1、2019/2/3,TS2内审技巧,1,ISO/TS 16949:2009 内审技巧,2019/2/3,TS2内审技巧,2,Contents 目录,1 Quality Audit体系审核 2 Audit Phases审核阶段 3 Planning Preparation策划准备 4 Conduct Audit实施审核 5 Report & follow up报告与跟进 6 Audit Skill审核技巧 7 Auditor 审核员 8 Automotive Audit Key Point汽车行业审核要点,2019/2/3,TS2内审技巧,3,Quality Audit Definition 质量
2、审核定义,Systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.,为获得审核证据并对其进行客观的评价,以确定满足审核准则的程度所进行的系统的,独立的并形成文件的过程.,2019/2/3,TS2内审技巧,4,Quality Audit Concepts 质量审核概念,The design of quality audi
3、t is not used to criticize or blame Theres no procedure to be perfect and no change in anytime Quality 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 process The auditor
4、 to determine whether the operation follow procedure The auditor shall perform audit with positive attitude The auditor must prepare well,质量审核的设计并非用以进行批判或责备 并没有一个程序是完美得于何时也不需要改变的 质量审核确立了基础以:- 改善公司产品的质量- 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进行 审核员应以正面的态度进行审核 审核员必须充分准备,2019/2/3,TS2内审技巧,5,Types
5、 of Audit 审核的种类,Customer 客户,Organization 企业,Supplier 供方,Independent Organization 独立机构,第2方 2 nd,第3方 3rd,第2方 2nd,第一方 1 st,2019/2/3,TS2内审技巧,6,Types of Audit 审核的种类,Document Audit文件审核 On-site audit现场审核 System audit体系审核 Process audit过程审核 Product audit产品审核,2019/2/3,TS2内审技巧,7,Audit Phases 审核阶段,审核报告,被审方进行 原因
6、分析和 纠正措施,跟踪检查 纠正措施,搜集资料 / 准备,安排审核员,制订审核计划,文件审核,准备检查表,结束会议,确认结果,记录不符合点,调整计划,寻找符合 要求的地方,开始会议,进行,准备,跟进,文件编写,2019/2/3,TS2内审技巧,8,Information Gathering / Preparation 搜集资料 / 准备,Standards Company background Number of Employee Location Site scale Audit scope Previous audit record Customer information Custome
7、r / contract special requirements Travel and other arrangement Process identification Process linkage,标准 公司背景 员工人数 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,2019/2/3,TS2内审技巧,9,Auditor Arrangement 安排审核员,Trained and qualified Have relevant experience Independent to the auditee Beware the
8、relationship between auditor and auditee Select 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,2019/2/3,TS2内审技巧,10,Audit Plan 审核计划,The annual schedule should consider: The importance of the process and its relationship with the system standard requirement Actual performance and the resul
9、t of previous audit Business conditions Customer complaints The date of customer audit The date of the third party certification audit Cover all elements of the standard Cover all the processes and activity,年度计划需考虑: 过程的重要度和与体系标准要求的相关程度 实际表现,以往审核结果 业务情况 客户投诉情况 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,2019
10、/2/3,TS2内审技巧,11,Audit Schedule 审核时间表,The auditee department / process Auditor / team Schedule Audit scope Cover all shifts and activities The audit duration according to the importance and scale of the department / function / process Beware the audit process flow / sequence Avoid / reduce walk aroun
11、d time,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 / 过程的重要度和规模 注意审核流程 / 顺序 避免 / 减少来回走动时间,2019/2/3,TS2内审技巧,12,Document Audit 文件审核,Standard clause vs quality system document Quality system document vs standards Quality manual, procedure document Quality plan Whether the system is complete and
12、 adequate Understand the operation method and control point of an organization Identify the core process and support process and also the interaction,标准条文 vs 质量体系文件 质量体系文件 vs 标准 质量手册,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,2019/2/3,TS2内审技巧,13,Audit Checklist 审核检查表,Only a reminder, not a
13、questionnaire Transfer according to the requirements of standards Transfer according to the organizations procedure document requirements Beware the special requirements of customer Beware the result of document audit Beware the result of previous audit Beware the customer complaints Use it as audit
14、 record,只是备忘,提醒,不是问卷表 按标准要求转化 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,2019/2/3,TS2内审技巧,14,Opening Meeting 开始会议,Chaired by team leader Introduction Audit propose Audit standard and disposition criterion Audit scope Confirm the audit schedule Audit method The guide The communication cha
15、nnel and contact The time of close meeting Other arrangement,由审核组长主持 介绍人员 审核目的 审核标准和判定准则 审核范围 确定审核时间表 审核方法 陪审员 沟通和联系渠道 末次会议时间 其它安排,2019/2/3,TS2内审技巧,15,On-site Audit 现场审核,Fact finding and objective evidence Not an exercise to nit pick Ensure to cover the audit scope Ensure to cover the standard requi
16、rements Check the operation conditions and previous result Check the conformance and adequacy Determine effectiveness Utilize the checklist Need to follow up with cross department Modify the audit plan when necessary Record the nonconformance Confirm the audit result with the auditee,找寻事实,客观证据 并非寻找错
17、误的练习 确保覆盖审核范围 确保覆盖标准要求 检查运行情况和以往结果 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,2019/2/3,TS2内审技巧,16,Closing Meeting 末次会议,Chaired by team leader Express thanks Re-confirm the audit standard and audit scope Report the positive audit result Report the nonconformance (NC) Mention the o
18、bservation and opportunity for improvement Report the audit conclusion reply time of the Corrective Action Request (CAR) Arrange the follow up audit Express thanks again,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 提出观察项,改进的建议 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,2019/2/3,TS2内审技巧,17,Nonconformance Definition 不
19、符合项定义,Major: the absence or total breakdown 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 shipme
20、nt of a nonconforming product. A condition 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 material
21、ly reduce its ability to assure controlled processes and products.,严重 质量体系缺少或完全失效ISO/TS 16949要求。在某一个体系要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装运的不符合情况。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。 任何可能导致质量体系失效或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。,2019/2/3,TS2内审技巧,18,Nonconformance Definition 不符合项定义,Minor Is a ISO/TS 16949
22、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 quality system relative to a ISO/TS 16949 , or A
23、single observed lapse in following one item of a companys quality system.,轻微 判断或经验与ISO/TS 16949的不一 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。,2019/2/3,TS2内审技巧,19,Nonconformance Definition 不符合项定义,Conform No major or minor nonconformities were noted in the au
24、dit.,符合项 - 在审核中没有发现严重不符合或轻微不符合。,2019/2/3,TS2内审技巧,20,Nonconformance Report 不符合报告,Findings 发现Attribution 依据Explanation 解释,2019/2/3,TS2内审技巧,21,Audit Report 审核报告,Audit date Auditor team Audit standards Audit scope Audit plan Audit result / findings Nonconformance Observation, opportunity for improvement
25、 Disposition conclusion Follow up action,审核日期 审核员小组 审核标准 审核范围 审核计划 审核结果 / 发现 不符合项 观察项,改进建议 判断结论 跟踪行动,2019/2/3,TS2内审技巧,22,Auditee Cause Analysis & Corrective Action 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 to avoid re-occurrin
26、g Extend the corrective action to the similar products / process/ system Verify the effectiveness of the action,了解不符合项问题 调查根本原因 针对原因,采取纠正措施,预防再发生 举一反三,扩大纠正措施到同类产品 / 工艺 / 系统 验证措施是否有效,2019/2/3,TS2内审技巧,23,Follow up Audit 跟踪审核,To verify whether the corrective action has been implemented To verify the ef
27、fectiveness of corrective action Check the relevant modified document / record Re-sample check the new operation record Re-check the operation method and implementation,验证纠正措施是否已实施 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 再检查运行方法和实施情况,2019/2/3,TS2内审技巧,24,Audit Skill 审核技巧,Fact Findings 找寻事实- Read 读- Observ
28、e 看 / 观察- Listen 听- Ask 问,2019/2/3,TS2内审技巧,25,Audit Skill 审核技巧,Read- Standards- Quality system document, record- customer contract, special requirements- previous audit records- customer complaints- 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,2019/2/3,TS2内审技巧,26,Audit Skill 审核技巧
29、,Observe - auditee the response, body language- response of other people- look at the auditees eyes- Sense judgment,看 / 观察被审方的反应,身体语言 其他人员的反应 看着对方的眼睛 感官判断,2019/2/3,TS2内审技巧,27,Audit Skill 审核技巧,Listen Beware the environmental influence Beware whether the auditee can represent Analyze information Summa
30、rize information Record to follow up Not to appraise the speaker Beware the side indication Show the interesting to listen,听 注意环境影响 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,2019/2/3,TS2内审技巧,28,Audit Skill 审核技巧,Ask closed question Leading question Open question Who When Where What How Why Sho
31、w me Double / multiple question Follow up question,问 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 给我看看 2个/ 多个问题 跟踪提问,2019/2/3,TS2内审技巧,29,Audit Skill 审核技巧,Audit Flow draft flow chart The first question From top down / from bottom up Trace forward / trace backward Horizontal check Focus check Sample check me
32、thod Apply ROLA,审核流程 粗略的流程图 第一条问题 由上而下/由下而上 往前追查/ 往后追查 横向检查 重点检查 抽样方法 运用ROLA,2019/2/3,TS2内审技巧,30,Audit Skill 审核技巧,Other remark time management / control Cover all related activities according to the plan Avoid side tracking Avoid being led / miss led Not to involve in the discussions of cause and re
33、sponsibility 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 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,2019/2/3,TS2内审技巧,31,Auditor Attitude/ Responsibility 审核员态度 / 责任,Good 好 Good listen
34、er 善于聆听 Open minded 思想开朗 Diplomatic 善于交往 Resilient 复原力强 Unbiased 公平 Honest 诚实 Patient 耐心 Self-disciplined 自律 Articulate 善于沟通 Able to communicate 表达力强 Interested 有好奇心 Unafraid of being unpopular 不怕受排挤 Empathetic 具同情心,Bad 坏 Arrogant 傲慢 Opinionated 偏见 Self-important 自大 Lazy 懒惰 Argumentative 好争辩 Shy 害羞
35、Timid 胆怯 Gullible 易受骗 Impatient 缺乏耐性 Poor communicator 不善于沟通 Desire to be liked 希望被喜欢 Unprofessional 不专业,2019/2/3,TS2内审技巧,32,Automotive Audit Key Points 汽车行业审核中的要点,Beware of customer specific requirements Collect customer requirements from Sales department and pass to other auditors Think about the
36、product application in automobile Consider the special characteristics Look into production process and check FMEA and control plan Use control plan to audit production process Feedback any corrective/preventive action to FMEA Link with technical manuals Always consider opportunity for improvement,注
37、意客户特殊要求 从销售部收集客户要求并分发给其他审核员 考虑产品在汽车行业的运用 考虑特殊特性 视察生产过程,检查FMEA和控制计划 审核生产过程中使用控制计划 反馈任何纠正 / 预防措施到FMEA 连接技术手册 始终考虑到改进的机会,2019/2/3,TS2内审技巧,33,Automotive Process Approach Auditing 汽车行业过程方法审核,The Automotive Process Approach to auditing for ISO/TS 16949:2002 must not be driven by a “clause” or a “section”
38、driven checklist. Any ISO/TS 16949:2002 auditor therefore must be capable of understanding the IATF Automotive Process Approach as well as the process approach and process map of the audited entity.,汽车行业应用过程方法审核ISO/TS 16949:2002标准时不能使用“条款”或“部门”为主导的检查清单。因此所有ISO/TS 16949:2002审核员必须能理解IATF汽车行业过程方法及过程方法和
39、被审核组织的过程描述。,2019/2/3,TS2内审技巧,34,Automotive Process Approach Auditing 汽车行业过程方法审核,识别组织的过程 按以下原则分析过程: 提供给顾客的产品或服务 对于顾客的风险 接口(输入/输出) 为了经济和有效的审核而识别的过程组 优化审核活动并考虑: 顾客要求,包括顾客关于质量管理体系的特殊要求 跟踪上次审核(内部和外部)中的发现 顾客满意及顾客抱怨的状况,包括顾客的报告和打分,至少过去12个月的关键指标趋势 给被审核方的价值(增值) 完成审核计划包括顺序/过程步骤,时间,被审方和规则的运用以满足IATF要求 实施审核并考虑如下:
40、 自制确定的过程包括它们的顺序和相互关系 在实施中,审核员应检查过程在何处发生 必须记录符合和不符合的客观证据。,2019/2/3,TS2内审技巧,35,Nonconformance decision 不符合项的确定,Consider the impact to the quality system Consider the impact to the customer Consider the impact to the automotive application,考虑对质量体系的冲击 考虑对客户的冲击 考虑对汽车使用的冲击,2019/2/3,TS2内审技巧,36,Process Mode
41、l Audit Approach 过程模式审核方式,Resources 资源,Output 输出,Result 结果,Control 控制,Objective 目标,Input 输入,Process 过程,P,D,C,A,2019/2/3,TS2内审技巧,37,Core Process 主要过程,Support Process 支持性过程,Process Model Audit Approach 过程模式审核方式,2019/2/3,TS2内审技巧,38,COP Customer Oriented Process 客户导向过程SOP Support Oriented Process 支持性导向过程MOP Management Oriented Process 管理导向过程,Process Model Audit Approach 过程模式审核方式,2019/2/3,TS2内审技巧,39,客 户,Core Process,客 户,Support Process,Process Model Audit Approach 过程模式审核方式,2019/2/3,TS2内审技巧,40,Thank You !,