Iftherehasbeen,ensureallrequirementsoftheprocedurehavebeenfollowedaccordinglytoscoreYES.在过去5年内是否有产品召回，如果有，产品召回程序是否有效？如果没有产品召回，SCOREN/A.300PR22Isthereawrittenprocedureoutliningtheprocessforconductinga

recall?Proceduremust

containresponsibleparties,methodologies,timelineforevents,recordkeepingrequirementsandreferencetocustomernotification,whereapplicable.是否有产品召回程序，程序界定责任方，方法，时间期限，记录保存以及参考客户通知（如适用）300PR23Doestheprocedurerequireconducting“mock”recallsorsome

othermeanstoverifytheadequacyandeffectivenessoftheprocedure?产品召回程序是否有关于模拟召回的规定或其他方式确认程序的有效性200PR24Isthereanadequateformalwrittenprogramfortheadministration

ofreturnedproducts?

Thisprogrammustensurethesafety,identification,quality,potency,andquantityofreturnedproductsareverifieduponreceiptofreturnedmaterial.是否有书面的程序管理被退回的产品？这个程序必须确保产品一旦被退回，受到后立即确认安全识别数量效能和品质200PR25Isthereevidencethatreturnedproductsarebeingappropriatelyprocessedaccordingtowrittenprocedures?

Recordsforreturnedproductsmustcontaindeterminationofreasonforreturn,determinationofscrap,rework,restock,orotherdispositionaccordingtotheprocedure.Recordsmustalsocontainassociateddatesandauthority.是否有证据证明被退回产品按照书面流程处理。处理记录必须包括退回原因，报废，返工，重新出货或其他处置。记录必须包括相关日期和作者200PR26Isthereawrittenprocedureforin-processmaterialsorfinished

productsthatfailtomeettherequiredmanufacturingstandards/specifications?Recordsforin-processproductsplacedon"HOLD"mustcontaindeterminationofreasonforreturn,determinationofscrap,re-work,restockorotherdispositionaccordingtotheprocedure.Recordsmustalsocontainassociateddatesandauthority.是否有在制品/成品的不良处理程序。关于生产“onhold”的不良必须有不良原因，报废，重工，重新装车或其他处理方式。要包括相关日期和作者300PR27Aretheinvestigationsofthenon-conformingmaterialsbeing

conductedinatimelymanner,asdescribedinthewrittenprocedure?不合格品是否按照程序及时处理300PR28Areinvestigationsinvolvingnon-conformingmaterialsadequately

documented?针对不良原材料的调查是否被归档200PR29Arenon-conformingmaterialsre-workedbaseduponadequate

qualification,asdefinedbytheprocedure?不合格材料重工是否依照程序被充分认证200PR30DoesQAapproveallofthere-workprocedures?QA是否批准重工程序300PR31Isthereanadequateformalwrittenprocedurefortheretentionofreservesamplesforeachbatchofproductmanufactured?

Thisprogrammustincludetimerequirements,responsibleparties,location,andanyotherrequirementnecessarybythetypeofproducttoensureconsistencyofthesamplewhencomparedtoreleasedfinishedproducts.是否有程序来规定保留每次不良的不良样品。这个程序必须包括时间要去，责任方，位置和任何其他根据产品类型来确保样品和处理样品想比较的信息200TOTALSCOREFORTHISSECTION7000PackagingSystemComponentTestingProgramPA1Arefinishedproductsadequatelycontrolleduntilreleasetodistribution?Samplemultiplefinishedmaterialandensurearecordexiststotracefromfinalinspectiontorelease.Ifnotrailofrecordexists,scoreNO.成品在出货之前有合适的控制，抽取一些材料来验证是否有成品检查记录，如果没有则为NO.300PA2DoesQAhavefullauthoritytoacce