TS16949内审课程(一).

1、Quality Audit体系宙核Audit Phases审核阶段Planning Preparation策划准备Conduct Audit实施审核Report & follow up报告与跟逬Audit Skill审核技巧Auditor审核员Automotive Audit KeyPoint汽车行业审核要点_确利达创造企业新动力、2 3 4 5 674Systematic, independentand documented process forobtaining audit evidenceand evaluating it objectivelyto determine the

2、 extent towhich audit criteria arefulfilled.The design of quality audit is not used tocriticize or blameThere、s no procedure to be pafectand nochange in anytimeQuality audit deiennine the basis for:-improve the quality of produclslo ensure the procedure can maintain thequality and reflect the effect

3、ive operationtake action to improve the process Theauditor to determine whether theoperation follow procedureThe auditor shall perfonn audit withpositive attitudeThe auditor must prepare well为获得审核证据并对 其逬行客观的评价，以 确定满足审核准则的 程度所逬行的系统的, 独立的并形成文件的 过程.质审核的设计并非用以逬行批判或 贲备并没有一个程序是完美得于何时也不 需要改变的质量审核确立了基岀以：改善公

4、司产品的质量确保程序能维护质量、反映有效的 作业采取纠正措施以改良过程审核员决定作业是否有跟从程序逬行 审核员应以正面的态度逬行审核 审核员必须充分准备Quality Audit Definition质量审核定义QualityAuditConcepts质豪审核概念确利达-创造企业新动力!Types of Audit目核的种类Customer客户第2方2 ndEnterprise企业於第2方2ndSub-contract分供方IndependentOrganization独立机构5Types of Audit审核的种类 Document Audit文件审核 On-site audit现场审核 S

5、ystem audit体系审核 Process audit过程审核 Product audit产品串核确利达创造企业新动力6Audit Phases审核阶段记录不符合点Information Gathering / Preparation搜集资料/准备 rStandardsCompany backgroundNumber of EmployeeLocationSite scaleAudit scopePrevious audit recordCustomer informationCustomer / contract specialrequirementsTravel and other a

6、rrangementProcess identification Processlinkage标准公司背景 员工入数 地点场地规模审核范围 以往审核记录客户情况客户/合同特殊要求交通和其它安排过程确定过程连接披审方进行鎭因分析和纠正措鹿审孩报吿文件审復结束合议确认结果准备逬行幵始会议寻找符合妾求的地方C0600UHIED确利达-创造企业新动力、10Auditor Arrangement安排审核员Trained and qualifiedHave relevantexperience Independentto the auditecBeware the relationshipbetween

7、auditor andauditceSelect the team leader经培训并有资格有相关经验与被审方有独立性注意审核员与被审方的个人关系 选定组长Audit Plan审核计划Audit Plan审核计划The annual schedule should consider:The annual schedule should consider:The importance of the process and itsThe importance of the process and itsrelationship with the system standardrequiremen

8、tActual performance and the result ofprevious auditBusiness conditionsrelationship with the system standardrequirementActual performance and the result ofprevious auditBusiness conditionsCustomer complain IsCustomer complaintsThe date of customer auditThe date of customer auditThe date of the third

9、party certificationThe date of the third party certificationauditauditCover all elements of the standardCover all elements of the standardCover all the processes and activityCover all the processes and activity年度计划需考虑：过程的更要度和与体系标 准妾求的相关程度-实际表现，以往审核结果-业务情况-客户投诉悄况-客户审核时间-第三方认证审核时间-覆盖标准所有要素-覆盖所有过程和活动年度

10、计划需考虑:过程的重要度和与体系标准要求的相关程度实际表现.以往审核结杲业务情况客户投诉悄况客户审核时间第三方认证审核时间覆盖标准所有要素覆盖所有过程和活动确利达创造企业新动力!确利达创造企业新动力!/12Audit Schedule审核时间表The auditee department / processAuditor / teamScheduleAudit scopeCover all shifts and activities Theaudit duration according to theimportance and scale of thedepartment / functio

11、n / processBeware the audit process How /sequenceAvoid / reduce walk around timeDocument Audit文件审核IUHTEDStandard clause vs qualitysystem documentQuality system document vsstandardsQuality manual, proceduredocumentQuality planWhether the system is completeand adequateUnderstand the operationmethod an

12、d control point of anorganizationIdentify the core process andsupport process and also theinteraction标准条文VS质量体系文件质量体系文件VS标准质量手册P程序文件质量计划体系是否完整和充分了解企业的运行方法和控制 要点确认主要过程支持过程和相 互关系被审部门/过程审核员/小组时间安排审核范围覆盖所有班次，活动 审核时间规乎部门/功能/过程的車要度和规模注意审核流程/顺序避免/减少来回走动时间1114Only a reminder,not aquestionnaireTransferaccord

13、ing lo therequirements ofstandardsTransferaccording to theorganizationsproceduredocumentrequirementsBeware thespecialrequireinems ofcustomerBeware the resultof documentauditBeware the resultof previous auditBeware the customer complaints Use itas audit recordChaired by team leaderintroductionAudit p

14、roposeAudit standard and dispositioncriterionAudit scopeConfirm the audit scheduleAudit methodThe guideThe communication channel andcontactThe time of close meetingOther arrangement毋次审核应该使用规定的检查表只是备忘，提醒，不是问卷表 按标底要求转化按企业程序文件要求转化注意客户特殊要求注意文件审核结果注意前次审核结果注意客户投诉情况作为审核记录Audit Checklist目核OpeningMeeting开始会议

15、由13UffiBOn-site Audit现场审核Fact finding and objective evidence Notan exercise to nit pick Ensure to coverthe audit scope Ensure lo cover thestandard requirementsCheck the operation conditions andprevious resultCheck the conformance and adequacyDetermine effectivenessUtilize the checklistNeed to follow

16、 upwith cross departmentModify the audit plan when necessaryRecord the noncon fonnanceConfirm the audit result with theauditcc找寻事实，客观证据 并非寻找错溟的练习 确保覆盖审核范围 确保覆盖标淮要求 检査运疔情况和以往结果 检查符合性，完整性 判断有效性利用检查表帮助 需要跨部门跟踪确认 需要时，调整审核计划 记录不符合项 与被审方确认审核结果務滋労丄初功!15Closing Meeting末次会议Chaired by team leaderExpress thank

17、sRo confirm the audit standard andaudit scopeReport the positive audit resultReport the nonconformance (NC)Mention the observation andopportunity for iinpnncmcnt Reportthe audit conclusion reply time of theCorrective Action Request (CAR)Arrange the follow up audit由审核组长主持致谢再确认审核标准和审核范围报告正面的审核结果报告不符合项

18、提出观察项，改逬的建议 宣报审核判断结论 纠正措施回复时间安排跟踪审核再次感谢确利达-创造企业新动力1618Major:-the absence or total breakdown of a systemto meet a ISO/TS 16949 requirement. Anumber of minor nonconformities againstone requirement can represent a tout Ibreakdown ot thesystem and thus beconsidered a majornonconformity.Any incompliance

19、that would result in- theprobable shipment of a nonconformingproduct. A condition that may result in thefailure of materially reduce the usability ofthetheproductsorservices fortheirintendedpurpose_-A noncompliance that judgmenl andexperience indicate is likely either to resultin the failure of the

20、quality system or tomaterially reduce its ability to assurenlrollcd processes and pniducls MinorIs a ISO/TS 16949 noncompliance tothat judgment and experienceindicate is not likely to result in thefailure of the quality system orreduce its abilityto assurecontrolledprocesses orproducts. Il may be ei

21、ther:a failure in some part of the suppliersdociunentcd quality system relative to aISO/TS 16949, orA single observed lapse in followmgone item of a company quality system.质星体系缺少或完全失效 ISO/TS 16949 要求。在某一个体系妾求出现 好几个轻微不符合可变成体系完全失 效，这也是严重不符合。任何可能使不合格产品裝运的不符合 悄况。任何导致产品或服务的规定使 用性能降低或失效的不符合情况。任何可能导致质体系失效或

22、严重降 低对产品和过程控制能力的判断或经 验的不符合情况。判断或经验与ISO/TS 16949的不致但又不可能导致体系失效,或降低对产品和过程能力的控制。供方与ISO/TS 16949有关的形成文件的质量体系某一部分 不符合要求。在公司质量体系中发现的单 个错误。Noncon不符QIAIKHccNsrxkc iiwKnNoncon不符17Ql/UKhC06IWuroNonconformance Definition Conform No major orminor non conformitieswere noted in the audit.不符合项定义符合项-在审核中没有发现严重 不符合或

23、轻微不符合。19Nonconformance Report不符合报告Findings发现Evidence依据Explanation解释20确利达-创造企业新动力!2222QW.IEO-rawMuwKnAudit Report审核报告Audit dateAuditor teamAudit standardsAudit scopeAudit planAudit result / findingsNonconformanceObservation, opportunityfor improvementDisposition conclusionFollow up action审核日期 审核员小组 审

24、核标准 审核范围审核计划审核结果/发现不符合项观察项，改逬建议判断结论跟踪行动214Auditee Cause Analysis & Corrective Actioiv被审方原因分析纠正措施 Understand the NC problem Investigate the root course Pinpoint to problem cause,take corrective action toavoid re-occurringExtend the corrective actionto the similar products /process/ system Verify

25、the effectiveness ofthe action 了解不符合项问题 了解不符合项问题调查根本原因调查根本原因针对原因，采取纠 正措施，预防再发 生针对原因，采取纠正措施，预防再发举一反三，扩大纠举一反三，扩大纠 正措施到同类产品/ 工艺/系统正措施到同类产品/工艺/系统验证措施是否有效24Follow up Audit跟踪审核To verify whether the correctiveaction has been implementedTo verify the effectiveness ofcorrective actionCheck the relevant modif

26、ieddocument / recordRe-sample check the newoperation recordRe-check the operation methodand implementation验证纠正措施是否己实施验证纠正措施是否有效 检查相关修改文件/记录再抽查新的运行记录再检査运行方法和实施情况C06JLMUMTEDAudit Skill审核技巧Fact Findings找寻事实-Read读 Observe看/观察-Listen听-Ask冋-确利达鼻创i2326ReadAudit Skill审核技巧 Standards Quality system documereco

27、rd-customer contract, specialrequirements-previous audit records customer complainls data analysis读:-标准质量体系文件，记录客户合同，特殊要求以往审核记录客户投诉情况-分析资料Audit Skill审核技巧Observe auditee the response bodylanguage-response of other people-look at the auditee s eyes-Sense judgment看/双察被审方的反应，身体语 言-其他人员的反应-看着对方的眼睛-感官判断25

28、Audit Skill审核技巧ListenBeware the environmentalinfluenceBeware whether the auditeecan represent Analyzeinformation Summarizeinformation Record tofollow up Not to appraisethe speakerBeware the side indicationShow the interesting tolisteni可听注意沐境影响注意对方是否有代表性分析资料总结信息记录以便跟踪切勿评价讲者注意言外之意表示有兴趣听C061WVTTn27Audi

29、t Skill审核技巧C061WUfflBclosed questionLeading questionOpen question-Who-WhenWhere-What-How-Why-Show meDouble / multiplequestion-Follow up question封闭式问题 带领式问题 开放式问题 何人 何时 何处 何事 怎么样 为什么 给我盲看2个/多个问题 跟踪提问确利达_创造企业新动力28Audit Skill审核技巧Audit Flow审核流程draft flow chartThe first question-From top down / frombotto

30、m up-Trace forward / tracebackwardHorizontal check-Focus check-Sample check method-Apply ROLA粗略的流程图-第一条问题- 宙上而下/由下而上往前追查/往后追查横向检查重点检査-抽样方法运用ROLA29LJHTEDAudit Skill审核技巧Other remarktime management / controlCover all related activities accordingto the planAvoid side trackingAvoid being led / miss ledNo

31、t to involve in the discussions ofcause and responsibilityNot to provide the detail method ofsolutionDont be afraid to say you dontunderstandThe effective 2 way communication其他注意时间管理/控制按计划，覆盖所有相关活 动不被转移目标不被引导/误导不参与讨论原因和责任不提供具体解决方法不要害怕说你不明白有效的双向沟通30确利达一32Use ofISO/TS standard checklistBeware of customer specificrequirementsCollect customer requirementsfrom Sales department and pass to otherauditorsThinkabout the product application