质量基础知识培训材料

Hi-PConfidentialInternational1Electro-MechanicsSolutionProviderIntegratedTheHi-PInternationalQUALITYBASIC质量基础知识Hi-PConfidentialInternational2Creator:Ong.ThianzhengFunction:QMSVerified:Whale.shenApprover:JuhaPoyryDocumentNo.:Corp-QA-O-TM-010Version/Status:2.1/ApprovedLocation:E-office/DMSVersionDateModifiedbyChangeofsummary1.020thMar2008Ong.TZInitialRelease2.06thNov2009WhaleShenAddGD&OMScontent2.119thMar2010Ong.TZReviewthecontentDocumentPropertiesChangeHistoryHi-PConfidentialInternational3内容Content•PhaseI:质量专业相关知识Quality-Overall-1.1质量的基本知识QualityBasic-1.2质量管理的基本知识QualityManagementBasic-1.3质量管理体系的基本知识QualityManagementSystemBasic-1.4质量管理系统的发展历史HistoryofQualityManagementSystem-1.5质量管理的八项原则8principlesofQualityManagement•PhaseII:QA介绍IntroductionofHi-PQAHi-PConfidentialInternational4PhaseI:质量专业相关知识Quality-OverallHi-PConfidentialInternational5没有卖不出去的产品只有卖不出去的品质QualityisthebasicfortomorrowsuccessQuality:ReducewasteandimproveproductivityHi-PConfidentialInternational6Quality:SecretforacompanytogrowcontinuouslyQuality:AneffectivewaytoattractcustomersHi-PConfidentialInternational7Quality:Anarenaforcompany’sfutureItiseasiertokeepanoldcustomerthanattract5newcustomersHi-PConfidentialInternational81.1质量的基本知识QualityBasic•GB/T19001-2008IDTISO9001:2008标准对质量作如下定义DefinitionofQualityBasicbyGB/T19001-2008IDTISO9001:2008•质量：一组固有的特性满足要求的程度包括明示的、隐含的或必须履行的需求或期望,法律法规的要求,公司的附加要求.Quality:Agroupofinherentcharacterstofulfillthestatedorimpliedrequirementsandexpectations,lawandregulationrequirementsorotheraddedrequirementsbycompanyHi-PConfidentialInternational91.1质量的基本知识QualityBasic质量具有的特性CharacteristicofQuality广义性Generalized时效性Timeliness经济性Economic相对性RelativityHi-PConfidentialInternational101.1质量的基本知识QualityBasic与质量有关的概念ConceptrelatedwithQualityProcess过程Customer顾客Input投入Output产出Supplier供给者Hi-PConfidentialInternational111.2质量管理的基本知识QualityManagementBasic质量管理QualityManagement包括制定质量方针，质量目标及质量策划，质量控制，质量保证和质量改进.IncludeQualityPolicy,QualityTarget,QualityPlanning,QualityControl,QualityAssurances,andQualityImprovement质量方针QualityPolicy质量目标QualityTargetHi-PConfidentialInternational12TimeRejectRateHistoricalLevel(0)NaturalVariationunder0(±30)SpecialVariationOptimumLevel(1)NaturalVariationunder1(±31)质量改进Qualityimproved1.2质量管理的基本知识QualityManagementBasicHi-PConfidentialInternational131.3质量管理体系的基本知识QualityManagementSystemBasic质量管理体系的基本术语Terms&Definitions文件:信息及其承载媒体。(信息:有意义的数据)例如:记录，程序文件，规范，工艺，图样，报告，标准Document:Information(Valuabledata)&itsmediaExample:Record,Procedure,Specification,Techniques,Drawing,Report,Standard,etc.文件的动态性DynamicofDocument文件的高增值性Highvalue-addedofDocument文件的价值ValueofDocumentationHi-PConfidentialInternational14PurposeofDocumentation文件的作用:Consolidate/Unifyaction统一行动:文件成为组织的法规，所有的人都必须通过认真的执行达到预期的目的.Documentsetasorganization’sregulations,allmemberswillachieveexpectedresultsifexecutedproperly.Communicationpurpose沟通意图:界定了职责和权限，处理好了接口，使质量体系成为职责分明，协调一致的有机整体.Defineroles&responsibilitiesandconnections,hencetotransformQualitySystemtoanorganicsystem质量管理体系的基本术语Terms&Definitions1.3质量管理体系的基本知识QualityManagementSystemBasicHi-PConfidentialInternational•程序：为进行某项活动或过程所规定的途径a.是一种方法，途经b.程序不是文件，但可以文件的形式存在c.含有程序的文件可称为程序文件•Procedure:Forcertainactivitiesorprocessesa.isamethodb.programisnotadocument,butcanbefiledasdocumentc.Documentscontainprocedurescanbenamedasprocedure•规定组织质量管理体系的文件•GB/T19001-2008标准的质量手册至少有以下内容：-质量管理体系的范围；-程序文件的汇编和引用；-过程间相互作用的描述•RegulateOrganizationalqualitymanagementsystemrequirementsdocuments•MinimumelementsinGB/T19001-2008:-ScopeofQualityManagementSystem;-Proceduresforacompilationofdocumentsandreferences;-Adescriptionofinteractionoftheprocesses15文件的类型TypeofDocument质量手册QualityManual程序文件Procedure作业指导书WorkingInstruction记录/表单Record/Form质量管理体系的基本术语Terms&Definitions1.3质量管理体系的基本知识QualityManagementSystemBasic•具体的操作性文件，用于具体指导工作、现场管理或其他工作等.•a.是对程序文件的补充和完善•b.具体指导现在操作•c.应放于便于得到的地方•Specificoperationaldocumentsforspecificguidance,on-sitemanagementorotherworks.a.supplementfortheprojectfilesb.Specificguidanceforcurrentoperationc.shouldbekeptinplaceandaccessible•阐明所取得的结果或完成活动的证据的文件(用于记录质量管理所要求的数据的表格)•a.记录的作用是阐明结果，提供证据•b.不需控制记录的版本•c.记录可用以提供证据，但证据不一定是记录•Asdocumentalevidencetoclarifytheresultsorcompletionofactivities,(fortherecordsneededforqualitymanagement)a.Theroleofrecordsistoclarifytheresults,andtoprovideevidenceb.Noneedtorecordthecontrolversionc.recordscanbeusedtoprovideevidence,buttheevidenceisnotnecessarilyrecordedHi-PConfidentialInternational161.3质量管理体系的基本知识(赫比方式)QualityManagementSystemBasic(Hi-PWay)ISO框架FrameworkOMS框架FrameworkISO9001GD(ISO9001、ISO／TS16949、ISO13485、ISO14001、OHSAS18001)质量管理体系统QMS管理系统基础ManagementSystemFoundation管理职责Managementresponsibilities战略管理StrategyManagement商务管理BusinessManagement资源管理ResourcesManagement人力资源管理HumanResources风险管理RiskManagement职业卫生与安全管理Operational,Healthy&SafetyManagement产品实现ProductRealization环境管理EnvironmentalMgmt企业安全管理CorporationSafetyMgmt知识产权与责任IntellectualPropertyRights&Liability产品质量计划PQP产品／服务安全和责任Product/Servicesafety&Liability需求／供应管理SCM产品／服务的开发和项目管理Product/ServiceDevelopment&ProgramMgmt供应商管理和采购SupplierMgmt&Purc