質量保證系統(tǒng)(QAS)

1、Quality Assurance System (QAS)質量保證系統(tǒng)（QAS）Quality Leadership質量領導1Core KOS approach to quality:- Never knowingly create, accept or pass on a defect. 達到質量目標的KOS核心： - 從不有意產(chǎn)生，接受或放過一個弊病。The QAS provides a structure for:QAS 提供一個框架給：Evaluating the need for process controls評估過程控制的需求Seeing range of options av

2、ailable尋找可供選擇的范圍The analysis, design, and implementation of countermeasures.對策的分析、設計和執(zhí)行QAS Quality Assurance SystemQAS 質量保證系統(tǒng)2Co-RequisitesTo succeed, this concept for managing quality must be embedded into the daily management system.All work is standardized Operations Staff ManagementAll work is p

3、art of an explicit PlanDoCheckAct cycleleaders 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.3伴隨的必要條件 要成功，就必須使質量管理的概念貫穿到日常的管

4、理系統(tǒng)中去。 所有的工作都必需標準化： 操作 員工 管理 所有的工作都只是循環(huán)的一部分：計劃 - 做- 檢查 行動 領導必需理解它、思考它、執(zhí)行它和講授它 任何都會導致整個過程的停止，適當?shù)纳墶⒍糁坪透恼?停 呼 等 沒有這些基本原理，就沒有KOS的方方面面。4QAS Quality Assurance SystemProduct DesignDesign SpecQualityProduct specificationsDefines What and 4 WsVerification Check - VOCTranslates design intent into manufactur

5、ing 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 - VOC5QAS 質量保證系統(tǒng)產(chǎn)品設計設計規(guī)范質量（制造規(guī)范）生產(chǎn)部門（日復一日的運

6、行）確認檢查 - VOC從設計理念轉化成制造業(yè)的理念標準作業(yè)，工作成分表，升級步驟。生產(chǎn)系統(tǒng)設計制造業(yè)/工程（執(zhí)行）有能力的過程檢查 - VOC產(chǎn)品規(guī)范定義“什么”和4個“為什么”確認檢查 - VOCQAS從這里進入6Quality Assurance Risk Assessment7質量保證風險評估8Quality Assurance Control Points9質量保證控制點10Quality Assurance Controls11質量保證控制12Layers of Countermeasures對策的層次No countermeasure is absolutely 100% eff

7、ective.沒有一個對策是100%有效的。Total quality depends on multiple, redundant layers to assure:所有的質量都是通過多元化和多層次化來得到保障的：Consistent execution.持續(xù)的執(zhí)行Verified outcome.檢驗結果13Layers of Countermeasures對策的層次Defect Prevention barriers to avoid a mistake that could lead to a defect 弊病的預防：避免可能導致弊病的錯誤的障礙。2） Defect Detectio

8、n detecting a defect if it occurs 弊病的探測：當弊病出現(xiàn)時，探出弊病。3） Process Control data collection verifying consistent execution and effectiveness of defect prevention and detection 過程控制 核實持續(xù)執(zhí)行和弊病預防及探測效率所需的數(shù)據(jù)收集。4） Successive Inspection second set of eyes/function check 持續(xù)性的檢查 第二套眼睛和功能檢測。5） Process Verification

9、 Check the execution of the QAS 過程確認 檢查QAS的執(zhí)行情況。 14Quality Assurance Control Plan質量保證控制計劃Understand the current condition against the risk assessment matrix and the countermeasure scores. Execution, Results 理解當前的形勢相對于風險評估矩陣和對策得分 執(zhí)行，結果。Understand the gap between the current condition and the target s

10、tate defined by the standard. 理解當前形勢與標準所定義的目標狀態(tài)之間的差距。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? 發(fā)展一個計劃縮小這個差距。在五個領域中的每一個領域，你將采用什么樣的對策來使你的過程達到標準。15Quality Assurance Control Assessment Plan16質量保證控制評估計

11、劃17Quality Assurance Controls18質量保證控制19Evaluate the product and process 評估產(chǎn)品和過程。2. Identify the transformations that take place 鑒別所發(fā)生的轉變。Assign each transformation or characteristic to a risk class 確定每一個轉變和特征的風險等級。For each transformation, review the required level of controls for its assigned risk c

12、lass 對于每一個轉變, 回顧一下對它所確定的風險等級所需要的控制程度。Complete the assessment worksheet of the current state and develop a plan to close the gap 完成當前狀態(tài)的評估工作表, 制訂一個計劃來縮短差距。Implement standard work for operations, team leaders, supervisors, and engineering support (quality assurance and manufacturing engineers/technici

13、ans, etc.) 對生產(chǎn)團隊領導, 主管和工程支持(質量保證和制造工程師/技術員)等實行標準化作業(yè)。Implement an escalation process to complete the QAS 實行升級程序來完成QAS。QAS Implementation SequenceQAS 執(zhí)行次序20QAS Quality Assurance SystemProduct DesignDesign SpecProduct specificationsDefines What and 4 WsVerification Check - VOCManufacturing EngineeringP

14、roduction 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 - VOC21QAS 質量保證系統(tǒng)產(chǎn)品設計設

15、計規(guī)范質量（制造規(guī)范）生產(chǎn)部門（日復一日的運行）確認檢查 - VOC從設計理念轉化成制造業(yè)的理念標準作業(yè)，工作成分表，升級步驟。生產(chǎn)系統(tǒng)設計制造業(yè)工程學（執(zhí)行）有能力的過程檢查 - VOC產(chǎn)品規(guī)范定義“什么”和4個“為什么”確認檢查 - VOCQAS從這里進入22QAS Roles and ResponsibilitiesQAS 作用和職責QualityTranslates design intent into mfg intent從設計理念轉化成制造業(yè)的理念QAS enters the process here(Manufacturing Spec)Owners of the QAS （ Q

16、AS的所有者 ）Primary tool is the Risk Assessment Rating 主要的工具就是風險評估等級 The rating of the key classification points is the responsibility of the quality organization. 主要分類等級點數(shù)評估是質量組織的職責。Look for key failure modes in manufacturing and assigning a rating to each possible failure mode. 尋找制造過程的主要失效模式，并確定每一個可能的

17、失效模式的等級。Quality should verify their assessment with engineers to ensure the design intent is met. 質量應該和工程 師一起鑒定他們的評估，以保證設計意圖得以滿足。23QAS Roles and ResponsibilitiesQAS 作用和職責Manufacturing EngineeringProduction system design生產(chǎn)系統(tǒng)設計(Execution)Based on the risk assessment rating from quality: 基于質量的風險評估等級：Ev

18、aluate the current level of countermeasures against the matrix and establish the gap 評估對策相對于矩陣的當前水平，并確定差距。Determine countermeasures for required for gap closure 確定關閉差距所需的對策。Implement countermeasures in the context of standard work 執(zhí)行成為標準作業(yè)的對策。Responsible for the physical and process countermeasures in layers 1,2, and 4 負責層次1,2,4當中物理的和過程對策。Countermeasure plan m