质量验厂清单

FCCAQualitySystemAuditOutlineFCCA质量体系审核纲要(Hardline杂货)(QualitySystempart质量体系部分)FactoryQualitySystem工厂质量体系责任人1.0FactoryFacilitiesandEnvironment工厂设施和环境1.0.1Thereissufficientlightingon:Production,revising,finishing,inspection,packingandloadingareas?在生产，修理，加工，检验，包装及装载的区域是否有足够的照明？1.0.2Thefacilitymaintainscleanandorganizedproduction,finishingandpackingareas.工厂是否保持清洁,在生产，加工和包装区域是否有秩序?1.0.3Facilityhasseparateinspectionareawithinspectiontableandproperventilation.工厂是否有单独的检验区与检验台并且通风良好?1.0.4Facilityhasdocumentedpests/mildewandmoisturecontrolprogram,whichincludesfrequentinspections.(In-houseor3rdparty)工厂是否有害虫/霉菌和湿度的控制程序文件?是否有经常巡查(公司内部或第三方检查)?1.0.5Nobrokenwindowsorleakingroofsthatmayresulttoproductcontaminationwasobservedduringaudit.在审核其间有没有发现窗户破损及房顶漏水可能导致产品污染。1.0.6(Critical)Factoryimplementsstrictsharptoolscontrolproceduretopreventscissors,knives,blades,brokenglasses,andneedlestobemixedwithproduct.(严重)工厂是否实行严格的利器控制程序，以防止剪刀、小刀、刀片、碎玻璃及针等混入产品中。1.1MachineCalibrationandMaintenance机器校准和维护1.1.1Factoryhasdocumentedsystemandprocedureforscheduledequipmentcleaningandrepairs.工厂是否有书面的文件系统和程序计划安排设备的清洁及维修。2C-PD0021.1.2Factorymachinesandequipmentsappeartobecleanandingoodrunningcondition.工厂的机器和设备是否清洁及运行良好。1.1.3Machines,equipmentsandtoolsareproperlylabeledwithdateoflastmaintenance/calibrationandschedule.机器、设备和工具是否有最近的维护/校准日期及计划日期的标识。1.1.4Machines,equipmentsandtoolsthatneedtoberepairedareproperlylabeledtoavoidaccidentaluse.需要维修机器、设备和工具是否有维修标识以避免意外使用。1.1.5Factoryhasproper,cleanandorganizedstorageareaofcriticaltooling(i.e.injectionmoulds)withlabeledshelves.工厂是否有适当，整洁的存储区域储存关键模具(比如:注射模具),并且放在有标识的架子上。1.1.6Factoryhasproperdocumentationandupdatedinventoryofmachines,tools,spareparts,andequipments.工厂有适当的机器、工具、零部件和设备的库存文件，并保持更新。1.1.7Factoryhasmaintenanceteamwithsuitableskilllevelandequipmentstoperformnecessaryrepairandcalibrationonmachines.工厂是否拥有一定技术水平的保养团队和设备可以执行必要的机器维修和校准的工作。2.0QualityManagementSystem质量管理体系2.0.1FactoryhasestablishedQualityManagementSystemthatisappropriatetotheirproductsandprocedures.工厂是否建立起符合他们产品和生产流程的质量管理体系。2.0.2Workers&Supervisorsarefamiliartothesequalitypoliciesandobjectives.工人与主管是否熟悉这些品质政策和目标。（全员品管，质量就是生命。）2.0.3Factoryhasdocumentedcustomercomplaintsystemanddocumentedrecallprogram.工厂是否建立了顾客投诉体系及产品召回程序。3C-QA0082.0.4(Critical)FactoryQCteamisindependentfromProductiondivision.(严重)工厂QC团队是否独立于生产部门。2.0.5ProductionmanagementandQCteamdiscussandworktogetherinsolvingQualityissues/concerns.(Documented)是否有书面记录显示生产管理和QC团队共同讨论、解决质量问题及其他相关的问题.2.0.6Factoryhassystemsandproceduresinplacetocontroltheriskofphysical,chemical,andbiologicalcontaminationthatmaydamagetheproductandpersonnelaswell.工厂是否有系统和程序去控制那些可能会影响产品或对人造成伤害的物理、化学和微生物污染风险。2.0.7Factoryconductsriskassessmentstoidentifyhazardsfromchemicals,rawmaterials,processequipments,andtools.工厂是否进行风险评估，以识别化学品、原材料、工艺设备和工具中带来的危害。2.0.8Isfactoryaccreditedwithanyinternational,nationalorcustomerqualitystandardsassociation(e.g.ISO9001,etc.)?工厂是否取得了国际的,国家的或客户的质量标准组织认证证书(例如:ISO9001证书,等.)?3.0IncomingMaterialsControl来料控制3.0.1Hasthefactorytakenadequatemeasurestoassurerawmaterialsconformancetorequiredspecificationsbeforeuse?工厂是否检测原物料以确认是否与要求的明细规格一致?3.0.2Properfirstin-firstout(FIFO)systemonmaterialsarepracticed.工厂是否实施物料先进先出(FIFO)体系。2C-WH0013.0.3Factoryhasprocedures(instructions,guidelines,anddocumentedrecords)forqualityinspectiononincomingrawmaterials,accessories,andcomponents.工厂是否有进仓原物料、配件和部件的质量检验程序,作业指导书,及记录文件。2C-QA0123.0.4Isneededtestingequipmentavailable,andmaintainedingoodcondition?所需的来料测试仪器是否配备及保持在一个良好的状态?3.0.5Arerawmaterialsproperlylabeled,stored,andtraceable?所有的原物料是否有合适的标识,储存及可溯性？3.0.6Factoryhasdocumentedprocessandreferencesamplesthatensureincomingrawmaterialsconformtospecifications.工厂是否有文件程序和参考样品以确保来料符合规格。3.0.7(Critical)Factoryhaspropersystemonmaterialsegregationtoavoidaccidentalcontaminationfromrejecteditems.(严重)工厂是否建立起适当的物料控制体系,以隔离不合格的原材料及避免意外污染?3.0.8Factoryproperlyseparategoodqualityitemsfromrejectsandidentifiesnon-conforming(rejects)materialsforreplacement.工厂是否分离良品与不良材料，并标识所需更换的不良材料。3.0.9Facility’sstorageareashavesufficientlighting,wellventilatedandcleansurrounding.厂房的存储区域是否有足够的照明、通风和清洁。3.0.10Materials,components,andaccessoriesareproperlystackedandidentifiedwithtags/labelsandoffthefloor.材料、部件和配件是否妥善堆放并有标牌/标签,且与地板隔离。3.0.11(Critical)Chemicalsandmaintenancesubstancesareproperlymarkedandstoredtopreventriskofcontamination.(严重)化学品和保养的物质是否妥善标识和储存，以防止污染的风险。3.0.12Doesfactoryhaveadocumentedsupplierselectionandapprovalprocess?工厂是否有书面的供应商的的选用和认可流程?3.0.13Doesfactorytrack,evaluateanddocumentmaterial’ssupplierreliability(performance)?工厂是否跟踪及评估物料供应商的可信度(表现)并记录在案?3.0.14Doesfactoryhaveanestablished,documentedqualityprocedureanddoesfactoryevaluate,monitorsub-contractorqualityperformanceandreliability?工厂是否建立起书面的对分包商的品质控制流程文件?是否有评估及监督分包商的品质表现及信赖度?4.0ProcessandProductionControl过程和生产控制4.0.1DoesfactoryPDstudyandapplyproductsafetyfeatures,evaluatespatterns,moulds,andsamplesduringproductdesignanddevelopment?产品设计和开发部门是否在产品设计及开发过程中研究与应用产品安全特性,评估样式、模具和样品？4.0.2FactoryhasdocumentedQualityprocedures(QP)ateachstageofoperation.工厂是否在每一