TS16949內審課程ppt課件

1、ISO/TS 16949Internal Audit1 黃治淮 先 生確 利 達 顧 問 有 限 公 司運作經理 ISO/TS16949:2002 Supplier AuditorIRCA EMS 注冊主任審核員 CNAB QMS 注 冊 審 核 員 注冊管理咨詢顧問2心態(tài)小測試31Quality Audit 體系審核2Audit Phases 審核階段3Planning Preparation 謀劃預備4Conduct Audit 實施審核5Report & follow up 報告與跟進6Audit Skill 審核技巧7Auditor 審核員8Automotive Audit Key P

2、oint 汽車行業(yè)審核要點4Quality Audit Definition 質量審核定義Systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.為獲得審核證據并對其進展客觀的評價,以確定滿足審核準那么的程度所進展的系統的,獨立的并構成文件的過程.5Quality Audit Concepts 質量審核概念The de

3、sign of quality audit is not used to criticize or blameTheres no procedure to be perfect and no change in anytimeQuality audit determine the basis for: - improve the quality of products - to ensure the procedure can maintain the quality and reflect the effective operation - take action to improve th

4、e processThe auditor to determine whether the operation follow procedureThe auditor shall perform audit with positive attitudeThe auditor must prepare well 質量審核的設計并非用以進展批判或指摘并沒有一個程序是完美得于何時也不需求改動的質量審核確立了根底以： - 改善公司產品的質量 - 確保程序能維護質量、反映有效的 作業(yè) - 采取糾正措施以改良過程審核員決議作業(yè)能否有跟從程序進展審核員應以正面的態(tài)度進展審核審核員必需充分預備6Types o

5、f Audit 審核的種類Customer客戶Enterprise企業(yè)Sub-contract分供方Independent Organization獨立機構第2方2 nd 第3方3rd第2方2nd第一方1 st7Types of Audit 審核的種類Document Audit 文件審核On-site audit 現場審核System audit 體系審核Process audit 過程審核Product audit 產品審核8Audit Phases 審核階段 審核報告被審方進展緣由分析和糾正措施跟蹤檢查糾正措施搜集資料 / 預備安排審核員制定審核方案文件審核預備檢查表 終了會議 確認結果

6、記錄不符合點調整方案 尋覓符合要求的地方 開場會議進展預備跟進文件編寫9Information Gathering / Preparation 搜集資料 / 預備StandardsCompany backgroundNumber of EmployeeLocationSite scaleAudit scopePrevious audit recordCustomer informationCustomer / contract special requirementsTravel and other arrangementProcess identification Process linka

7、ge規(guī)范公司背景員工人數地點場地規(guī)模審核范圍以往審核記錄客戶情況客戶 / 合同特殊要求交通和其它安排過程確定過程銜接10Auditor Arrangement 安排審核員Trained and qualifiedHave relevant experienceIndependent to the auditeeBeware the relationship between auditor and auditeeSelect the team leader經培訓并有資歷有相關閱歷與被審方有獨立性留意審核員與被審方的個人關系選定組長11 分組討論以確定審核組長 和審核員的詳細職責與要求練習12Au

8、dit Plan 審核方案The annual schedule should consider:The importance of the process and its relationship with the system standard requirement Actual performance and the result of previous auditBusiness conditionsCustomer complaintsThe date of customer auditThe date of the third party certification auditC

9、over all elements of the standardCover all the processes and activity年度方案需思索：過程的重要度和與體系規(guī)范要求的相關程度實踐表現，以往審核結果業(yè)務情況客戶贊揚情況客戶審核時間第三方認證審核時間覆蓋規(guī)范一切要素覆蓋一切過程和活動13Audit Schedule 審核時間表The auditee department / process Auditor / teamScheduleAudit scopeCover all shifts and activitiesThe audit duration according to

10、the importance and scale of the department / function / processBeware the audit process flow / sequenceAvoid / reduce walk around time 被審部門 / 過程審核員 / 小組時間安排審核范圍覆蓋一切班次，活動審核時間規(guī)乎部門 / 功能 / 過程的重要度和規(guī)模留意審核流程 / 順序防止 / 減少來回走動時間14典型的審核方案15分組練習就本工廠制定一份內審計劃要求 1.共6人/天 2.分3小組進行練 習16Document Audit 文件審核Standard cla

11、use vs quality system documentQuality system document vs standardsQuality manual, procedure documentQuality planWhether the system is complete and adequate Understand the operation method and control point of an organization Identify the core process and support process and also the interaction 規(guī)范條文

12、 vs 質量體系文件質量體系文件 vs 規(guī)范質量手冊，程序文件質量方案體系能否完好和充分了解企業(yè)的運轉方法和控制要點確認主要過程,支持過程和相互關系17Audit Checklist 審核檢查表Only a reminder, not a questionnaireTransfer according to the requirements of standardsTransfer according to the organizations procedure document requirementsBeware the special requirements of customerBe

13、ware the result of document auditBeware the result of previous auditBeware the customer complaintsUse it as audit record每次審核應該運用規(guī)定的檢查表只是備忘，提示，不是問卷表按規(guī)范要求轉化按企業(yè)程序文件要求轉化留意客戶特殊要求留意文件審核結果留意前次審核結果留意客戶贊揚情況作為審核記錄18典型的檢查表19Opening Meeting 開場會議Chaired by team leaderIntroductionAudit proposeAudit standard and d

14、isposition criterion Audit scopeConfirm the audit scheduleAudit methodThe guideThe communication channel and contactThe time of close meetingOther arrangement由審核組長主持引見人員審核目的審核規(guī)范和斷定準那么審核范圍確定審核時間表審核方法陪審員溝通和聯絡渠道末次會議時間其它安排20練習由講師模擬一次初次會議,后由各組委托人模擬,講師及學員共同點評.21On-site Audit 現場審核Fact finding and objective

15、 evidenceNot an exercise to nit pickEnsure to cover the audit scopeEnsure to cover the standard requirementsCheck the operation conditions and previous resultCheck the conformance and adequacy Determine effectiveness Utilize the checklistNeed to follow up with cross department Modify the audit plan

16、when necessaryRecord the nonconformance Confirm the audit result with the auditee找尋現實，客觀證據并非尋覓錯誤的練習確保覆蓋審核范圍確保覆蓋規(guī)范要求檢查運轉情況和以往結果檢查符合性，完好性判別有效性(!)利用檢查表協助需求跨部門跟蹤確認需求時，調整審核方案記錄不符合項與被審方確認審核結果22練習 選擇不同的場景,如倉庫.人事部.工程部.生產現場等;學員為內審員.講述審核方式并提問,講師扮演被審核方.23Closing Meeting 末次會議Chaired by team leaderExpress thanks

17、 Re-confirm the audit standard and audit scopeReport the positive audit resultReport the nonconformance (NC)Mention the observation and opportunity for improvementReport the audit conclusion reply time of the Corrective Action Request (CAR)Arrange the follow up auditExpress thanks again由審核組長主持致謝再確認審

18、核規(guī)范和審核范圍報告正面的審核結果報告不符合項提出察看項，改良的建議宣報審核判別結論糾正措施回復時間安排跟蹤審核再次贊賞24Nonconformance Definition 不符合項定義Major:the absence or total breakdown of a system to meet a ISO/TS 16949 requirement. A number of minor nonconformities against one requirement can represent a toatl breakdown of the system and thus be consi

19、dered a major nonconformity. Any noncompliance that would result in the probable shipment of a nonconforming product. A condition that may result in the failure of materially reduce the usability of the the products or services for their intended purposeA noncompliance that judgment and experience i

20、ndicate is likely either to result in the failure of the quality system or to materially reduce its ability to assure controlled processes and products.嚴重質量體系短少或完全失效ISO/TS 16949要求。在某一個體系要求出現好幾個細微不符合可變成體系完全失效，這也是嚴重不符合。 任何能夠使不合格產品裝運的不符合情況。任何導致產品或效力的規(guī)定運用性能降低或失效的不符合情況。任何能夠導致質量體系失效或嚴重降低對產品和過程控制才干的判別或閱歷的不

21、符合情況。 25MinorIs a ISO/TS 16949 noncompliance to that judgment and experience indicate is not likely to result in the failure of the quality system or reduce its ability to assure controlled processes or products. It may be either:a failure in some part of the suppliers documented quality system rela

22、tive to a ISO/TS 16949 , or A single observed lapse in following one item of a companys quality system.細微判別或閱歷與ISO/TS 16949的不一致但又不能夠導致體系失效， 或降低對產品和過程才干的控制。供方與ISO/TS 16949有關的構成文件的質量 體系某一部分不符合要求。在公司質量體系中發(fā)現的單個錯誤。Nonconformance Definition 不符合項定義26ConformNo major or minor nonconformities were noted in th

23、e audit. 符合項- 在審核中沒有發(fā)現嚴重不符合或細微不符合。Nonconformance Definition 不符合項定義27Nonconformance Report 不符合報告Findings 發(fā)現Evidence根據Explanation解釋28Audit Report 審核報告Audit dateAuditor teamAudit standardsAudit scopeAudit planAudit result / findingsNonconformanceObservation, opportunity for improvementDisposition concl

24、usion Follow up action 審核日期審核員小組審核規(guī)范審核范圍審核方案審核結果 / 發(fā)現不符合項察看項，改良建議判別結論跟蹤行動29Auditee Cause Analysis & Corrective Action 被審方緣由分析糾正措施Understand the NC problemInvestigate the root coursePinpoint to problem cause, take corrective action to avoid re-occurringExtend the corrective action to the similar prod

25、ucts / process/ system Verify the effectiveness of the action了解不符合項問題調查根本緣由針對緣由，采取糾正措施，預防再發(fā)生舉一反三，擴展糾正措施到同類產品 / 工藝 / 系統驗證措施能否有效30Follow up Audit 跟蹤審核To verify whether the corrective action has been implementedTo verify the effectiveness of corrective action Check the relevant modified document / reco

26、rdRe-sample check the new operation recordRe-check the operation method and implementation 驗證糾正措施能否已實施驗證糾正措施能否有效檢查相關修正文件 / 記錄再抽查新的運轉記錄再檢查運轉方法和實施情況31Audit Skill審核技巧Fact Findings找尋現實 - Read 讀 - Observe 看 / 察看 - Listen 聽 - Ask 問32Read - Standards - Quality system document, record - customer contract, s

27、pecial requirements - previous audit records - customer complaints - data analysis讀： - 規(guī)范 - 質量體系文件，記錄 - 客戶合同，特殊要求 - 以往審核記錄 - 客戶贊揚情況 - 分析資料Audit Skill審核技巧33Observe - auditee the response, body language - response of other people - look at the auditees eyes - Sense judgment 看 / 察看被審方的反響，身體言語其他人員的反響看著對

28、方的眼睛感官判別Audit Skill審核技巧34Listen Beware the environmental influenceBeware whether the auditee can represent Analyze informationSummarize information Record to follow upNot to appraise the speakerBeware the side indication Show the interesting to listen 聽留意環(huán)境影響留意對方能否有代表性分析資料總結信息記錄以便跟蹤切勿評價講者留意言外之意表示有興趣

29、聽Audit Skill審核技巧35Ask closed questionLeading questionOpen question WhoWhen WhereWhatHowWhyShow meDouble / multiple questionFollow up question 問封鎖式問題帶著式問題開放式問題何人何時何處何事怎樣樣為什么給我看看2個/ 多個問題跟蹤提問Audit Skill審核技巧36Audit Flowdraft flow chartThe first questionFrom top down / from bottom upTrace forward / trace

30、 backwardHorizontal checkFocus checkSample check method Apply ROLA審核流程粗略的流程圖第一條問題由上而下/由下而上往前清查/ 往后清查橫向檢查重點檢查抽樣方法運用ROLAAudit Skill審核技巧37Other remarktime management / controlCover all related activities according to the planAvoid side tracking Avoid being led / miss ledNot to involve in the discussion

31、s of cause and responsibility Not to provide the detail method of solution Dont be afraid to say you dont understandThe effective 2 way communication 其他留意時間管理 / 控制按方案，覆蓋一切相關活動不被轉移目的不被引導 / 誤導不參與討論緣由和責任不提供詳細處理方法不關鍵怕說他不明白有效的雙向溝通Audit Skill審核技巧38Auditor Attitude/ Responsibility 審核員態(tài)度 / 責任Good 好Good list

32、ener 擅長傾聽Open minded 思想開朗Diplomatic 擅長交往Resilient 復原力強Unbiased 公平Honest 老實Patient 耐心Self-disciplined 自律Articulate 擅長溝通Able to communicate 表達力強Interested 有獵奇心Unafraid of being unpopular 不怕受排斥Empathetic 具同情心Bad 壞Arrogant 傲慢Opinionated 偏見Self-important 自大Lazy 懶惰Argumentative 好爭辯Shy 害羞Timid 膽怯Gullible 易上當Impatient 缺乏耐性Poor communicator 不擅長溝通Desire to be liked 希望被喜歡Unprofessional 不專業(yè)39Automotive Audit Key Points 汽車行業(yè)審核中的要點Use of ISO/TS standard checklistBeware of customer specific requirementsCollect customer requiremen