質(zhì)量保證系統(tǒng)(QAS)

1、Quality Assurance System (QAS)質(zhì)量保證系統(tǒng)（QAS）Quality Leadership質(zhì)量領(lǐng)導(dǎo)1Core KOS approach to quality:- Never knowingly create, accept or pass on a defect. 達(dá)到質(zhì)量目標(biāo)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(shè)計和執(zhí)行QAS Quality Assurance SystemQAS 質(zhì)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(zhì)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(biāo)準(zhǔn)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(lǐng)導(dǎo)必需理解它、思考它、執(zhí)行它和講授它 任何都會導(dǎo)致整個過程的停止，適當(dāng)?shù)纳?、遏制和改正?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(zhì)量保證系統(tǒng)產(chǎn)品設(shè)計設(shè)計規(guī)范質(zhì)量（制造規(guī)范）生產(chǎn)部門（日復(fù)一日的運

6、行）確認(rèn)檢查 - VOC從設(shè)計理念轉(zhuǎn)化成制造業(yè)的理念標(biāo)準(zhǔn)作業(yè)，工作成分表，升級步驟。生產(chǎn)系統(tǒng)設(shè)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(rèn)檢查 - VOCQAS從這里進(jìn)入6Quality Assurance Risk Assessment7質(zhì)量保證風(fēng)險評估8Quality Assurance Control Points9質(zhì)量保證控制點10Quality Assurance Controls11質(zhì)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(zhì)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(jié)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(yù)防：避免可能導(dǎo)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(dāng)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(yù)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(rèn) 檢查QAS的執(zhí)行情況。 14Quality Assurance Control Plan質(zhì)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(dāng)前的形勢相對于風(fēng)險評估矩陣和對策得分 執(zhí)行，結(jié)果。Understand the gap between the current condition and the target s

10、tate defined by the standard. 理解當(dāng)前形勢與標(biāo)準(zhǔn)所定義的目標(biāo)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(lǐng)域中的每一個領(lǐng)域，你將采用什么樣的對策來使你的過程達(dá)到標(biāo)準(zhǔn)。15Quality Assurance Control Assessment Plan16質(zhì)量保證控制評估計

11、劃17Quality Assurance Controls18質(zhì)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(zhuǎn)變。Assign each transformation or characteristic to a risk class 確定每一個轉(zhuǎn)變和特征的風(fēng)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(zhuǎn)變, 回顧一下對它所確定的風(fēng)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(dāng)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(tuán)隊領(lǐng)導(dǎo), 主管和工程支持(質(zhì)量保證和制造工程師/技術(shù)員)等實行標(biāo)準(zhǔn)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(zhì)量保證系統(tǒng)產(chǎn)品設(shè)計設(shè)

15、計規(guī)范質(zhì)量（制造規(guī)范）生產(chǎn)部門（日復(fù)一日的運行）確認(rèn)檢查 - VOC從設(shè)計理念轉(zhuǎn)化成制造業(yè)的理念標(biāo)準(zhǔn)作業(yè)，工作成分表，升級步驟。生產(chǎn)系統(tǒng)設(shè)計制造業(yè)工程學(xué)（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(rèn)檢查 - VOCQAS從這里進(jìn)入22QAS Roles and ResponsibilitiesQAS 作用和職責(zé)QualityTranslates design intent into mfg intent從設(shè)計理念轉(zhuǎn)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(fēng)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(zhì)量組織的職責(zé)。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(zhì)量應(yīng)該和工程 師一起鑒定他們的評估，以保證設(shè)計意圖得以滿足。23QAS Roles and ResponsibilitiesQAS 作用和職責(zé)Manufacturing EngineeringProduction system design生產(chǎn)系統(tǒng)設(shè)計(Execution)Based on the risk assessment rating from quality: 基于質(zhì)量的風(fēng)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(dāng)前水平，并確定差距。Determine countermeasures for required for gap closure 確定關(guān)閉差距所需的對策。Implement countermeasures in the context of standard work 執(zhí)行成為標(biāo)準(zhǔn)作業(yè)的對策。Responsible for the physical and process countermeasures in layers 1,2, and 4 負(fù)責(zé)層次1,2,4當(dāng)中物理的和過程對策。Countermeasure plan m