质量管理体系策划控制程序中英文版本.docx

1、质量管理体系策划控制程序中英文版本1.0 目的 purpose本程序规定了为满足产品、项目、合同和/或顾客规定的要求，确定和配备必要的控制方法、过程、设备（包括检验和试验设备）、工艺装备、资源和技能，使与产品和服务有关的工作有所依循及有效实施，确保产品质量和服务符合和满足顾客和公司要求。This procedure is to meet requirements of products ,items ,contracts and requirements customers stipulate and determine and equip control method ,process ,e

2、quipment (including inspecting and testing equipment ) technology equipment ,resource and skill and make working relevant with service and products have basis and is carried out effectively and make sure service and product quality meet requirements of customers and company2.0 范围 Scope适用于公司质量管理体系产品范

3、围所涉及到的所有过程和活动。It can be applied to all the processes and activities involved with product range of quality management system3.0 职责Responsibilities3.1 总经理负责质量管理体系的策划、建立和完善以及质量管理体系所需资源的配备和确定。General manager is responsible to plan ,set up and perfect quality management system and equip and identify res

4、ource quality management system needs3.2 管理者代表、各部门领导负责质量管理体系的实施、贯彻和落实。Management representatives and leaders of each dept are responsible to carry out quality management system3.3 各管理层及全体员工负责质量管理体系文件各项规定的执行。Management and all the personnel are responsible to carry out stipulation in quality manageme

5、nt system docs3.4 品保部负责质量管理体系的内部审核与督导。QA dept are responsible to guide quality management system and responsible for internal censoring 3.5 各责任部门负责质量手册、程序文件、作业指导书和表单的建立与维护。Responsible depts. are responsible to draw up and maintain quality manual ,procedure docs and forms3.6 品保部负责统筹组建多方论证小组。QA dept a

6、re responsible to plan and set up cross functional team 3.7 工艺部负责制定控制计划。MI dept are responsible to draw up 4.0 简称/定义 Abbreviation/Definition 4.1 质量管理体系：指为实施质量管理所需的组织结构、程序、过程和资源，建立质量方针和质量目标，并实现这些目标的相互关联的或相互作用的一组要素的集合。Ruality management system :set quality policy and quality goal for organization stru

7、cture ,procedure ,process and resource and a group of interrelated and interactional factors to realize these goals4.2 质量策划：指一种确定生产某具体产品或系列产品（如：零件、材料等）所用方法（如：测量和试验等）的结构化的过程，是质量管理的一部分，致力于制定质量目标并规定必要的作业过程和相关资源以实现其质量目标；与缺陷探测大不相同，质量策划包括防错和持续改进的思想。Quality planning :The process to determine the method we

8、use to produce some product or series products (such as parts ,material ,etc )its a part of quality management. it devotes itself into setting quality goal and stipulates necessary operation process and relevant resource to realize quality goal . Unlike defect detection ,quality planning includes th

9、e idea of error-proofing and continuous improvement4.3 质量计划：指对特定的项目、产品、过程或合同，规定由谁及何时应使用哪些程序相关资源的文件。当控制计划作为质量计划时，质量计划便成为一种广义概念。Quality plan: it stipulates by whom, when and use docs of which procedure to a given item ,product ,process or contract .when control plan is used as quality plan, it becomes

10、 a generalized concept4.4 质量手册：指依据公司质量方针而拟定和执行质量方针为达成质量目标的要求，并明确其途经和职责及有效地执行质量管理体系所使用之原则性的基本质量管理活动，为保证满足顾客的要求和需求及期望而描述质量管理体系要素的原则性管理的书面化文件；其目的在于提供一套执行与维持质量管理体系正常运作之有效性和适切性的基本指导纲要原则和与程序文件的衔接桥梁。Quality manual :Its drew up in accordance with quality policy and it regards enforcement of quality policy a

11、s requirements of reaching quality goal and defines its approach and responsibilities and basic quality management activities we use to carry out quality management system effectively .they are docs that describe factors of quality management system to ensure we can meet customers requirements and n

12、eeds and expectations .its purpose is to provide basic principle for carrying out quality management system and maintaining normal running of quality management system and it acts as a bridge between procedure docs and quality management system4.5程序文件：指为维持质量管理体系的运作，当工作涉及到组织内多种职能和部门时将其形成文件的过程，使其作业的目的

13、、范围、权责单位和作业内容透过流程步骤和先后顺序或流程图式地加以说明，以利便于各项工作的实施和管理；其目的在于规范管理性的质量管理活动，促使企业内所有与产品质量、交付和服务有关的过程得到明确规定，并延伸到质量手册使所有活动更具体表现。 Procedure docs :The process to form docs to maintain running of quality management system when work involves many function and depts. to make its operation purpose ,range,responsible

14、 depts. And operation content are explained in order or as flow chart to make it easy for enforcement and management . its purpose is to standardize quality management activities relevant with management and make stipulation for all the processes relevant with product quality ,delivery and service a

15、nd extend to quality manual to make all the activities manifest themselves better4.6 作业指导书：指在质量管理体系中为有效地实施和执行及完成某一功能所进行的工作（如：生产准备工作、检验和试验、返工和返修、设置、人员等），将每一项动作的基准加以详细地说明，包括适用范围、机器、测量设备和监控装置、使用工装/工具/模具/治具/夹具/刀具和方法或方式及人员、时间、地点等详细说明的步骤，便于第一线的作业者参考使用，以免发生错误或因人的理解能力不同而有所差异，造成质量管理体系运作有所偏差而未能达成质量目标和质量方针；其目的

16、在于规范作业的质量管理活动，并具体指出与质量有关的作业指导和要求。Working instruction: the task we do to carry out and finish some functions effectively in quality management system (such as preparation for production ,inspection and test ,rework and repair ,setting ,personnel ,etc)it describes standard of every operation in detail

17、 ,including detailed specification such as applicable scope ,machine ,measurement equipment and monitoring equipment, method ,manner ,personnel , time ,place of using moulds/tools /fixture/clamp /knives and to be referred by operators to avoid mistakes or difference caused by understanding capacity

18、.Its purpose is to standardize quality management activities for operation and point out working instruction and requirements relevant with quality4.7 表单/表格和记录：指阐明所取得的结果或提供所完成活动的证据的文件。Form/table and records :Docs that clarify achieved results or provide evidence for finished activities .5.0 培训和资格 Tr

19、aining and qualification 参加质量策划人员，均应参加TS16949:2002标准和本程序的培训。Personnel who attend quality planning should attend training of this procedure and TS16949:2002 standard6.0 指示内容 Indication content 6.1 公司最高管理者(即总经理)依据ISO/TS16949：2002版质量管理体系要求，结合本公司质量管理体系所制定颁布的质量方针、目标和公司的实际生产经营状况及产品特性/性质，规划和建立本公司生产和服务所需的质量

20、管理体系文件结构，公司质量管理体系文件结构由质量手册、程序文件、作业指导书、表单/表格和记录等共四个层次的管理性文件组成，其文件的制定、编码、审查、核准、修订、发放、回收、归档、销毁等由品保部按文件和资料控制程序执行。The highest management (namely general manager )draws up and plan docs structure of quality management system production and service need in accordance with requirements In 2002 edition of IS

21、O/TS16949 :quality management system and quality policy ,goal and actual management condition and product characteristics /quality .Docs structure of quality management system are made up of quality manual ,procedure docs ,working instruction , forms ,tables and records .QA draw up , code , censor ,

22、 approve , revise , distribute , recycle , file and cancel docs in accordance withcontrol procedure for docs and information 6.2 总经理根据公司实际的生产和经营状况，以ISO/TS16949：2002质量管理体系标准要求为准则建立公司质量管理体系所需要的过程及其在整个组织中的应用，本公司质量管理体系所需的过程包括：管理活动，资源提供，产品实现，测量、分析和改进。General manager sets processes quality management syst

23、em needs and application of quality management system in whole organization in accordance with actual production and management condition regarding standard requirements of quality management system as guideline . quality management system in our company includes management activities , resource sup

24、plying ,product realization ,measure ,analysis and improvement6.3 公司总经理根据质量管理体系所需的过程决定这些过程的先后顺序和其相互作用。General manager of our Company decides sequence of these processes and interaction in accordance with processes quality management system needs6.4 公司各部门根据质量管理体系所需的过程决定其所需的准则和方法，以确保对这些过程进行有效的运行与控制。Ea

25、ch dept decide guideline and method in accordance with processes quality management system needs to ensure normal running of these procedures and they are under control6.5 公司各部门应确保必要的资源和信息的适用性，以支持这些过程的运行和监控。Each dept should ensure applicability of necessary resource and information to support the ru

26、nning and supervision of these processes6.6 公司各部门应对这些过程进行测量、监控、分析和改进。Each dept should measure ,monitor and improve these processes6.7 对质量管理体系所需的过程实施必要的措施，以达成所计划/策划的结果并持续改进这些过程。Carry out necessary measure to processes of quality management system to reach planned result and improve these processes co

27、ntinuously6.8 当公司选择将某些过程委托给供应商进行加工时，公司按照供应商管理程序、采购控制程序对其监控和管理，同时对这些委外加工过程的控制在程序中予以明确鉴别。Company monitor and manage subcontract in accordance with management procedure for suppliers 、 control procedure for purchasingand identify these subcontracting processes in procedure when entrusting some processe

28、s to suppliers to process6.9 为确保本公司质量管理体系的有效运作和其内容的适宜性，品保部应根据公司每年实际的生产经营状况拟定质量审核计划，定期对质量管理体系进行审核，其具体的执行工作按内部审核控制程序执行。QA dept should make censoring plan and censor quality management system regularly in accordance with actual production and management condition andcontrol procedure for internal censo

29、ring to ensure effective running of quality management system and appropriateness of its content6.10 公司最高管理层应根据管理职责程序规定定期对质量管理体系的运作进行管理评审，以评价质量管理体系的运作状况并予以持续改进和不断完善。The highest management should review its running in accordance with stipulation in management responsibilities procedure to evaluate ru

30、nning condition of quality management system and improve and perfect it continuously6.11 质量策划：为满足产品、项目或合同和顾客规定的要求及结合本公司实际的生产和经营状况以及产品特性/性质，公司最高管理层必须对质量管理体系覆盖产品中所涉及到的所有过程和环节进行质量策划；当公司对质量管理体系的变更进行策划和实施时，应保持质量管理体系的完整性。Quality planning :The highest management should do quality planning for all the proce

31、sses and sections involved with products that quality management system covers to meet requirements for products ,items or contract and customers requirements and actual management and production condition and products characteristics /quality. When plan and carry out quality management system alter

32、ation ,we should keep completeness of quality management system6.11.1 质量策划的时机Opportunity of quality planning:（1）按照ISO/TS16949：2002质量管理体系要求建立、改进公司质量管理体系时；When setting and improving quality management system in accordance with ISO/TS16949：2002 quality management system（2）公司已制定并颁布和实施的质量方针、目标、组织结构发生重大变化或重新制定颁布时；When The quality policy ,goal and organization structure company have issued change greatly or are re-set and issued（3）资源配置、市场情况发生重大变化时；When resource configuration ,market condition change greatly