统计过程控制（SPC）实施指南 第1部分：统计过程控制要素

[中文适用范围]： 统计过程控制（SPC）涉及使用统计技术和/或统计或随机控制算法来实现以下一个或多个目标： a) 增加有关过程的知识； b) 引导流程以期望的方式运行； c) 减少最终产品参数的变化，或以其他方式提高过程的性能。 这些指南给出了实施 SPC 系统以实现这些目标的要素。 统计过程控制的共同经济目标是增加给定资源投入量所产生的良好过程输出。 注 1：SPC 通过控制过程参数或与最终产品参数相关的过程中产品参数的变化来最有效地运行；和/或通过提高过程针对这种变化的鲁棒性。 供应商的最终产品参数可以是下一个下游供应商的过程的过程参数。 注 2：虽然 SPC 涉及制成品，但它也适用于生产服务或交易的流程（例如，涉及数据、通信、软件或材料移动的流程）。 ISO 11462 的这一部分规定了 SPC 系统的使用指南——当供应商减少与设计或生产相关的流程变化的能力需要得到证明或改进时；或者 - 当供应商开始实施 SPC 来实现这种能力时。 这些指南不适用于合同、监管或认证用途。 [外文原描述]： Statistical process control (SPC) concerns the use of statistical techniques and/or statistical or stochastic control algorithms to achieve one or more of the following objectives: a) to increase knowledge about a process; b) to steer a process to behave in the desired way; c) to reduce variation of final-product parameters, or in other ways improve performance of a process. These guidelines give the elements for implementing an SPC system to achieve these objectives. The common economic objective of statistical process control is to increase good process outputs produced for a given amount of resource inputs. NOTE 1 SPC operates most efficiently by controlling variation of a process parameter or an in-process product parameter that is correlated with a final-product parameter; and/or by increasing the process's robustness against this variation. A supplier's final-product parameter may be a process parameter to the next downstream supplier's process. NOTE 2 Although SPC is concerned with manufactured goods, it is also applicable to processes producing services or transactions (for example, those involving data, communications, software, or movement of materials). This part of ISO 11462 specifies SPC system guidelines for use _ when a supplier's capability to reduce variation in processes associated with design or production needs to be proven or improved; or _ when a supplier is beginning SPC implementation to achieve such capability. These guidelines are not intended for contractual, regulatory or certification use.