QA-003 SPC Regulation 统计过程控制实施规范-中英对照.docx

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1、LOGOManagement regulationNumber文件编号： WD-QA-003管理规范Department 部门：QA质量部Subject文件名称：SPC Regulation统计过程控制实施规范Revision 版本：1.0Effective Date生效日期:2012-01-01Page 1 of 6批准：审核：作成：Change History 变更记录,Revision 版 本Effective Date 生效日期Originator 编写人Reasons for Change 修改原因1.0 Purpose 目的定义SPC控制图制作的操作规范，并运用控制图进行过程统计分

2、析。Define the procedure for making SPC control chart, and perform process statistical analysis by control chart.2.0 Scope 范围2.1所有汽车产品的特殊特性需按此规范进行生产过程能力监控：2.1 Production process capability of all vehicle products special characteristics shall be monitored according to this procedure;Definitions 定义3.1

3、SPC:指“统计过程控制，是Statistical Process Control的英文缩写。3.2 SPC refers to and is the abbreviation for Statistical Process Control.3.3 CpK：稳定过程的能力指数。它是一项有关过程的指数，计算时需同时考虑过程数的趋势及该趋势接近于 规格界限的程度。3.4 CpK refers to process capability index. It reflects process capability, and during calculation, it shall consider p

4、rocess tendency as well as how close a process is running to its specification limits.3.5 PpK：初期过程的能力指数。它是一项类似于CpK的指数，但计算时是以新产品的初期过程性能研究所 得的数据为基础。3.6 PpK refers to the capability index at initial process. Although similar to CpK, its calculation is based on the performance data at the initial proces

5、s of new products.3.7 Ca：过程准确度。指从生产过程中所获得的资料，其实际平均值与规格中心值之间偏差的程度。3.8 Ca refers to process accuracy. It is the difference between the mean value counted from the data collected from actual production process and the target value.3.9 CP：过程精密度。指从生产过程中全数抽样或随机抽样(一般样本在50个以上)所计算出来的样本标准 差(。*),以推定实际群体的标准差(。)

6、用3个标准差(3。)与规格容许差比较。3.10 CP refers to process precision. It uses sample standard deviation (ax) calculated from full sampling or random sampling (generally samples are over 50) during production process to determine the standard deviation (a) of actual products. Compare three standard deviations (3a)

7、 with allowance.3.11 PPM：质量水准，即每百万个零件不合格数。指一种根据实际的缺陷材料来反映过程能力的一种方法。PPM数据常用来优先制定纠正措施。3.12 PPM refers to quality level, i.e.: the non-conformity of 1,000,000 parts. It is a method that reflects processcapability according to actual defective materials. PPM is primarily used to establish corrective mea

8、sures.3.13 Cmk设备能力指数：是反映科技设备在受控条件下，当其人例/法不变时的生产能力大小。3.14 Cmk refers to equipment capability index. It reflects the production capability of mechanical equipment under control when operator/materials/methods have no change.3.15 值X：代表该数据的分布的中心位置，所以也称为位置参数。包括子组均值X和。样本均值X。3.16 Average value X refers to

9、the center position of all data, so it is also called as position parameter, including average value for sub-group X and that for sample X.3.17 差R：表示一组数据的分布范围，是指数据中最大值与最小值的差。3.18 Range R reflects the distribution range of a group of data, and refers to the difference between maximum and minimum.3.19

10、 标准差。：表示标准偏差，即用来描述任一过程参数的平均值的分布或离散程度。3.20 Standard deviation a is used to show how much variation or dispersion there is from the average value.3.21 上控制线UCL：表示样本数据的上限控制范围，由统计分析计算所得。3.22 Upper control limit UCL refers to the top limit for sample data and is obtained from statistical analysis and calc

11、ulation.3.23 下控制线LCL：表示样本数据的下限控制范围，由统计分析计算所得。3.24 Lower control limit LCL refers to the bottom limit for sample data and is obtained from statistical analysis and calculation.3.25 工程规范上线USL：表示产品特性的规格上限，如板厚1.5mm,公差为0.13时，其USL为1.63。3.26 Upper specification limit USL refers to the top limit for product

12、 specification, e.g.: when plate thickness is 1.5mm and tolerance is 0.13, USL is 1.63.3.27 工程规范下线LSL：表示产品特性的规格下限，如板厚1.5mm,公差为0.13时，其USL为1.37。3.28 Lower specification limit LSL refers to the bottom limit for product specification, e.g.: when plate tolerance is 1.5mm and deviation is 0.13, USL is 1.3

13、7.3.29 中心线CL：样本均值所代表的控制线。3.30 Central line CL refers to the line of the average value of samples.3.31 过程能力乙按标准偏差为单位来描述的过程均值与规范界限的距离。3.32 Process capability Z reflects how close the process average value is running to its specification limit and it is shown by standard deviation.3.33 子组：连续采集510个数据为一个

14、子组。3.34 Sub-group is composed of 510 data collected continuously.3.1 Responsibility 权责工艺工程师：负责分析用控制图的数据收集和绘制，并对分析用控制图进行分析、稳定性判定、初始过程 能力分析计算：控制用控制图异常分析和工艺改进。4.1 Process engineer is responsible to collect data and draw control chart used for analysis, analyze control chart, determine stability and ana

15、lyze and calculate initial process capability, as well as to analyze the abnormity of control chart used for control and to improve its technology.4.2 质量工程师：负责控制用控制图数据收集、绘图，控制图异常时向工艺工程师及质量部报警。4.3 Quality engineer is responsible to collect data and draw control chart used for control, and alarm proce

16、ss engineer and Quality Department in case of abnormality.5.0 Procedure 程序5.1分析用控制图的制作5.1 Making of control chart used for analysis当有下列情况时，要采用分析用控制图：Control chart shall be used in case of the following circumstances:5.1.1 特殊特性首次采用控制图进行分析与统计过程控制；5.1.2 Special characteristics are controlled by control

17、 chart for analysis and SPC for the first time;5.1.3 关键设备出现故障后苜次运行：5.1.4 Key equipment runs for the first time after its failure is solved.5.1.5 生产产品工艺流程有更改时；5.1.6 When process flow for producing products are changed;5.1.7 生产设备停机超过一个月后首次运行。5.1.8 Production equipment runs for the first time after it

18、is stopped for more than one month.5.2 数据的采集规范5.3 Specification on data collection同一批次连续检测5个数据，做为一个子组，填入控制图相应表格中。每班每天各取2批，取满100个数 据为止。Check 5 data continuously from the same batch and make these 5 data as a sub-group. Fill the data into the corresponding space in control chart. Each shift should col

19、lect data from 2 batches each day until 100 data is collected.5.4 数据处理5.5 Data process利用Minitab或Excel等工具计算控制上下限和CPK,绘制控制图。Use Minitab or Excel to calculate and control top limit, bottom limit and CPK, and to draw control chart.5.6 控制图的分析5.7 Analysis of control chart5.7.1 控制图编制好后，当出现以卜.情况时，说明过程不稳定，过程

20、能力不能满足要求，由工艺工程师立即召集生产部、工程部、质量部共同分析原因，并采取相应措施。5.7.2 After control chart is finished, the following situation indicates that process is not stable and process capability cannot conform to requirements. Under such circumstances, process engineer shall call Production Department, Engineering Department

21、and Quality Department together to jointly analyze the causes and to take corresponding measures.A)有一个或多个点在控制界限外The one or more points outside the control limitB)连续七点上升或下降：A) There are seven points continuously ascend or descend;5.7.3 实施改善措施后，重新按5.25.3步骤绘制控制图。对控制图进行分析，如果控制图未有以上5.4.1 条款情形，则认定此过程稳定，由此

22、计算的控制线及中线可延伸，作为连续生产时控制用控 制图规范。5.4.2 After improvement measures are taken, draw control chart according to 5.25.3 again. Analyze control chart. If nothing described in 5.4.1 appears, then the process may be considered as stable. The control line and central line calculated thereby may be extended and

23、 taken as the specification on control chart used for control during continuous production.5.4.3 分析用控制图需在控制图中注明“初始能力分析”。5.4.4 Initial capability analysis shall be clearly indicated in control chart used for analysis.5.5控制用控制图的编制5.5 Making of control chart used for control当过程能力进行初始分析为稳定过程时方可进行编制控制用控制

24、图。5.5.1 Control chart used for control can only be made when process capability is initially analyzed as stable.5.5.2 Collect data 数据的收集A)初期过程能力的计算应在同一批产品中将125个数据收集完毕后再计算PPKA) Calculate PPK should be collected 125 products data in the same batch at the Initial period B)量产后每天连续采集5个数据，作为一个子组，将数据记录在控制图

25、中。B) After the long term collect 5 data continuously each day, make these 5 data as a sub-group, and record the data in control chart553计算子组平均值X,极差R。用描点法在控制图中绘出相应的点，并用实线将各点连接起来。5.5.3 Calculate the average value X and range R of sub-group. Draw corresponding points in control chart by mark the points

26、 and line them together by real line.5.5.4 每月数据为一张控制图，月底最后一组数据完成后计算CPK,如果当月数据不足20组数据时，暂 不予计算CPK.该控制图延用至下月，待数据采集为20组时再计算CPK.5.5.5 One control chart for the data of one month. At the end of the month, when the final group of data is finished, calculate CPK. If data of that month is less than 20 groups

27、, CPK is not calculated, and this control chart is extended to and used in the next month. CPK can only be calculated when and until there are 20 groups of collected data.5.5.6 当制程稳定时，控制图中上下控制线、中线可一直延伸作为下月控制线、中线。5.5.7 When production process is stable, the line of top limit and bottom limit as well

28、as the central line may be extended to and used in the next month.5.5.8 当控制图中数据有异常(中内容)时，由工艺工程师召集各相关部门进行原因分析，消除异 常原因。5.5.9 When data abnormality occurs in control chart (as described in 5.4.1), process engineer call all departments concerned together to analyze causes and solve problems.5.5.10 异常原因消

29、除后，应按5.15.3重新进初始能力分析，当分析结果为过程稳定时，再进行编制控 制用控制图并运用。5.5.11 When abnormality is solved, analyze initial capability according to 5.1 5.3. Control chart used for control can only be made and used when analysis result is stable.5.5.12 控制线与中线延用12个月后，需按5.15.3重新对过程进行能力分析，计算上、下控制线及中 线。5.5.13 When limit line an

30、d central line is used for 12 months, analyze process capability again according to 5.1 5.3 and calculate top line, bottom line and central line.5.5.14 程能力指数评估默认值要求：5.5.15 Default value requirements for assessment of process capability index a.若客户对过程能力有指定要求，则依客户指定要求评估。a. If customer has specific req

31、uirements to process capability, assessment shall be conducted according to customer requirements.b.若客户对过程能力无指定要求，则依下表默认值进行评估。b. If customer has no specific requirements to process capability, assessment shall be conducted according to the default value as listed below.c.不属正态分配之数据，可依顾客之需求，采用CPK以外之方法

32、评估过程能力，如PPM值法。c. Data that is not under normal distribution may be assessed by other methods beyond CPK according to customer needs, such as PPM value method.阶段 Stage阶段说明 Stage description应用指数 Applied index指数要求 Index requirements处理方式说明Treatment description初期 Initial period批量生产前(试 产)Prior to batch pr

33、oduction (trialproduction)PPK1.67过程符合顾客要求 Process conforms to customer requirements.避All VII过程可能不符合顾客要求,PPAP批准后开 始生产时对控制特性需特别注意，直到过程 中的CPK达到1.33以上.Process may not conform to customer requirements. After approved by PPAP, special characteristics shall be paid special attention when production begins

34、until CPK in process is above 1.33.1.33不符合顾客要求，.必须改善过程Process does not conform to customer requirements and shall be improved.长期 Long-term过程稳定且数据 呈正态分配时CPK2 1.33过程符合顾客要求 Process conforms to customer requirements.When process is stable and when data is under normal distributionCPK1.33不符合要求须改善Process

35、does not conform to customer requirements and shall be improved.Reference Documents 参考文件无NoneReference Forms 参考表单FN-QA-018 Process capability certification report 过程能力报告Flow Chart 流程图责任部门Responsibility流程图Flow ChartReference / Remark参考文件或表单工艺工程师 PE engineer工艺工程师 PE engineer工艺工程师 PE engineer质量工程师QA engineer质品工程师QA engineer侦量工程师 QA engineer侦星工程师QA engineer相关部门RelateddepartmentsTake measures分析用控制图Control chart used for analysis控制用控制图Control chart used for control