分层审核 Modified Revision

1、There are two Types of Layered Process Audits: 有两种分层过程审核有两种分层过程审核: Process Control Audits 过程控制审核过程控制审核 Error & Mistake Proofing Verification Audits 防错防误验证审核防错防误验证审核Layered Process Audits (LPA) are a system of audits performed by multiple Layered Process Audits (LPA) are a system of audits perfor

2、med by multiple levels of management. Key process characteristics are audited frequently to levels of management. Key process characteristics are audited frequently to verify process conformance. verify process conformance. 分层过程审核分层过程审核(LPA)(LPA)是一种标准化的审核是一种标准化的审核, ,在组织的所有层面上定期在组织的所有层面上定期, ,经常实施经常实施

3、, ,由多个管理由多个管理层进行的系统审核。对关键过程特性进行频繁的审核以验证过程符合性。层进行的系统审核。对关键过程特性进行频繁的审核以验证过程符合性。The purpose of Layered Process Audits is to ensure continuous conformance The purpose of Layered Process Audits is to ensure continuous conformance thereby improving process stability and first-time through capability. ther

4、eby improving process stability and first-time through capability. 分层过程审核的目的是确保持续的符合性，从而提高过程稳定性和一次通过率。分层过程审核的目的是确保持续的符合性，从而提高过程稳定性和一次通过率。LPAs assure that defined methods and work instructions are utilized, problem solving solutions are held in place, and all process issues are identified and quickly

5、 corrected.分层过程审核确保使用固定的方法和操作说明， 确保使用问题解决方案， 所有过程问题都被识别并被迅速纠正。LPA is an ongoing system of process checks that verify proper methods, settings, operator craftsmanship, error proofing devices and other inputs are in place to ensure a defect free product. 分层过程审核是一项持续的过程检查系统， 用来验证正确的方法、 设置、 操作员技能、防错装置和其

6、他输入是否到位从而确保产品无缺陷产生。 Anybody can perform a Layered Process Audit. 任何人都能够执行分层过程审核。 Manufacturing management must own the process and perform audits. 生产管理部门必须领导此程序并执行审核。 All managers, regardless of function, can be auditors. 所有经理，无论他的职责是什么， 都可以作为审核员。 Each management level should perform audits. 每个管理层都应

7、该执行审核。Process Control Audits shall be performed once per shift by supervisors. Plant management shall perform the audit once per week.过程控制审核过程控制审核应该在每班生产时由车间主管进行一次审核。工厂管理应该在每周执行一次审核。Error & Mistake Proofing Verification audits shall be conducted once per shift. Only qualified employees shall per

8、form Error & Mistake Proof Verification Audits. Set-up, maintenance or quality auditors are usually qualified.防错防误验证审核防错防误验证审核应该在每班生产执行一次。由具备资格的人员进行防错防误验证审核。 建立、维护或质量审核员通常是具备资格的人员。SQAPSafety regulations 安全法规安全法规Reinforces加强加强Facilitates简化简化Operator training 操作员培训操作员培训Management/operator interfac

9、e 管理管理/操作员界面操作员界面First time through capability 一次通过率一次通过率Morale 士气士气Improves提高提高Build variation based on work standardization 因为工作的标准化而产生的多样性因为工作的标准化而产生的多样性End-of-line inspection 线尾检验线尾检验Part defects 零件缺陷零件缺陷Reduces减少减少18-0221-0224-0227-0230-0233-0236-0239-0242-0245-0248-0251-021-034-037-0310-0313-0

10、316-0319-0322-0325-0328-0331-0334-0337-0340-0343-0346-0349-0352-03Weekly 周周# of LPA Checks / Week每周每周LPA检查次数检查次数556065707580859095100First Time Through (%)一次通过率（一次通过率（%)KTP Now conducting 6700 Process Layered Audit ChecksKTP目前正执行6700 逐层过程审核0 Process Layered Audits 0层过程审epair Inventory修理

11、库存FTC一次通过率Repair Inventory vs First Time Capability vs LPA对比：对比： 修理库存修理库存/一次通过率一次通过率/逐层过程审核逐层过程审核PROCESS过程过程ErrorProofing 防错防错 Process Audits 过程审核过程审核CorrectiveActions 纠正行动纠正行动PreventionActions 预防行动预防行动EmployeeWorkshops 车间职工车间职工ContinuousImprovementInputs 持续改进输入持续改进输入Audits are conducted regularly b

12、y all levels of supervision 各监督级定期地进行审核各监督级定期地进行审核Non-conformances are immediately addressed 立即发现（记录）不符合处立即发现（记录）不符合处LAYERED PROCESSAUDITS ARE PROCESSBASED, NOT PART BASED.分层过程审核是基于过程的分层过程审核是基于过程的,而不而不是基于零件的是基于零件的确定从哪里开始实施确定从哪里开始实施LPA Review 回顾: Customer Complaints, Quality Alerts 客户抱怨，质量警告 First-Ti

13、me Through data, Scrap Reports 一次通过数据，废品报告 Key Characteristics and Process Capability: Cpk & Gage R&R 关键特性和过程能力：CPK与检具 R&R PFMEA, Process Flow Diagram, Control Plan PFMEA, 过程流程图，控制计划 Set-up Sheets, Work Instructions, Inspection Instructions 工艺卡片、作业指导书、检验指导书 Error and Mistake Proofing 防错防

14、误 Quality System Audits, Dock Audits, Inspection Reports 质量体系审核，货场审核，检验报告 Rework instructions 返工指导书 The Area of Highest Risk should be the first area to implement the Layered Process Audit 最高风险区域最高风险区域应该是实施分层过程审核的第一个区域 This area will also be used as a Lessons Learned for implementing the Layered Pro

15、cess Audit across the entire manufacturing facility. 此区域也被用于整个制造厂学习如何实施分层审核。 Use Discretion when adding items to the checklist在向检查表中添加项目的时候使用判断力判断力。 Audit items are issues that would cause Customer Dissatisfaction. 审核项目是那些导致客户不满客户不满的问题。2 X Week 每周两次每周两次Area Management 区域管理者区域管理者1 X Shift 每班一次每班一次Pro

16、duction Supervisor 生产主管生产主管1 X Week 每周一次每周一次Plant Manager 工厂经理工厂经理 Encourages Management Involvement 鼓励管理层参与鼓励管理层参与 Encourages Operator Feedback 鼓励操作员反馈鼓励操作员反馈 Establishes Accountability 建立责任制建立责任制EXAMPLE: LPA FREQUENCY AND STRUCTURE举例：举例： 分层过程审核频率与结构分层过程审核频率与结构123123123123123123123123123MONXXTUESXX

17、WEDXXTHURXXFRIXXSATXXMONXXTUESXXWEDXXTHURXXFRIXXSATXXPLANNEDCOMPLETEDSHIFT 1XEVERY LINE IS AUDITED ACROSS EACH SHIFT EVERY 9 DAYS IN ROTATIONSHIFT 2XPLACE A CHECK MARK IN THE ABOVE BOX FOR YOUR SHIFT FOR AUDITS COMPLETEDSHIFT 3X1 10 0PRODUCTION SUPERVISOR WEEKLY LAYERED AUDIT LINE SCHEDULE1 14 4121

18、11 149 987 75Note: Example Illustrates that 3rd Shift Not Being Audited Per the Rotation Matrix Unacceptable Condition!注意注意: 例子显示例子显示, 在每个循环矩阵中第三班生产中没有进行审核在每个循环矩阵中第三班生产中没有进行审核 不可接受不可接受的状况的状况!生产生产 主管周主管周LPA检查计划安排表检查计划安排表SENIO R SUPERVISO R W EEKLY LAYERED AUDIT LINE SCHEDULEQ U AR TER 1Q U AR TER 298

19、751412114109875141211410W EEK 1XW EEK 14XW EEK 2XW EEK 15XW EEK 3XW EEK 16XW EEK 4XW EEK 17XW EEK 5XW EEK 18XW EEK 6XW EEK 19XW EEK 7XW EEK 20XW EEK 8XW EEK 21XW EEK 9XW EEK 22XW EEK 10XW EEK 23XW EEK 11XW EEK 24XW EEK 12XW EEK 25XW EEK 13XW EEK 26XQ U AR TER 3Q U AR TER 498751412114109875141211410W

20、 EEK 27XW EEK 40XW EEK 28XW EEK 41XW EEK 29XW EEK 42XW EEK 30XW EEK 43XW EEK 31XW EEK 44XW EEK 32XW EEK 45XW EEK 33XW EEK 46XW EEK 34XW EEK 47XW EEK 35XW EEK 48XW EEK 36XW EEK 49XW EEK 37XW EEK 50XW EEK 38XW EEK 51XW EEK 39XW EEK 52XPLANNEDCOMPLETEDD AYSXEVER Y LIN E IS AU D ITED EVER Y 9 W EEKSPLAC

21、 E A C H EC K M AR K IN TH E AB O VE B O X FO R AU D ITS C O M PLETED每条线轮流在每9周进行一次审核. 在上面表格中, 用差号标明已经完成了审核工厂经理周工厂经理周LPA检查计划安排表检查计划安排表和日期的蓝点措施并实施一个纠正行动请求.提问应该包含对操作、设备、文件等的完整说明。 Reaction to non-conformances must assure immediate response. 对不符的响应速度必须及时。). Auditors must understand LPA strategy and purpo

22、se. 审核员必须理解LPA策略和目的。 Review checklist and reactions with auditors. 和审核员共同分析检查清单和反应计划。 Auditors must know to respond immediately after finding a nonconformance. 审核员必须在发现一个不符合时快速作出响应。 EMPV Auditors shall be qualified to perform error and mistake proofing verification. EMPV审核员具备执行防错防误验证的资格。 Perform a p

23、ractice audit where appropriate. 在适用的时候执行一次审核实践。Once the LPA plan is approved, the Supplier shall train their Layered Process Auditors. 一旦一旦LPA计划得到批准，供应商应该培训自己的分层过程审核员计划得到批准，供应商应该培训自己的分层过程审核员 Explain why the LPA is being implemented. 解释为什么为什么LPA在被执行。 Explain the purpose and benefits of the LPA proce

24、ss. 解释LPA程序的目的和益处益处。 Inform workforce of LPA activity and what to expect when audits are performed in their work areas. 当在工作地点执行审核时，将LPA活动和对结果的期望 通知通知给操作工人。 Encourage workforce feedback. 鼓励鼓励操作工人进行反馈。 Communicate LPA results frequently. 经常对LPA的结果进行交流进行交流。 Review audit results frequently when startin

25、g process. 在启动程序的时候经常经常对审核结果进行回顾。 Improve audit checklist based on auditor feedback. 根据审核员的反馈来改进审核检验表。 Management must instill discipline early in the process to complete audits on time and provide resources for immediate corrective action. 管理层必须在程序的早期时候逐渐进行灌输，来按时完成审核并提供资 源给快速更正行动。 During early phas

26、e - Management audits will find problems, but later management audits will find improvements. 在早期- 管理层的审核将发现问题， 但是以后管理层的审核会发现（这些问题的）改进。 - Develop and apply Lessons Learned to improve audit. - 制定并运用吸取的教训吸取的教训来改进审核。 Corrective actions shall be documented as required by ISO/TS 更正行动应该按照ISO/TS的标准进行文件记录. There must be a system to maintain the audit schedule and track completion. 必须有