TS16949內(nèi)審課程(一)

1、1ISO/TS 16949Internal Audit21Quality Audit 體系審核體系審核2Audit Phases 審核階段審核階段3Planning Preparation 策劃準(zhǔn)備策劃準(zhǔn)備4Conduct Audit 實(shí)施審核實(shí)施審核5Report & follow up 報(bào)告與跟進(jìn)報(bào)告與跟進(jìn)6Audit Skill 審核技巧審核技巧7Auditor 審核員審核員8Automotive Audit Key Point 汽車行業(yè)審核要點(diǎn)汽車行業(yè)審核要點(diǎn)3Quality Audit Definition 質(zhì)量審核定義質(zhì)量審核定義Systematic, independen

2、t 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(jù)并對(duì)為獲得審核證據(jù)并對(duì)其進(jìn)行客觀的評(píng)價(jià)其進(jìn)行客觀的評(píng)價(jià),以以確定滿足審核準(zhǔn)則的確定滿足審核準(zhǔn)則的程度所進(jìn)行的系統(tǒng)的程度所進(jìn)行的系統(tǒng)的,獨(dú)立的并形成文件的獨(dú)立的并形成文件的過程過程.4Quality Audit Concepts 質(zhì)量審核概念質(zhì)量審核概念The design of quality

3、 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 the processThe au

4、ditor to determine whether the operation follow procedureThe auditor shall perform audit with positive attitudeThe auditor must prepare well 質(zhì)量審核的設(shè)計(jì)并非用以進(jìn)行批判或質(zhì)量審核的設(shè)計(jì)并非用以進(jìn)行批判或責(zé)備責(zé)備并沒有一個(gè)程序是完美得于何時(shí)也不并沒有一個(gè)程序是完美得于何時(shí)也不需要改變的需要改變的質(zhì)量審核確立了基礎(chǔ)以：質(zhì)量審核確立了基礎(chǔ)以： - 改善公司產(chǎn)品的質(zhì)量改善公司產(chǎn)品的質(zhì)量 - 確保程序能維護(hù)質(zhì)量、反映有效的確保程序能維護(hù)質(zhì)量、反映有效的 作業(yè)作業(yè)

5、 - 采取糾正措施以改良過程采取糾正措施以改良過程審核員決定作業(yè)是否有跟從程序進(jìn)行審核員決定作業(yè)是否有跟從程序進(jìn)行審核員應(yīng)以正面的態(tài)度進(jìn)行審核審核員應(yīng)以正面的態(tài)度進(jìn)行審核審核員必須充分準(zhǔn)備審核員必須充分準(zhǔn)備5Types of Audit 審核的種類審核的種類Customer客戶客戶Enterprise企業(yè)企業(yè)Sub-contract分供方分供方Independent Organization獨(dú)立機(jī)構(gòu)獨(dú)立機(jī)構(gòu)第第2方方2 nd 第第3方方3rd第第2方方2nd第一方第一方1 st6Types of Audit 審核的種類審核的種類 Document Audit 文件審核文件審核 On-site

6、audit 現(xiàn)場(chǎng)審核現(xiàn)場(chǎng)審核 System audit 體系審核體系審核 Process audit 過程審核過程審核 Product audit 產(chǎn)品審核產(chǎn)品審核7Audit Phases 審核階段審核階段 審核報(bào)告審核報(bào)告被審方進(jìn)行被審方進(jìn)行原因分析和原因分析和糾正措施糾正措施跟蹤檢查跟蹤檢查糾正措施糾正措施搜集資料搜集資料 / / 準(zhǔn)備準(zhǔn)備安排審核員安排審核員制訂審核計(jì)劃制訂審核計(jì)劃文件審核文件審核準(zhǔn)備檢查表準(zhǔn)備檢查表 結(jié)束會(huì)議結(jié)束會(huì)議 確認(rèn)結(jié)果確認(rèn)結(jié)果記錄不符合點(diǎn)記錄不符合點(diǎn)調(diào)整計(jì)劃調(diào)整計(jì)劃 尋找符合尋找符合要求的地方要求的地方 開始會(huì)議開始會(huì)議進(jìn)行進(jìn)行準(zhǔn)備準(zhǔn)備跟跟進(jìn)進(jìn)文件編寫文件編寫

7、8Information Gathering / Preparation 搜集資料搜集資料 / 準(zhǔn)備準(zhǔn)備StandardsCompany backgroundNumber of EmployeeLocationSite scaleAudit scopePrevious audit recordCustomer informationCustomer / contract special requirementsTravel and other arrangementProcess identification Process linkage標(biāo)準(zhǔn)標(biāo)準(zhǔn)公司背景公司背景員工人數(shù)員工人數(shù)地點(diǎn)地點(diǎn)場(chǎng)地規(guī)

8、模場(chǎng)地規(guī)模審核范圍審核范圍以往審核記錄以往審核記錄客戶情況客戶情況客戶客戶 / / 合同特殊要求合同特殊要求交通和其它安排交通和其它安排過程確定過程確定過程連接過程連接9Auditor Arrangement 安排審核員安排審核員Trained and qualifiedHave relevant experienceIndependent to the auditeeBeware the relationship between auditor and auditeeSelect the team leader經(jīng)培訓(xùn)并有資格經(jīng)培訓(xùn)并有資格有相關(guān)經(jīng)驗(yàn)有相關(guān)經(jīng)驗(yàn)與被審方有獨(dú)立性與被審方有獨(dú)立性注

9、意審核員與被審方的個(gè)人關(guān)系注意審核員與被審方的個(gè)人關(guān)系選定組長(zhǎng)選定組長(zhǎng)10Audit Plan 審核計(jì)劃審核計(jì)劃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 audit-Business conditions-Customer complaints-The date of customer audit

10、-The date of the third party certification audit-Cover all elements of the standard-Cover all the processes and activity年度計(jì)劃需考慮：年度計(jì)劃需考慮：-過程的重要度和與體系標(biāo)過程的重要度和與體系標(biāo)準(zhǔn)要求的相關(guān)程度準(zhǔn)要求的相關(guān)程度-實(shí)際表現(xiàn)，以往審核結(jié)果實(shí)際表現(xiàn)，以往審核結(jié)果-業(yè)務(wù)情況業(yè)務(wù)情況-客戶投訴情況客戶投訴情況-客戶審核時(shí)間客戶審核時(shí)間-第三方認(rèn)證審核時(shí)間第三方認(rèn)證審核時(shí)間-覆蓋標(biāo)準(zhǔn)所有要素覆蓋標(biāo)準(zhǔn)所有要素-覆蓋所有過程和活動(dòng)覆蓋所有過程和活動(dòng)11Audit Sche

11、dule 審核時(shí)間表審核時(shí)間表The auditee department / process Auditor / teamScheduleAudit scopeCover all shifts and activitiesThe audit duration according to the importance and scale of the department / function / processBeware the audit process flow / sequenceAvoid / reduce walk around time 被審部門被審部門 / 過程過程審核員審核員

12、 / 小組小組時(shí)間安排時(shí)間安排審核范圍審核范圍覆蓋所有班次，活動(dòng)覆蓋所有班次，活動(dòng)審核時(shí)間規(guī)乎部門審核時(shí)間規(guī)乎部門 / 功能功能 / 過程的重要度和規(guī)模過程的重要度和規(guī)模注意審核流程注意審核流程 / 順序順序避免避免 / 減少來回走動(dòng)時(shí)間減少來回走動(dòng)時(shí)間12Document Audit 文件審核文件審核Standard clause vs quality system documentQuality system document vs standardsQuality manual, procedure documentQuality planWhether the system is co

13、mplete and adequate Understand the operation method and control point of an organization Identify the core process and support process and also the interaction 標(biāo)準(zhǔn)條文標(biāo)準(zhǔn)條文 vs 質(zhì)量體系文件質(zhì)量體系文件質(zhì)量體系文件質(zhì)量體系文件 vs 標(biāo)準(zhǔn)標(biāo)準(zhǔn)質(zhì)量手冊(cè)，程序文件質(zhì)量手冊(cè)，程序文件質(zhì)量計(jì)劃質(zhì)量計(jì)劃體系是否完整和充分體系是否完整和充分了解企業(yè)的運(yùn)行方法和控制了解企業(yè)的運(yùn)行方法和控制要點(diǎn)要點(diǎn)確認(rèn)主要過程確認(rèn)主要過程,支持過程和相支持過程和

14、相互關(guān)系互關(guān)系13Audit Checklist 審核檢查表審核檢查表Only a reminder, not a questionnaireTransfer according to the requirements of standardsTransfer according to the organizations procedure document requirementsBeware the special requirements of customerBeware the result of document auditBeware the result of previous

15、 auditBeware the customer complaintsUse it as audit record每次審核應(yīng)該使用規(guī)定的檢查表每次審核應(yīng)該使用規(guī)定的檢查表只是備忘，提醒，不是問卷表只是備忘，提醒，不是問卷表按標(biāo)準(zhǔn)要求轉(zhuǎn)化按標(biāo)準(zhǔn)要求轉(zhuǎn)化按企業(yè)程序文件要求轉(zhuǎn)化按企業(yè)程序文件要求轉(zhuǎn)化注意客戶特殊要求注意客戶特殊要求注意文件審核結(jié)果注意文件審核結(jié)果注意前次審核結(jié)果注意前次審核結(jié)果注意客戶投訴情況注意客戶投訴情況作為審核記錄作為審核記錄14Opening Meeting 開始會(huì)議開始會(huì)議Chaired by team leaderIntroductionAudit proposeAud

16、it standard and disposition criterion Audit scopeConfirm the audit scheduleAudit methodThe guideThe communication channel and contactThe time of close meetingOther arrangement由審核組長(zhǎng)主持由審核組長(zhǎng)主持介紹人員介紹人員審核目的審核目的審核標(biāo)準(zhǔn)和判定準(zhǔn)則審核標(biāo)準(zhǔn)和判定準(zhǔn)則審核范圍審核范圍確定審核時(shí)間表確定審核時(shí)間表審核方法審核方法陪審員陪審員溝通和聯(lián)系渠道溝通和聯(lián)系渠道末次會(huì)議時(shí)間末次會(huì)議時(shí)間其它安排其它安排15On-si

17、te Audit 現(xiàn)場(chǎng)審核現(xiàn)場(chǎng)審核Fact finding and objective 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 w

18、ith cross department Modify the audit plan when necessaryRecord the nonconformance Confirm the audit result with the auditee找尋事實(shí)，客觀證據(jù)找尋事實(shí)，客觀證據(jù)并非尋找錯(cuò)誤的練習(xí)并非尋找錯(cuò)誤的練習(xí)確保覆蓋審核范圍確保覆蓋審核范圍確保覆蓋標(biāo)準(zhǔn)要求確保覆蓋標(biāo)準(zhǔn)要求檢查運(yùn)行情況和以往結(jié)果檢查運(yùn)行情況和以往結(jié)果檢查符合性，完整性檢查符合性，完整性判斷有效性判斷有效性(!)利用檢查表幫助利用檢查表幫助需要跨部門跟蹤確認(rèn)需要跨部門跟蹤確認(rèn)需要時(shí)，調(diào)整審核計(jì)劃需要時(shí)，調(diào)整審核計(jì)劃記錄不

19、符合項(xiàng)記錄不符合項(xiàng)與被審方確認(rèn)審核結(jié)果與被審方確認(rèn)審核結(jié)果16Closing Meeting 末次會(huì)議末次會(huì)議Chaired by team leaderExpress thanks 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

20、Corrective Action Request (CAR)Arrange the follow up auditExpress thanks again由審核組長(zhǎng)主持由審核組長(zhǎng)主持致謝致謝再確認(rèn)審核標(biāo)準(zhǔn)和審核范圍再確認(rèn)審核標(biāo)準(zhǔn)和審核范圍報(bào)告正面的審核結(jié)果報(bào)告正面的審核結(jié)果報(bào)告不符合項(xiàng)報(bào)告不符合項(xiàng)提出觀察項(xiàng)，改進(jìn)的建議提出觀察項(xiàng)，改進(jìn)的建議宣報(bào)審核判斷結(jié)論宣報(bào)審核判斷結(jié)論糾正措施回復(fù)時(shí)間糾正措施回復(fù)時(shí)間安排跟蹤審核安排跟蹤審核再次感謝再次感謝17Nonconformance Definition 不符合項(xiàng)定義不符合項(xiàng)定義Major:-the absence or total breakdow

21、n 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 considered a major nonconformity. -Any noncompliance that would result in the probable shipment of a nonconforming product. A conditio

22、n that may result in the failure of materially reduce the usability of the the products or services for their intended purpose-A noncompliance that judgment and experience indicate is likely either to result in the failure of the quality system or to materially reduce its ability to assure controlle

23、d processes and products.嚴(yán)重嚴(yán)重-質(zhì)量體系缺少或完全失效質(zhì)量體系缺少或完全失效ISO/TS 16949要求。在某一個(gè)體系要求出現(xiàn)要求。在某一個(gè)體系要求出現(xiàn)好幾個(gè)輕微不符合可變成體系完全失好幾個(gè)輕微不符合可變成體系完全失效，這也是嚴(yán)重不符合。效，這也是嚴(yán)重不符合。 -任何可能使不合格產(chǎn)品裝運(yùn)的不符合任何可能使不合格產(chǎn)品裝運(yùn)的不符合情況。任何導(dǎo)致產(chǎn)品或服務(wù)的規(guī)定使情況。任何導(dǎo)致產(chǎn)品或服務(wù)的規(guī)定使用性能降低或失效的不符合情況。用性能降低或失效的不符合情況。-任何可能導(dǎo)致質(zhì)量體系失效或嚴(yán)重降任何可能導(dǎo)致質(zhì)量體系失效或嚴(yán)重降低對(duì)產(chǎn)品和過程控制能力的判斷或經(jīng)低對(duì)產(chǎn)品和過程控制能力

24、的判斷或經(jīng)驗(yàn)的不符合情況。驗(yàn)的不符合情況。 18MinorIs 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 qu

25、ality system relative to a ISO/TS 16949 , or -A single observed lapse in following one item of a companys quality system.輕微輕微判斷或經(jīng)驗(yàn)與判斷或經(jīng)驗(yàn)與ISO/TS 16949的不的不一一致但又不可能導(dǎo)致體系失效，致但又不可能導(dǎo)致體系失效， 或降低對(duì)產(chǎn)品和過程能力的控制?；蚪档蛯?duì)產(chǎn)品和過程能力的控制。-供方與供方與ISO/TS 16949有關(guān)的形有關(guān)的形成文件的質(zhì)量成文件的質(zhì)量 體系某一部分體系某一部分不符合要求。不符合要求。-在公司質(zhì)量體系中發(fā)現(xiàn)的單在公司質(zhì)量體系中發(fā)現(xiàn)的

26、單個(gè)錯(cuò)誤。個(gè)錯(cuò)誤。Nonconformance Definition 不符合項(xiàng)定義不符合項(xiàng)定義19ConformNo major or minor nonconformities were noted in the audit. 符合項(xiàng)符合項(xiàng)- 在審核中沒有發(fā)現(xiàn)嚴(yán)重不在審核中沒有發(fā)現(xiàn)嚴(yán)重不符合或輕微不符合。符合或輕微不符合。Nonconformance Definition 不符合項(xiàng)定義不符合項(xiàng)定義20Nonconformance Report 不符合報(bào)告不符合報(bào)告Findings 發(fā)現(xiàn)發(fā)現(xiàn)Evidence依據(jù)依據(jù)Explanation解釋解釋21Audit Report 審核報(bào)告審核報(bào)告Au

27、dit dateAuditor teamAudit standardsAudit scopeAudit planAudit result / findingsNonconformanceObservation, opportunity for improvementDisposition conclusion Follow up action 審核日期審核日期審核員小組審核員小組審核標(biāo)準(zhǔn)審核標(biāo)準(zhǔn)審核范圍審核范圍審核計(jì)劃審核計(jì)劃審核結(jié)果審核結(jié)果 / 發(fā)現(xiàn)發(fā)現(xiàn)不符合項(xiàng)不符合項(xiàng)觀察項(xiàng)，改進(jìn)建議觀察項(xiàng)，改進(jìn)建議判斷結(jié)論判斷結(jié)論跟蹤行動(dòng)跟蹤行動(dòng)22Auditee Cause Analysis &

28、 Corrective Action 被審方原因分析糾正措施被審方原因分析糾正措施Understand the NC problemInvestigate the root coursePinpoint to problem cause, take corrective action to avoid re-occurringExtend the corrective action to the similar products / process/ system Verify the effectiveness of the action了解不符合項(xiàng)問題了解不符合項(xiàng)問題調(diào)查根本原因調(diào)查根本原

29、因針對(duì)原因，采取糾針對(duì)原因，采取糾正措施，預(yù)防再發(fā)正措施，預(yù)防再發(fā)生生舉一反三，擴(kuò)大糾舉一反三，擴(kuò)大糾正措施到同類產(chǎn)品正措施到同類產(chǎn)品 / 工藝工藝 / 系統(tǒng)系統(tǒng)驗(yàn)證措施是否有效驗(yàn)證措施是否有效23Follow up Audit 跟蹤審核跟蹤審核To verify whether the corrective action has been implementedTo verify the effectiveness of corrective action Check the relevant modified document / recordRe-sample check the new

30、 operation recordRe-check the operation method and implementation 驗(yàn)證糾正措施是否已實(shí)施驗(yàn)證糾正措施是否已實(shí)施驗(yàn)證糾正措施是否有效驗(yàn)證糾正措施是否有效檢查相關(guān)修改文件檢查相關(guān)修改文件 / 記錄記錄再抽查新的運(yùn)行記錄再抽查新的運(yùn)行記錄再檢查運(yùn)行方法和實(shí)施情再檢查運(yùn)行方法和實(shí)施情況況24Audit Skill審核技巧審核技巧Fact Findings找尋事實(shí)找尋事實(shí) - Read 讀讀 - Observe 看看 / 觀察觀察 - Listen 聽聽 - Ask 問問25Read - Standards - Quality syste

31、m document, record - customer contract, special requirements - previous audit records - customer complaints - data analysis讀：讀： - 標(biāo)準(zhǔn)標(biāo)準(zhǔn) - 質(zhì)量體系文件，記錄質(zhì)量體系文件，記錄 - 客戶合同，特殊要求客戶合同，特殊要求 - 以往審核記錄以往審核記錄 - 客戶投訴情況客戶投訴情況 - 分析資料分析資料Audit Skill審核技巧審核技巧26Observe - auditee the response, body language - response of ot

32、her people - look at the auditees eyes - Sense judgment 看看 / 觀察觀察-被審方的反應(yīng)，身體語被審方的反應(yīng)，身體語言言-其他人員的反應(yīng)其他人員的反應(yīng)-看著對(duì)方的眼睛看著對(duì)方的眼睛-感官判斷感官判斷Audit Skill審核技巧審核技巧27Listen -Beware the environmental influence-Beware whether the auditee can represent -Analyze information-Summarize information -Record to follow up-Not

33、to appraise the speaker-Beware the side indication -Show the interesting to listen 聽聽-注意環(huán)境影響注意環(huán)境影響-注意對(duì)方是否有代表性注意對(duì)方是否有代表性-分析資料分析資料-總結(jié)信息總結(jié)信息-記錄以便跟蹤記錄以便跟蹤-切勿評(píng)價(jià)講者切勿評(píng)價(jià)講者-注意言外之意注意言外之意-表示有興趣聽表示有興趣聽Audit Skill審核技巧審核技巧28Ask -closed question-Leading question-Open question -Who-When -Where-What-How-Why-Show me-

34、Double / multiple question-Follow up question 問問-封閉式問題封閉式問題-帶領(lǐng)式問題帶領(lǐng)式問題-開放式問題開放式問題-何人何人-何時(shí)何時(shí)-何處何處-何事何事-怎么樣怎么樣-為什么為什么-給我看看給我看看-2個(gè)個(gè)/ 多個(gè)問題多個(gè)問題-跟蹤提問跟蹤提問Audit Skill審核技巧審核技巧29Audit Flow-draft flow chart-The first question-From top down / from bottom up-Trace forward / trace backward-Horizontal check-Focus

35、check-Sample check method -Apply ROLA審核流程審核流程-粗略的流程圖粗略的流程圖-第一條問題第一條問題-由上而下由上而下/由下而上由下而上-往前追查往前追查/ 往后追查往后追查-橫向檢查橫向檢查-重點(diǎn)檢查重點(diǎn)檢查-抽樣方法抽樣方法-運(yùn)用運(yùn)用ROLAAudit Skill審核技巧審核技巧30Other remark-time management / control-Cover all related activities according to the plan-Avoid side tracking -Avoid being led / miss led

36、-Not to involve in the discussions of cause and responsibility -Not to provide the detail method of solution -Dont be afraid to say you dont understand-The effective 2 way communication 其他注意其他注意-時(shí)間管理時(shí)間管理 / 控制控制-按計(jì)劃，覆蓋所有相關(guān)活按計(jì)劃，覆蓋所有相關(guān)活動(dòng)動(dòng)-不被轉(zhuǎn)移目標(biāo)不被轉(zhuǎn)移目標(biāo)-不被引導(dǎo)不被引導(dǎo) / 誤導(dǎo)誤導(dǎo)-不參與討論原因和責(zé)任不參與討論原因和責(zé)任-不提供具體解決方法不提供具體

37、解決方法-不要害怕說你不明白不要害怕說你不明白-有效的雙向溝通有效的雙向溝通Audit Skill審核技巧審核技巧31Auditor Attitude/ Responsibility 審核員態(tài)度審核員態(tài)度 / 責(zé)任責(zé)任Good 好好Good listener 善于聆聽善于聆聽Open minded 思想開朗思想開朗Diplomatic 善于交往善于交往Resilient 復(fù)原力強(qiáng)復(fù)原力強(qiáng)Unbiased 公平公平Honest 誠(chéng)實(shí)誠(chéng)實(shí)Patient 耐心耐心Self-disciplined 自律自律Articulate 善于溝通善于溝通Able to communicate 表達(dá)力強(qiáng)表達(dá)力強(qiáng)I

38、nterested 有好奇心有好奇心Unafraid of being unpopular 不怕不怕受排擠受排擠Empathetic 具同情心具同情心Bad 壞壞Arrogant 傲慢傲慢Opinionated 偏見偏見Self-important 自大自大Lazy 懶惰懶惰Argumentative 好爭(zhēng)辯好爭(zhēng)辯Shy 害羞害羞Timid 膽怯膽怯Gullible 易受騙易受騙Impatient 缺乏耐性缺乏耐性Poor communicator 不善于溝通不善于溝通Desire to be liked 希望被喜歡希望被喜歡Unprofessional 不專業(yè)不專業(yè)32Automotive Audit Key Points 汽車行業(yè)審核中的要點(diǎn)汽車行業(yè)審核中的要點(diǎn)Use of ISO/TS standard checklistBeware of customer specific requirementsCollect customer requirements from S