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1、Quality Assurance System (QAS) 质量保证系统（QAS）Quality Leadership质量领导Core KOS approach to quality: - Never knowingly create, accept or pass on a defect.达到质量目标的KOS核心：- 从不有意产生，接受或放过一个弊病。 The QAS provides a structure for: QAS 提供一个框架给： Evaluating the need for process controls 评估过程控制的需求 Seeing range of option
2、s available 寻找可供选择的范围 The analysis, design, and implementation of countermeasures. 对策的分析、设计和执行QAS Quality Assurance System QAS 质量保证系统Co-RequisitesTo succeed, this concept for managing quality must be embedded into the daily management system.All work is standardized Operations Staff ManagementAll wo
3、rk is part of an explicit PlanDoCheckAct cycle leaders understand it, think it, execute it, teach itAny process failures lead to a process stop, appropriate escalation, containment, and correction. Stop Call WaitWithout these fundamentals in place, no aspect of KOS can sustain.伴随的必要条件要成功，就必须使质量管理的概念
4、贯穿到日常的管理系统中去。所有的工作都必需标准化： 操作 员工 管理所有的工作都只是循环的一部分：计划 - 做- 检查 行动领导必需理解它、思考它、执行它和讲授它任何都会导致整个过程的停止，适当的升级、遏制和改正。 停 呼 等没有这些基本原理，就没有KOS的方方面面。QAS Quality Assurance SystemProduct Design Design SpecQualityProduct specifications Defines What and 4 WsVerification Check - VOCTranslates design intent into manufac
5、turing intentManufacturing EngineeringProduction DepartmentProduction system designQAS enters the process hereStandard work, Job element sheets, escalation process(Manufacturing Spec)(Execution)(Day to Day running)Verification Check - VOCCapable Process Check - VOCQAS 质量保证系统产品设计 设计规范质量 （制造规范）生产部门 （日
6、复一日的运行）确认检查 - VOC从设计理念转化成制造业的理念标准作业，工作成分表， 升级步骤。生产系统设计制造业/工程 （执行）有能力的过程检查 - VOC产品规范 定义“什么”和4个“为什么”确认检查 - VOCQAS从这 里进入Quality Assurance Risk Assessment质量保证风险评估Quality Assurance Control Points质量保证控制点Quality Assurance Controls质量保证控制Layers of Countermeasures 对策的层次No countermeasure is absolutely 100% eff
7、ective. 没有一个对策是100%有效的。 Total quality depends on multiple, redundant layers to assure:所有的质量都是通过多元化和多层次化来得到保障的： - Consistent execution.- 持续的执行 - Verified outcome.- 检验结果Layers of Countermeasures 对策的层次Defect Prevention barriers to avoid a mistake that could lead to a defect弊病的预防：避免可能导致弊病的错误的障碍。 2） Defe
8、ct Detection detecting a defect if it occurs弊病的探测：当弊病出现时，探出弊病。 3） Process Control data collection verifying consistent execution and effectiveness of defect prevention and detection过程控制 核实持续执行和弊病预防及探测效率所需的数据收集。 4） Successive Inspection second set of eyes/function check 持续性的检查 第二套眼睛和功能检测。 5） Process
9、Verification Check the execution of the QAS过程确认 检查QAS的执行情况。Quality Assurance Control Plan 质量保证控制计划Understand the current condition against the risk assessment matrix and the countermeasure scores. Execution, Results理解当前的形势相对于风险评估矩阵和对策得分 执行，结果。Understand the gap between the current condition and the
10、target state defined by the standard. 理解当前形势与标准所定义的目标状态之间的差距。Develop a plan to close the gap. What countermeasures are you going to deploy in each of the five areas to bring your process up to the standard?发展一个计划缩小这个差距。在五个领域中的每一个领域，你将采用什么样的对策来使你的过程达到标准。Quality Assurance Control Assessment Plan质量保证控制
11、评估计划Quality Assurance Controls质量保证控制Evaluate the product and process评估产品和过程。 2. Identify the transformations that take place鉴别所发生的转变。 Assign each transformation or characteristic to a risk class确定每一个转变和特征的风险等级。 For each transformation, review the required level of controls for its assigned risk clas
12、s对于每一个转变, 回顾一下对它所确定的风险等级所需要的控制程度。 Complete the assessment worksheet of the current state and develop a plan to close the gap完成当前状态的评估工作表, 制订一个计划来缩短差距。 Implement standard work for operations, team leaders, supervisors, and engineering support (quality assurance and manufacturing engineers/technicians
13、, etc.)对生产团队领导, 主管和工程支持(质量保证和制造工程师/技术员)等实行标准化作 业。 Implement an escalation process to complete the QAS实行升级程序来完成QAS。QAS Implementation Sequence QAS 执行次序QAS Quality Assurance SystemProduct Design Design SpecProduct specifications Defines What and 4 WsVerification Check - VOCManufacturing EngineeringPro
14、duction DepartmentProduction system designStandard work, Job element sheets, escalation process(Execution)(Day to Day running)Verification Check - VOCQualityTranslates design intent into manufacturing intentQAS enters the process here(Manufacturing Spec)Capable Process Check - VOCQAS 质量保证系统产品设计 设计规范
15、质量 （制造规范）生产 部门 （日复一日的运行）确认检查 - VOC从设计理念转化成制造业的理念标准作业，工作成分表，升 级步骤。生产系统设计制造业 工程学 （执行）有能力的过程检查 - VOC产品规范定义“什么”和4个“为什么”确认检查 - VOC QAS从这 里进入QAS Roles and Responsibilities QAS 作用和职责QualityTranslates design intent into mfg intent 从设计理念转化成制造业的理念QAS enters the process here(Manufacturing Spec)Owners of the QA
16、S （ QAS的所有者 ） Primary tool is the Risk Assessment Rating主要的工具就是风险评估等级 The rating of the key classification points is the responsibility of the quality organization.主要分类等级点数评估是质量组织的职责。 Look for key failure modes in manufacturing and assigning a rating to each possible failure mode.寻找制造过程的主要失效模式，并确定每一个可能的失效模式的等级 。 Quality
