沃尔玛工厂产能能力(质量管理)

NoYESNON/A1.0□□□1.1□□□1.2□□□1.3□□□1.4□□□1.5□□□1.6□□□2.1□□□2.2□□□3.1□□□3.2□□□3.3□□□4.1□□□4.2□□□4.3□□□4.4□□□4.5□□□4.6□□□4.7□□□4.8□□□5.1□□□5.2□□□5.3□□□项目与内容Item工厂自我评估表Wal-MartFactoryPre-AuditQuestionnaire工厂简介Briefintroductionoffactory营业执照Businesslicense公司组织架构图Organizationchart（公司）厂区/厂房平面图Factory'splanefigurefloorplans生产工序流程图Productionprocesschart管理体系证书(质量/不保/社会责任等)CertificateofvariousmanagementsystemsISO9001/ISO4001/ICTE/GSCP.etc虫鼠控制/防潮防霉控制程序(制度)及记录Documentedpests/mildewandmoisturecontrolprogram利器(刀片,断针等)收发控制/断针控制/验针记录Procedureandrecordsofsharptoolscontrolprogram利器设备校验程序/记录和报告Procedurerecordsofequipmentcalibration设备(生产机器检验设备/工具/备件)清Listofmachines,tools,sparepartsandequippments设备维修保养记录Maintenanceandrepairingrecordsformachine/equipment质量手册(质量方针/目标)/程序文件Qualitymanual/procedures客户投诉处理程序及记录Procedureandrecordsofcuslomerincluding产品紧急事故处理程序(包括召回程序)及记录Recallprogramincludingprocedureandrecordswhenapplicable品管组织架构图OrganizationchartofQMS/QC质量管理体系/控制关键人员职责RoleandResponsibilityofQCporsonnel定期不定期质量管理体系/控制会议的机制及记录Mechanismandrecordsofregular/irregularreview/meetingonQNS/QC潜在危害风险评估(物理异物如金属,玻璃等/化学/微生物方面的危害)Riskassessmenttoidentifyhazardsfromchemicals/rawmaterials/process/equipmentandtools控制(生产及产品受物理异物/化学微生物等)污染风险的控制程序及记录(可能对产品或人造成伤害)Proceduresandrecordsaboutcontrolriskofphysical/chemical/biologicalcontamination(whichmaydamagetheproductandpersonnel)来料检验控制程序Procedureofqualitycontrolonincomingmaterials各种来料检验标准及缺陷分类Insectioncriteria(e.g.samplingplan/AQL/defectiveclassification)IQC来料检验报告/不良品处理(退货,挑选及让步接收等)记录Inspection/testreportsofincomingmaterialsincludingrejecteditemsandconcessionwhenapplicable沃尔玛工厂产能能力沃尔玛工厂产能能力沃尔玛工厂产能能力沃尔玛工厂产能能力（（（（质量管理质量管理质量管理质量管理））））审核文件清单审核文件清单审核文件清单审核文件清单RequestDocumentList(forMal-MartFCCA)5.4□□□5.5□□□5.6□□□5.7□□□6.1□□□6.2□□□6.3□□□6.4□□□6.5□□□6.6□□□6.7□□□7.1□□□7.2□□□7.3□□□7.4□□□7.5□□□7.6□□□8.1□□□8.2□□□8.3□□□9.1□□□9.2□□□来料中免检产品的符合性证书或测试报告Certificateofcomplianceortestreportofincomingmaterialswhenapplicable物料库存/周转控制的程序或规定Procedure/rulesofmaterialsrotationcontrolandinventorymanegementwarehouse(e.g.FIFO)供应商评审程序及记录(包括初次供应商挑选批准评估及后续定期的供应商表现评估)SupplierAssessmentSystem(includinginitialevaluationandregularassessment)供应商来料状况统计KPIofongoingperformance产品设计程序及记录(适合时)Procedureandrecordsofproductdesignwhenapplicable(量产前进行)试产的制度记录及相应的纠正改善措施(有需要时Mechanismofpilot-runandthecorrespondingCAPwhenapplicable)产前会议制度及记录Procedure/recordsofpre-productionmeeting制造各工序包括包装的作业指导书/规格要求,参考样板,批准板,Workinginstruction/specification/approvalandreferencesampleformanufacturingandpacking过程质量控制的程序/标准/记录(首件检验,在线检验,巡检,抽检,全检.批次检验)Procedure/criteria/recordsofIPQC(firstpieceinspection,onlineinspection,lotinspectionetc)过程不良处理机制及记录Procedureofnon-conformancecontrolduringmanufacturing内部测试清单/测试手册(操作指引)/测试记录Listofin-housetesting/testingmanual/testingrecords过程不良的纠正预防CAPincaseofrejectedproducts/lotsofsemi-products终检验程序(可能多种形式,叫法也可能不同)包括FQC或OQC或QAProcedureoffinalinspection(e.g.FQC/OQC/QA)终检验标准(可能多种形式,叫法也可能不同)包括FQC或OQC或QAInspectioncriteria/specificationandreferencesample/recordsoffinalinspection成品不良处理机制及记录Procedureofnon-conformancecontroloffinishedproducts在现场抽查与公司生产运作有关的任何其它相关文件与记录。谢谢支持和合作。Someotherdocuments/recordsmayberequiredduringon-siteauditbasedonFCCArequirementsandactualsituationThanksforyoursupportandcooperationinadvance备注Remark仪器校验记录Calibrationoftestingequipment测试人员资质培训记录Trainngrecordsoftestingtechnician培训的机制及记录(包括入职前,岗前培训,定期培训,包括普通操作员/检验员/工程技术人员)Trainingprocedureandrecords(pre-worktraining,onjobtrainingandregulartraining)forworkers/QCmembers/technician/engineers对熟练工技人员的招聘前的考核Pre-hiretestforskilledpersonnel成品不良的纠正预防CAPincaseofrejectedproducts/lots成品出货放行机制Procedureofshipmentrelease标识及可追溯性:批次标识/日期标Identificationandtraceability(batchtestingmanual/testingrecords)