产品审核 Product Audit-OK范本

公司LOGO工作指引

WorkInstruction文件编号：DocNo.WI-QA057版本Rev.A标题Title产品审核ProductAudit页码Page文控印ControlStamp核对Checkedby日期Date审核Reviewedby日期Date批准Approvedby日期Date生效日期Effectivedate版本Rev.修订内容DescriptionofChange修订日期UpdatedDate编制PreparedbyA初版发行FirstRelease2021-12-31Cooler分发部门及分发数量Departmentandnumberofcopytobedistributed总经理Generalmanager()质量部QA()生产部PD()维修部MA()人力资源部HR()销售部SA()采购部PUR()仓库Warehouse()原材料RM()干压DP()模具MW()技术TD()烧结SI()加工MAC()分拣Sortingteam()1.0目的Purpose建立产品审核规范，为持续改善提供证据。Establishaworkinstructiontoletusknowhowtomaketheproductauditandprovidetheevidenceforcontinuousimprovement.2.0适用范围Scope适用于对待出货产品的审核。Applicablefortheproductaudit.3.0定义Definition3.1产品审核:通过抽样检验和可靠性试验，了解和验证待出货的产品是否符合图纸要求和客户要求，分析和发现系统缺陷、重点缺陷及较长时期的质量趋势范围，为持续改进提供依据;Productaudit:theactivitytocheckbysamplinginspectionandreliabilitytestiftheproductswhichwillbesenttocustomercanmeettherequirementsfromcustomer/accordingtodrawingsornot,analyseanddetectsystemdefects,criticaldefectsandqualitytrendofalongtime,finallyprovidetheevidenceforcontinuousimprovement;3.2质量特征值：在产品审核中将缺陷理解为未满足规定要求的项目的数值。QKZ：QualitätwertzahleninGerman,thevalueusedtounderstanddefectsthatdonotmeetspecifiedrequirementsduringproductaudit.4.0职责Responsibility4.1管理代表:负责批准年度<产品审核计划>及<产品审核报告>,任命审核组长及审核员，监督产品审核活动。Managementrepresentative:appointtheauditteamleader,approvethe<processauditplan>andproductauditreport,supervisetheprocessaudit4.2质量部：编制<产品审核计划>、<产品审核检查表>,组织并实施过程审核并负责对审核记录的管理；Qualitydepartment:preparethe<Productauditplan>and<Checklistforprocductaudit>,organizetocarryouttheprocessauditandsavetherecordsintheaudit;4.3审核组长：编制<产品审核报告>，主导监督产品审核活动；Auditteamleadermakethe<Productauditreport>andleadtheproductaudit;4.4审核员：审核实施,记录审核结果；跟踪不合格项的改进。Auditor:carryouttheproductauditmaketherecordfortheauditandfindings,followuptheimprovementmeasuresandverifytheeffectiveness;4.5各部门:支持并参与产品审核工作，实施对不合格项的改进。Otherdepartments:positivelysupporttheaudit,makerootreasonanalysisforfindingsandtakecorrectiveandpreventiveactionsforimprovement5.0工作程序Procedure5.1产品审核的时机Opportunityforproductaudit1)审核计划内（包括体系审核、过程审核、产品审核）的同步要求；Therequirementfromtheplannedaudits(systemaudit,processauditandproductaudit)2)第三方（认证机构）验证/或认证需要；Verification/certificationrequiredfromtheThirdParty(CertificationBody)3)第二方（顾客）要求；Customerrequirement;4)公司需要（如管理评审前）确认或验证质量缺陷或评定QWZ情况。Internalrequirement(beforemanagementreview)5.2编制审核计划Productauditplan5.2.1由管理者代表主导成立审核组，任命审核组长、审核员并通知对应人员；Managementrepresentativeisresponsibletoformtheauditteam,appointtheauditteamleader,andauditorsandinformrelatedperson;5.2.2质量部编制<产品审核计划>,产品审核计划内容应包括如下所示，将<产品审核计划>报管理代表审批，将审批后的<产品审核计划>发放至相关部门。Qualitydepartmentisresponsibletopreparethe<Productauditplan>whichshouldincludebelowitems,thensendmanagementrepresentativetoapprovethe<Processauditplan>.审核目的；Purpose参考资料；Referencedata被审核的产品；Product/referenceundertheaudit检查表；Checklist审核的时间和频次；Dateandfrequencyofproductaudit审核员；Auditors5.2.3本公司产品审核频次每年依实际情况安排产品审核。Frequencyofproductauditisconductedastheactualsituationeveryyear.5.3审核准备Productauditpreparationandimplementation5.3.1审核前,审核组了解清楚要审核产品生产进度，根据生产进度安排具体的审核日期，在具体审核日期确定后7天内需通知相关的部门及人员,说明产品审核的具体时间、审核地点、审核员及其审核范围；Beforetheauditauditteamneedtoknowclearlyabouttheproductionscheduleofreferencesunderaudit,accordingtotheproductionscheduleconfirmthefinaldate,informrelateddepartment/personinsevendaysandexplaintheauditdate,site,auditorsandscope;5.3.2审核员审核时可使用以下产品的参考资料:带有更改状态的图纸；Drawingswithrevisionhistory技术规范；TechnicalspecificationPFMEA；工艺文件；Technologicaldocument检验规范；Inspectionspecification缺陷目录；Defectcatalog限度样板；Limitsample包装图；Packagedrawing评定方法规定；Evaluationmethodspecification控制计划等。Controlplanandetc.5.3.3审核员按随机抽样方法抽取样品，并对样品进行编号；Auditorshouldmakesamplinginspectionandnumberthem;5.3.4由审核员负责产品审核的具体实施工作。审核员依据相关的工作指引及缺陷分级原则和产品检验指导书、检验标准对产品样本依次检查,并在<产品审核记录表>上记录检查结果。Auditorscarryouttheproductauditandcheckthesamplesaccordingtorelatedworkinstruction,defectgradingandinspectionworkinstructioninorder,savetheresultinthe<Checklistforproductaudit>.5.4缺陷分级原则:Defectgrading缺陷类型Type系数Coefficient性质CharacterA类10关键CriticalB类5主要MajorC类1次要Minor5.5审核结果统计分析Statisticalanalysisforauditresult5.5.1缺陷点数总和计算(FP): Calculationforthedefects FP=10dA+5dB+1dC 式中:A.dA—审核产品样本中发现的A级缺陷个数；QuantityofdefectAB.dB—审核产品样本中发现的B级缺陷个数；QuantityofdefectBC.dC—审核产品样本中发现的C级缺陷个数；QuantityofdefectC5.5.2质量特征值计算(QKZ):CalculationforQKZ QKZ=100-缺陷点数/样品个数QKZ=100-sumofdefects/samplequantity5.5.3统计分析Statisticalanalysis5.5.3.1审核员需同相关部门一同对审核的结果作分析,找出质量缺陷及发生原因,重点是关注A类/B类缺陷及多频次发生的C类缺陷；Auditorneedtocheckwithrelateddepartmentabouttheauditresult,findqualitydefectandrootcause,focusonthedefectA,BandrepeatedC;缺陷产生的直接原因；Directreasonfordefect管理不良造成的缺陷；Defectcausedbypoormanagement应采取的措施。Appropriatemeasures5.5.3.2质量特征值QKZ分析QKZanalysisNoQKZ值缺陷类型DefectA缺陷类型DefectB缺陷类型DefectC结果Result1≥93无No无No有Yes放行Pass2≥93无No有Yes有Yes退回车间Return3≥93有Yes无No有Yes退回车间Return393＞Q≥85无No无No有Yes再抽样Doublecheck493＞Q≥85无No有Yes有Yes退回车间Return593＞Q<≥85有Yes无No有Yes退回车间Return6<85无No无No有Yes退回车间Return7<85无No有Yes有Yes退回车间Return8<85有Yes有(无)Yes(No)有Yes退回车间Return5.5编制审核报告Auditreportpreparation5.5.1审核组长需依据<产品审核记录表>及分析结果，做出<产品审核报告>,内容包括:Auditteamleadermakethe<Productauditreport>accordingtothe<Checklistforproductaudit>andanalysisresult,inthereportneedtodefine:审核对象、样品数；Auditedobject,samplequantity;审核结果统计资料；Statisticaldataforauditresult质量缺陷及说明；Quantitydefectandrelateddescription5.6审核组长将<产品审核报告>由管理者代表批准。Auditteamleadersendthe<Productauditreport>forapprovalbymanagementrepresentative.5.7不合格处理Dispositionofnonconformity5.7.1以下结果必须由审核组发出通知责任部门改善；a.审核中发现A类/B类缺陷；DefectAorBfoundduringauditb.QKZ值不达标的；ThevalueofQKZisover.5.7.2审核结束后,由审核组长将发现不合格问题以邮件形式发送给责任部门并同时抄送管理者代表及总经理；责任部门对于不发现的不符合项依<纠正预防措施控制程序>要求进行回复改善；Aftetheauditprocessauditteamleaderneedtosendallthefindingstoresponsibledepartments(managementrepresentativeandgeneralmangerincopy)byemail,responsibledepartmentsreplyandimproveasthe<CorrectiveandPreventiveActionsControlProcedure>;5.7.3审核员跟踪不合格改进的实施情况，直至不合格项关闭。Auditorsmustfollowupthecorrectiveandpreventiveactionsandverifytheeffectivenesstilltheclosethenonconformingitem.5.8审核的结果的改善依实际需要可纳入月会或年度管理评审输入资料中。Theauditresultsandimprovementcanbetheinputformonthlymeetingorannualmanagementreview.5.9产品审核过程中的记录依<记录控制程序>规定执行。Recordsgeneratedinthisfileiscontrolledbyqualitydepartmentas<RecordControlProcedure>.6.0相关文件与资料Relevantdocumentanddata6.1<记录控制程序RecordControlProcedure>P-QA0026.2<纠正与预防措施控制程序CorrectiveandPreventiveActionsControlProcedure>P-QA0117.0相关记录Relevantrecord7.1<产品审核计划表ProductAuditPlan>WI-QA057-001.fmt7.2<产品审核记录表Checklistforproductaudit>WI-QA057-002.fmt7.3<产品审核报告Productauditreport>WI-QA057-003.fmt8.0流程图Flowchart产品审核控制程序流程图Flowchartforprocessaudit权责部门Responsible作业流程FlowChart重点提示KeyTIP相关文件/记录Relateddocument/record管理者代表managementrepresentative审核组长Auditteamleader产品审核计划产品审核计划Productinternalauditplan管理者代表指定审核组长，审核组长编制过程审核计划，管理者代表审核批准，managementrepresentativetoappointauditteamleader,Auditteamleaderprepare<processAuditplan>,sendtoreviewedandapprovedbymanagementrepresentative<产品审核计划><ProductAuditPlan>管理者代表managementrepresentative审核组Auditteam组成内审小组组成内审小组Auditteam管理者代表指定组成成员managementrepresentativetoappointauditors审核组Auditteam审核检查表审核检查表Checklistforproductaudit审核组长负责编制<产品审核检查表Auditor