1、1Electro-MechanicsSolution Provider IntegratedTheHi-P InternationalQUALITY BASIC质量基础知识质量基础知识2Creator: Ong. ThianzhengFunction: QMSVerified: Whale.shenApprover: Juha Poyry Document No.: Corp-QA-O-TM-010 Version/Status : 2.1/ApprovedLocation: E-office/DMSVersionDateModified by Change of summary1.0 20t
2、h Mar 2008Ong.TZInitial Release2.06th Nov 2009WhaleShenAdd GD & OMS content2.1 19th Mar 2010Ong.TZReview the contentDocument PropertiesChange History 3内容内容 Content Phase I: 质量专业相关知识质量专业相关知识 Quality - Overall - 1.1 质量的基本知识 Quality Basic - 1.2 质量管理的基本知识 Quality Management Basic - 1.3 质量管理体系的基本知识 Quali
3、ty Management System Basic- 1.4 质量管理系统的发展历史 History of Quality Management System- 1.5 质量管理的八项原则 8 principles of Quality Management Phase II: QA 介绍介绍 Introduction of Hi-P QA4Phase I :质量专业相关知识质量专业相关知识Quality - Overall5没有卖不出去的产品没有卖不出去的产品 只有卖不出去的品质只有卖不出去的品质Quality is the basic for tomorrow successQualit
4、y: Reduce waste and improve productivity6Quality: Secret for a company to grow continuouslyQuality: An effective way to attract customers 7Quality: An arena for companys future It is easier to keep an old customer than attract 5 new customers 81.1 质量的基本知识质量的基本知识 Quality Basic GB/T 19001-2008 IDT ISO
5、 9001: 2008 标准对质量作如下定义 Definition of Quality Basic by GB/T 19001-2008 IDT ISO 9001: 2008 质量：一组固有的固有的特性满足要求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: A group of inherent characters to fulfill the stated or implied requirements and expectations, law and regulation requirements or other added r
6、equirements by company91.1 质量的基本知识质量的基本知识 Quality Basic质量具有质量具有的特性的特性Characteristic of Quality 广义性广义性Generalized时效性时效性Timeliness经济性经济性Economic相对性相对性Relativity101.1 质量的基本知识质量的基本知识 Quality Basic与质量有关的概念与质量有关的概念 Concept related with QualityProcess过程过程Customer顾客顾客Supplier供给者供给者111.2 质量管理的基本知识质量管理的基本知识 Q
7、uality Management Basic 质量管理质量管理 Quality Management包括制定质量方针质量方针，质量目标质量目标及质量策划，质量控制，质量保证质量策划，质量控制，质量保证和质量改进质量改进.Include Quality Policy, Quality Target, Quality Planning, Quality Control, Quality Assurances, and Quality Improvement质量方针质量方针 Quality Policy质量目标质量目标 Quality Target12TimeReject RateHistoric
8、al Level ( 0)Natural Variation under 0 (30)Special VariationOptimum Level ( 1)Natural Variation under 1(31)质量改进质量改进 Quality improved1.2 质量管理的基本知识质量管理的基本知识 Quality Management Basic 131.3 质量管理体系的基本知识质量管理体系的基本知识 Quality Management System Basic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 :
9、 记录，程序文件，规范，工艺，图样，报告，标准Document: Information (Valuable data) & its mediaExample : Record, Procedure, Specification, Techniques, Drawing, Report, Standard, etc.文件的动态性Dynamic of Document 文件的高增值性High value-added of Document文件的价值文件的价值 Value of Documentation14Purpose of Documentation文件的作用:Consolidate/Uni
10、fy action 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 .Document set as organizations regulations, all members will achieve expected results if executed properly.Communication purpose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.Define roles & responsibilities and connections, hence to transform Quality Syste
11、m to an organic system 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质量管理体系的基本知识 Quality Management System Basic15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: For certain activities or processesa. is a methodb. program is not a document, but can be filed as document c.
12、Documents contain procedures can be named as procedure 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Regulate Organizational quality management system requirements documents Minimum elements in GB/T19001-2008:- Scope of Quality Management System;- Procedures for a c
13、ompilation of documents and references;- A description of interaction of the processes文件的类型文件的类型Type of Document质量手册质量手册Quality Manual程序文件程序文件Procedure作业指导书作业指导书Working Instruction记录记录/表单表单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质量管理体系的基本知识 Quality Management System Basic具体的操作性文件，
14、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 Specific operational documents for specific guidance, on-site management or other works. a. supplement for the project files b. Specific guidance for current operation c. should be kept in place and accessible 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
15、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As documental evidence to clarify the results or completion of activities, (for the records needed for quality management) a. The role of records is to clarify the results, and to provide evidence b. No need to record the control version c.
16、 records can be used to provide evidence, but the evidence is not necessarily recorded161.3 质量管理体系的基本知识质量管理体系的基本知识 (赫比方式赫比方式) Quality Management System Basic (Hi-P Way)ISO 框架框架 FrameworkOMS 框架框架 FrameworkISO 9001 GD (ISO9001、ISOTS16949、 ISO13485、ISO14001、OHSAS18001)质量管理体系统 QMS管理系统基础 Management Syste
17、m Foundation管理职责 Management responsibilities 战略管理 Strategy Management 商务管理 Business Management资源管理Resources Management人力资源管理 Human Resources风险管理 Risk Management职业卫生与安全管理 Operational, Healthy & Safety Management产品实现 Product Realization环境管理 Environmental Mgmt 企业安全管理 Corporation Safety Mgmt知识产权与责任 Inte
18、llectual Property Rights & Liability 产品质量计划 PQP产品服务安全和责任 Product / Service safety & Liability 需求供应管理 SCM产品服务的开发和项目管理 Product / Service Development & Program Mgmt 供应商管理和采购 Supplier Mgmt & Purchasing测量分析改进Measurement, Analysis & Improve物料控制 Material Control 生产过程管理 Production Process Mgmt生产中的检查和测试管理 In
19、spection & Test Mgmt in Production产品服务的维护、保养和生命周期终止的管理 Product / Service Maintenance, Care & End-Of-Life Mgmt171.4 质量管理系统的发展历史质量管理系统的发展历史 History of Quality Management System质量 管理大体经历了三个发展阶段，赫比依据其他的先进的管理方法进行了精炼：There are three seedtime of Quality Management System in the world. Hi-P purify it with o
20、ther advanced management system:由由 Mr. Yao始创于始创于14th Jul 2009Created by Mr. Yao 14th Jul 2009Quality Inspection 质量检验阶段质量检验阶段Total Quality Management全面质量管理阶段全面质量管理阶段 (TQM)Organic Management System有机的管理系统有机的管理系统 (OMS)Statistical Quality Control统计质量控制阶段统计质量控制阶段(SQC)181.5 质量管理的八项原则质量管理的八项原则 8 Principles
21、 of Quality Management1）以顾客为关注焦点 Customer Focus2）领导作用 Leadership3）全员参与 All Staff involved4）过程方法 Process 5）管理的系统方法 Systematically management6）持续改进 Continuous Improvement7）基于事实的决策方法 Fact-Based Decision8）与供方互利的关系 Win-win with Supplier191. 以以顾客为关注焦顾客为关注焦 Customer Focus组组织织Company顾顾客客Customer识别顾客识别顾客需求需求
22、和期望和期望Customer requirements转化为产品要求转化为产品要求Turn into product requirements提供提供顾客所需产品顾客所需产品Provide customer required products顾客满意度监控顾客满意度监控Monitor customer satisfaction增强顾客满意增强顾客满意Improve customer satisfaction确立良好的沟通确立良好的沟通Good communication企业获利企业获利，永，永续经营续经营Profit & Grow20方 针Policy目 标Target顾 客需 求Custom
23、er Requirement整合力量Integration最高管理者 Top Management2. 领导作用领导作用 Leadership规划远景,建立方针、目标;Plan for future, setup target;营造良好环境;Create good working environment;规定明确的职权和任务;Assign roles and responsibilities领导者确立组织统一的宗旨及方向。他们应当创造并保持使员工充分参与实现组织目标的内部环境。Leader should align the companys Objective and targets. The
24、y should create those environment and ensure all staff involved.提供所需资源;Provide resources承认绩效,激励员工;Motivate employees, recognize KPI21基层Basic LevelISO(OMS)领导层Leader3. 全员参与全员参与 All staff involved各级人员是组织之本，只有他们的充分参与 ，才能使他们的才干为组织带来收益。真正实现员工参与的关键之一是领导作用是否得力All level of employee is the foundation of compa
25、ny. Company will not gain profit without employee involvement. Leader plays an important role to encourage employee involvement. 22测量分析和改进测量分析和改进Measure, analysis, improve管理职责管理职责 Management Responsibilities资源管理资源管理Resource Mgmt产品实现产品实现Product Realization质量管理体系持续改进质量管理体系持续改进QMS Continuous improvemen
26、t产产 品品Product4. 过程方法过程方法 Process客户客户 customer要要 求求 Requirement满满 意意 Satisfaction客户客户 Customer将活动和相关的资源作为过程进行管理，可以更高效地得到期望的结果。Expected results can be achieved effectively if we gather all activities and related resource into process management. 235. 管理的系统方法管理的系统方法 Systematically Management顾顾客客的的需需求求和
27、和期期望望确定过程和确定过程和职责职责确定过程测确定过程测量方法量方法确定必要的确定必要的资源资源实实现现并并测测量量过过程程质质量量方方针针质质量量目目标标建建立立并并实实施施改改进进过过程程确确定定纠纠正正和和预预防防措措施施Customer requirementQuality Policy & TargetDefine Process & ResponsibilityDefine measurementDefine necessary resourcesMeasurement Corrective Action & Preventive action Establish changed
28、 process 246.持持续续改改进进 Continuous Improvement持续改进总体业绩应当是组织的一个永恒的目标。QMS是一个完全动态向上的系统，持续改进是QMS螺旋上升的驱动力。Continuous improvement is an eternal goal. QMS is a fully dynamic system, and continuous improvement is the spiral driving force of QMS.理想状况理想状况Ideal真实状况真实状况Actual持续改进持续改进Continuous ImprovementP: PlanD
29、: DoC: CheckA: Action创新Creativity创新Creativity创新Creativity创新Creativity创新CreativityP PD DC CA A创新Creativity时间时间 Time257. 基基于于事事实实的的决决策方法策方法 Fact-Based Decision 竞争对手资讯Info from competitors客户期望Customer Expectation统计技术分析真实资讯实施改进管理信息Information Management顾客满意正确决策有效的决策是建立在数据和信息分析的基础上。真实的数据和信息反映事物发展规律或趋势。对真
30、实数据和信息的正确分析是有效决策的基础。Effective decision in build on data and information analysis. The real data and info will reflect the trend & development of an issue. Real InfoRight DecisionImprovementCustomer SatisfactionStatistically Analysis268. 互利的供方互利的供方关系关系 Win-win with Supplier 供方供方Supplier原材料原材料Material
31、组织组织Company产品产品Product客户客户Customer 满意满意Satisfaction$协助、指导Support共同增强创造价值的能力共同增强创造价值的能力Improve Together协助、指导Support27Phase II: QA 介绍Introduction of Hi-P QA28Hi-P Quality Policy 赫比质量方针赫比质量方针Quality PolicyBuilding on the pillars of our corporate culture, cohesive teamwork and focusing on technology and
32、 continual improvement, Hi-P Industries strives to achieve absolute customer satisfaction, gain market share and increase profitability.Through the fostering of employee growth and a harmonious and safe environment, the development of a partnership with supplies, and the commitment to meet or exceed
33、 expectation in quality, service and deliver, we contend to add value to our customers.29Product Realization in Hi-P 赫比的产品实现过程赫比的产品实现过程CustomerCustomer Requirements Requirements 客户需求客户需求Documentation编写文件编写文件Training培训培训Maintenance维护维护Early SupplierInvolvement (Customer Focus Team)QMS SOP Inspection
34、PlansWork InstructionsProduct familiarization for all relevant staffQuality ControlAudits (System/Process)G6Periodical ReviewOptionalG5G5MP reviewMP reviewG4G4ReadinessReadinessReviewReviewG3Periodical ReviewG2Periodical ReviewGate1Gate1InitializationInitializationReviewReview Start-upPhase 1Phase 1
35、Ph2Ph2Ph3Ph3Ph4Ph4Ph5Ph5Ph6Ph6Ph7Ph7G7EOLEOLPhase 1Phase 1InvestigationInvestigationPhase 2Phase 2Project & Concept Project & Concept FeasibilityFeasibilityPhase 4Phase 4Pilot / Test /Pilot / Test /QualificationQualificationPhase 3Phase 3Product & ProcessProduct & ProcessDevelopmentDevelopmentPhase
36、5Phase 5Ramp-UpRamp-UpProductionProductionPhase 6Phase 6MassMassProductionProductionPhase 7Phase 7Ramp-downRamp-downBaseBase30ISO 9001:2008 ISO 13485:2003ISO/TS 16949:2002International Standards Certified 通过认证国际标准通过认证国际标准ISO14001:2004OHSAS18001Tools management Tools management 工具管理工具管理Technology Roa
37、dmapTechnology RoadmapData management Data management 数据管理数据管理Reliability implement Reliability implement 可靠性执行可靠性执行Data BaseReliability Reliability testingtesting OperationOperationStrategyRaw material Plastic partsMetal partsSurface finishing partsFinal partsEnvironment testEMC (Electro Magnetic Compatibility) testOther test /MeasurementLaboratory Framework实验室工作框架实验室工作框架 32
