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1、1 目的/Purpose 为以下活动提供制度和指导，并明确责任： To provide system and guidance for the following activities and define responsibilities: 统计技术的应用 The application of statistic technique 进行初始过程能力研究 Conduct research of preliminary process capability 监视现有过程能力 Monitoring existing process capability 2 适用范围/Application Sc
2、ope本程序主要适用于关键工序。直接与产品小组、质量部有关。 The procedure is applicable to key procedures, which directly link to product team and quality team. 3 术语和定义/Terms and definition 无/Nil 4 程序流程图/Process Flow Chart 无/Nil 5 职责和权限/Responsibilities and Authorization 产品小组负责确定 SPC 控制点，并写入控制计划。 Product team is responsible for
3、 determining SPC control point, composing control plan. 质量部和生产部负责 SPC 控制和其它统计技术的实施。 Quality Dept. and Production Dept. are responsible for SPC control and implementation of other statistic technique. 6 工作程序/Working Procedures 6.1 初始过程能力的研究/Research on Preliminary Process Capability 6.1.1 初始过程能力研究用于验
4、证关键工序有能力生产满足顾客要求的产品。该研究通 常由产品小组在产品试生产阶段进行。 The research of preliminary process capability is designed for verifying key procedures and ensures capability to satisfy customers requirements. Basically, the research is conducted in trial-production stage by product team. 6.1.2 数据收集及绘制控制图/Collect Data a
5、nd Protract Control Drawing 6.1.2.1 “初始过程能力研究”中介绍了进行初始过程能力研究的步骤，该章节作为本 程序文件的一部分。 “Research of Preliminary Process Capability” introduces procedures of the research; the chapter is a part and parcel of the procedures documents. 6.1.2.2 只有计量型数据才进行初始过程能力研究。 Only attribute data is applicable to research
6、 of preliminary process capability. 6.1.2.3 初始过程能力研究通常采用“均值和极差图”和“单值和移动极差值”进行分 析，除非有理由采用其它控制图。产品小组最终决定采用何种控制图和样本的组数及 个数。 Research of preliminary process capability, basically, adopts methods of “X-R Chart” and “Individual and Moving Range” to conduct analysis, unless convincing enough to adopt other
7、 control drawing. Product team decides finally to adopt what control drawing, group number and individual number of samples. 6.1.2.4 QS9000-“统计过程控制”手册中提供了有关控制图的空白表格及计算均值和极 差、绘制控制图的详细指导。 QS9000- the manual of “Statistic Process Control” provides blank form related to control drawing and detail instru
8、ction on X bar computation, range and control drawing. 6.1.3 控制图的评价及过程能力支书的计算 Control drawings appraisal and computation of process capability analysis 6.1.3.1 当绘制均值和极差后，接着计算平均极差、平均均值机控制限，并绘制在控制 图上。这时控制图即可用来评价过程的不稳定性。有关控制图的解释和评价详见 QS9000-“统计过程控制”手册。 After protract X bar and range, continue to comput
9、e means range and control limit, then protract in control drawing. By then, the control drawing is used for appraising process instability. The explanation of control drawing and appraisal details were provided in the manual of “Statistic Process Control”. 6.1.3.2 当控制图显示过程不稳定时，必须调查引起不正常波动的特殊原因并加以消除。
10、 当过程趋向稳定时，即可计算过程能力指数 Cpk，有关计算方法详见 QS9000-“统计过 程控制”手册。 When the control drawing shows process instability, must investigate special reason caused abnormal fluctuation and eliminate. When the process trend stable, proceed computing Cpk, the details were provided in the manual of QS9000-“Statistice Pro
11、cess Control”.6.1.4 接受标准和顾客批准/Acceptance Standard And Customers Approval 6.1.4.1 过程的接受标准由顾客决定。当顾客未指定接受标准是可由产品小组自行决定。 Customer decided acceptance standard of process. When there in no designated acceptance standard from customers, products team decide themselves. 6.1.4.2 若过程能力指数 Ppk 和/或 Cpk 低于顾客/ 自行规
12、定的接受标准时，有关部门必 须进行研究以发现引起不正常波动的特殊原因，必要时实施纠正措施以消除或减少过 程波动。 In the event of Ppk and/or Cpk lower than acceptance standard of customers/self-decided, the related departments must conduct analysis to find out the special reason, which cause abnormal fluctuation, implement corrective measures to eliminate
13、 or minimize the process fluctuation. 6.1.4.3 若过程的能力指数不能进一步改进以达到顾客的要求，但所生产的产品能满足 顾客要求，则必须及时与客户联系，询问是否能降低过程能力指数要求。 If fail to further improve Cpk to meet customers requirements, however, the products are able to meet customers requirements, please contact customers immediately, check weather can lowe
14、r Cpk. 6.2 监控现有生产过程/Monitoring the existing production process 6.2.1 现有生产过程中的关键工序必须运用统计过程控制技术进行连续监控。质量部及 生产部门负责数据的收集、控制图的绘制。质量部负责能力指数的计算。由应用部门 决定过程是否受控及是否需要实施纠正措施。 We must adopt statistic process control technique to conduct consecutive monitoring on key procedures of existing production process. Qu
15、ality Dept. and Production Dept. are responsible for collecting data and protracting control drawing. Quality dept. is responsible for computing Cpk. The application Dept. decided whether control the process and implement corrective measures. 6.2.2 数据收集和绘制控制图/Collect Data and Protract Control Drawin
16、g 6.2.2.1 “控制计划”中明确了所有的关键控制点、控制方法、样本数量及取样频率。 “Control Plan” defines all key control point, control method, samples quantity and sampling frequencies. 6.2.2.2 控制图中必须记录所有会导致过程参数改变的事项。该信息将用于研究这些事 项对过程能力的影响。 The control drawing must contain all items, which cause process parameter change. The information will be used for researching impact to process capability. 6.2.3 过程能力评价/Process Capability Appraisal 6.2.3.1 当有一个点或多个点超出控制限外，或呈现某种失控模式时，操作者必须立即 通知主管，主管负责采取适当的措施。 Whe
