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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 op
2、tions 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-Requisites,To succeed, this concept for managing quality must be embedded into the daily management system. All work is standardized Operations Staff Manageme
3、nt All work is part of an explicit PlanDoCheckAct cycle leaders understand it, think it, execute it, teach it Any process failures lead to a process stop, appropriate escalation, containment, and correction. Stop Call Wait Without these fundamentals in place, no aspect of KOS can sustain.,伴随的必要条件,要成
4、功，就必须使质量管理的概念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 System,Product Design Design Spec,Quality,Product specifications Defines What and 4 Ws,Verification Check - VOC,Translates de
5、sign intent into manufacturing intent,Manufacturing Engineering,Production Department,Production system design,QAS enters the process here,Standard work, Job element sheets, escalation process,(Manufacturing Spec),(Execution),(Day to Day running),Verification Check - VOC,Capable Process Check - VOC,
6、QAS 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 - VOC,QAS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 Counterm
7、easures 对策的层次,No countermeasure is absolutely 100% effective. 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
8、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） Defect 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
9、 of eyes/function check 持续性的检查 第二套眼睛和功能检测。 5） Process 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
10、。 Understand the gap between the current condition and the 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
11、的对策来使你的过程达到标准。,Quality Assurance Control Assessment Plan,质量保证控制评估计划,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 transformat
12、ion, review the required level of controls for its assigned risk class 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 enginee
13、ring support (quality assurance and manufacturing engineers/technicians, 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 System,Product Design Design Spec,Product specificatio
14、ns Defines What and 4 Ws,Verification Check - VOC,Manufacturing Engineering,Production Department,Production system design,Standard work, Job element sheets, escalation process,(Execution),(Day to Day running),Verification Check - VOC,Capable Process Check - VOC,QAS 质量保证系统,产品设计 设计规范,质量 （制造规范）,生产 部门
15、（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,Quality,Translates 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 QAS
16、（ 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
17、一个可能的失效模式的等级。 Quality should verify their assessment with engineers to ensure the design intent is met. 质量应该和工程 师一起鉴定他们的评估，以保证设计意图得以满足。,QAS Roles and Responsibilities QAS 作用和职责,Manufacturing Engineering,Production system design 生产系统设计,(Execution),Based on the risk assessment rating from quality: 基于质
18、量的风险评估等级： Evaluate the current level of countermeasures against the matrix and establish the gap 评估对策相对于矩阵的当前水平，并确定差距。 Determine countermeasures for required for gap closure 确定关闭差距所需的对策。 Implement countermeasures in the context of standard work 执行成为标准作业的对策。 Responsible for the physical and process c
19、ountermeasures in layers 1,2, and 4 负责层次1,2,4当中物理的和过程对策。 Countermeasure plan must be verified by quality as meeting the intent of the quality control specification. 对策计划必须通过质量检验, 如同符合质量控制规范的理念一样。,QAS Roles and Responsibilities QAS 作用和职责,Production Department,Standard work, Job element sheets, escala
20、tion process 标准作业，工作成分表，升级步骤。,(Day to Day running),Leadership 领导 Develop standard work for operations team members 为操作队员发展标准作业。 Follow standard work as a part of layers 3 & 5 遵循标准作业作为层次3和5的一部分。 Operations team members 操作团队成员 Follow standard work as a part of layers 1, 2, & 4 遵循标准作业作为层次1,2,4的一部分。 Provide feedback to quality and engineering 提供反馈给质量和工程人员。 Escalate problems immediately. 立即升级问题。,