供应商质量体系及监督审查之管制程序

TITLECORPORATEPROCEDUREFORSUPPLIERQUALITYSYSTEMSANDSURVEILLANCEAUDIT供应商质量体系及监督审查之管制程序DocumentNo.:PR20002Rev.No.:A00Page1of25RevisionHistoryREVDCN#INITIATEDBYEFFECTIVEDATE(MM/DD/YY)DESCRIPTIONA00D142525WilliamMagramo6/16/14InitialReleaseApprovedDCNonFileinDocumentControlAPPROVEDBYMotoakiWakuiAUTHORIZEDBYSKLamCONFIDENTIALPROPERTYOFZHONGSHANSUNMINGOPTICALTECHNOLOGIESLIMITEDThisdocument,andtheinformationitcontains,arethepropertyofZhongshanSunmingOpticalTechnologiesLimitedandareprotectedbylaw.Bothmustbeheldinstrictconfidenceatalltimes.Nolicenseexpressedorimplied,underanypatent,copyrightorotherintellectualpropertyrightisgrantedorimpliedbytheprovisionorpossessionofthisdocument.Nopartofthisdocumentmaybereproduced,transmitted,transcribed,storedinaretrievalsystem,translatedintoanylanguageorcomputerlanguage,inanyformorbyanymeans,whatsoever,withoutthepriorwrittenconsentofZhongshanSunmingOpticalTechnologiesLimited.?2014ZHONGSHANSUNMINGOPTICALTECHNOLOGIESLIMITEDALLRIGHTSRESERVED(AnyhardcopyprintoutofthisdocumentisuncontrolledunlessitbearsDCCredcontrolledstamp)?2014ZHONGSHANSUNMINGOPTICALTECHNOLOGIESLIMITEDConfidential(AnyhardcopyprintoutofthisdocumentisuncontrolledunlessitbearsDCCredcontrolledstamp)?2014ZHONGSHANSUNMINGOPTICALTECHNOLOGIESLIMITEDConfidential(AnyhardcopyprintoutofthisdocumentisuncontrolledunlessitbearsDCCredcontrolledstamp)TITLE:CORPORATEPROCEDUREFORSUPPLIERDOC.NO.PR20002QUALITYSYSTEMSANDSURVEILLANCEAUDITREVISIONA00供应商质量体系及监督审查之管制程序PAGE2_OF_25PURPOSE目的ThisspecificationdescribesthegeneralrequirementandprocedureforqualitysystemsandsurveillanceauditofSUNMINGSupplier.此规格书描述了SUNMING对供应商质量体系的一般要求及监督审查程序。SUNMINGuseaqualitysystemassessmenttoolAttachment1"toensurethatsupplierssupplyingproductsormaterialpiecepartsmeetalltherequirementsforbasicqualitysystemsasdefinedbythecompany.Therequirementsspecifiedareaimedprimarilyatachievingcustomersatisfactionbypreventingnonconformityatallstagesfromdesignthroughtoservicing.SUNMING使用质量体系评估工具(附件1)确保供应商提供的产品或 材料 关于××同志的政审材料调查表环保先进个人材料国家普通话测试材料农民专业合作社注销四查四问剖析材料 部件符合公司基本质量体系的要求。这些要求所要达成的目标是从研发到售后服务预防不合格品的发生并将客户的满意度放在第一位。SCOPE范围AnysupplierofalldirectmaterialsasdescribedbelowwheretherequirementfortheaudittoISO9001areidentified.ISO9001要求审核直接材料供应商包括以下所描述的方面?ElectroMechanical电子机械?ElectricalHardware电气硬件DEFINITIONS&ABBREVIATIONS定义与缩写Directmaterials-ThosematerialsbeingusedduringmanufacturingoftheProduct,whicharecomponentsintheProduct.直接材料-指那些产品生产过程中用到的材料，是产品的部件。Indirectmaterials-Thosenon-productrelatedgoodsuchasequipments,officesuppliesandfurniture,etc.间接材料-那些与产品无关的物件，如设备，办公用品及办公设备。CLCA-CloseLoopCorrectiveAction闭环更正措施FG-FinishGoodsQSA-QualitySystemAudit质量体系审核SQE-SupplierQualityEngineer供应商质量工程师SUNMING-ZhongshanSunmingOpticalTechnologiesLimited(Chinaregisteredcompany)/中山三鸣光学科技有限公司(中国注册公司)/SunmingTechnologies(HK)Limited(HongKongregisteredcompany)三鸣科技香港有限公司(香港注册公司)TITLE:CORPORATEPROCEDUREFORSUPPLIERQUALITYSYSTEMSANDSURVEILLANCEAUDIT供应商质量体系及监督审查之管制程序?2014ZHONGSHANSUNMINGOPTICALTECHNOLOGIESLIMITEDConfidential(AnyhardcopyprintoutofthisdocumentisuncontrolledunlessitbearsDCCredcontrolledstamp)TITLE:CORPORATEPROCEDUREFORSUPPLIERQUALITYSYSTEMSANDSURVEILLANCEAUDIT供应商质量体系及监督审查之管制程序?2014ZHONGSHANSUNMINGOPTICALTECHNOLOGIESLIMITEDConfidential(AnyhardcopyprintoutofthisdocumentisuncontrolledunlessitbearsDCCredcontrolledstamp)DOC.NO.PR20002REVISIONA00PAGE3_OF_25ASSOCIATEDDOCUMENTS相关文件PR20001GENERALREQUIREMENTS一般要求QA(SQE)andPurchasing(Buyer)shouldconductSupplierQualityAudit.Ifnecessary,additionalpersonnelshallbeincludedintheauditteamtoprovidetechnicalexpertise(e.g.fromR&DandManufacturing).QA部门(供应商质量工程师)及采购部门(采购员)应实施供应商质量审核。必要的话，审核小组要包含其他人提供专业技术(例如：研发部或生产部人员的加入)。SupplierClassification供应商等级?Level1-SupplierswhoareISO9001certified.1级-获ISO9001认证的供应商?Level2-SupplierswhoarenotISO9001certified.2级-未获得ISO9001认证的供应商Level1Suppliers1级供应商Level"1"suppliersareauditedforminimumofonceeveryyearandskipfortwoyearsifthereisnoqualityissueorcomplain.1级供应商每年至少审核一次，若没有质量问题或投诉可以两年审核一次。SupplierQualityEngineer(SQE)shallrequiresupplierstosendthelatestcopyofISOcertificateforfileandreference.供应商质量工程师应要求供应商发送最新的ISO证书副本以归档并参考。Level"2"suppliersareauditedforminimumofonceeverysixmonths.2级供应商至少6个月需审核一次。AuditPreparationandQuestionnaire审核准备及问卷Priortotheaudit,acopyofthequalityauditquestionnaire,attachment1,“shallbesendtotheproposedauditeeforcompletionintwoweek'stime.审核前，将质量审核问卷(附件1)发送给被审核单位，被审核单位需在两周内完成问卷。DOC.NO.REVISIONPAGETITLE:CORPORATEPROCEDUREFORSUPPLIERQUALITYSYSTEMSANDSURVEILLANCEAUDIT供应商质量体系及监督审查之管制程序?2014ZHONGSHANSUNMINGOPTICALTECHNOLOGIESLIMITEDConfidential(AnyhardcopyprintoutofthisdocumentisuncontrolledunlessitbearsDCCredcontrolledstamp)DOC.NO.REVISIONPAGETITLE:CORPORATEPROCEDUREFORSUPPLIERQUALITYSYSTEMSANDSURVEILLANCEAUDIT供应商质量体系及监督审查之管制程序?2014ZHONGSHANSUNMINGOPTICALTECHNOLOGIESLIMITEDConfidential(AnyhardcopyprintoutofthisdocumentisuncontrolledunlessitbearsDCCredcontrolledstamp)PR20002A004OF25Prioraweektotheaudit,theauditeeshallreturnthecompletedquestionnairetogetherwithanyadditionalinformationrequiredi.e.Organizationalchart,Qualitycertification,CompanyproductBrochure,QualitySystemCertification,Auditrecordsforthepastsixmonthsbothinternalandexternalaudit,&GeneralInformationSheet.审核前一周，被审核单位需将完成的问卷同要求的其他附加信息一起送还，附加信息包含:组织结构图，质量证书，公司产品手册，质量体系证书，过去6个月里内部及外部的审核记录，一般信息表。Theauditeeshallbenotifiedontheproposedauditanddate.审核方需通知被审核方审核 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 及日期。Theexactdateshallbeagreedbetweentheauditeeandauditor.审核日期需经过双方确认一致。AuditChecklistRequirement审核清单要求Thefollowingdocumentsandproceduresneedtobeprovidedbytheauditeeatthebeginningoftheaudittoexpeditetheauditprocess.被审核方在审核初期需提供以下文件及制程使审核顺利进行：Workmanshipstandards工艺 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 Drawingsifapplicable图纸，如果适用的话TestSpecifications测试规格书Productspecifications产品规格书Manufacturing/QualityPlans制造/品质计划QualityManual质量手册QualityManuallevel2procedures质量手册2及程序文件QualityPerformanceMeasures质量绩效评估ProcessFlowDiagrams制程流程图OrganizationChart(s)组织机构图JobDescriptions工作描述On-GoingReliabilityTestingPlans持续可靠性测试计划ISOCertification(ifapplicable)ISO证书(可用的话)DocumentControlIndex文件控制指引CalibratedEquipmentList已校正设备清单CorrectiveActionLog更正措施记录Auditrecordsforthepastsixmonths,internalandexternal过去6个月内外审核记录DOC.NO.REVISIONPAGEPR20002A00PAGE\*MERGEFORMAT#OF~25TITLE:CORPORATEPROCEDUREFORSUPPLIERQUALITYSYSTEMSANDSURVEILLANCEAUDIT供应商质量体系及监督审查之管制程序?2014ZHONGSHANSUNMINGOPTICALTECHNOLOGIESLIMITEDConfidential(AnyhardcopyprintoutofthisdocumentisuncontrolledunlessitbearsDCCredcontrolledstamp)DOC.NO.REVISIONPAGEPR20002A00PAGE\*MERGEFORMAT#OF~25TITLE:CORPORATEPROCEDUREFORSUPPLIERQUALITYSYSTEMSANDSURVEILLANCEAUDIT供应商质量体系及监督审查之管制程序?2014ZHONGSHANSUNMINGOPTICALTECHNOLOGIESLIMITEDConfidential(AnyhardcopyprintoutofthisdocumentisuncontrolledunlessitbearsDCCredcontrolledstamp)helpfulinimprovingthesupplierSUNMING质量审核小组应根据附件能有利于提高供应商质量体系的建议。5.7.15.7.25.7.35.7.45.7.55.7.65.7.75.7.85.7.9ManagementResponsibilityQualitySystem质量体系DocumentandDataControlPurchasing/SupplierSelectionIdentificationandTraceabilityProcessControl制程控制管理职责文件数据控制采购/供应商选择标示与可追溯性InspectionandTesting检视与测试ControlofMeasuring,InspectionandTestEquipmentInspectionandTestStatus检视与测试状态测量，检视及测试设备控制SUNMINGshallrequirethesuppliertoprovideitsinternalauditandthirdpartyauditresultswhennotauditedonsiteaccordingtothesupplierauditplanprovision.SUNMING需要求供应商提供其内审结果及未根据供应商现场审核计划规定的第三方审核结果。SuppliershallprovidecopyofinternalqualityandISOsurveillanceauditfindingsandcorrectiveactiononannualbasis.供应商应每年提供内部质量及ISO监督审核结果及更正措施。TheSUNMINGqualityauditteamshallphysicallyassessesthevendorcapabilitiesusingsupplierratingsheet(Attachment1)aschecklistandmakerecommendationthatmightbes/vendor'squalitysystem.1供应商评级表作为检查表亲自评估供应商的能力并提出可ControlofNonconformingProduct不符合产品控制CorrectiveandPreventiveAction更正及预防措施Handling,Storage,Packing,Preservation,Delivery搬运，存储，包装，保护及运输内部品质审核统计技术持续改进QualityRecords品质记录InternalQualityAuditsTraining培训IStatisticalTechniquesContinuousImprovementEachcategoryisassessingagainstchecklisttoevaluatevendorsystembasedontheauditors'professionaljudgment.应检查每个类别对比检查表并根据审核人的专业判断来评估供应商体系。Theauditmeasurementsconsolidatenumberofdiscrepancy(critical,major,andminor)forallthecategoriestocomeupwithanoverallrating.整合审核测量值及所有类别的不符合值(重大，主要，次要)形成一个综合评级。Theratingsummaryisclassifiedfortheoverallratingintodifferentcommentsasshowninitem8.Thiswilldeterminethevendorqualitysystemorasthebasisofrecommendation,ifapplicable.评级总结分类将综合评级分成项目8所示的不同的评论。这将决定供应商质量体系，适用的话,作为建议的基础。5.11Attheendoftheaudit,theteamshouldholdwrapupmeetingwiththevendorrepresentativestodiscusstheaudithighlight,concern,recommendationandcorrectiveactionrequestforforimprovement.审核结束，审核小组与供应商代表召开总结会议，讨论审核重点，关注，建议及改善的更正措施建议。5.12TheLeadAuditorshouldsubmitthereporttotheHeadofQualitywithanoverviewnarrativeofthestrengths,anycritical,majorandminordiscrepanciesnotedintheaudit,alongwiththeobservationrecommendation.AppropriatecorrectiveactionreportusingCLCAtogetherwiththeAuditratingscorecard.审核组长应向品质部领导提供一份 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 ，该报告包括：优势的综合叙述，审核中任何重大、主要、次要的不符及观察建议，适当的更正措施报告（闭环纠正措施）,审核评级计分卡。5.12AuditDiscrepancyCategory审核不符合类别5.12.1CriticalDiscrepancies重大不符Adiscrepancywhichisconsideredtojeopardizesafety,functionalityandreliabilityandmayrequireshutdowntotakecorrectiveaction.被认为危及安全，功能性，可靠性及可能需求无法用更正措施弥补的不符。Example例如：?Usingawrongdrawing(wrongdrawingnumber/version)使用了错误的图纸(错误的图纸编号/版本)?ReliabilityTestfailure.可靠性测试失败Courseofaction行动步骤:?Recalldefectiveproductifnecessaryintheeventofsafetyissue.如果存在安全问题，必要的话召回不合格产品。?QuarantineeverythingintheFGwarehouse(supplier&customer)forreworkandrecertificationforcompliancebeforereleasinggoodstocustomer.隔离供应商及客户的成品仓进行返工，在产品发给客户前应满足符合性再认证。?Stoptheproductionline/stationandtakecorrectiveaction.停止生产线并采取更正措施。?Quarantinespecificcomponentshavingnon-conformityinmaterialstore.thesupplierin-comingDOC.NO.REVISIONPAGEPR20002A00PAGE\*MERGEFORMAT#of~25TITLE:CORPORATEPROCEDUREFORSUPPLIERQUALITYSYSTEMSANDSURVEILLANCEAUDIT供应商质量体系及监督审查之管制程序?2014ZHONGSHANSUNMINGOPTICALTECHNOLOGIESLIMITEDConfidential(AnyhardcopyprintoutofthisdocumentisuncontrolledunlessitbearsDCCredcontrolledstamp)DOC.NO.REVISIONPAGEPR20002A00PAGE\*MERGEFORMAT#of~25TITLE:CORPORATEPROCEDUREFORSUPPLIERQUALITYSYSTEMSANDSURVEILLANCEAUDIT供应商质量体系及监督审查之管制程序?2014ZHONGSHANSUNMINGOPTICALTECHNOLOGIESLIMITEDConfidential(AnyhardcopyprintoutofthisdocumentisuncontrolledunlessitbearsDCCredcontrolledstamp)隔离供应商来料仓的不符合的特定部件。?QuarantinecomponentatsupplierFGstores.隔离在供应商成品仓的部件。?Reviewandconfirmsupplierscourseofactionisadequatetopreventrecurrence.审查和确认供应商的行动步骤足以预防复发。?UponvalidationofcomplianceandwithauthorizationbySUNMINGQAstaff,suppliercanresumeproductionanddeliveryofproducts.确认符合后，由SUNMINGQA人员 授权 个人房产授权委托书公司各类授权委托书模版医师授权办法餐饮分店授权书产品代理授权书范本 ，供应商可恢复生产并运送货物。2MajorDiscrepancies主要不符?Asignificantdiscrepancywhichisconsideredtoindicatenon-compliancetothequalitysystem(QMS)oranunacceptablethreattoqualityandreliabilityoftheproduct.重要不符指与质量管理体系不符或对产品的质量和可靠性造成无法接受的威胁的产品。Examples例如:?HandlingtheESDsensitivecomponentwithoutESDprotection.有没防静电保护的情况下处理静电敏感部件。?Useofexpiredmaterialwithouthavingapprovalorrecertification在没有得到批准或再认证的情况下使用过期材料。?Useofnonapprovedmaterial.使用未批准的材料。Courseofaction行动步骤:?QuarantineeverythingintheFGwarehouse(supplier)forreworkandrecertificationforcompliancebeforereleasinggoodstocustomer.隔离供应商及客户的成品仓进行返工，在产品发给客户前应满足符合性再认证。?Stopproductionline/stationforcorrectiveaction.停止生产线并采取更正措施。?Quarantinespecificcomponentshavingnon-conformityinsupplierin-comingmaterialstore.隔离供应商来料仓的不符合的特定部件。?Quarantinecomponentatsupplierstoresforcloseloopcorrectiveaction(CLCA).隔离供应商仓库的部件并实施闭环纠正措施。?Reviewandconfirmsupplierscourseofactionisadequatetopreventrecurrence.审查和确认供应商的行动步骤足以预防复发。?UponvalidationofcomplianceandwithauthorizationbySUNMINGQAstaff,suppliercanresumeproductionanddeliveryofproducts.确认符合后，由SUNMINGQA人员授权，供应商可恢复生产并运送货物。3MinorDiscrepancy次要不符Adiscrepancywhichisaestheticinnaturethatcouldbeviewedasaminorquality/noncomplianceissue.次要不符本质上是一种审美不符，可以看做是次要的质量/不符问题。Examples例如:?Partoftheoperatingsystemisnotdocumented.部分操作系统没有文书化。?Objectiveevidenceinaparticularoperationisnotcarriedout.一个特定操作的客观凭证没有被执行。?Missingdocumentinaparticulararea某个特定领域缺失文件。?Workingdocumentisnotupdatetoreflectthelatestversionofspecification.作业指导书没有更新以反映最新版本的规范。?Typographicalerror.打字错误?Faintscratches.微弱的划痕?Slantedlabeling.标签倾斜Courseofaction行动步骤:?Reviewandconfirmsuppliercourseofactionisadequatetopreventrecurrence.审查和确认供应商的行动步骤足以预防复发。4Observations/Recommendation观察健议Thisincludessuggestionorrecommendationtoimproveexistingprocessorproductivitythatmayhaveadeficiency.Fromobservation,highlightkeyareasofstrengthandweakness.包含对已有的可能存在缺陷的制程/生产力改进的观察或建议，从观察中，突出重点领域的优势及劣势。Examples例如：?UseofrealtimemonitoringdeviceforESDcontrol.使用ESD控制实时监视装置。?Recommendabetterjigdesign.建议更好的治具设计。?Recommendabetterhandlingmethod.建议更好的处理办法。?RecommendabetterprocesssequenceTITLE:CORPORATEPROCEDUREFORSUPPLIERQUALITYSYSTEMSANDSURVEILLANCEAUDIT供应商质量体系及监督审查之管制程序?2014ZHONGSHANSUNMINGOPTICALTECHNOLOGIESLIMITEDConfidential(AnyhardcopyprintoutofthisdocumentisuncontrolledunlessitbearsDCCredcontrolledstamp)?2014ZHONGSHANSUNMINGOPTICALTECHNOLOGIESLIMITEDConfidential(AnyhardcopyprintoutofthisdocumentisuncontrolledunlessitbearsDCCredcontrolledstamp)DOC.NO.PR20002REVISIONA00PAGE9_OF_25建议更好的制程顺序Courseofaction行动步骤:Suppliertoconsiderwhethertotakeactionontherecommendation.供应商考虑是否采取建议的措施。Ifrecommendationisaccepted,thenweneedtofollowupifimplementationiseffectiveanddesiredresultisachieved,formalizeanddocumentthechangesmade.如果供应商采纳建议，我们需跟进改进措施是否有效，预想结果是否达成，并将变更形式化和文件化。Theauditreportshallbesenttotheauditeewithinaweekaftercompletionoftheauditforthemtoresponseforcorrectiveactionplanwithin14daysfromdateofreceipt.审核完成后，审核员应在一周内将审核报告交给供应商，供应商在收到审核报告后14天内回应更正措施计划。TheQADepartmentshalldistributecopyoftheauditreporttoPurchasingandProductDevelopmentDepartmentforreference.品质部应将审核报告的副本分发给采购及产品发展部门参考。Vendorresponseshouldbereviewed,verifiedorgatherobjectiveevidencetoverifyvalidityofcorrectiveaction.对供应商的回应进行评估验证或收集客观证据来验证更正措施的有效性。TheQAOrganizationshallmaintainadatacontainingallsupplieraudits.品质部应维护包含所有供应商审核的数据。ASSESSMENTTOOL评估工具Theratingsystemisbasedonpercentageofthetotalpointsavailable.Itneedstoscoreatleast80%andeveryauditeditemmustscore60%andabove.Byusingthisassessmenttool,inconjunctionwithsuppliedsupplierqualitydata,SUNMINGwillestablishaninitialqualificationstatus.AdditionalinformationontheuseofthistooliscontainedwithinAttachment'1'ofthisdocurTheassessmentscoresarerecordedandreturnthecompletedformtoSUNMINGauditor.ThesupplierassessmentwillthenbereviewedandafollowupauditifrequiredbySUNMINGpersonnelshallbescheduled.评级系统是基于可用总分的百分比。至少打分要在80%以上且每个审核项目打分要在60%或以上。使用此评估工具，结合提供的供应商质量数据，SUNMING将建立一个内部的鉴定状态。使用此工具的附加信息见附件1。记录评估分数并将完成的表格交给SUNMING的审核员。若SUNMING有要求，应安排人员对供应商评估进行评审及跟进审核。TITLE:CORPORATEPROCEDUREFORSUPPLIERDOC.NO.PR20002QUALITYSYSTEMSANDSURVEILLANCEAUDITREVISIONA00供应商质量体系及监督审查之管制程序PAGE10_OF_25DISQUALIFICATION取消资格ThesuppliershallbesubjectedforremedialorpossibledisqualificationfromApprovedVendorListifcontinuedfailuretoprovideevidenceofeffectivenessofcorrectiveaction.如果供应商未能提供证据证明更正措施的有效性，那么应将其从合格供应商名单移除到候补或可能取消资格。ASSESSMENTSCORE评估分数/eSESSMENTSCORE舁的分TMfollOAangparol2二兽。Imuied匕暂小ua帕pwtarmsneea.alualingor4valofownpliBneiir「s日ment用段改善200D00「QTAL合计MIK200如00DOC.NO.REVISIONTITLE:CORPORATEPROCEDUREFORSUPPLIERQUALITYSYSTEMSANDSURVEILLANCEAUDIT供应商质量体系及监督审查之管制程序?2014ZHONGSHANSUNMINGOPTICALTECHNOLOGIESLIMITEDConfidential(AnyhardcopyprintoutofthisdocumentisuncontrolledunlessitbearsDCCredcontrolledstamp)DOC.NO.REVISIONTITLE:CORPORATEPROCEDUREFORSUPPLIERQUALITYSYSTEMSANDSURVEILLANCEAUDIT供应商质量体系及监督审查之管制程序?2014ZHONGSHANSUNMINGOPTICALTECHNOLOGIESLIMITEDConfidential(AnyhardcopyprintoutofthisdocumentisuncontrolledunlessitbearsDCCredcontrolledstamp)PAGEPR20002—AGO-12OF25rfSSESSIfENFSCORE带右鼻分gtI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