工厂质量评估报告

WrittenbyPeterat2021inJanuary工厂质量评估 报告 软件系统测试报告下载sgs报告如何下载关于路面塌陷情况报告535n,sgs报告怎么下载竣工报告下载 GeneralMillsNON-DOMESTICAUDIT.Asia,MiddleEast,India)QUALITYASSESSMENTREPORT工厂质量评估报告Date日期:August20to21,2007Auditor审核员:MrLeeFaiDateofVisit审核日期:FORMTEXT
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     ReasonforVisit:XInitial/NewFacilityAudit新厂审核审核原因FORMCHECKBOX
Re-Audit/Follow-upVisit复审/跟踪访问FORMCHECKBOX
Production/In-lineSurveillance生产/线上监督FORMCHECKBOX
Other____________________TypeofManufacturing:FORMCHECKBOX
Printing印刷生产类型FORMCHECKBOX
InjectionMolding啤塑FORMCHECKBOX
Overwrapping自动包装FORMCHECKBOX
Plush(SoftToy)毛绒玩具FORMCHECKBOX
DieCast合金XOther其它__密胺餐具____________________Supplier供应商:BlancoManufacturer生产商:昆山统福美耐磁制品有限公司Location地址:中国江苏省昆山市同丰东路９６８号FORMTEXT
     Telephone:０５１２－５７０３３６６６，５７０２２３８８FORMTEXT
     Fax:０５１２－５７３１６８６８，５７３０２０４６FORMTEXT
     E-mail:FORMTEXT
     Premium(s)beingconsideredformanufactureifapplicable:FORMTEXT
     若适用,赠品亦在考虑生产之内:GMI/CPW/LaboratoryAttendees审核方参加者Supplier/FactoryAttendees;Titles工厂参加者/职位FORMTEXT
     ＭR,GU/厂长FORMTEXT
     MRS,ZHOU／人事经理Requirement要求Result结果CriticalItems严重项目MEET/DNMSectionMinimumAcceptablePercentage章节最低接受百分比MEET/DNMOverallSectionScore(1-6),87%minimum整体章节分数(1-6),87%最低MEET/DNMOverallSectionScore(7-10),%minimum整体章节分数(7-10),%最低MEET/DNMScoringofAssessment评估得分章节Minimumaccepted(%)最低接受(%)%yesSectionweighting章节比重Minimum最少%xweight比重Section1Facility&Maintenance厂房设备和维修保养8544Section2ControlofIncomingRawMaterials来料控制8545Section3Sanitation(Molding,Production,Assembly,Packout)卫生(啤塑,生产,装配,包装)853217Section4QualitySystems:质量系统OrganizationandManagement组织和管理8567QualityPrograms质量程序9071In-ProcessControlandTesting制程控制与测试9076Section5Pre-ShipmentInspections出货前检验851005Section6ProductTesting产品测试8500OverallSectionScore(1-6)整体部份得分Limitoverallsectionscore(1-6)限制整体部份得分87Section7Wages&LaborPractices工资与劳工8510025Section8ChildLabor童工1003325Section9Health&Safety健康与安全859223Section10Dormitories宿舍8590OverallSectionScore(7-10)整体部份得分Limitoverallsectionscore(7-10)限制整体部份得分NOTE:Itemsmarkedwith"*"areconsideredascriticalnon-complianceareas.Any'No'ratedinthe(*)willleadtoimmediatefailureoftheFactoryAudit.注意:有"*"部份为重要不符合地方。任何在(*)位置上有'No'将立即导致工厂审查不合格。Thepercentageofyes'withineachsectionmustmeetorexceedtheminimumacceptablepercentagerequirementforthatsection.Non-compliancewiththisrequirementwillresultinanoverallfailureoftheaudit.在每一部份的”yes”百分比必须达到或超过该部份的最低可接受百分比要求。如不能符合这项要求，审查结果将会视为整体不合格。FinalapprovaloffactoryisdeterminedbyGeneralMills/CPW.最终工厂审批由GeneralMills/CPW负责。AssessmentScopeandSummary:审查范围及总结:SignatureofAuditor审查员签署：PrintName全名:FactoryProfile-SelfQuestionnaire工厂简介-自我调查表A.CertificateofQualityLicenseforExportCommodities出口许口证发证日期[FORMTEXT
 √    ]YesDateofIssueJan201994__________[FORMTEXT
     ]NoB.IsthefactoryISO9002certified是否通过ISO9002认证若无,预计日期[FORMTEXT
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 √        ]Yes[FORMTEXT
     ]NoIfnot,dateanticipated_________C.IsfactoryISO14001certified是否通过ISO14001认证若无,预计日期[FORMTEXT
     ]Yes[FORMTEXT
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 √      ]NoIfnot,dateanticipated____未定_____D.FactoryOrganizationalStructure工厂组织架构ManagingDirector董事长FORMTEXT
 √    GeneralManager总经理FORMTEXT
 √    MarketingManager市场部经理FORMTEXT
 √    TechnicalManager技术部经理FORMTEXT
 √    EngineeringManager 工程 路基工程安全技术交底工程项目施工成本控制工程量增项单年度零星工程技术标正投影法基本原理 部经理FORMTEXT
 √    ./.Manager品质经理FORMTEXT
 √    ProductionManager生产经理FORMTEXT
 √    FactoryManager工厂经理FORMTEXT
 √    E.Yearofestablishment/operation建厂年限１３年F.FactorySizeblocks:storiescovering:ProductionAreasq.m:G.CapabilityofFactory(indicateallthatapply):生产能力Injectionmoldedtoys注塑玩具Ｎ／ＡRoto-castmoldedtoys搪胶玩具Ｎ／ＡBlowmoldedtoys吹塑玩具Ｎ／ＡElectrical/Batteryoperatedtoys电动/电子玩具Ｎ／ＡStuffed/Plushtoys填充/毛绒玩具Ｎ／ＡDie-casttoys合金玩具Ｎ／ＡOthers(List)其它密胺餐具　２５０万／月H.MajorBusiness主要业务[FORMTEXT
     ]Premiums赠品[FORMTEXT
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 √       ]Retail零售I.DoesfactorysubcontractanyworkIfyes,specifywhatissubcontracted.本厂是否给其它工厂加工若有,需特别注明[FORMTEXT
     ]Yes[FORMTEXT
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 √       ]NoFactoryProfile-SelfQuestionnaire工厂简介-自我调查表J.Numberofemployeesinfactory:工厂人数Workers工人５１９./(excludeproductionQC)品质人员３０Engineering工程人员１２Maintenance维修人员７Tooling夹具部人员１０Mgmt.staff管理人员９２Total总计６７０K..Manager/.Managerreport(s)to:品质经理报告给:总经理L.Does.Manager/.ManagerhaveresponsibilitiesotherthanqualityIfyes,pleasespecify.品质经理除质量外是否对负责其它若有,请指明[FORMTEXT
     ]Yes[FORMTEXT
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 √       ]NoM.MajorMachinesandEquipment(includenumberofeach):主要机器与设备(包括数量)集尘器１３立式沙带机１９打孔机６抛光机３０高周波机１１８油压成型机１２０SewingMachines:衣车无DieCuttingPress:冲压机无HairRooting:车发机无AssemblyLines:生产线无RotocastMachines:搪胶机无InjectionMolding:啤塑机无BlowMolding:吹气机无Plating:电镀无ToolingEquipment工具装备Lathes:车床4EDM:火花机Other其它DryingOvens:焗炉１４MetalDetectors(type)-includeaperturesizeanddetectioncapabilities:金属探测器无PowerGenerator:发电机无UVTunnels(type):紫外光管道无AdditionalEquipment:其它设备无Facility&Maintenance设备/维修保养YesNoNACommentsArethefactorygroundsandsurroundingenvironmentwithinfactoryboundariescleanandfreeofundesirablecontamination公司的周边环境及地面都保持干净,不受污染吗√Doesfactoryhaveamastersanitation/maintenanceprogram有没有卫生保养 制度 关于办公室下班关闭电源制度矿山事故隐患举报和奖励制度制度下载人事管理制度doc盘点制度下载 √没有具体的清洁方法和程序及清洁人员培训记录NoappropriateprocedureoncleaningmethodandtrainingrecordDorecordsindicatecleaning/sanitationforequipment/machines/productionschedulelinesDefinescheduleinComments.是否有设备/机器及生产线的清洁/卫生记录√Arefactory'smaintenancepolicyandproceduresformajorequipmentadequate.,generator,injection,moldingmachines,etc.),frequentenoughandbeingfollowedAremaintenancerecordsofmachinesandequipmentdocumented工厂有没有对主要设备(发电机,啤机及模具等)制定维修保养政策及程序,并保持充分及符合有无机器及设备的维修保养记录√Doesfactoryhaveawell-organized/establishedmaintenance/engineeringteamtogiveappropriateresponsetomachinerybreakdownoremergencythataffectsproduction在机器故障或紧急情况以致影响生产的情况下,工厂有无适当的维修及工程人员作出立即行动√Areregularlyscheduledpesteliminationservicesprovidedbyaprofessionalserviceinsideandoutsidefactory,ordoesthefactoryhavedocumentedregularinternalprocedureDefinescheduleinComments.(Reviewdocumentation.)AdvisenameofpestserviceinComments.有没有厂内或厂外专业的服务提供定期的害虫控制,或者有定期内部程序文件提供PCO服务者名称.√工厂没有进行定期的害虫控制及无杀虫剂使用清单Noregularpestcontrolserviceanddonothavethelistofpesticideusedinthefty.DoesFactoryhaveapesticideusagelog工厂有无杀虫剂使用日记√工厂无杀虫剂使用日记。Nopesticideusagerecord.已建议工厂去完成日记，在每次灭害后。Suggestftytoaddrecord.DoesFactoryhaveMSDSsheetsforallpesticidesanddangerouschemicalsusedatthisfacility所有杀虫剂及危险化学品设备,工厂是否保留MSDS证明√工厂无杀虫剂及危险化学品的MSDS证明。NoMSDScertavailable.已要求工厂保留MSDS证明。SuggestftytoobtainacopyofMSDScertforallchemicalusedinthefacilities.Arechecksofbaitstationsandinsectelectrocutersdocumented是否有诱饵区及电子脉冲装置检查记录√工厂外墙内侧未诱饵区及蒱获器Nobaitstationaroundtheexteriorofthefacility.DoesFactoryhaveareportofpestcontrolactivityincludingcorrectiveaction工厂是否有害虫活动迹象控制报告(CAP)√Areroofsinaccessibletopestsandfreeofexcessdebrisandattractants厂内无明显害虫及远离死昆虫和碎片√Arefactorygrounds(factorycompoundareas)pavedtopreventdust工厂地面铺面可防止灰尘吗√工厂地面（生产区域）是普通水泥地面。Productionareawithcementfloor.Arebuildingsadequatefortheprocessesandwellmaintained建筑物有适当监控及及较好维护√Tohaveorderlystorageinsidethefactory,areadequate(clean,wellmaintained)plasticstoragecontainersavailableforin-processstorageandfinishedproduct厂内有没有提供足够的干净好的容器来贮存半品及成品,且存货整齐有序√许多用来贮存半品及成品存在灰尘Heavydustfoundonthesemiandfinalproduct.Aretoiletsprovidedwithinfacilityboundaries生产区有没有厕所√AretoiletsandurinalscleanandfunctioningHowoftenaretoiletscleanedDefinefrequencyinComments.SanitizingagentusedforcleaningDefineinComments.厕所及便槽是否干净可用清洁周期:____________消毒剂:_____________√工厂使用外购的消毒剂清洁消毒（无固定牌号），清洁周期：每天一次。Nospecificbrandnameofsanitizerusedtocleanthetoilet.Theycleanthetoiletonceaweek.建议清洁工人经常性的巡检，保持厕所的卫生。Suggestftytocleanthetoiletmoreoftenandapplysanitizer.Arethereadequatehandsanitizingfacilitiesavailablein/neartoilets(liquidsoap,waterandhanddryersorhandsanitizer)厕所内有没有洗手设施(洗手液/水/干手机/杀毒剂)√工厂使用外购的滴露除菌洗手液和使用纸巾擦手，外购的消毒剂清洁消毒无固定牌号）。但是，有多个水龙头损坏Ftyuse“Dettol”ashandsanitizerandusetissuepapertodryhandsinsteadofairdryer.SeveralwashstationsarenotworkingAretheremapsoffireexitsoneachfloor每层楼有没有安全走火通道图√Areallemergencypassagesandexitsclear走火通道及出口是否畅通√部分车间的走火通道被货物堵塞，以及有走火门被关闭。Emergencypassageblockedwithproductsandthefireexitislocked.已建议所有指定的走火途径须保持畅通，以及不用锁走火门。Arefireextinguishers,sandand/orotherfireprotectionequipmentonhandproperlymaintainedwithinexpirationdate灭火器、消防沙及其它灭火设施是否在有效期内适当保养及随时可取√Total44%ControlofIncomingRawMaterials来料控制YesNoNACommentsArerawmaterialskeptincontrolled(sealed),lockedstoreroomstoavoidtheft,lossandqualitydeterioration原材料的使用是否受控,是否锁在仓库以避免被盗、损失及变质√全部来料处理依照来料控制程序，但部分原料未放置在指定的区域，及没有温湿度控制。Allincomingmaterialsarecontrolledaccordingtotheincomingmaterialcontrolprocedure,howevernotsignorpostertospecifytheproductlocationareaandnotemp/humiditycontrol.Isan18”perimetermaintainedforinspectionandcleaning储存区保持最小周长为18英寸(45cm)的检查区域及清洁区√在原料仓摆放的原料之间未有预留18英寸的检查及清洁通道。Rawmaterialareplacedwithlessthan18”perimeter.工厂须重摆放，以预留该通道。Explainedtotheftyonthisrequirement.Areincomingmaterialsclearlyidentified,properlypackagedforstorageandtraceabletosourcesofmanufactureasrequired来料有没有清楚标识、适当包装以便储存,并根据生产需要作追踪√部分材料的标识未有及时更新，以及外包装破损。Someincomingmateriallabelarenotuptodateandpackagingarebroken.建议工厂及时更新标识，以及采取措施，封好已破损的包装，防止污染。Explaintotheftythatthiswillcausecontaminationoftheproduct.Aretoxicandpotentiallyhazardousmaterialsadequatelyandeffectivelycontained,identified,storedanddocumented有毒及危险材料是否有效标识,储存并有文件记录√无指定的有毒或危险材料使用在工厂。Notoxicmaterialbeingusedinthefty.AreMSDSsheetsmaintainedfortoxicandpotentiallyhazardousmaterials可提供有毒物质及潜在危险材料的MSDS√两种材料，密胺粉及尿素粉是制造产品的主要材料，但工厂只能提供密胺粉的MSDS。Twomaintypeofrawmaterial–melaminemoldingcompoundandurea-formaldehydecompound.TheftyonlyabletoprovideMSDSformelaminecompound.已要求工厂提供有关尿素粉的MSDS。ExplaintotheftyandsuggestthemtoobtaintheMSDSofureacompound.Arereceivingproceduresandrecordsadequatetokeeptrackofthedateofreceipt,lotnumberandvendor是否有来料控制程序,并记录收据日期,批次及供应商名称以便追踪√Arequalityrequirementsandacceptancecriteriaclearlydefinedwithsignedsamplesavailableforreference客户对质量的要求及接受 标准 excel标准偏差excel标准偏差函数exl标准差函数国标检验抽样标准表免费下载红头文件格式标准下载 是否明确,以及签办是否可供参考√Isnon-conformingmaterialproperlysegregatedfromotherproductionmaterialstopreventuseinproduction不合格材料有没有合理地与其它生产材料隔离以避免在生产中不小心使用√部分不合格原料与合格原料存放在同一区域，且没有明显的标识。Nonconformingandconformingmaterialarebothplaceintheareaandnosignorpostertosegregatethesematerial.要求工厂立刻隔离不合格原料，并正确的标识。Isnon-conformingmaterialproperlylabeledastothestatusanddispositioninstruction不合格材料是否正确标识其状况及处理方法(不合格品的处理程序)√部分不合格原料未被正确的标识。Nonconformingmaterialnotproperlylabeled.已要求工厂立刻去正确的标识不合格原料。Areinspectionrecordsavailableandcomplete,whichidentifyacceptedandnon-conformingmaterials可否提供完整的确认合格或不合格材料的检验报告√IQC收货或退货报告。Yes,withIQCreport.DoesFactoryhavealistofapprovedrawmaterialsuppliers工厂有无合格供货商的名单√Isthereawrittensuppliercertificationprocedureusedforselectionandapprovalofsuppliers在选择及确认合格供货商时有无用到书面供货商证书程序作依据√Total45%Sanitation(Molding,Production,Assembly,Packout)卫生-啤塑/生产/装配/包装YesNoNACommentsWORKERS工人IsliquidhandsanitizerorotherhandcleanersavailablePleasespecifyinComments.有没有洗手液或其它√外购的滴露洗手液。Yes,useDettolsanitizer.Aresignspostedinstructingworkerstousesanitizerbeforeenteringtheproductionarea有没有张贴标识说明工人在进入生产区域前要洗手及干手√建议工厂张贴GMP指引在生产区域入口。SuggestftytohaveposteronGMPinstructionintheproductionareaDoworkerswearhairnetsAretheywornproperlyPleasespecifyinComments.工人有没有戴工作帽,且是否佩戴正确√各部门都有部分工人没有戴帽，及佩戴不正确。Nohairnetforsomeworkersandnotproperlyworn.建议工厂给工人明确的佩戴方法以及管理人员须经常去检查和纠正不正确的佩戴。Demonstratehowwearthehairnetproperlyandsupervisorneedtocontinuouslycheckandremindtheworkers.Areallworkersfreeofdanglingjewelry所有工人不准戴摇晃的饰物√生产车间仍有工人佩戴手链等饰物。建议工厂加强GMP教育。Danglingjewelryfoundintheproductionarea.SuggestedtheftytotrainupworkersonGMPmanagement.Doallworkershaveclean,fullyprotectiveclothes(smocks)所有工人是否穿着干净且有保护作用的工作服√部分工人没有穿着工作服工作。Someworkerswithoutprotectiveclothing.建议加强GMP教育。SuggestedtheftytotrainupworkersonGMPmanagement.Areemployeepersonalitemssuchaseatingutensils,cups,etc.,restrictedfromtheproductionareas生产区域不可放置有个人物品,例如饭兜、水杯等√工人的饮用水杯随意摆放在工作位。Drinkingcupsfoundintheproductionarea.建议加强GMP教育。SuggestedtheftytotrainupworkersonGMPmanagement.*Areworkerswhoarevisiblysick,haveopenwoundsorsoresexcludedfromdirectcontactwithrawmaterialsorproducts对于明显生病或有伤口的工人有没有被禁止直接接触原材料或产品√FACILITY设备Aredoorentrances,windows,vents,andfans(inallareasoffactory-molding,spraypainting,assembly,packout,etc)adequatelysealedorscreenedwithfinemeshtoexcludeinsects,birdsandanimals工厂内(啤塑/喷油/装配/包装等区域)出入口、窗户、排气扇、风扇有没有适当的纱网围住或屏蔽以防害虫,鸟及动物入内√所有生产部门的主要出入口没有安装塑料屏蔽帘及风机，且大门是被打开的。此外，货仓没有装上适当的纱网。Noplasticcurtainsatallentrance,nofinemeshforventsandfans.Doorwideopenattheproductionarea.Isrubbishstoredanddisposedtominimizeodorsandpreventtheattractionofinsects,birdsandanimalsHowoftenisitdisposedDefineScheduleinComments.垃圾贮存及有效清理减至最低气味并防止吸引昆虫/鸟及动物多久一次清理√所有垃圾贮存筒没有封盖，有吸引动物的可能，清洁垃圾筒每天一次。Trashbinarenotproperlycoveredwithlidandeasyattractinsects.Trashemptyonceperday.要求工厂使用可开合的垃圾筒，以及及时的清理垃圾。Advisedtheftytousepropertrashbin.Isproductionareafreeofobviousevidenceofinsects,mosquitoes,flies,rodentsorotherpests生产区是否没有昆虫、蚊、苍蝇、齿咬类动物等√包装车间的入口发现蜘蛛网。工厂内还有废弃水塘和大约二千平方米的杂草地Spiderwebwerefoundinthepackingareaanddesertpondintheftyarea.要求工厂立刻清理及进行灭害。Requestedtheftytocleanup.Areinsectelectrocuters,baitstationsandotherpestcontroldeviceslocatedinappropriatelocation.neardoorentrancesawayfromtheproductzone)andmaintained电子脉冲/诱饵盒或其它害虫控制装置布置在合适区域,远离生产范围,良好维护√工厂外墙内侧未诱饵区及蒱获器.Nobaistationorelectrocuterswerefoundintheproductionarea.Areceilings,floorsandwallsingoodconditiontopreventcontaminationfrompaintchips,dust,leaks,etc.天花板/地板及墙维护良好,以免被油漆碎片/灰尘/渗漏物污染√压制成型车间、打磨车间、地面上随处可看见灰尘以及产品的毛边。Allproductionareawithheavydust.建议工厂增加清洁的频次。Suggestftytoimprovecleannessoftheenvironment.Areoverheadstructures.piping)locatedaboveproductionzonesfreeofpeelingpaint,excessivedust,leaks,crumblinginsulation,etc生产区顶部结构(管道)有没有防止油漆脱落,多尘,泄漏或倒塌等√Isalllightingcoveredwithshattershields是否所有的灯具都有保护罩或安装防碎灯泡√Isthefloorfreeofdebris所有地面是否保持干净且无垃圾√包装车间地面随处可见包装物料的残余。Packingmaterialanddebriswerefoundonproductionfloor.Doallmachineslookcleanandfreefromoil,dirt,andothercontaminationandappeartobemaintainedingoodcondition是否所有的机器均保持干净,且无油、无尘及无污染并良好保养√部分没有使用机器随便摆放，同时也未标识其待维修或待用，车间电箱也未有警告标识和隔离。Nosignforthosemaintenancemachinesandnowarningsignfortheelectricpowerbox.DotabletopsurfaceshavedurableplasticorlaminatesurfacesHowoftenaretabletopscleanedNotefrequencyinComments.桌面有没有铺上防火胶板或其它耐磨的材料台面清洁周期：_____√每班清洁一次工作桌。包装车间的桌面未被完全用胶板覆盖。Tabletoptobecleanedoncepershit.Packingfloortabletoparenotcoveredwithplasticsheets.Arecleaningcompounds,pesticidesandsanitizersproperlystoredandhandledtopreventcontaminationofproductandpackagingmaterials清洁工具,杀虫剂及消毒剂正确贮存并交付以防与产品及包装物料交叉污染√垃圾车与花纸车间的运输车摆放在同一区域。Trashandproductplaceinthesamearea.已要求工厂划分不同的区域摆放，避免产生污染。Requestedtheftytoassignareafortrashandworkinprocesszoneinordertoavoidcontaminations.3.17.1Arecleaningcompounds,pesticidesandsanitizersproperlylabeledandidentified清洁工具,杀虫剂及消毒剂是否适当贴标签及清晰标识√清洁工具,杀虫剂及消毒剂无标识及未有指定放置区域。Cleaningcompounds,pesticidesandsanitizersarenotproperlystoredindesignatedarea.已要求工厂须加以标识。Advisedtheftytoaddsignandstorethecleaningcompoundincabinet.Arewastematerialsproperlycontainedandidentified垃圾物料是否适当贮放及标识√无标识且无指定的贮放区域。Noassignedzoneforthewastematerialwerefound.已要求工厂加以标识及提供贮存区域。Advisedtheftytoaddwastematerialzoneandaddsign.Aretheredesignatedareasforinterimstorageofincomingrawmaterials,workin-process,andfinishedproductthatprovides18"clearancefromwalls,ceilingandequipment有没有指定暂时的区域来存放外来的原材料、半品及成品,且离墙/天花板/器材18”距离√Areallrawmaterials/in-process/finishedproductsstoredinappropriatecontainers.,plasticcoveredbins)是否所有的外来半加工材料均放置在干净适当的容器中例:胶盆带盖√所有存放成品、半成品的胶篮均未加盖，且可发现灰尘。Nocoverorlidforthesemiproductandfinishedproduct.已要求工厂清洁用于贮放产品的容器，保持清洁，并加以封盖，防止污染。Requestedtheftytoaddlidforallcontainerandthecontainershouldcloseboxtype.Isthereabarrierbetweenallrawmaterials/in-processproductandthefloor.palletoroverturnedbin)所有的原料/半成品与地面之间有无卡板隔开√Ifpalletsareusedaretheyfreeofsplinters,loosenails,andanycontamination,orevidenceofinsectorrodentactivity是否所有的卡板都干净且良好,无破裂、脱钉、污染或虫鼠活动的迹象√包装车间使用木卡板摆放成品。Woodenpalletswerefoundinthepackingarea.Suggestedtouseplasticpallet.Areproductionoperationsappropriatelyseparatedtopreventodor,microbiological,foreignmaterialandothertypesofcontamination生产运作适当隔离以免受气味/细菌/外来物污染√来料仓及压制成型车间没有封闭，可见生产过程产生的灰尘飘落在原料仓内。Incomingmaterialwarehouseandcompressionproductionareaarenotclearlysegregatedwhichresultthematerialwarehouseverydusty.AreproductscleanedbeforebeingpackedoutNotecleaningprocessinComments.产品包装前是否清洁√使用风枪吹尘清洁。Useairguntocleantheproduct.Ifcleanedwithcompressedair,isairfilteredtoremovemoisture若用压缩气清洁,空气过滤器是否除去湿气√过滤器只安装在压缩机上，生产现场没有安装。Airfilterinstalledonthecompressor.*Arefinishedproducts,workinprocessorpolybaggedproductsfreefromdustorotherfilth/contamination成品/半成品或包装产品上有没有灰尘或污染物的痕迹√成品及半成品均可见到尘。Bothfinishedproductandsemifinishedproductarenotfreefromdust.已要求工厂须及时的清洁产品及使用干净的容器存放产品，并密封防止污染。INJECTIONMOLDINGONLY啤塑IsinjectionmoldingcoolingwatertreatedwithasanitizingagentIdentifyagentinComments啤机用的水是否由消毒代理处理指明代理商√无此生产工序N/AArelogskeptindicatingwhenthewaterischangedIndicatefrequencyinComments有没有换水的记录指明换水频率√无此生产工序N/APAINTONLY喷油Isthereapaintsprayventilationsystemthatremovesfumestotheoutsideofthebuilding有没有一通风系统将喷油的油雾排至建筑物外√无此生产工序N/AIsthepaintsprayroomfreeofasolventsmell喷油车间是否没有强烈的气味√无此生产工序N/AArespraymaskscleanedregularly(DefinefrequencyinComments.)Whatisusedtocleanspraymasks(NoteinComments.)喷油模是否定周期清洗用什么来清洗喷油模√无此生产工序N/AIstheproductfreeofasolventsmellatthetimeofpackaging产品包装时是否无强烈气味√无此生产工序N/AIspaintedproductovendriedSpecifythetemperatureandlengthoftimeproductisovendried.喷油产品是否烘干指明产品烘干温度及时间长短.√无此生产工序N/AIspaintedproductairdriedSpecifylengthoftimeproductisairdried.喷油产品是否风干指明风干时间长短.√无此生产工序N/ATotal32%QualitySystems:质量系统YesNoNACommentsORGANIZATIONANDMANAGEMENT组织与管理Isthereanorganizationchartshowingthestructureandreportingchannelsofallfunctions有无工厂人员组织架构图√IstheheadofQA/QCindependentofanyotherproductionrelatedfunctions,andreportingdirectlytothetopmanagementofthefactoryIfno,pleasecommentQC/QA部负责人是否独立运作,直接向总经理汇报√Aretheresponsibilitiesofallkeystaffaffectingqualityclearlydefinedanddocumented对质量构成影响的每一个员工的职能是否有书面的规范√Haveproceduresbeenestablishedforidentifyingtrainingneedsfornewlyrecruitedstaffandcontinualupgradingofstaffskillsandknowledge对于新入及旧有的员工有没有一个持续的培训√新员工入职前须参加培训，但旧员工没有持续的培训及考核。Newworkersshouldhavetrainingbeforestartworking.建议工厂给工人一个定期的培训及考核，并记录在档案。Suggesttheftytoprovideconstanttrainingtoallworkers.Aretrainingrecordsavailable,completeandproperlymaintained培训记录均妥善保管及可供查阅吗√仅有新员工的培训记录。Onlynewworkerstrainingrecordwerefound.Arequalityrecordsavailable,completeandup-to-date品质记录是否有效并完成,且为最新√Areinternalauditsplannedanddocumented是否有内审 计划 项目进度计划表范例计划下载计划下载计划下载课程教学计划下载 及文件记录√每年进行一次。OnceayearArecorrectiveactionreportsfrominternalauditsimplementedtoimprovequality内审不合格项目的CAP执行√Doesthefactoryhaveaqualitymanualwithstandardoperatingproceduresandworkinstructionstodocumentthequalitysystemeffectively工厂对于运作程序及工作指引有没有制定相关的标准文件—质量手册√DoesthefactoryhaveanestablishedGMPprogram工厂是否建立GMP手册√无GMP手册。NOGMPmanual.SuggestftytopreparetheirownGMPmanualbasedontheirproductionprocess.已建议工厂去建立GMP手册。DoestheGMPprogramincludeatrainingprogramforworkersGMP手册包括工人的培训程序吗√无GMP手册。NOGMPmanual.SuggestftytopreparetheirownGMPmanualbasedontheirproductionprocess.已建议工厂去建立GMP手册。Areinternalself-auditsofGMPsconductedanddocumented内审对GMP执行及文件证明√无GMP手册。NOGMPmanual.SuggestftytopreparetheirownGMPmanualbasedontheirproductionprocess.已建议工厂去建立GMP手册。Arecorrectiveactionreportsfrominternalauditsimplementedtoimprovecompliance内审不合格项的CAP及改善执行√无GMP手册。NOGMPmanual.SuggestftytopreparetheirownGMPmanualbasedontheirproductionprocess.已建议工厂去建立GMP手册。Total62%Quali