1、1,CONTROL PLAN 控制计划,QUALITY 質量,PRODUCE ABILITY 製作能力,MAINTAIN ABILITY 維持能力,FAILURE ANALYSIS 失效分析,CONTROL PROCESS 控制過程,2,Course objectives 课程目的,在课程的最后学员有能力： At the end of this module, the student will be able to:描述控制计划的价值观 Describe the value of a control plan.解释控制计划中的关键因素 Explain the critical componen
2、ts of a control plan.,3,Control Plans 控制计划,什么 控制计划的构成要素 What elements make up a control plan?为什么 我们要费心这些要素 Why should we bother with them?Who contributes to their preparation?什么人 要为此作准备 How do we develop one?怎样 制定控制计划 When do we update them?何时 我们更新控制计划 Where should the plan reside? 何处 计划归属于何处,What?
3、Why? Who? How? When? Where?,High risk areas only!高危险区域,4,Importance to Customer (Why)為什麼 顧客重視,A control plan exists to ensure we consistently operate and manage processes. 控制计划可保证我们始终如一的操作和管理工艺过程 Resulting product meets customer requirements ALL THE TIME! 生产的产品始终满足客户的要求,5,Control Plan Content (What)
4、 控制计划内容（什么）,Control plans integrate process flow,控制计划要结合工艺流程 critical process characteristics,危急工艺特性 preventative maintenance, 预防性维护process control, 工艺控制reaction procedures,应对程序metrology and 测量标准和负责人 persons responsible.,6,Factors Impacting a Good Control Plan,Measurement测量系统 System,CalibrationRequi
5、rement,Sampling &Testing Plans,Improvement 改进行动Activities,Procedures程序,Preliminary初步分析Analysis,Control Plan控制计划,Process工艺图Maps,FMEA,Training培训材料 Material,SOPs,CustomerRequirement,May already have some of these,Trouble 故障排除辅助工具Shooting Aids,C&E因果矩阵Matrix,Initial Control最初控制计划评估 Plan Assessment,Short
6、Term短期能力 Capability,Maintenance维护计划 Schedule,Reaction 应对计划 Plans,MSA, %R&R %PT,Long Term长期能力 Capability,DOEs,Noise Variable 干扰变量补偿 Compensation,SPC Plans 统计控制计划,Operating 操作窗口 Windows,影响控制计划的因素,标定要求,采样和实验计划,可以使用其中的一部分,客户要求,7,Control Plan Format Recommended 控制计划表格推荐,See Control Plan.doc 参见控制计划plan.do
7、c,产品/产品族： 工艺控制计划进料检验 工艺 生产检查 工艺监控 质保监查 设备配置 预防性维护工艺流程 操作， 工艺操作， 产品/工艺特性 SPEC CPK/日期（采样范），制图方法 ，采样计划 / 频率， 应对计划（OOCAP) 维护程序手册 ， 责任区 参考文献,8,Control Plan Format Recommended 控制计划表格推荐,See Control Plan.doc 参见控制计划plan.doc,产品/产品族： 工艺控制计划 进料检验 工艺 生产检查 工艺监控 质保监查 设备配置 预防性维护工艺流程 操作 工艺操作 产品/工艺特性 SPEC CPK/日期（采样范围
8、）制图方法 采样计划/频率 应对计划（OOCAP) ， 维护程序，手册 责任区 参考文献,度量衡学,REPEATABILITY AND REPRODUCABILITY 重複性和再現能力,9,Control Plan Format Recommended 控制计划表格推荐,See Control Plan.doc 参见控制计划plan.doc,产品/产品族： 工艺控制计划 进料检验 工艺 生产检查 工艺监控 质保监查 设备配置 预防性维护工艺流程 操作 工艺操作 产品/工艺特性 SPEC CPK/日期（采样范围）制图方法 采样计划/频率 应对计划（OOCAP)， 维护程序手册， 责任区 ，参考文
9、献,度量衡学,REPEATABILITY AND REPRODUCABILITY 重複性和再現能力,10,Control Plan Roadmap How控制计划路线图怎样做,1) Determine scope of process for current control plan.确定当前控制计划的工艺范围2) Collect existing operating documentation for process.收集已有工艺操作文件 3) Update documentation more than one quarter old. 更新超过一个季度的文件 4) Short term
10、capability studies should be replaced with long term capability results.采用长期能力结果代替短期能力5) Fill in Control Plan Summary based on review of updated operating documentation.根据对更新的操作文件回顾填写控制计划总结,6) Identify missing or inadequate components - gaps.确认缺少的或不充的部件-失蹤差距 7) Complete missing planelements. 完成缺少的计划
11、要素8) (Re)train operators and maintenance personnel. （再）培训操作工和维修人员 9) Verify control plan effectiveness in 6 months with long term capability study. 根据长期能力研究核实，6个月内控制计划的效果,11,FMEA vs Control Plan FMEA 对 控制计划,FMEA,links to 连接到,Control Plan 控制计划,潜在失效模式,潜在失效影响 严重度,潜在原因 发生频率,当前控制,工艺流程 工艺操作 生产/工艺特性 SPEC 测
12、量 CPK/日期 制图方法 采样计划/频率 维护手册 责任区 参考文件操作 重複性 （采样范围） 应对计划,步骤,部件,12,Continuous variables:连续变量/ Determine optimal operating window (spec)規格 .确定最佳的操作窗口(SPEC) Discrete / attribute variables:离散/分立的/特征变量/变异 Determine optimal setting, procedure, material, etc.确定最优的设置、程序、材料等Uncontrollable noise variables:不可控制的干
13、扰变量 Determine acceptable operating windows for compensating variables(i.e. humidity, vibration).,Control Plan Development Operating Windows控制计划制定 操作窗口,为补偿这些变量（如湿度、振动）确定可接受的操作窗口,13,Control Plan Development Control Methods 控制计划 制定控制方法,Inspection and test methods. 检查和实验方法 Standard Operating Procedures
14、(SOP), checklist. 标准操作规程，检查表 Mistake-proofing systemsand devices:防错系统与装置 Color tags 颜色标签 single use devices 单一用途装置 SPC 统计过程控制 Choice of control charts and sampling plan.控制图和采样计划的选择 Procedures for identifying and responding to out-of-control points and undesirable trends.对失控点和不良趋势的确认与应对程序 Procedures
15、for preventing recurrence of special causes.防止特殊问题复发的程序 Automated process control.自动化的工艺控制,提高Better,For continuous / discrete variables: 连续/ 离散变量,14,Control Plan Development Control Methods 控制计划 制定控制方法,For noise (uncontrollable input) variables: 干扰变量（不可控输入）Document any needed compensation changes to
16、 Attributes (based on known relationships, not tweaking or opinion!).针对各种干扰记录下任何必须的补偿措施（基于已知的关系，而不是人为看法）Define shutdown conditions.定义关机条件Use alternative quality control procedures (inspection, sorting, rework, etc.).应用可选的质量控制程序（检查、分类、返工等）,15,Reaction Plan and Procedures应对计划与程序,Actions taken should b
17、e the responsibility of people closest to the process (process owner/ manufacturing).应由与该工艺关系联系最紧密的人负责采取行动（工艺负责人/制造负责人）The reaction plan can simply refer to an SOP and identify the person responsible for the reaction procedure.应对计划可以仅仅为参看SOP和指定应对程序负责人 In all cases, suspect or nonconforming product m
18、ust be clearly identified and quarantined.在任何情况下，必须明确的确认、隔离可疑的或非一致性的产品 Can be built from FMEA.可以根据FMEA制定应对计划,16,Changes in the process require changes to the control method.当工艺改变时，必须改变控制方法 Control methods identify person responsible for control of each critical variable and details about how to reac
19、t to out-of-control conditions.控制方法明确对每一个危急变量控制的责任人，和对失控情况如何应对的细节。 Control methods include a training plan and process auditing system, e.g. ISO / QSR.控制方法包含培训计划和工艺监控系统，例如ISO/QSR. Control Plans need to be updated quarterly.控制计划必须每季度更新。,Control Methods Finale 控制方法,17,Tech Tips技术提示,A control plan is a
20、 logical, systematic approach for finding and correcting root causes of out-of-control conditions, and will be a valuable tool for process improvement.控制计划是发现和根本解决失控情况的一种合理的系统方法。 A key advantage of the reaction plan form is its use as a troubleshooting guide for operators. A systematic guide of what
21、 to look for during upset conditions is valuable on its own. 应对计划表格的关键益处是可作为操作工排除故障的指导。在混乱情况下有需要做什么的系统指导是颇有价值的。,18,(1),(2),(3),(4),(5),(6),(7),(8),(9),(10),(11),(12),19,20,21,QCP,(1),(2),(3),(4),(5),(6),(7),(8),(9),(10),(11),(12),(13),22,Appendix 附录,Control Plan Description控制计划描述,23,Control Plan Des
22、cription - Optional Information Includes 控制计划描述-可选的资料包括,Control Plan Enter the control plan document number usedNumber for tracking, if applicable. For multiple control pages,控制计划号码 enter page number (page_of_). 在适合的情况输入控制文件号码以便跟踪。对于多的控制页，输入页码（第?页共 ?页） Part Number Enter the number of the system, sub
23、system or 部件号码 component being controlled. 输入系统、子系统或被控部件的号码 Part Name Enter the name and description of the product部件名称 /process being controlled. 输入被控产品/工艺的名称和描述 Supplier PlantEnter the name of the company and the 供应商工厂 appropriate division/plant/department preparing the control plan. 输入参与控制计划的公司名称
24、及其相应的部门、工厂、车间。 Supplier CodeEnter the identification number as requested by 供应商代码 the procuring organization.按合作公司的要求输入标识代码 Key Contact / Enter the name and telephone number of the Phone primary contact responsible for the control 重要联系/电话 plan. 输入控制计划主要联系负责人的姓名和电话,24,Control Plan Description控制计划描述,C
25、ore Team Enter the name(s) and telephone number(s) 核心团队 of the individual(s) responsible for preparing the Control Plan to the latest revision. It is recommended that all of the team members names, phone numbers, and locations be included on an attached distribution list.输入最新版的制定控制计划的每个人的姓名和电话。建议在附加
26、分类表中列出所有团队成员的姓名、电话和职位。Supplier/ Plant供应商/工厂Obtain the responsible manufacturing plant Approval/ Date批准/日期approval (if required). Date 日期 要得到负责的制造工厂的批准（如果需要的话）Enter the date that the original control plan was complied. 输入最初的控制文件生效日期 Date (Rev) Enter the date of the latest Control Plan 日期（再版） updates.
27、输入最新的控制计划更新日期。Customer客户 Obtain the responsible engineering approval Engineering 工程技术 (if required). 要得到可靠的工程技术批准Approval/Date批准/日期Customer Quality客户质量Obtain the responsible supplier quality Approval/Date批准/日期 representative approval (if required).要获得供应商质量代表的批准,25,Control Plan Description控制计划描述,Othe
28、r其他 Obtain any other agreed upon approval Approval / (if required).Date批准/日期 获得其他的要求的批注（如需要） Part / Process This item number is usually referenced from Number the Process Flow Chart. If multiple part 部件/工艺号码 numbers exist, list the individual part numbers & their processes accordingly.这个条款的号码通常是引用工艺
29、流程 图。如果有多个部件号码，列出每个部件和相应的工艺。 Process Name / All steps in the manufacturing of a system, Operation subsystem, or component are described in a Description process flow diagram. 工艺名称和操作描述 Identify the process/operation name from the flow diagram that best describes the activity being addressed.工艺流程图要描述
30、系统、子系统和部件的所有加工步骤。在工艺流程图中确认最能描述当前行动的工艺/操作。 Machine, For each operation that is described, identify Device, Jig, the processing equipment, e.g. machine, Tools for Mfg. device, jig, or other tools for manufacturing, as 机器、装置、夹具和工具组成信息流图appropriate.对于列出的每一操作，确认工艺需要的设备，例如：机器、装置、夹具或其他加工需要的工具。,26,Control P
31、lan Description控制计划描述,Process工艺 Process Characteristics are the process variables (input variables) that have a cause and effect relationship with the identified Product Characteristic. A Process Characteristic can only be measured at the time it occurs. The Core Team should identify Process Charact
32、eristics for which variation must be controlled to minimize product variation. There could be one or more Process Characteristics listed for each Product Characteristic. In some processes one Process Characteristic may affect several Product Characteristics. 工艺特性是那些对特定的产品性能有影响和关联的工艺参数（输入变量）。工艺特性只有在进
33、行的当时可以测量。核心团队应确认的工艺特性为必须受控，并可使产品变化最小的特性参数。对于每一个工艺特性可能为一个或更多的工艺参数。在一些工艺过程，一个工艺特性可能影响几个产品特性。 Special Use the appropriate classification as required by the Characteristic OEM, to designate the type of special characteristic Classification or this field can be left blank for other undesignated 特性分类 char
34、acteristics. Customers may use unique symbols to identify important characteristics, such as those that affect customer safety, compliance with regulations, function or fit. These characteristics are variously termed, “Critical”, “Key”, “Safety”, or “Significant”.按OEM(原始设备制造商)要求的分类法指定产品特性的类型，或在此区域空出
35、其他未指定特性。客户可通过唯一的符号识别重要特性，例如那些影响客户安全、法令、功能或安装的特性。这些特性以不同名称定义，临界的（Critical)、关键的(key)、安全（safety)或重要的(Significant).,27,Control Plan Description控制计划描述,Characteristics特性 A distinguishing feature, dimension, or property of a process or its output on which variable or attribute data can be collected. Use vi
36、sual aids where applicable. 要收集的特性有构造、尺寸或工艺性质，或者工艺要输入的变量或属性数据。如果合适，使用视觉辅助装置。 Number号码 Enter a cross reference number from all applicable documents such as, but not limited to, process flow diagram, numbered blue print, FMEAs, and sketches if required.在所有生效的文件中输入交叉的标识号码,这些文件包括工艺流程图、有编码的蓝图、FMEAs和必须的草图
37、，但不限于这些文件。 Product产品 Product Characteristics are the features or properties of a part, component or assembly that are described on drawing or other primary engineering information. The Core Team should identify the Special Product Characteristics that are a compilation of important Product Character
38、istics from all sources. All Special Characteristics must be listed on the Control Plan. In addition, the manufacturer may list other Product Characteristics for which process controls are routinely tracked during normal operations. 产品特性是指图纸规定的部件、元件或装配总成的构造或性能，也可以是其他的重要的工程技术要求。核心团队必须指定专门的产品特性，这种产品特性
39、是对所有的原始资料中重要产品性能的整合。所有的专门产品特性必须列入控制计划。此外，制造者也可以列出其他的在正常操作时为工艺控制例行跟踪的产品特性。,28,Control Plan Description控制计划描述,Method方法 A systematic plan using procedures and other tools to control a process.使用程序和其他工具控制工艺的系统计划。 Spec Limits Spec / tolerance may be obtained from various 技术规范界限 engineering documents, suc
40、h as, but not limited to, drawings, design reviews, material standard, computer-aided design data, manufacturing, and / or assembly requirements.技术规范/公差可由不同的工程技术文件获得，例如，图纸、设计回顾、材料标准、计算机辅助设计资料、加工和/或装配要求，但并不限于这些文件。 Evaluation Identifies the measurement system being used. This Measurement could include
41、 gages, fixtures, tools, and/or test Technique equipment required to measure the part/process/ 评估测量技术 manufacturing equipment. An analysis of the linearity, reproducibility, repeatability, stability and accuracy of the measurement system should be done prior to relying on a measurement system and im
42、provements made accordingly. 鉴定使用的测量系统。包括量规、工件夹具、工具以及要求用来测定部件/工艺制造设备的实验装置。在使用测量系统前，要进行线性、再现性、再生性、稳定性和精度的分析，并进行相应的改进。 Sample Size /取样范围When sampling is required list the corresponding Frequency/频率 sample size and frequency.要求采样时，列出相应的采样范围和频率。,29,Control Plan Description控制计划描述,Control This column cont
43、ains a brief description of how the Method控制方法 operation will be controlled, including procedure numbers where applicable. The control method utilized should be based on effective analysis of the process. The control method is determined by the type of process that exists. Operations may be controll
44、ed by, but are not limited to, SPC, inspection, attribute data, mistake-proofing, (automated / non-automated), and sampling plans. The Control Plan descriptions should reflect the planning and strategy being implemented in the manufacturing process. If elaborate control procedures are used, the plan
45、 will typically reference the procedure document by a specific identification name and / or number. 本栏简述了怎样进行操作控制，并包括有效的程序号码。使用的控制方法应以对工艺的有效分析为基础。控制方法是由已有的工艺类型决定的。操作可由SPC（数据统计过程控制）、检查、属性数据、防错（自动的或不自动的）和采样计划控制，但控制方法不局限于这些。控制计划描述应反映加工工艺计划和策略。对于优秀的控制程序，计划应参考有特定名称或编码的程序文件。 The method of control should b
46、e continually evaluated for effectiveness of process control. For example, significant changes in the process or process capability should lead to an evaluation of the control method. 根据工艺控制的有效性对控制方法进行连续的评估。例如，工艺或工艺能力的重大变化后，应对控制方法进行评估。,30,Control Plan Description控制计划描述,Reaction Plan The reaction pla
47、n specifies the corrective 应对计划 actions necessary to avoid producing nonconforming products or operating out of control. The actions should normally be the responsibility of the people closest to the process, the operator, or supervisor, and be clearly designated in the plan. Provisions should be ma
48、de for documenting.应对程序要详细说明避免产生非一致性产品和操作失控的矫正措施。这些措施由该工艺负责人、操作工或主管负责，在控制计划中要有明确的指明。规定条款要制定成文件。In all cases, suspect and nonconforming products must be clearly identified and quarantined, and disposition made by the responsible person designated in the reaction plan. This column may also refer to a specific reaction plan number and identify the person responsible for the reaction plan.无论任何情况，可疑的和不一致的产品必须被明确的识别、隔离，并由应对计划中指定的责任人进行部署。本栏也适于特定的应对计划，并确定应对计划负责人。,
