WM-FCCA-质量验厂审核重点介绍(非电器类)-2014年

33FCCAHardlines-Non-ElectricalChecklist杂货-非电类审核表34ContentOfTheChecklist审核表內容Section章Scope&Description范围及描述1.0FactoryFacility&Environment工厂设施及环境2.0QualityManagementSystem质量管理系统3.0IncomingMaterialQualityControl来料质量控制4.0ProcessandProductionControl过程及生产控制5.0In-HouseTesting内部测试6.0FinalInspection最终检验7.0PeopleResourcesandTraining人力资源及培训353210WellDocumented,ControlledandEffectivelyImplemented好的文件化并有效的执行EffectivelyimplementedbutnotwellDocumented有效的执行,但文件化不够DocumentedbutPartiallyImplemented有文件化,部分的执行Nodocumentationand/ornotImplemented.没有文件化,没有执行PRINCIPLESINRATINGGUIDELINES判分指引的原则FactoryCapability&CapacityAudit(FCCA)SupplerSeminar供应商研讨会Section1.0FactoryFacilitiesAndEnvironment第1.0章工厂设施及环境37Section1.0FactoryFacilitiesAndEnvironment第1.0章工厂设施及环境1.Arelightingsufficientinthefollowingkeyareas以下主要区域光度是否充足?1.1.InspectionAreas检测区1.2.ProductionAreas生产区1.3.Packaging包装1.4Warehouse/StorageandLoadingAreas货舱/存放及上落货区InspectionAreas检测区ProductionAreas生产区Warehouse/Storage&LoadingAreas货舱/存放及上落货区LightIntensity光亮度Packaging包装38LightSource光源Inspectiontable1检测台1Inspectiontable2检测台2Inspectiontable3检测台3Sample1取样1Sample2取样2Sample3取样3•Atleast3samplepointstakenforlightingmeasurement光度量度最少取3个样本•Reportthelowestone以最低度数作报告NOTE:Ifthelightingreadingishigherthanthemaximumrangebaseontheratingguidelines,givethehighestpossiblescore.备注:如果照明的读数高于评分规则中的最高值，给最高分Section1.0FactoryFacilitiesAndEnvironment第1.0章工厂设施及环境39✔✔✘MinimumRequirement1.1.InspectionAreas检测区75-100footcandles尺烛光(750-1000lux勒克斯)orabove及以上1.2.ProductionAreas生产区50-75footcandles尺烛光(500-750lux勒克斯)orabove及以上1.3.Packaging包装30-50footcandles尺烛光(300-500lux勒克斯)orabove及以上1.4.Warehouse/StorageandLoadingAreas货舱/存放及上落货区20-30footcandles尺烛光(200-300lux勒克斯)orabove及以上Section1.0FactoryFacilitiesAndEnvironment第1.0章工厂设施及环境401.0.1Minimum3readingsshouldbetaken(Luminanceontask)andonlythelowestreadingwillbethebasisandwillbegradedaccordingtotheratingguidelines光度量度最少取3个样本,以最低度数作报告NOTE:Ifthelightingreadingishigherthanthemaximumrangebaseontheratingguidelines,givethehighestpossiblescore注意:如光度数超出准则最大范围,将获取最高分数Section1.0FactoryFacilitiesAndEnvironment第1.0章工厂设施及环境41►2.Thefacilitymaintainscleanandorganizedproduction,finishingandpackingareas.工厂的生产，成品和包装区域保持干净和有序的生产Theareashouldbecleanandwithoutunnecessaryequipment.Shouldfollowalogicalflowofproduction.Noblockedaisles.Throughoutthecourseoftheassessment,observationofcleanlinessshouldbetaken.Cleanlinessshouldbedefinedasanenvironmentthatreducesand/oreliminatesthepotentialforcontamination这些区域应保持干净且没有不必要的设备；应合乎生产流程；通道不能堵塞；审核过程中应观察各区域干净整洁与否。清洁度应定义为能减少或消除潜在污染风险环境要求。✘✔Section1.0FactoryFacilitiesAndEnvironment第1.0章工厂设施及环境42►3.Facilityhasseparateinspectionareaforeachdepartmentwithinspectiontablesandproperventilation工厂每个部门有独立的检验区域，有检验桌和适宜的通风。Enclosedroomthatisonlyusedforqualityinspectionsisbest.Areaonthefloorthatisonlyusedforinspectionsisalsoacceptable.Clearingoffaproductiontable,etc.isNOTacceptableandwillreceiveaZero(0)Score.ItmusthaveenoughroomforbothQCInspectorandworkerstoperformtheirjobswithoutinterferenceandinsafeconditions.Enoughroomfortheequipmenttofunctionasintendedandwellventilatedwithconstantairmovement:Ceilingfans,wallfans,roofvents,etc.Theareashouldbecomfortableforworkersascountryconditionspermitandappropriate&havesufficientlightingenoughtobeabletoperforminspectionwithouthavingtostraineyesight.Noblockedaisles.ForInline/Dupro(IPQC)couldconductinspectionusingworkingtableofworkers最好是有密闭的单独用作质量检验的房间,指定某个区域专门用做检验的也可以接受；若借用生产用的工作台,只是清理一番后作为检测台是不能接受,会评为0分;作业员和检验员都应有足够的（安全且互不干扰的）空间来完成各自的工作。空间应确保操作设备的需要且通风良好：吊扇、壁扇、屋顶通风口等。这些区域应适于员工作业和检验；且通道畅通楼层有特定的检测位置是可以接受的..要有足够的空间供给检验人员做检验工作。如果和工人共用桌面，应互不干扰。Section1.0FactoryFacilitiesAndEnvironment第1.0章工厂设施及环境43Ifcontracted,thatacontractexiststhatdocumentsaregularlyscheduledpestcontrolserviceprogram.Thecontractpackageshouldincludeataminimum:a)Writtendocumentationregardingtheserviceperformedandtypeofmaterialsused;b)Acurrentmapindicatingthelocationsofallrodenttraps;c)Copiesofthelicensesandcertificatesofinsuranceforthepestcontrolcompanyandcurrentlicenseforinspectors.Reviewarepresentativesampleofinspectionrecordsfromthelast12months.Ensurethatanypestproblemsnotedhavebeenaddressedandhadbeenaddressedpriortothenextinspection.Ensurethetraps/devicesaretraceableeitherbynumericallabeling,bar-codingorothermethod.Ensurethatthepestcontrolinspectorhasinitialedorprovidedsomeotherdocumentationtosupportthatalltrapshadbeenproperlyinspected.►4.Facilityhasdocumentedandadequatepestscontrolprogramwhichincludesfrequentinspections.(in-houseor3rdparty)工厂有文件化的和足够的害虫控制程序和检验记录（内部或第三方）Section1.0FactoryFacilitiesAndEnvironment第1.0章工厂设施及环境44Section1.0FactoryFacilitiesAndEnvironment第1.0章工厂设施及环境外部害虫控制：则定期的虫害控制服务合同应至少包括以下几点：控制计划，服务具体内容，用药类型，灭害装置（扑鼠器，灭蝇灯）位置图（编号，检查记录），提供服务的第三方的资质证书及虫害控制员的资质证书评估最近12月内的有代表性的检查记录，确保所有发现的虫害问题在下次检查前已被解决确保所有的捕鼠装置可按照标签、条形码或其它方法进行追溯；虫害控制员确保可提供其它必要的支持文件以证明所有的捕鼠装置均已检查Ifdonebyfactory(in-house),check:a)Writtendocumentation:procedure,workinstructionsandrecordsofscheduleb)Acurrentmapindicatingthelocationsofallrodenttraps;Finally,toreceivea3scoreforthisquestion,nosignofrod