控制计划程序文件.doc

质量程序文件No. / 编号. 530Issue/发布 2.1Sheet/形式 11 of/von 11Issue/Ausgabe: 1Sheet/Seite11/11 Department/部门Control plan 控制计划Author/作者 ZiehmDate /日期 19.09.2008Author/Verfasser: ZiehmDate/Datum: 29.9.061. Purpose and objective2. Process definitions2.1 Scope2.2 Process responsibility2.3 Involved functional divisions2.4 Definitions2.5 Measurables3.0 Procedure3.1 Control plan for prototypes3.2 Control plan for pre-launch3.3 Control plan for production3.4 Product and process changes, relocation of production3.5 Archiving4. Notes and remarks5. Other applicable documents1. 目的2.过程定义2.1范围2.2过程职责2.3相关职能部门2.4 定义2.5评价3.0流程3.1 样件控制计划3.2试生产控制计划3.3 生产控制计划3.4产品和工艺变更，生产地的变更3.5 存档4. 备注和注释5. 其他适用文件reviewed / 复审released / 发布from / 从date / signature日期/签名1. Purpose and objectiveDuring product and process development, every individual production step for product manufacture must be planned in such a way that adherence to all specified product characteristics is guaranteed using controlled, economical sequences. all planned production, assembly and testing sequences for a product from receipt of the production materials through to delivery of the finished product to the customer are collated in a clearly manageable layout in the form of a control plan. changes to described production, assembly and testing sequences are only introduced following prior assessment and approval.The control plan is maintained as a controlled document throughout the entire production period and can consequently be presented to the customer / to approval authorities as a verification document as objective evidence of a methodically planned and specified production sequence.1.目的在产品和工艺发展阶段，产品制造的每一步生产步骤必须以下的方式进行计划： 确保所有规定的产品特性在生产过程中受控以及经济的。 一个产品从生产材料的验收到成品交货给顾客的整个过程的所有计划的生产、装配和检验的流程都要与控制计划中的清晰可实现的流程图对应。 产品描述,装配,检验的流程变更前一定要先评审、批准控制计划是作为贯穿整个生产周期的受控文件，因此要提交给客户/批准，并作为一个有序的计划和规定的生产流程的有效文件验证证明。2.0 Process definitions2.1 ScopeThe definitions contained in this Central Quality Procedure are applicable worldwide to all Automotive divisions and factories. (see IMS Volume1_1.3 Organization Chapter 1.3.2).2.0 过程定义2.1 范围本中心质量程序囊括的定义适用于世界范围内所有Automotive的部门和工厂。（见IMS 1卷1.3章1.3.2节）。2.2 Process responsibility/fields of responsibility Process responsibility for the compilation, assessment, updating, release and distribution of prototype control plans (A and B samples) lies with Development Process responsibility for the compilation, assessment, updating, release and distribution of production control plans for pre-launch (C samples) and production (D samples) models lies with the Production Planning Department of the producing plant.2.2 过程职责或职责范围 开发部门在过程中负责样件控制计划的编写、评估、更新、发布和下发（A和B样品）。 为前期开发（C样品）和生产样品（D样品）编写评估、更新、发布和下发的样件控制计划，这些过程职责取决于制造工厂的生产计划部门。2.3 Involved functional divisionsDevelopment divisions which produce and supply samples or prototypes for customers (e.g. EEV,EEG,ELT)Production PlanningLogisticsQuality ManagementSupplier Quality Assurance2.3 相关职能部门开发部门生产并向客户提供样品 (如. EEV,EEG,ELT)生产计划部门物流部门质量管理部门供应商质量保证部门2.4 Definitions Control plan: see ISO/TS 16949 chap. 7.5.1.1 and Annex A Production material: Material which is used in the manufacture of products. Prototypes: Prototypes are products manufactured under the responsibility of Development and supplied to the customer. Parts, components and manufacturing methods do not have to comply with the subsequently used production process. Quality responsibility lies with the delivering Development Department. Pre-launch products: Pre-launch products are products manufactured under the responsibility of Production Planning from parts and components with differing release statuses. The production processes used are still in the optimization and release phase. Employee qualification is not yet completed. Quality responsibility lies with the plant/QM Series products: Series products are products manufactured under the responsibility of Production made from released parts and components. The used production processes comply with the released production status. Responsibility for quality lies with Production. Part groups: This describes parts of a similar nature which are manufactured using identical process steps, e.g. Duroplast reflector production for different headlamps etc. Product families: This describes different vehicle model-related headlamp types such as Halogen, right-hand drive version or halogen left-hand drive version for right-hand / left-hand mounting respectively. Product history: This is a product-specific documentation in which all major product and process changes are listed in chronological order with date of introduction and agreed identifying markings on the product. This guarantees product traceability. Submission level PPAP, VDA Volume 2 PPR process2.4 定义 控制计划: 见ISO/TS 16949 7.5.1.1 章，附件 A 生产材料: 用于制造产品的材料 样件: 样件是在开发部门负责制作并向客户提供的产品。零件、部件和制造方法不要求与量产相同。质量方面的职责在于负责交货的开发部门。 试生产件:试生产件是在生产计划部门负责的条件下制造的产品，其零部件和组件可以不同于发布状态的零部件和组件。使用的生产工艺仍然处于优化和发展的状态。员工的作业资格不完全符合。质量方面的职责在于工厂或质量管理部。 批量生产:批量生产时产品制造是在正式发布的零件与部件条件下，产品制造过程与发布的正式生产状态一致，质量责任在于生产。 零件类: 这个描述了具有相似性能的零部件，它们是采用相同的工艺步骤制造的，如前灯的反射镜生产. 产品系列: 这描述了不同的车辆车型，如卤素前大灯，右驾版本或左驾版本只为右驾/左驾安装顺序。 产品记录: 这是具体产品的文件，在这个文件里，按采用日期的时间顺序对所有主要的产品和工艺变更进行记载，还记载了一致认同的标记产品的标识。这就确保了产品的可追踪性。 提交等级PPAP, VDA 2卷 PPR工艺2.5 MeasurablesNone defined.2.5 评价没有定义3.0 Process sequenceIn accordance with the QM plan (CP531), control plans must be produced during the product development process. A distinction must be made between: Control plan for prototypes Control plan for pre-launch products Control plan for series productsThese different control plans take into consideration different production, assembly and test steps depending on the product development phase.A control plan can refer to: Part groups (e.g. Duroplast reflector production) Product families (e.g. left-hand drive and right-hand drive headlamps of the same type) The condition for this is that these are produced within the framework of identical processes at the same location and that they each take into consideration the entire manufacturing process from incoming goods through to delivery.Remark1:In the case of control plans for part groups, care must be taken to ensure that if a control plan already exists, the requirements for newly added products are taken into account. The control plan must be updated accordingly.Schematic structure of the control plan:A) Product identification information such as Product name, vehicle type AL item number and revision status and if required customer item number and release status. AL production plant, (plant identification DUNS No.) Author and involved team Release (by involved organization, customer if requested) Process designation (e.g. assembly) Type of control plan (prototype, pre-launch or production)B) Process steps must be listed and indicated: All product characteristics influenced by the process and special product characteristics All process characteristics to be monitored and special process characteristicsC) For all characteristics, the methods and actions for product and process control must be defined. This relates to: Target values with tolerance Test methods Test frequencies with random sample size Control method Recording of results Actions in case of non-conformance, i.e. reaction plan and corrective action planRemark 1:In the control plan, special characteristics must be marked with the symbol requested by the customer (ISOTS 16949 7.3,2.3). If no customer request exists, then the symbol for marking is a # (in accordance with ZV586)Remark 2:If requested by the customer, the customers forms must be used for drawing up the control plan.Remark 3:On process acceptance / release of a product, as a rule customers request submission level 3. An agreement must be reached with the customer regarding the language to be used for submission of the control plan.Remark 4:The control plan does not replace the work and inspection instructions for each individual process step. However, their contents form the basis for the control plan. In work instructions, the process stipulations are converted into task-based work instructions for the relevant process step. The inspection instructions describe the individual test and inspection methods.3.1 Control plan for prototypesIf the customer requests a prototype control plan, then the customers stipulations must be taken into account for this.The AL standard for prototype control plans comprises order-specific documentation with: Sample order (requirement catalogue, parts list, production steps in prototyping) Test sheet for the product sample Documentation of results If applicable indication of the development status / software status for electronics. If applicable concession where samples have to be delivered despite non-conformance.The prototype control plan is compiled and released by the delivering development department, e.g. light prototype by ELT, electronic prototype by EEG, assembly prototype by EEV, design prototype by ELD/EAP.3.2 Control plan for pre-launchThe structure of the pre-launch control plan must be drawn up in accordance with the ISO/TS 16949 stipulations (see Annex 1) and subsequent production, i.e. a pre-launch control plan must be drawn up in analogy with the planned production and test steps. Points to note: The pre-launch control plan must contain control actions and reaction plans for temporary production and test steps. ( see Annex 1 and 2) It is admissible to produce different control plans for pre-launch production processes and assembly processes. The product and process control methods which deviate from production must be specified. The pre-launch control plan must be continuously adjusted in accordance with advancing product and process maturity and assigned to the supplied pre-launch products (product history)The basis for compilation of the control plan are findings from the FMEAs, QRCs, information from the drawing, test specifications, IMS procedures, the target and performance specification and from the process planning activities. Remark:Temporary production and test steps are defined as production and test steps deviating from production. (e.g. production and test facilities not yet released). Production Planning is responsible for compilation of the control plan. It coordinates the relevant contributions to the control plan from other divisions, such as: Maintenance, e.g. preventive maintenance, repairs of machines, fixtures and tools Logistics, e.g. transport and storage, incoming goods Supplier Quality Assurance e.g. inspection plans for receiving inspections Quality Management e.g. product audit, pre-launch testing, Release is performed by the responsible Head of Quality Management for new products / the Quality Manager of a plant. 3.3 Control plan for productionOnce process validation is complete, all production and test steps from incoming goods to goods dispatch must be drawn up and documented in chronological order in production control plans. These control plans are binding following formal release by Production Planning, Quality Assurance and the other responsible functions and must be strictly adhered to. Release is issued by the responsible:- Head of Quality Management in the plant and - Head of Production Planning, Assembly / Pre-launch Production 3.4 Product and process changes, relocation of productionThe control plans must document the current product and production status. This encompasses updating of the control plan in case of:- All process changes and - Product changes with repercussions on the control plan Remark:Relocation of production to a new location always constitutes a process change. 3.0 过程顺序根据质量计划（CP531），控制计划在产品开发过程中必须完成。必须区分： 样件的控制计划 试生产的控制计划 量产的控制计划这些不同种类的控制计划要考虑由产品发展阶段决定的不同类别产品的生产、安装和测试步骤。一个控制计划要包括： 零件类 (如脲醛反射器生产) 产品系列(如同一款型的右手驱动版本和左手驱动版本的前大灯) 这个的条件是在同一地点采用相同的工艺流程生产这些产品，还有也要考虑从进货到交货的整个制造过程。注释1:就零件类的控制计划必须保证，如果已有了控制计划，又新增加的产品要求，控制计划必须相应的更新。控制计划的简要结构：A) 如产品验证信息 产品名称，车型 AL项目编号和修订状态，并且如果有要求的话，客户的项目编号和发布状态 AL-生产工厂 (工厂身份证明 邓白氏编码.) 作者和相关团队 发布, (如果要求的话，涉及的部门和客户) 过程设计 (如装配) 控制计划的类型 (样件, 试生产或生产)B) 过程流程必须列出和指示： 影响所有产品特性的过程和特殊产品特性 监控所有过程特性C) 为了实现所有的性能，必须确定产品和过程控制的方法和行动。这个涉及到： 公差范围 测试方法 随机抽样的大小与频率 控制方法 记录结果 如果不合格事件发生，采取的行动，即反应计划和纠正行动计划注释 1在这个控制计划里，特殊特性必须用客户要求的标识标记ISOTS 16949 7.3,2.3)，如果客户没有要求，就用“#”标记 (根据CP586)注释 2如果客户有要求的话，编写控制计划时，必须采用客户所要求的形式。注释 3在工艺认可或产品的发布方面，作为一个原则，客户要求按3级的方法提交控制计划。关于提交的控制计划采用何种语言必须与客户达成一致。注释 4这个控制计划不取代每个工艺步骤的工序和检验指导书。然而，它们的内容是控制计划的基础。在工序指导书中，工艺规范转变为基于任务的相关工艺步骤的工作指导。检验指导书描述了每项测试和检查方法。3.1 样件的控制计划如果客户要求有样件控制计划，那么客户的规范必须考虑进去。AL标准控制计划标准包括特定的订单文件，具体如下： 样品订单(需求目录、零部件清单，样件的生产流程) 样件测试记录 结果的记录 如果适用于表明开发状况/电子器件的软件状况 如果适用于让步，尽管不合格仍须交付样件样件控制计划由负责交货的开发部门编制和发布，如ELT编制和发布灯样品控制计划，EEG编制和发布电子样品控制计划，EEV编制和发布安装样品控制计划，ELD/EAP.编制和发布设计样品控制计划。3.2试生产控制计划试生产控制计划的结构必须根据ISO/TS 1694的规范（见附件1）和后来的生产进行编制，即试生产控制计划必须根据规划的生产和试验步骤编制。需要注意一下几点： 试生产控制计划必须包括控制行动和临时反应计划和试验步骤的计划（见附件1和2）。 在前期开发生产过程和安装过程中实施不同的控制计划是允许的。 偏离生产的产品和过程控制方法必须予以规定。 试生产控制计划必须根据产品和工艺进程不断地进行调整，并且必须指定前期开发产品的提供者（产品开发史）。编写控制计划的基础是FMEAs, QRCs的结果，图纸信息，测试规范，IMS程序，目标和规范的执行度和过程规划的行动。注释 :临时的生产和测试步骤被定义为偏离生产的生产和测试步骤（如没有发布的生产和测试设备）。生产计划部门负责编写控制计划，它需要协调其他部门对控制计划所起的作用。如： 维修部，如预防性维修，机器、设备和工具维修。 物流部门，如运输、储存和进货。 供应商质量保证部门，如接受检查的检查计划 质量管理部门，如产品审核，前期开发试验。前期开发控制计划发布由负责新产品的质量管理部门经理或工厂的质量管理经理执行。3.3 生产的控制计划一旦过程验证完成，从进货到货物发运整个过程所有的生产和测试步骤必须按时间顺序编写和记录在生产控制计划里。在生产计划部门、质量保证部门和其他负责的职能部门正式发布之后，将这些控制计划整合在一起，并且必须坚持这些计划。其发布由以下部门负责：:- 工厂质量管理经理- 生产计划经理，安装或前期开发生产经理3.4 产品和工艺变更，生产变更这个控制计划必须记载目前的产品和生产状态。这个计划包括以下条件下控制计划的更新：- 所有工艺变更- 受产品变化影响的控制计划注释:生产转移到新的位置总是形成一个过程变化。3.5 ArchivingAll prototype control plans must be retained for at least 3years in the responsible department. Pre-launch and production control plans must be retained for at least 15 years following production discontinuation in the responsible department. In the case of relocated production, all control plans must be relocated at the same time and kept at the new location. 3.5 存档所有样品控制计划由负责的部门必须保留三年以上。前期开发和生产控制计划在停止生产以后由负责的部门必须保留15年以上 如果生产变更发生，所有的控制计划必须同时随之变化，并符合新的变更。4. Notes and remarks Issue 2:Completely revised and adjusted in line with ISO/TS 169494. 备注和注释全部修订第2章，调整ISO/TS 16949的相关内容5. Other applicable documents-5. 其他试用文件-Annex/Anlage 132011.d9dd86dab057db3c366f0bd13bc336fd.pdfAnnex/附件 2: Examples of control methods / 控制方法的例子 Control methods /控制方法Document /文件Record /记录Process / 过程Product / 产品Receiving inspection / 接受的检查Inspection plan /检查计划Inspection report / 检查报告xSet-up specifications / 建立规范Set-up plan /编写计划Records automatically or manually / 自动或人工记录xFirst produced part release /首批生产的零部件的发布Setter checklist / 首批生产者名单Records automatically or manually /自动或人工记录xxCalibration with GO and NOGO samples for testing facilitiese.g. 100 % leak testing / 测试设备能的例子，分为正常运行和不能正常运行Calib