ISO9000-ISO16949-QS9000推行.ppt

1、,葵花寶典:品質管理系統/QMS (e.g. ISO 9001/9004:2000 , QS-9000 , ISO/IEC 17025 , ISO/TS 16949等) 之推行 Request current CSPM before the audit, perhaps in the audit plan; Review the CSPM as the first item of the audit; Include a notice to the client of the flexibility of the auditor to change the audit track or tim

2、ing based on the results of the initial review of CSPM;,RAB supports a less rigid audit plan to handle this variability; Auditor should maintain an awareness of the applicable CSPM requirements by each OEM; Poor CSPM results should guide the auditor towards evaluations of potential source deficienci

3、es in the QMS; If auditor is not satisfied, system deficiencies can become a documented basis for issuing non-conformance; The CSPM and revised audit trail are documented;,Insufficient coverage of required surveillance items - because of unplanned auditing resulting from evaluating CSPM and related

4、system non-conformities - is not acceptable; added effort should be planned. TS-2 Rule: The organization shall provide the following documentation to the CB for review, and for use in planning the audit:,Quality manual (for each site to be audited) Internal audit and management review planning and r

5、esults from previous twelve months List of qualified internal auditors List of customer specific requirements Customer complaints status Operational performance trends for the previous 12 months, minimum. QS-9000 4.1.5 Analysis and Use of Company Level Data The supplier shall document trends in qual

6、ity, operational performance (productivity, efficiency , effectiveness, cost of poor quality) and current quality levels for key product and service features.,These should be compared with those of competitors and/or appropriate benchmarks. Trends in data and information should be compared with prog

7、ress toward overall business objectives and lead to action to support: Development of priorities for prompt solutions to customer-related problems, Determination of key customer-related trends and correlations to support status review, decision-making and longer-term planning.,TS-2 8.4.1 Analysis an

8、d use of data Trends in quality and operational performance shall be compared with progress toward objectives and lead to action to support the following: Development of priorities for prompt solutions to customer-related problems; Determination of key customer-related trends and correlation for sta

9、tus review, decision-making and longer term planning; An information system for the timely reporting of product information arising from usage. NOTE Data should be compared with those of competitors and/or appropriate benchmarks.,IATF Guidance to TS-2: 8.4.1 Analysis and use of data Operational perf

10、ormance may include productivity, cost of poor quality , process efficiency and effectiveness, production output, quality performance, and equipment utilization. TS-2 Rule: 2.10 The audit plan shall include evaluation of all of the organizations QMS requirements for effective implementation of ISO/T

11、S 16949:2002 as well as for effectiveness in practice. Assessment shall evaluate the effectiveness of the system, its linkages, its performance and its requirements.,Note: Effectiveness of the system should consider how well the system is deployed, as demonstrated by the measures defined by the orga

12、nization to meet customer satisfaction and company objectives. Initial certification audit activities shall be conducted according to the following rules: Review effectiveness of the implementation of the ISO/TS 16949:2002 requirements and for effectiveness in practice, related to planned and achiev

13、ed quality performance.,The Automotive Industrys (IATF) Categorization of QMS Processes are: Customer Oriented Processes (COPs): 常見之10 COPs Market Analysis/Customer Requirements Bid/Tender Order/Request Product and Process Design Product and Process verification / validation Product Production Deliv

14、ery,Payment Warranty/Service Post Sales/Customer Feedback 2) Support Processes: 常見之Support Processes: Sales 或以後製程人員稽核前製程(Internal Customer之觀念),儘量採用精兵制或委外給專業人士來執行，而且要嚴格執行後續之“Auditor Qualification Maintenance”之規定(可參閱 ISO 10011-1,-2 或授權以Internal audit planner/scheduler責任，在每次排audit schedule/agenda時，必需re

15、view先前所開之CARs決定是否要增加稽核頻率。,Process oriented auditing IATF expects TS-2 auditors to audit Customer Owned Processes (COP，也有人稱為Customer Oriented Processes 或 Core Processes). The COP is a model that was introduced by ISO 9001:2000 and refers to the fact that any organization needs customer input to compl

16、y to specified and expected needs of the customer (output). This is accomplished by value adding processes of product realization and appropriate support processes, both enabled by management activities and provided resources. The audit approach of TS-2 must not be driven by an “element” or a “secti

17、on” driven checklist. Instead the checklist shall be a tool to identify the completeness of the audit, which means that the auditor shall audit all applicable requirements to an identified COP.,Automotive Value-Added Assessment vs. CSPM-driven Audit Planning Best Practice #Auto 1: Effective Automoti

18、ve Sector Auditing - Using Customer Satisfaction Performance Metrics to Guide On-site Audit Focus. It was important that the OEMs see an improvement in supplier performance - and that the supplier performance metrics should be a first item on any audit. If these were beneath expectations, they shoul

19、d be used as a guide for auditing potentially non-conforming systems. Auditors should look at each OEMs metrics relevant to a site (not just one chosen for contract review) at every audit event.,“Output matters” - use Customer Satisfaction Performance Metrics, CSPM, as an indicator of QMS effectiven

20、ess and implementation; Request current CSPM before the audit, perhaps in the audit plan; Review the CSPM as the first item of the audit; Include a notice to the client of the flexibility of the auditor to change the audit track or timing based on the results of the initial review of CSPM;,RAB suppo

21、rts a less rigid audit plan to handle this variability; Auditor should maintain an awareness of the applicable CSPM requirements by each OEM; Poor CSPM results should guide the auditor towards evaluations of potential source deficiencies in the QMS;,If auditor is not satisfied, system deficiencies c

22、an become a documented basis for issuing non-conformance; The CSPM and revised audit trail are documented; Insufficient coverage of required surveillance items - because of unplanned auditing resulting from evaluating CSPM and related system non-conformities - is not acceptable; added effort should

23、be planned.,MONITOR: “Observe, supervise, keep under review, measure or test at intervals, especially for the purpose of regulation or control” MEASURE: “Ascertain or determine the spatial magnitude or quantity of something, by the application of some object of known size or capacity or by compariso

24、n with some fixed unit”,Glossary Correction (C): Action to eliminate a detected nonconformity NOTE 1 A correction can be made in conjunction with a corrective action NOTE 2 A correction can be, for example, rework or regrade Corrective Action (CA): Action to eliminate the cause of a detected nonconf

25、ormity or other undesirable situation NOTE 1 There can be more than one cause for a nonconformity.,NOTE 2 Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent occurrence. NOTE 3 There is a distinction between correction and corrective action. Preventive Acti

26、on (PA): Action to eliminate the cause of a potential nonconformity or other undesirable potential situation NOTE 1 There can be more than one cause for a potential nonconformity. NOTE 2 Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence.,Contin

27、ual Improvement (CI): Recurring activity to increase the ability to fulfill requirements (ISO 9000) NOTE The process of establishing objectives and finding opportunities for improvement is a continual process through the use of audit findings and audit conclusions (8.2.2), analysis of data (8.4), ma

28、nagement reviews (5.6) or other means and generally leads to corrective action (8.5.2) or preventive action (8.5.3). 說明:建立目標和尋找改善之機會(CI)是一透過使用ISO 9001之3工具(i. e. 管審 , 稽核和資料分析)或其他方式之持續不斷之流程 , 並且通常會導致於CA和PA。因此 , 此概念也說明了新版ISO 9001之條文編排順序: MR IA AOD CI CA PA 想一想: ISO 9001 是一個大的 tool kit , 裡面有各種不同之tools (

29、e.g. MR, IA, AOD等),含“small-step, on-going improvement activities ( i.e. continuous/incremental/local improvement on existing processes)”逐步漸進式的持續改善和 “breakthrough projects (i.e. discontinuous improvement it will usually reveal entirely new business processes at which an organization must excel)”突破式的流

30、程/企業再造工程, e.g. 6-sigma strategies, Re-engineering (QS-9000: CI requirement does not replace the need for innovative improvement(流程/技術/知識)創新) ISO/TS 16949: optimization of characteristics and parameters of a product or process at a target value NOTE Continual improvement is only applicable where conf

31、ormance has been established.,Customer Satisfaction (CS): Customers perception of the degree to which the customers requirements have been fulfilled NOTE 1 Customer complaints are a common indicator of low customer satisfaction but their absence does not necessarily imply high customer satisfaction.

32、 NOTE 2 Even when customer requirements have been agreed with the customer and fulfilled, this does not necessarily ensure high customer satisfaction.,Customer Delight (CD): ISO 9004: Organizations depend on their customers and therefore should understand current and future customer needs, should me

33、et customer requirements and strive to exceed customer expectations (i.e. 顧客喜悅customer delight.) 。,試由下列三條文來區分Correction和CA之差異: 8.2.3 Monitoring and measurement of processes: when planned results are not achieved,correctionand corrective action shall be taken, as appropriate, to ensure conformity of

34、the product. 8.2.2 內部稽核 8.3 不良品管制 Problem Resolution CD Progression (演進):,條文 說明 Immediate/Interim/Remedial Action(s) e.g. rework/repair, regarde/downgrade, containment, scrap/reject, concession, G8D之D3 (Develop the Interim Containment Action) , 治標e.g. 打退燒針, 頭痛 (只是syndrome): 吃普拿 疼, 但root-cause 可能 是腦瘤

35、,C,8.3 (8.2.2 objective criteria must be defined to ensure consistent inspections.”(主觀性用詞不好，必須訂定客觀性基準用以確保一致性之檢驗結果)。尤其是碰到一些外觀檢驗 (visual inspections)，或QS-9000所謂的外觀件 (Appearance Items) 之Controls/Inspections，需做到The conformance/acceptance criteria must be clearly defined and the procedure for deciding if

36、 these criteria are met must produce consistent results over time)允收/符合基準必須定義清楚，而且用來決定是否符合這些基準之“程序”必須都能產出一致性之結果)。,舉例如下: Acceptance Spec. Surface should be free from flaws. (表面不可以有瑕疵.) Surface should conform to master standard in color, texture, brightness and imperfection. (表面必須符合顏色/光澤比對標準),Comment

37、What is a flaw? -Do inspectors agree? -How measured? Conform to what degree? How measured?,QS-9000 4.9.6 (Appearance Items外觀件) 要求工廠必須提供: Appropriate lighting for evaluation areas (執行外觀檢驗之區域要有適當的亮度) Masters for color, grain, gloss, metallic brillance, texture, distinctness of image (DOI) as appropria

38、te (適當之外觀比對標準) Maintenance and control of appearance masters and evaluation equipmentSee ISO 9001:1994 4.11.2b (比對標準/設備之維護及管制) Verification that personnel making appearance evaluations are qualified to do so (執行外觀比對人員之資格証明),-另外，出現在條文8.2.4 這個字 “the acceptance criteria”也表示values with tolerances or min

39、imum/maximum values must be specified (公差或最大/最小值必須訂清楚) (Common AR: 檢驗用之尺寸圖面沒有訂公差 , Max.值或 Min.值). -Assessor對於前述之檢驗報告沒有記上實測值，只show “checked OK”之情況，最好investigate further by witnessing tests to validate records (親自抽樣請工廠之inspector表演他是如何進行檢驗，用以驗證他填上“checked OK”之有效性)。,-當然，記錄實測值之目的大部分是為了執行製程/產品能力分析 當客戶退貨時，

40、必須執行 Root-Cause Analysis 和 CA process! ISO/TS 16949 8.2.3.1: The organization shall initiate a reaction plan from the control plan for characteristics that are either unstable or non-capable. These reaction plans shall include containment of product and 100% inspection as appropriate. A corrective a

41、ction plan shall then be completed by the organization, indicating specific timing and assigned responsibilities to assure that the process becomes stable and capable. The plans shall be reviewed with and approved by the customer when so required.,ISO/TS 16949 8.5.2.4 Rejected product test/analysis

42、The organization shall analyse parts rejected by the customers manufacturing plants, engineering facilities and dealerships. The organization shall minimize the cycle time of this process. Records of these analyses shall be kept and made available upon request. The organization shall perform analysi

43、s and, initiate corrective action to prevent recurrence. NOTE Cycle time related to rejected product analysis should be consistent with determination of root cause, corrective action and monitoring the effectiveness of implementation.,e.g. 2): 有時客戶報怨是客戶找碴或錯不在工廠，雖然 Rule #1: Customer is always right.

44、Rule #2: If customer is wrong, go to rule #1。但是碰到“澳洲來的客戶”客怎麼辦呢？ 注意 : 此處所指之nonconformities包含nonconforming incoming materials/parts(進料不良)，所以不能只用8.3 Control of nonconforming product來處理進料不良(例如只做退貨處理)。甚至也要考慮QS-9000/TS 16949: 2002所規定的“Product with unidentified or suspect status shall be classified as nonc

45、onforming product (檢驗狀態不明或處於懷疑狀態之產品均需視同不良品)” (e.g. 逾期品，前一次校驗合格距離本次校驗NG之gage所量測過之產品)。,- b) determining the causes of nonconformities, - c) evaluating the “need for action” to ensure that nonconformities do not recur, 說明: 觀念同前述對 “CAs shall be appropriate to the effects of the nonconformities encounter

46、ed”之說明。 - d) determining and implementing “action needed”, - e) records of the results of action taken, e.g. Root-Cause Analysis: Root Cause Analysis is a logical, systematic approach to identifying the basic reasons (causes, mechanisms, etc.) for a problem, failure, non-conformance, process error,

47、etc. Whenever a significant problem occurs (i.e. low frequency of occurrence with high cost in time and/or money, or high frequency of occurrence), Root Cause Analysis should be implemented.,The result of Root Cause Analysis should always be the identification of the basic mechanism by which the pro

48、blem occurs and a recommendation for corrective action. “No corrective action required” is an acceptable recommendation for corrective action when properly justified. Root Cause Analysis cannot be closed out until all required corrective action has been developed and implemented. When Root Cause Ana

49、lysis is performed, all of the investigation, analysis, and results (including corrective action) must be completely documented.,-(新)to define requirements for (f) reviewing CA taken:含CA之效果確認之意。 ISO/IEC 17025 4.10.2 (Root-) Cause analysis The procedure for corrective action shall start with an inves

50、tigation to determine the root cause(s) of the problem. Note: (Root-) Cause analysis is the key and sometimes the most difficult part in the corrective action procedure. Often the root cause is not obvious and thus a careful analysis of all potential causes of the problem is required. Potential caus

51、es could include client requirements, the samples, sample specifications, methods and procedures, staff skills and training, consumables, or equipment and its calibration.,Paynter Chart- The Paynter Chart is used to demonstrate the effectiveness of corrective actions. It has the same categories as t

52、he Pareto Chart and identifies when changes have been made. In some situations, problems may be connected. Therefore, the corrective action applied to a problem on the Pareto Chart may have an influence on other sub-problems. The corrective action may either improve another problem or have a negativ

53、e effect. The Paynter Chart provides a means of evaluation, not only the problem that was the primary focus for Problem-Solving, but also others that might be affected.,The Paynter Chart Abstract The Paynter chart is similar to a Pareto Chart except that each Pareto bar is split up into subgroups. T

54、his enables you to look at what subgroups are going into the makeup of the pareto bar and you can use it to spot trends or troublespots. Keywords: Paynter, gpaynter, pareto Product: Statit, 4.3 5.2 The Paynter Chart is a tool that goes beyond a Pareto. A Pareto shows the problems with the most frequ

55、ency. A Paynter Chart shows the Pareto information but breaks the Pareto Bars into subgroups. The Subgroups could be days, hours or subgroups from a p chart. The examples below illustrate the Paynter Chart.,This Paynter was run by restricting the number of groups to 5 and the number of subgroups to

56、4. In this case it took the last 4 subgroups to plot.,ISO/IEC 17025 4.10.3 Selection and implementation of corrective actions Where corrective action is needed, the laboratory shall identify potential corrective actions. It shall select and implement the action(s) most likely to eliminate the proble

57、m and to prevent recurrence (i.e. 最佳解決方案)。 Common AR: CA/PA case was prematurely closed，例如對策: 加強檢驗或訓練。效果確認: yes/結案。 -QS-9000 4.14.1.1: Problem Solving Methods A Supplier shall use disciplined problem solving methods when an internal or external nonconformance to specification or requirement occurs.,

58、When external nonconformance occur, the supplier shall respond in a manner prescribed by the customer. Refer to the customer documents .e.g. DC-7D, Ford-G8D(Global 8D Analysis), GM- Problem Reporting in short, SIC Code 3674(Semiconductors For attribute data, C.I. 指”縮緊規格”之後之C.I.,PPAP要求Cpk 1.67 , 但是當C

59、p3時 , QS-9000 4.9.2When process/product data indicate a high degree of capability (e.g. Cp3), the supplier may revise the Control Plan, as appropriateby reducing inspection/sampling (cost) 也是C.I. 4.9.3 Modified Process Control Requirements: In some cases, the customer may require either higher or lower capability or performance (see 4.9.2) requirements. In t