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按一下以編輯母片文字樣式,第二層,第三層,第四層,第五層,73,內部審核 Internal Auditing,QSM 施軼軼,2006/9/9,內部審核技巧 Internal Auditing Skills,基礎概念,Basic Concept,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,重要概念 Key Concept,確認 評估是否符合要求,Verification 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,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),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,reference,(ISO9000:2000),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),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,against criteria,(ISO9000:2000),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),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 Party(Purchaser)-External Audit,第三方(獨立)-外部審核,Third Party(Independence)-External Audit,執行者層面,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 product,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:,Evaluate the degree of implementation of management system,Does it conforms to planned arrangements,Has it been properly implemented and maintained,內部審核 Internal Auditing,審核計划,Audit Plan,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,prioritization,資源resource,組織結構Organization Structure,審核計划,Audit planning,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,customer/regulatory/standard,reqt,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 storage area,審核計划 Audit Plan,審核計划 Audit Plan,內部審核 Internal Auditing,內部審核,Internal Audit,審核階段 Audit Stage,准備,Preparation,執行,Execution,報告,Reporting,效果跟進,Follow up,跟進,follow up,10%,准備,preparation,40%,報告,reporting,10%,執行,execution,40%,內部審核 Internal Auditing,准備,審核,Audit Preparation,准備審核 Audit Preparation,失敗的准備,就是准備失敗,fail to prepare is prepare to fail,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,notify audit arrangement,/conduct opening meeting,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,Change,選擇審核小組 Audit Team Selection,選擇時應考慮,:,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 standard,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,language 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 quality,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 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,審核時間表 Audit Program,時間 標准要求 審核員,Time,Standard requirements,Auditor,10.31.1999,09:00-12:00,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 action,management responsibility,internal audit,文件控制,記錄控制 張強,document control,record control K Zhang,12:00-13:00 午膳lunch,13:00-16:00 ,.,審核時間表 Audit Program,時間 部門 審核員,Time,Department,Auditor,12.2.1999,09:00-12:00,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,12:00-13:00 午膳lunch,13:00-16:00 .,.,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,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,requirement and elements of internal document,(operation procedure,work instruction),需要審查的記錄,record needed to be checked,審核檢查表 Audit Checklist,內部審核檢查表,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 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 mandatory,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 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 technique,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 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,內部審核 Internal Auditing,執行審核,Audit Execution,審核技巧,Auditing Skills,Is the management system in place and effective?,管理体系在實施中,并有效嗎?,可采用路徑式審核,Audit trails should be discernible,進行程序審核,作為補充,Supplement with procedural audits,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,evaluation,審查文件 Documents Review,確認已建立系符合標准要求,determine if established system comply with the,standard requirements,手冊,quality manual,程序,procedures,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 conditions?,誰是關鍵人員,?,Who are the key personnel?,有任何作業控制嗎,?,Any operational control?,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 information?,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,Performance,檢查方法,Checking Method,抽查的方向不一定需要從頭到尾,可以任何,一點展幵,No fixed direction,it can start at any points,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 order,Approval requirement approved supplier list supplier evaluation,records supplier evaluation requirement,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 evidence,內部審核,Internal Auditing,報告,Reporting,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 prepare,Nonconformity Report(NC Report),不符合事項的類別,Category of Nonconformity,不符合事項的模式,Mode of Nonconformity,不符合事項的分類,Category of NC,第一類,不符合事項的分類,Category of NC,第二類,第三類,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 documents,不符合事項的模式,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 requirements,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 mistake,不符合事項報告,Nonconformity 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),不符合事項報告,Nonconformity Report,糾正及預防措施,Corrective&Preventive 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,- Let,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 potential nonconformity in order to prevent recurrence,- Let problem dont happen-,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 problem,Have 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,Documented requirements,訓練不足,Insufficient training,管理不善,Poor management,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 correction of nonconformity has been corrected,and problem has been fixed after action taken,需記錄確認結果,record verification result,不符合事項報告,Nonconformity Report,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,corrected,已解決,fixed,沒問題,no problem,不符合事項報告,Nonconformity Report,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,審核報告,Audit Report,報告目的,objective,總結審核的發現,Summarize the audit findings,評价審核結果,Comment audit result,報告管理階層,Report to management,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 implementation,審核流程 Audit Flow,程序,檔案和記錄,Procedure,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 effectiveness,4,不符合事項報告,Nonconformity Report,案例 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.,發現的問題,problem,客觀証据,objective evidence,結論,conclusion,不符合事項報告,Nonconformity Report,案例 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 ISO 9001:2000 requirements 5.6.2,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:It was against ISO9000:2001 requirements 5.6.2,不符合事項報告,Nonconformity Report,報告方法,Report method,方法 method2-述句式 Assay form,根据2000年的評審記錄,在該年的管理評審中,沒有對糾正及預防行動及客戶投訴進行評審.違反ISO9001:2000條文5.6.2的要求,Corrective and preventive action,and customer complaint were not addressed in the management review of 2000(refer 2000 management review record).It was against ISO 9001:2000 requirements 5.6.2,不符合事項報告,Nonconformity Report,案例 Case2:,文件WI-016規定: “所有QC員工在上崗前,必須通過一天的技朮培訓.”當審核員要求查看QC員工王小虎及馬小玲的培訓記錄時,QC部主管說: “我已對他們進行了培訓,但是沒有保存記錄.”,In document WI-016, it specified that all QC operator should go through an 1 day pre-job training.,When auditor asked for the training records of QC operator Mr. Wang and Ms Ma, the QC supervisor said “Ive trained them,but havent kept the records.”,發現的問題,problem,客觀証据,objective evidence,結論,conclusion,不符合事項報告,Nonconformity Report,報告方法,Report method:,問題: 沒有客觀証据証明,QC部已按文件WI-016要求,對,員工進行了上崗前培訓.,problem: There is no objective evidence to show that QC,Department performed the pre-job training to the operator according to document WI-016 requirement.,証据: 在審核時,未能提供QC員工王小虎及馬小玲的培,evidence: during audit,the training records of QC operator,結論: 違反ISO9001:2000條文6.2.2.e的要求,conclusion:against the ISO9001:2000 requirement 6.2.2.e,訓記錄.,Mr.Wang and Ms Ma,were not retrieved.,內部審核 Internal Auditing,謝謝,!,The end,
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