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1、Electro-MechanicsSolution Provider IntegratedTheHi-P InternationalQUALITY BASIC質量基礎知識1Creator: 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 20th Mar 20

2、08Ong.TZInitial Release2.06th Nov 2009WhaleShenAdd GD & OMS content2.1 19th Mar 2010Ong.TZReview the contentDocument PropertiesChange History 2內容 ContentPhase I: 質量專業(yè)相關知識 Quality - Overall - 1.1 質量的基本知識 Quality Basic - 1.2 質量管理的基本知識 Quality Management Basic - 1.3 質量管理體系的基本知識 Quality Management Syste

3、m Basic- 1.4 質量管理系統(tǒng)的發(fā)展歷史 History of Quality Management System- 1.5 質量管理的八項原則 8 principles of Quality ManagementPhase II: QA 介紹 Introduction of Hi-P QA3Phase I :質量專業(yè)相關知識Quality - Overall4沒有賣不出去的產品 只有賣不出去的品質Quality is the basic for tomorrow successQuality: Reduce waste and improve productivity5Quality

4、: Secret for a company to grow continuouslyQuality: An effective way to attract customers 6Quality: An arena for companys future It is easier to keep an old customer than attract 5 new customers 71.1 質量的基本知識 Quality BasicGB/T 19001-2008 IDT ISO 9001: 2008 標準對質量作如下定義 Definition of Quality Basic by GB

5、/T 19001-2008 IDT ISO 9001: 2008 質量:一組固有的特性滿足要求的程度包括明示的、隱含的或必須履行的需求或期望,法律法規(guī)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 requirements by company81.1 質量的基本知識 Quality Basic質量具有的特性Charac

6、teristic of Quality 廣義性Generalized時效性Timeliness經濟性Economic相對性Relativity91.1 質量的基本知識 Quality Basic與質量有關的概念 Concept related with QualityProcess過程Customer顧客Input投入Output產出Supplier供給者SIPOC101.2 質量管理的基本知識 Quality Management Basic 質量管理 Quality Management包括制定質量方針,質量目標及質量策劃,質量控制,質量保證和質量改進.Include Quality Po

7、licy, Quality Target, Quality Planning, Quality Control, Quality Assurances, and Quality Improvement質量方針 Quality Policy質量目標 Quality Target11TimeReject RateHistorical Level (0)Natural Variation under 0 (30)Special VariationOptimum Level (1)Natural Variation under 1(31)質量改進 Quality improved1.2 質量管理的基本

8、知識 Quality Management Basic 121.3 質量管理體系的基本知識 Quality Management System Basic質量管理體系的基本術語 Terms & Definitions文件 : 信息及其承載媒體。(信息:有意義的數(shù)據)例如 : 記錄,程序文件,規(guī)范,工藝,圖樣,報告,標準Document: Information (Valuable data) & its mediaExample : Record, Procedure, Specification, Techniques, Drawing, Report, Standard, etc.文件的動

9、態(tài)性Dynamic of Document 文件的高增值性High value-added of Document文件的價值 Value of Documentation13Purpose of Documentation文件的作用:Consolidate/Unify action 統(tǒng)一行動: 文件成為組織的法規(guī),所有的人都必須通過認真的執(zhí)行達到預期的目的 .Document set as organizations regulations, all members will achieve expected results if executed properly.Communication

10、 purpose溝通意圖:界定了職責和權限,處理好了接口,使質量體系成為職責分明,協(xié)調一致的有機整體.Define roles & responsibilities and connections, hence to transform Quality System to an organic system 質量管理體系的基本術語 Terms & Definitions1.3 質量管理體系的基本知識 Quality Management System Basic14程序:為進行某項活動或過程所規(guī)定的途徑a.是一種方法,途經b.程序不是文件,但可以文件的形式存在c.含有程序的文件可稱為程序文件P

11、rocedure: For certain activities or processesa. is a methodb. program is not a document, but can be filed as document c. Documents contain procedures can be named as procedure 規(guī)定組織質量管理體系的文件 GB/T19001-2008標準的質量手冊至少有以下內容:- 質量管理體系的范圍;- 程序文件的匯編和引用; 過程間相互作用的描述Regulate Organizational quality management sy

12、stem requirements documentsMinimum elements in GB/T19001-2008:- Scope of Quality Management System;- Procedures for a compilation of documents and references;- A description of interaction of the processes文件的類型Type of Document質量手冊Quality Manual程序文件Procedure作業(yè)指導書Working Instruction記錄/表單Record / Form質

13、量管理體系的基本術語 Terms & Definitions1.3 質量管理體系的基本知識 Quality Management System Basic具體的操作性文件,用于具體指導工作、現(xiàn)場管理或其他工作等. a.是對程序文件的補充和完善 b.具體指導現(xiàn)在操作 c.應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 filesb. Specific guidance for curren

14、t operationc. should be kept in place and accessible 闡明所取得的結果或完成活動的證據的文件(用于記錄質量管理所要求的數(shù)據的表格) a.記錄的作用是闡明結果,提供證據 b.不需控制記錄的版本 c.記錄可用以提供證據,但證據不一定是記錄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 clarif

15、y the results, and to provide evidenceb. No need to record the control version c. records can be used to provide evidence, but the evidence is not necessarily recorded151.3 質量管理體系的基本知識 (赫比方式) Quality Management System Basic (Hi-P Way)ISO 框架 FrameworkOMS 框架 FrameworkISO 9001 GD (ISO9001、ISOTS16949、 I

16、SO13485、ISO14001、OHSAS18001)質量管理體系統(tǒng) QMS管理系統(tǒng)基礎 Management System Foundation管理職責 Management responsibilities 戰(zhàn)略管理 Strategy Management 商務管理 Business Management資源管理Resources Management人力資源管理 Human Resources風險管理 Risk Management職業(yè)衛(wèi)生與安全管理 Operational, Healthy & Safety Management產品實現(xiàn) Product Realization環(huán)境管理

17、 Environmental Mgmt 企業(yè)安全管理 Corporation Safety Mgmt知識產權與責任 Intellectual Property Rights & Liability 產品質量計劃 PQP產品服務安全和責任Product / Service safety & Liability 需求供應管理 SCM產品服務的開發(fā)和項目管理 Product / Service Development & Program Mgmt 供應商管理和采購 Supplier Mgmt & Purchasing測量分析改進Measurement, Analysis & Improve物料控制

18、Material Control 生產過程管理 Production Process Mgmt生產中的檢查和測試管理 Inspection & Test Mgmt in Production產品服務的維護、保養(yǎng)和生命周期終止的管理 Product / Service Maintenance, Care & End-Of-Life Mgmt161.4 質量管理系統(tǒng)的發(fā)展歷史 History of Quality Management System質量 管理大體經歷了三個發(fā)展階段,赫比依據其他的先進的管理方法進行了精煉:There are three seedtime of Quality Man

19、agement System in the world. Hi-P purify it with other advanced management system:由 Mr. Yao始創(chuàng)于14th Jul 2009Created by Mr. Yao 14th Jul 2009Quality Inspection 質量檢驗階段Total Quality Management全面質量管理階段 (TQM)Organic Management System有機的管理系統(tǒng) (OMS)Statistical Quality Control統(tǒng)計質量控制階段(SQC)171.5 質量管理的八項原則 8 Pr

20、inciples of Quality Management1)以顧客為關注焦點 Customer Focus2)領導作用 Leadership3)全員參與 All Staff involved4)過程方法 Process 5)管理的系統(tǒng)方法 Systematically management6)持續(xù)改進 Continuous Improvement7)基于事實的決策方法 Fact-Based Decision8)與供方互利的關系 Win-win with Supplier181. 以顧客為關注焦 Customer Focus組織Company顧客Customer識別顧客需求和期望Custom

21、er requirements轉化為產品要求Turn into product requirements提供顧客所需產品Provide customer required products顧客滿意度監(jiān)控Monitor customer satisfaction增強顧客滿意Improve customer satisfaction確立良好的溝通Good communication企業(yè)獲利,永續(xù)經營Profit & Grow19方 針Policy目 標Target顧 客需 求Customer Requirement整合力量Integration最高管理者 Top Management2. 領導作用

22、 Leadership規(guī)劃遠景,建立方針、目標;Plan for future, setup target;營造良好環(huán)境;Create good working environment;規(guī)定明確的職權和任務;Assign roles and responsibilities領導者確立組織統(tǒng)一的宗旨及方向。他們應當創(chuàng)造并保持使員工充分參與實現(xiàn)組織目標的內部環(huán)境。Leader should align the companys Objective and targets. They should create those environment and ensure all staff invol

23、ved.提供所需資源;Provide resources承認績效,激勵員工;Motivate employees, recognize KPI20基層Basic LevelISO(OMS)領導層Leader3. 全員參與 All staff involved各級人員是組織之本,只有他們的充分參與 ,才能使他們的才干為組織帶來收益。真正實現(xiàn)員工參與的關鍵之一是領導作用是否得力All level of employee is the foundation of company. Company will not gain profit without employee involvement. L

24、eader plays an important role to encourage employee involvement. 21測量分析和改進Measure, analysis, improve管理職責 Management Responsibilities資源管理Resource Mgmt產品實現(xiàn)Product Realization質量管理體系持續(xù)改進QMS Continuous improvement產 品Product4. 過程方法 Process客戶 customer要 求 Requirement滿 意 Satisfaction客戶 Customer將活動和相關的資源作為過程進

25、行管理,可以更高效地得到期望的結果。Expected results can be achieved effectively if we gather all activities and related resource into process management. 225. 管理的系統(tǒng)方法 Systematically Management顧客的需求和期望確定過程和職責確定過程測量方法確定必要的資源實現(xiàn)并測量過程質量方針質量目標建立并實施改進過程確定糾正和預防措施Customer requirementQuality Policy & TargetDefine Process & Re

26、sponsibilityDefine measurementDefine necessary resourcesMeasurement Corrective Action & Preventive action Establish changed process 236.持續(xù)改進 Continuous Improvement持續(xù)改進總體業(yè)績應當是組織的一個永恒的目標。QMS是一個完全動態(tài)向上的系統(tǒng),持續(xù)改進是QMS螺旋上升的驅動力。Continuous improvement is an eternal goal. QMS is a fully dynamic system, and cont

27、inuous improvement is the spiral driving force of QMS.理想狀況Ideal真實狀況Actual持續(xù)改進Continuous ImprovementP: PlanD: DoC: CheckA: Action創(chuàng)新Creativity創(chuàng)新Creativity創(chuàng)新Creativity創(chuàng)新Creativity創(chuàng)新CreativityPDCA創(chuàng)新Creativity時間 Time247. 基于事實的決策方法 Fact-Based Decision 競爭對手資訊Info from competitors客戶期望Customer Expectation統(tǒng)計技

28、術分析真實資訊實施改進管理信息Information Management顧客滿意正確決策有效的決策是建立在數(shù)據和信息分析的基礎上。真實的數(shù)據和信息反映事物發(fā)展規(guī)律或趨勢。對真實數(shù)據和信息的正確分析是有效決策的基礎。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 SatisfactionSt

29、atistically Analysis258. 互利的供方關系 Win-win with Supplier 供方Supplier原材料Material組織Company產品Product客戶Customer 滿意Satisfaction$協(xié)助、指導Support共同增強創(chuàng)造價值的能力Improve Together協(xié)助、指導Support26Phase II: QA 介紹Introduction of Hi-P QA27Hi-P Quality Policy 赫比質量方針Quality PolicyBuilding on the pillars of our corporate cultur

30、e, cohesive teamwork and focusing on technology and 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 expectation in quality, service and deliver, we contend to add value to our customers.28Product Realization in Hi-P 赫比的產品實現(xiàn)過程Customer

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