1、按一下以編輯母片標題樣式,按一下以編輯母片文字樣式,第二層,第三層,第四層,第五層,*,单击此处编辑母版标题样式,单击此处编辑母版文本样式,二级,三级,四级,五级,*,ISO 9000 2000,版,內部稽核培訓教材,1,內容摘要,品質詞匯解釋,ISO 9000 2000,修訂背景、精神、特色,ISO 9000 2000,標準架構,ISO 9000 2000,品質管理制程模式,內部稽核方法,2,應用上:,技術上:,一個物體有關需要及期望方面之性能;在技術定義,上意思是一整套可實現的品質特性及它們之價值.,在,ISO9000,標準家族,一個物體性能與需要期望之,間關係是與滿足或滿足需要及期望的能
2、力有關.,需要及期望之滿意,品質,3,品質管理:,系統:,由相互關聯或相互影響之要素組成之物體,使用在品質管理系統內一整套制程.,4,ISO/DIS 9000:2000 修訂背景,組織:ISO/TC176/SC2,歷次時程:1987,1994 2000,-ISO 9000,品質管理系統-基礎與辭彙,-ISO 9001品質管理系統-要求事項,-ISO 9004品質管理系統-績效改善指導綱要,-ISO 10011品質系統稽核指導綱要未來與ISO 14011合併為ISO 19011,5,ISO/DIS 9000:2000 精神,ISO 9001:1994,Quality systems-Model
3、for quality assurance in design/development,production,installation and servicing,-品質系統-設計、開發、生產、安裝及服務之,品質保,證模式,-對產品及/或服務提供品質保證,ISO 9001:2000,Quality management systems-Requirements,-,品質管理系統-要求事項,-產品品質保證及展現達成客戶滿意之能力,6,ISO/DIS 9000:2000 特色,ISO 9001/2/3,合併為單一標準,ISO 9001,ISO 9001,與,ISO 9004,可參照使用,建立顧客導
4、向為主的管理模式,強調,PDCA,流程管理模式,著重持續改善及預防在先的精神,強化系統、流程、作業的有效性,7,ISO/DIS 9000:2000 特色,採用與,ISO 14000 EMS,系統相容性,組織依其適用性及需求允許採取排除條款(,Permissible Exclusions),適用於各種產業及各種組織規模,8,ISO/DIS 9000:2000 標準架構,條文,-0簡介(Introduction),-1,適用範圍(Scope),-2參考標準(Normative reference),-3辭彙與定義(Terms and definition),-4品質管理系統要求事項,(Qualit
5、y management system requirements),-5,管理責任(responsibility),-6資源管理(Resource management),-7產品及/或服務實現(Product and/or service realization)Management,-8量測、分析及改進(Measurement,analysis and improvement),9,品 質 管 理 制 程 模 式,品質管理系統提續改善,客 戶 滿 意 度,輸入,輸出,品質管理系統,管理責任,量測、分析,及改進,產品服務,資源管理,產品及/或,服務實現,客 戶 之 要 求,10,TRAINI
6、NG MANUAL,FOR INTERNAL AUDITOR,內部稽核員訓練手冊,製造二處幹部訓練,制 作:郭新義,富金精密工業(深圳)有限公司,11,PURPOSE:,目的:,1.Master and understand quality audit procedure.,掌握理解品質稽核程序.,2.Study the method and technique of audit.,學習稽核方式與技巧,3.Achieve a certificate as a qualified auditor and,have a capable to perform internal quality aud
7、it.,獲得品質稽核的證明及執行稽核的能力.,Scope:,範圍:,1.All quality supervisor and engineer.,所有品質主管與工程師,.,2.Internal auditor.,內部稽核員.,3.All concerned supervisor.,所有相關主管.,12,富金公司,foxteq,品 質 政 策,傾聽客戶對產品之要求及做出他們的期望,QUALITY POLICY,foxteq LISTENS TO ITS CUSTOMERS NEEDS,AS WELL AS,DEVELOPS&MAKES PRODUCTS THAT MEET THEIR EXPEC
8、TATIONS,SIGNATURE:_ SIGNATURE:_,Tony Gou K.C.Liu,General Manager Engineering Standard Div.Manager,13,DEFINITION:,定義:,COMPLIANCE AUDIT:,COMPLIANCE AUDIT IS A AUDIT TO COMPARE THE ACTUAL,OPERATION WITH SPECIFIED AS THE THIRD GRADE DOCUMENT OR,MORE SUPERIOR DOCUMENT,依循稽核:,將規格內容之要求與實際作業比對之稽核,規格內容含地方之三階文
9、件要求及更高階之,規格內容(QS與ES)要求.,PROCEDURE AUDIT:,TO SEE WHETHER THE LOWER LEVEL SPEC.100%COMPLY WITH,THE HIGH LEVEL SPEC.ON PROCEDURE OR NOT.,程序稽核:,低階規格是否在程序上100%遵守高階規格在程序上之要求.,DEVIATION:,NOT COMFORM TO SPEC.REQUIREMENTS IS AS A DEVIATION.,稽核缺失:,不符合文件內容要求,謂之稽核缺失.,FOLLOW UP AUDIT:,THE VERIFICATION TO THE COR
10、RECTIVE ACTION AFIER AUDIT IS A,FOLLOW UP AUDIT:,跟催稽核:,在稽核后,對稽核后改正行動實施狀況之驗證謂之跟催稽核.,14,ISO 9000 DEFINITION QUALITY AUDIT,ISO-9000,定義品質稽核員,A systematic and independent examination to determine,whether quality activities and related results comply with,planned arrangements and whether these arrangement
11、 are,implemented effectively and are suitable to achieves objectives.,一個系統化的獨立的檢查來決定該品質行動和其相關結,果是否符合計劃之安排和其執行結果是否符合預計目標.,NOTE:,Quality audits are carried out by staff not have direct,responsibility in the areas being audited by,preferably working in cooperation with the relevant staff.,注:,品質稽核員不能是被稽
12、核部門的直接責任人,以同工作相關,人員較為合適.,15,AUDITING TOOLS,稽核工具,TRAINED AUDITORS,合格審核員,SPEC.SYSTEM,規格系統,CHECKLIST,檢核項目,16,INTERNAL AUDIT PROCESS FLOW,內部審核程序,1.Audit plan,稽核計劃,2.Department notification,通知各部門,3.Audit execution,稽核執行,4.Closing meeting,稽核結束會議,5.Prepare and distribute report,準備和發佈結果,6.Follow up,跟進,17,Aud
13、it Plan,1.Audit responsibility,稽核責任,2.Scope,範圍,3.Team leader/members,稽核者,4.Escort,稽核陪同人員,5.Checklist,稽核項目,6.Scoring level,評分標準,AUDIT TEAM SELECTION,挑選稽核小組成員,Must be independent of the activities being audited.,必須於稽核對象無關.,Auditors must be trained and qualified.,稽核員必須經培訓並合格.,A team leader should be pl
14、aced in overall charge.,稽核隊長應該全面負責,.,18,CHECKLIST,檢核項目,Para.of each spec.(FUJIN document)to be audited,will be directly considered as a checklist.,被稽核的程序文件將直接當作稽核項目,DEPARMENT NOTIFICATION,部門通知,Audit&schedule,稽核日期和安排,Audit scope&procedures,核範圍和程序,Audit Locations,稽核位置,Audit team members,稽核組成員,Faciliti
15、es needed,需要設備,19,INTERNAL AUDIT NOTIFICATION,(內部稽核通知),1.Audit Purpose:,Internal quality audits are performed to ensure that quality system are effectively,maintaining the level of quality required by level 1.2.3 documents of Fu Jin.,執行內部稽核目的是來保證富金公司一,二,三階文件所要求的品質要求水,準被有效地維持.,2.Audit Schedule,稽核計劃,2
16、1 According to level 1.2.3 documents of Fu Jin,the actual operation of each,department will be audited.,根據一,二,三階文件,對各部門進行稽核.,2.2 Audit Date,稽核日期,Internal Audit Notification,內部稽核通知,2.3 Definition,定義,3.Submit a escort to QA.,各部門提供稽核陪同人員給品保處.,20,AUDIT EXECUTION,稽核執行,Operational analysis.,執行分析.,Questio
17、ning techniques.,提問技巧.,Active listening.,主動性的聽.,Tracking.,跟進.,Collecting evidence.,收集證據.,21,AUDIT EXECUTION OPERATION ANALYSIS,稽核執行操作分析,An operation usually consists of the following.,執行通常包括下列步驟.,Examine a work or service operation.,檢查一個工作或服務的執行.,Determine the relationship between the related elemen
18、ts.,決定關聯因素之間的關系.,人,People,輸入,Input,輸出結果,Output,文件,Document,設備,Equipment,22,OPERATIONAL ANALYSIS INPUT/OUTPUT,執行分析輸入/輸出,Is it the correct type?E.G Model.,是否正確類型?,How is product quality preserved during transit,between operations.,在生產中轉移產品如何保證品質.,Is the product properly identified.,產品是否被良好標識.,How is c
19、onformance verified.,合格品怎樣被驗證.,23,OPERATIONAL ANALYSIS-PEOPLE,執行分析-人,TRAINING,訓 練,Is there a defined authority and responsibility.,是否指定權力和責任.,Is training requirement defined and followed.,需要的培訓是否指定並躍進.,Is any special skill required.,是否需特別的培訓.,Is the training effective.,培訓是否有效.,Does the individual fo
20、llow the document procedures,and use the equipment correctly.,每一個人是正確使用設備 及跟進文件程序,.,Therefore,所 以:,It is necessary to talk to the operating personnel directly.,需直接向操作者詢問.,24,Operational analysis-Equipment,執行分析-設備,How does the individual performing the task know,what equipment to use.,單獨使用時怎知使用何設備.,W
21、hat condition is the equipment in.,此設備設定在何種條件.,Is the equipment subject to scheduled calibration or,prevention.,設備是否被有計劃的校正和保養.,OPERATIONAL ANALYSIS DOCUMENT,執行分析文件,Questioning,提問:,Get the necessary information.,給出必要信息,Do not suggest answer.,不可提供答案,25,AUDIT EXCUTION QUESTIONING TECHNIQUES,稽核執行-提問技巧,
22、Problems in communication.,溝通中的問題,-,What is spoken may not be heard.,所說的可能沒有被聽到,-,What is heard may not be understood.,聽到的可能沒有被理解,-,What is understood may be accepted.,所理解的可能接受,-,Interpersonal distance.,縮短距離.,QUESTIONING TECHNIQUIES TYPES,OPEN QUESTION,揭開問題,Closed question.,結束問題,Clarifying question.
23、闡明問題,Leading question.,引導問題,Hypothetical question.,假設問題,26,OPEN QUESTION,揭開問題,APPLICATION:,適用,-,Obtain wide ranging answers.,獲得寬範圍的回答,-,Ask for an explanation of how something is done.,詢問怎麼做事情的解釋,-,Determine the reason behind an action.,決定行動的原因,EXAMPLE:,例如:,-,What is your job in the organization.,你
24、在組織中的工作是什么.,-,Where are these operations defined.,這些執行在哪里被指定.,-,Why were those AQLS chosen?,為什麼要選擇那種允收率?,-,How do you determine upper control limit?,你怎樣決定控制上限?,27,OPEN QUESTION,揭開問題,AUDITORS ROLE,稽核員角色,-Passive.,-Bring the conversation back to the original topic if,side-tracking occurs.,使交談保持主題上以防偏離
25、Close question,結束問題,APPLICATION:,應用:,-Obtain specific information.EG.“YES”or“No”.,限制答案如:“是”或“不是”.,-Ensure that the question being asked is fully understood.,保證問題被完全理解.,-Focus and guide the discussion down a certain route.,引導討論在預定主題.,28,ESAMPLE,例如:,-Do you use checklist for performing internal audi
26、ting?,在執行內部稽核中你是否使用CHECKLIST?,-Has that lot been inspected?,那LOT被檢查過嗎?,-Is this what you mean?,你說的是這樣的嗎?,-When is that vernnier caliper next due for calibration.,游標卡尺下次甚麼時候校正?,DISADVANGE,-Preclude any further response from the subject.,防止更多的回復,CLARIFYING QUESTION,闡 明 問 題,APPLICATION,應用:,-Provide a c
27、alming effect because the auditor seems to listen carefully.,防止因稽核員聽的過多以致冷場,-Ensure understanding,eliminate ambiguity and obtain further information.,保證清楚理解取消模糊不清,並獲得進一步信息.,EXAMPLE,例如:,-Just to make sure I understand this means what.,讓我明白這些意味甚麼.,29,HYPOTHETICAL QUESTION,假設提問,Applicable,應用:,If there
28、is little or no objective evidence available.,當沒有或很少直接證據可取時.,EG.,如:假如?,Let us suppose?,讓我設想?,EXERCISEQUESTIONING,Define what type of questions are?,定義提問類型?,Open,close,clarifying or leading.,揭開,結束,闡明或引導.,Rewrite the questions to,“,open,”,type if it is a,“,close,”,type,由結束提問改為揭開提問.,EXAMPLE,例如:,1.,Do y
29、ou approve this mistaken?,你核準此失誤了嗎?,2.,How is the management review performed?,怎樣執行管理審核?,3.,Who is responsible for the distribution of the quality system procedure?,誰負責分發品質系統程序?,30,4.As you mention,The corrective action has been carried out as follow,Am I right?,根據你的描述,改正行動照如此進行,我說的對嗎?,5.What correc
30、tive action do you take when this happens?,你在此情況下採取何行動?,6.What is the revision of the receiving inspection procedure?,收料程序版本是甚麼?,7.Can you explain what is mean by that?,你能理解這意味甚麼?,8.Is the procedure to check that calibration is valid before use?,這程序是在使用前進行檢查調校以免誤用?,AUDIT EXECUTION ACTIVE LISTENING,稽
31、核執行聽,Listen with understanding,理解性的聽,Stop talking or interruption.,停止討論或打斷,Concentrate and alert to escorts or operators clues of spoken and unspoken meaning.,注意被稽核者說和不說意味甚麼.,Keep the conversation open.,保持自由的對話.,Maintain good eye contact and frequent verbal encouragement.,保持良好的態度及頻繁口頭鼓勵.,Convey a si
32、ncere interest and gain escort or operators confidence.,傳達真誠的態度以達致被稽核者的信任.,31,-Can you explain what do you mean by this.,你能解釋你說的意思是甚麼?,DISADVANTAGE,The escort or operators begins to wonder why his/her answer is not,understood the first time.,被稽核者會奇怪為甚麼不理解他/她的話.,LEADINGQUESTION,Application,應用:,To sug
33、gest the“expected answer”to the subject,給出提示,Disadvantage,條件:,Bias the information that is received in response,收到偏題信息,Example,例如:,Do you always take a 13 sample with this batch size?,在同樣批量里你總是抽取13只樣板嗎?,32,Audit execution-active listening,稽核執行-主動的聽,Avoid becoming upset when a conversation contains,w
34、orks irritating to the escort.,在交談中避免偏激的語言.,Accept the disagreement as a change to review and clarify,the audit finding.,接受不同建議來審核澄清所發現的,Encourage the escort or operator to explore the problems with the auditor.,鼓勵稽核員與被稽核者討論問題,Paraphrasing or summarizing.,蓋括和解釋,As a guideline the time for asking and
35、 listening are about 20%,and 80%respectively.,問占20%時間度,聽占80%時間.,33,AUDIT EXECUTION-TRACKING,稽核執行-跟進,Forward tracking,正向跟進,Backing tracking,反向跟進,Random tracking,自由跟進,34,Tracking,R&D,設計開發,Sales,銷售,Purchasing,採購,Production,生產,Inspection&Testing,檢查測試,Packing,Delivery,After sales service,正向追溯,FORWARD TRA
36、CKING,反向追溯,BACKING TRACKING,35,Collecting evidence-what to record,收集証據-記錄類別:,Key person interviewed,主要會見人員,Document numbers and revisions(include the,revision and paragraph number),文件編號和版本(包括句或段落號碼),Equipment numbers or other identification details,設備編號或識別細節.,Observation-Location-Time-Facts,觀察:位置,時間
37、事實.,Collecting Evidence,例如:,-,Documents,reports,computer printouts.,文件,記錄,電腦輸出,Observation,-Demonstration of how the work is actually performed,工作怎樣執行之証明.,Re-performance,重新執行,-,EG,recalculation,例如:重新計算,36,37,Corrective action Prior to closing meeting,早期改正行動會議,Save the escort or operator s face,保留被稽
38、核者的面子,Give the escort or operator the chance to,display a genuine concern to improve matters.,給他們機會來展示真正的改進,Maintain a good relationship.,保持良好的關系,Save a re-audit or follow-up.,重新稽核或跟進,38,Closing meeting,稽核結束會議,Finding summary elaboration,問題摘要描述,Scoring,得分,Compliance audit summary report(Appendix 1),
39、依循,稽核摘要報告(附表一),Area for improvement suggestion,建議改正部分,Benchmarking,改善標準化,Corrective action requirements,要求改正行動,Compliance audit Deviation Report(Appendix 2),依循稽核偏差報告(附表二),39,40,41,FOLLOW-UP,跟 進,The cause of the problem has been identified,發現問題,Action have been taken to correct the specific,problem in all areas.,在所有的地方已採取改正行動,Action to prevent recurrence have been identified.,要防止問題再次發生.,Specific responsibilities and dates have been identified,負責人及何時完成已指明,These actions have been or shall be taken in a timely manner,這些行動已經采取或即將進行.,42,此课件下载可自行编辑修改,供参考!,感谢您的支持,我们努力做得更好!,






