ISO 内审员训练课程教材

1、內部審核 Internal AuditingQSM 施軼軼2006/9/9QSM Yiyi_Shi 9/9內部審核技巧 Internal Auditing Skills 基礎概念 Basic ConceptQSM Yiyi_Shi 9/9什么是審核? What is audit? 健康檢查 Health check 關鍵用字 Key word系統的 Systematic 文件記錄 Documented 定期 Periodic 客觀 Objective 確認 Verification QSM Yiyi_Shi 9/9重要概念 Key Concept確認 評估是否符合要求Verification

2、Evaluate compliance to requirements系統的 依設定的方法進行Systematic Carried out in accordance to set protocols定期 依時間表實施Periodic Conducted to established schedule客觀 立場客觀的審核員Objective Auditors have some independence文件記錄 制定報告Documented Reports are prepared QSM Yiyi_Shi 9/9審核 Audit為獲得証据并對其進行客觀地評价,以確定滿足審核准則的程度所進行的

3、系統的,獨立的并形成文件的過程systematic,independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled. (ISO9000:2000)QSM Yiyi_Shi 9/9審核准則 Audit criteria用作比較的一組方針,程序或要求set of policies,procedures or requirements used as a

4、reference(ISO9000:2000)QSM Yiyi_Shi 9/9審核証据 Audit evidence與審核准則有關的記錄,事實陳述或其他信息records,statements of fact or other information which are relevant to the audit criteria (ISO9000:2000)QSM Yiyi_Shi 9/9審核發現 Audit finding將收集的審核証据與審核准則相比較的評价結果results of the evaluation of the collected audit evidence agains

5、t criteria(ISO9000:2000)QSM Yiyi_Shi 9/9驗証 Verification通過証据的提供以確認特定要求經已被滿足confirmation,through the provision of objective evidence that specified requirements have been fulfilled(ISO9000:2000)QSM Yiyi_Shi 9/9審核的種類 Type of Audit 第一方(供方)-內部審核 First Party(supplier)-Internal Audit 第二方(買方)-外部審核 Second Pa

6、rty(Purchaser)-External Audit 第三方(獨立)-外部審核 Third Party(Independence)-External Audit執行者層面QSM Yiyi_Shi 9/9審核的種類 Type of Audit 体系審核 System Audit 符合性審核 Compliance Audit執行方法層面桌上 desktop文件 document現場 site活動 activity過程 process產品 productQSM Yiyi_Shi 9/9審核的目的 Audit Objective 是否符合計划中的安排 是否實施和維持客觀評估管理体系執行的情形:E

7、valuate the degree of implementation of management systemDoes it conforms to planned arrangementsHas it been properly implemented and maintainedQSM Yiyi_Shi 9/9內部審核 Internal Auditing 審核計划 Audit PlanQSM Yiyi_Shi 9/9審核計划 Audit Plan潛在問題區potential problem area不符合歷史Nonconformity history變動 Change优先順序prior

8、itization資源resource組織結構Organization Structure審核計划Audit planningQSM Yiyi_Shi 9/9審核計划的設定 Audit Plan Setting 風險高/低 high/low risk 改變change決定因素factor 與產品/過程有關項目的關鍵性 importance of related product/process items 人事personnel 過程/技朮/管理/体系process/technique/mgnt/system 法規/標准變動 regulatory/standard 客戶/法規/標准的要求 cus

9、tomer/regulatory/standard reqtQSM Yiyi_Shi 9/9審核單位 Audit Unit 組織結構 organization structure 程序 administrative and operational procedures 部 departments 課 division 工作區,作業和過程 work areas,operations and processes 文件控制 document control 廢棄物管理 waste management 維修工作站 maintenance workshop 材料儲存區 materials storag

10、e areaQSM Yiyi_Shi 9/9審核計划 Audit PlanQSM Yiyi_Shi 9/9審核計划 Audit PlanQSM Yiyi_Shi 9/9內部審核 Internal Auditing 內部審核 Internal AuditQSM Yiyi_Shi 9/9審核階段 Audit Stage准備 Preparation執行 Execution報告 Reporting效果跟進 Follow up跟進follow up10%准備preparation40%報告reporting 10%執行execution40%QSM Yiyi_Shi 9/9內部審核 Internal A

11、uditing 准備審核 Audit PreparationQSM Yiyi_Shi 9/9准備審核 Audit Preparation 失敗的准備,就是准備失敗 fail to prepare is prepare to failQSM Yiyi_Shi 9/9准備活動 Preparations確定范圍 define scope 選擇審核小組 select audit team制定審核時間表 prepare audit program准備檢查表 prepare audit checklist召開審核小組會議 conduct audit team briefing通知審核安排/召開開始會議 n

12、otify audit arrangement /conduct opening meetingQSM Yiyi_Shi 9/9審核范圍 Audit Scope標准的要求 Standards requirement 公司內管理体系的要求 Internal management system requirement客戶要求 Customer requirements以往的審核的改正措施 Corrective action of previous audit質量表現Performance 變更 ChangeQSM Yiyi_Shi 9/9選擇審核小組 Audit Team Selection選擇時

13、應考慮: Process should consider 要被審核的組織,過程,活動或功能 type of organization,processes,activities or functions being audited審核小組數目和組成 number and composition of audit teams標准所要求的資格 qualifications as identified in the standardQSM Yiyi_Shi 9/9選擇審核小組 Audit Team Selection審核員資歷 Auditor qualification語言能力和專業程度 langua

14、ge skills and expertise 對被審核的部分的運作及相關應用技朮有基本認識 knowledge of the related operations and applicable technique of the area曾受完整的審核訓練 well trained審核經驗 auditing experience獨立性 independence審核員素質 auditor qualityQSM Yiyi_Shi 9/9審核時間表 Audit Program審核時間分配的考慮因素 factors for allocation of auditing time審核的項目 audit

15、items審核單位的操作員數目 number of operators of audited unit審核單位的工作內容 job contents of audit unit位置及面積 location and space QSM Yiyi_Shi 9/9審核時間表 Audit Program時間 標准要求 審核員Time Standard requirements Auditor10.31.199909:00-12:00 客戶投訴,預防及糾正措施, 黃大偉 管理者責任,內部審核 D Wong customer complaint, corrective and preventive acti

16、on management responsibility internal audit 文件控制,記錄控制 張強 document control,record control K Zhang12:00-13:00 午膳lunch13:00-16:00 . QSM Yiyi_Shi 9/9審核時間表 Audit Program時間 部門 審核員Time Department Auditor12.2.1999 09:00-12:00 生產部 周一明 Production M Zhou采購部 陳大文 Purchasing M Chen 市場部 李林Marketing Y Li 12:00-13:0

17、0 午膳lunch 13:00-16:00 . .QSM Yiyi_Shi 9/9檢查表 Checklist一連串的問題 a series of written questions in sequence審核的指引 route map and prompt for auditing 確保覆蓋需審核的范圍 ensure all ground is covered QSM Yiyi_Shi 9/9檢查表內容 Content of Checklist標准的要求和要素 requirement and elements of standards內部文件(作業程序,工作指引)的要求和要素 requirem

18、ent and elements of internal document (operation procedure,work instruction) 需要審查的記錄 record needed to be checked QSM Yiyi_Shi 9/9審核檢查表 Audit ChecklistQSM Yiyi_Shi 9/9內部審核檢查表QSM Yiyi_Shi 9/9檢查表的好處 Advantage of Checklist優點Advantages可用來指導審核過程 guide to the audit process記錄証据records evidence作為審核証据evidence

19、 of audit新手的好幫手-備忘錄good help for beginners- aide-memories缺點Disadvantages需要時間准備 preparation time needed忽視其他觀點blindered view略微麻煩somewhat cumbersome建議使用,非強制性advised but not mandatoryQSM Yiyi_Shi 9/9審核小組會議 Audit Team Briefing審核組長于審核前召集 conducted by team leader prior to the audit確認准備工作均已完成及審核員分工 confirm

20、completion of preparation work and job content of team members討論可能出現的問題及需注意事項 share information and discuss problems交流經驗及審核技巧 share experience and auditing techniqueQSM Yiyi_Shi 9/9開始會議/審核通知 Opening Meeting/Audit Notice發出審核時間表 issue audit program 說明審核目的,內容,方法和時間安排 specify the audit contents,methods

21、and time與被審核部門/項目的負責人確認審核時間和人員安排 confirm the audit schedule and arrangement with the responsible person of the audited department/activities QSM Yiyi_Shi 9/9內部審核 Internal Auditing 執行審核 Audit ExecutionQSM Yiyi_Shi 9/9審核技巧 Auditing SkillsIs the management system in place and effective? 管理体系在實施中,并有效嗎?可

22、采用路徑式審核Audit trails should be discernible進行程序審核,作為補充Supplement with procedural auditsQSM Yiyi_Shi 9/9審核活動 Audit Activity審查文件 Review documents會談/溝通 Interview/Communication現場觀察/收集証据 site observation/evidence collection評審 evaluationQSM Yiyi_Shi 9/9審查文件 Documents Review 確認已建立系符合標准要求 determine if establi

23、shed system comply with the standard requirements 手冊 quality manual程序 proceduresQSM Yiyi_Shi 9/9審核路徑 Audit Trail 是否設定了目標和任務?Have any objectives and targets been set? 是否這些目標和任務都已放在管理計划內?Are these addressed in the management program? 有任何文件嗎?Any document? 法規/標准/要求狀態?Regulatory/standard/requirement cond

24、itions? 誰是關鍵人員?Who are the key personnel? 有任何作業控制嗎?Any operational control?QSM Yiyi_Shi 9/9審核路徑 Audit Trail 判斷控制程度?Degree of control? 調查培訓資料 Investigate training information? 表現測量記錄?Records of performance measurements? 表現報告?Performance reports? 相關方(如:客戶)的反餽資料?Interested parties(e.g.customer)feedback

25、 information?QSM Yiyi_Shi 9/9檢查方法 Checking Method 隨机抽樣型式形進行,而非100%全檢Random sample instead of 100% full check 決定抽樣的數量時應考慮 Sample size depends on 被審查部門/項目的文件,工作,人員和記錄的數量Amount of documents,jobs,personnel and records of the audited dept/item 過去的表現PerformanceQSM Yiyi_Shi 9/9檢查方法 Checking Method 抽查的方向不一定

26、需要從頭到尾,可以任何一點展幵No fixed direction,it can start at any pointsQSM Yiyi_Shi 9/9檢查方法 Checking Method 抽查的文件/人員/記錄間應有連貫關系Interrelationship of checked documents/personnel/records采購文件 申購單 采購單 審批者要求合格分供方名單 分供方評審記錄 分供方評審要求Purchasing document purchase requisition purchase orderApproval requirement approved sup

27、plier list supplier evaluation records supplier evaluation requirementQSM Yiyi_Shi 9/9評審觀察點 Evaluate Observation 記錄下所有觀察點Record all observations 評審觀察點以確定不符合事項Evaluate observations to identify any nonconformities 對所有不符合事項須有証据作為依据All nonconformities must be based on evidenceQSM Yiyi_Shi 9/9內部審核 Intern

28、al Auditing 報告ReportingQSM Yiyi_Shi 9/9准備不符合事項報告 Preparing NC Report 分析觀察所得的不符合事項,以准備不符合事項報告Analyze nonconformity observed and prepareNonconformity Report(NC Report) 不符合事項的類別 Category of Nonconformity 不符合事項的模式 Mode of NonconformityQSM Yiyi_Shi 9/9不符合事項的分類 Category of NC第一類QSM Yiyi_Shi 9/9不符合事項的分類 Ca

29、tegory of NC第二類第三類QSM Yiyi_Shi 9/9不符合事項的模式 Model of NC 沒有把標准的要求文件化文件問題 documentation problem Standard requirements are not documented 文件不能反映實際運作情況 Document cannot reflect the actual practice 文件內容不當,不足或錯誤 Inappropriate contents,incomplete or wrong 文件之間有矛盾 Conflict between documentsQSM Yiyi_Shi 9/9不符合

30、事項的模式 Model of NC 沒有按文件要求執行工作執行問題 implementation problem implementation does not follow documented requirementsQSM Yiyi_Shi 9/9不符合事項的模式 Model of NC 方法錯誤技朮問題 -設計/方法/工具 technical problem-design/method/tool Wrong method 工具設計錯誤 Tool design mistake 技朮錯誤 Technical mistakeQSM Yiyi_Shi 9/9不符合事項報告 Nonconform

31、ity Report 發現的問題(觀察所得的事實)不符合事項的說明 Description of nonconformity Findings(fact observed) 客觀証据 Objective evidence 結論(違反標准或文件的章節) Conclusion(against which element of standard of document) 類型(嚴重,輕微) Category(major,minor)QSM Yiyi_Shi 9/9不符合事項報告 Nonconformity ReportQSM Yiyi_Shi 9/9糾正及預防措施 Corrective&Preven

32、tive Action糾正措施 Corrective action 為了防止已出現的不符合事項再次發生,消除其原因所采取的措施Action taken to eliminate the cause of existing nonconformity in order to prevent recurrence- LetQSM Yiyi_Shi 9/9糾正及預防措施 Corrective&Preventive Action預防措施 Preventive action 為了防止潛在的不符合事項發生,消除其原因所采取的措施Action taken to eliminate the cause of

33、potential nonconformity in order to prevent recurrence- Let problem dont happen-QSM Yiyi_Shi 9/9糾正及預防措施 Corrective&Preventive Action必須針對不符合事項的起因 文件不當 documentation problemHave to focus on the root cause of nonconformity 設計失誤-方法,工具 design problem-methods,tools 沒有按規定要求執行工作 implementation against Docum

34、ented requirements 訓練不足 Insufficient training 管理不善 Poor managementQSM Yiyi_Shi 9/9糾正及預防措施的跟進 Follow Up Action 需跟進相關的糾正/預防措施,確認 follow up corrective/preventive action taken,verify 執行情況 implementation 有沒有在規定期限內實施 if action has been taken within time frame 有效性 effectiveness 實施之后,不符合事項有沒有改正,問題有沒有 解決 if

35、correction of nonconformity has been corrected and problem has been fixed after action taken需記錄確認結果 record verification resultQSM Yiyi_Shi 9/9不符合事項報告 Nonconformity ReportQSM Yiyi_Shi 9/9糾正及預防措施的跟進 Follow Up Action 糾正/預防措施確認結果的記錄: record verification result of corrective/preventive action 已糾正 correct

36、ed已解決 fixed沒問題 no problem QSM Yiyi_Shi 9/9不符合事項報告 Nonconformity ReportQSM Yiyi_Shi 9/9審核結束 Audit Close out 在所有糾正/預防措施的有效性都經已完全確認時,審核才是正式結束When the effectiveness of all corrective/preventive actions have been verified QSM Yiyi_Shi 9/9審核報告 Audit Report報告目的 objective 總結審核的發現 Summarize the audit finding

37、s 評价審核結果Comment audit result 報告管理階層 Report to managementQSM Yiyi_Shi 9/9審核報告的內容 Contents of Audit Report 審核的范圍和目的 audit scope and objective 審核的時間表 audit program 審核的結果 audit result 不符合事項 nonconformity 觀察事項 observation 評价体系与實施的符合程度Comment on the degree of compliance of system and implementationQSM Yiy

38、i_Shi 9/9審核流程 Audit Flow程序,檔案和記錄Procedure,files&records時間表Schedule公正,經培訓的審核員Trained independent auditors記錄的結果Results recorded向負責的管理階層報告Reported to management responsible即時實施糾正制動Timely corrective action追蹤,確認有效性Follow-up to verity effectiveness4QSM Yiyi_Shi 9/9不符合事項報告 Nonconformity Report案例 Case1: 在檢查

39、2000年的管理評審記錄時,審核員發現管理評審 內容未包括糾正及預防行動及客戶投訴.During the audit of management review record for 2000, auditor found that corrective and preventive action,and customer complaint were not addressed in the review. 發現的問題problem 客觀証据objective evidence 結論conclusionQSM Yiyi_Shi 9/9不符合事項報告 Nonconformity Report案例

40、 Case1: 在檢查2000年的管理評審記錄時,審核員發現管理評審 內容未包括糾正及預防行動及客戶投訴.During the audit of management review record for 2000, auditor found that corrective and preventive action,and customer complaint were not addressed in the review.客觀証据 objective evidence發現的問題 problem結論:違反ISO9001:2000條文5.6.2的要求Conclusion;against IS

41、O 9001:2000 requirements 5.6.2QSM Yiyi_Shi 9/9不符合事項報告 Nonconformity Report報告方法 Report method 方法 method1-分點式 point form 問題: 2000年管理評審中,沒有對糾正及預防行動及客戶投訴進行評審. problem: Corrective and preventive action,and customer complaint were not addressed in the management review of 2000証据: 2000年的管理評審記錄 evidence: 2000 management review record 結論: 違反ISO9001:2000條文5.6.2的要求 conclusion:I