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1、分层审核过程分层审核过程DateAuthor2Disclosure or duplication without consent is prohibited分层分层 审核的目的审核的目的u Reduce the number of non-conformances to existing procedures Reduce the number of non-conformances to existing procedures and policiesand policies减少对现行程序和政策的不符合项减少对现行程序和政策的不符合项u Increase the frequency at w

2、hich various levels of management Increase the frequency at which various levels of management perform auditsperform audits增加各管理层面的审核频率增加各管理层面的审核频率u Remove roadblocks to correcting unsatisfactory itemsRemove roadblocks to correcting unsatisfactory items去除障碍以纠去除障碍以纠正不满意项正不满意项u Standardize types of it

3、ems audited / checked by plant personnelStandardize types of items audited / checked by plant personnel标标准类型项目的审核准类型项目的审核/ /检查由工厂人员执行检查由工厂人员执行. .DateAuthor3Disclosure or duplication without consent is prohibited什么是分层审核什么是分层审核? ?u Conducted by various levels of plant leadershipConducted by various le

4、vels of plant leadership由工厂各层级的由工厂各层级的领导团队执行领导团队执行 Typically conducted by first line personnel 典型上由第一线人员执行u An audit to assure non-conformances to the quality system are An audit to assure non-conformances to the quality system are identified and correctedidentified and corrected一个确保识别和纠正不符合质量体系的审核一

5、个确保识别和纠正不符合质量体系的审核 Supporting personnel from various functions支持人员来自各个功能 Middle and upper plant management工厂管理中层和上层u Covers the entire manufacturing facilityCovers the entire manufacturing facility覆盖整个制造工厂覆盖整个制造工厂 Departments部门Shipping and Receiving出货和收货Maintenance维修Fabrication加工Assembly装配 Areas区域 S

6、hifts班次DateAuthor4Disclosure or duplication without consent is prohibited如何实行分层审核如何实行分层审核 u Review documentationReview documentation检讨文件检讨文件 Work instructions作业指导书 Standardized work标准化工作 Routings路径 Control plans控制计划 Standardized changeover instructions标准化切换指令u Observe department activitiesObserve de

7、partment activities观察部门活动观察部门活动u Observe workplace organizationObserve workplace organization观察工作场所组织安排观察工作场所组织安排u Document actual data / dates found during auditDocument actual data / dates found during audit文件实际数据文件实际数据/ /审核期间发现的数据审核期间发现的数据 Dates of incoming material (FIFO verification)来料数据(先进先出验证

8、) Date and / or time of last Control Plan check数据和/或上次控制计划检查的时间u Interview manufacturing personnelInterview manufacturing personnel和制造人员面谈和制造人员面谈 Do NOT adversely affect:勿被反过来影响: Safety安全 Quality质量 Production生产DateAuthor5Disclosure or duplication without consent is prohibited分层审核检查表分层审核检查表-沟通沟通u Int

9、erview OperatorsInterview Operators员员工检讨工检讨Awareness of quality issues (formal and informal)质量问题的意识(正式和非正式)Knowledge of alarm limits警报极限的知识Use of control plans控制计划的使用u Verify that quality Verify that quality alerts are postedalerts are posted确认确认质量警告发布质量警告发布LAYERED AUDIT CHECKLISTLAYERED AUDIT CHECK

10、LISTAUDITOR:_ DEPT:_ DATE:_AUDITOR:_ DEPT:_ DATE:_LINE/MACHINE/CELL:_ SHIFT:_LINE/MACHINE/CELL:_ SHIFT:_Process ElementProcess ElementY YN NCommentsCommentsDate CorrectedDate CorrectedCommunicationCommunicationAre employees aware of any recent PRRs/quality issues? Is a Quality alert posted for any r

11、ecent WFCCs/quality isssues?Any observations from operator interviews or other input communicated?Workplace Organization & EnvironmentWorkplace Organization & EnvironmentIs in-process & outgoing material properly IDd?Any mix or wrong material found in process?Is FIFO used?Is nonconformin

12、g or suspect product identified and placed in a designated area?Are proper containers used?Is material in containment properly identified & segregated?Are working and environmental conditins suitable?Set-UpSet-UpAre Masters being run if required by the Control Plan?Are Visual Aids (required by t

13、he Control Plan)available?Is Set-Up current per routing?Are Change Over instructions followed?Operator Certification/Standardized WorkOperator Certification/Standardized WorkAre Operators following standardized work?Are Operators certified on the job?Control PlanControl PlanAre control plan checks m

14、ade at the proper frequency, with the correct sample size and on the correct form?Are product/process checks with in specification? If not, are reaction plans being followed?First Time QualityFirst Time QualityAre alarm limits being adhered to?Measurement SystemsMeasurement SystemsAre Error Proofing

15、 verification checks complete?Are Error Proofing devices, gages and fixtures used properly?Are all gages(required by the Control Plan)availble at the workstation? Are the gages numbered, calibrated and mathch the Control Plan? Are significant process events recorded?Containment/ReworkContainment/Rew

16、orkIs containment information documented when the product is nonconforming?Is in-plant rework/teardowns completed per instrctions with proper identification?Are out-of spec conditions recorded and corrective actions documented?P.M.ActivitiesP.M.ActivitiesAre QNPM/TPM activities verified as complete?

17、Section #1-Communication第一部分-沟通DateAuthor6Disclosure or duplication without consent is prohibited分层审核检查表分层审核检查表工作现场组织安排和环境工作现场组织安排和环境u Check all material Check all material identificationidentification检查所有材料标识检查所有材料标识Incoming进来料In-process过程在制Outgoing出货Re-work返工Scrap报废Containment遏制u Verify material f

18、low (FIFO)Verify material flow (FIFO)确认确认物流物流( (先进先出先进先出) )u Verify that proper containers Verify that proper containers are being usedare being used确认恰当的容器确认恰当的容器使用使用u Observe overall Observe overall environmental conditionsenvironmental conditions观察观察总体环境情况总体环境情况LAYERED AUDIT CHECKLISTLAYERED AUDI

19、T CHECKLISTAUDITOR:_ DEPT:_ DATE:_AUDITOR:_ DEPT:_ DATE:_LINE/MACHINE/CELL:_ SHIFT:_LINE/MACHINE/CELL:_ SHIFT:_Process ElementProcess ElementY YN NCommentsCommentsDate CorrectedDate CorrectedCommunicationCommunicationAre employees aware of any recent PRRs/quality issues? Is a Quality alert posted fo

20、r any recent WFCCs/quality isssues?Any observations from operator interviews or other input communicated?Workplace Organization & EnvironmentWorkplace Organization & EnvironmentIs in-process & outgoing material properly IDd?Any mix or wrong material found in process?Is FIFO used?Is nonco

21、nforming or suspect product identified and placed in a designated area?Are proper containers used?Is material in containment properly identified & segregated?Are working and environmental conditins suitable?Set-UpSet-UpAre Masters being run if required by the Control Plan?Are Visual Aids (requir

22、ed by the Control Plan)available?Is Set-Up current per routing?Are Change Over instructions followed?Operator Certification/Standardized WorkOperator Certification/Standardized WorkAre Operators following standardized work?Are Operators certified on the job?Control PlanControl PlanAre control plan c

23、hecks made at the proper frequency, with the correct sample size and on the correct form?Are product/process checks with in specification? If not, are reaction plans being followed?First Time QualityFirst Time QualityAre alarm limits being adhered to?Measurement SystemsMeasurement SystemsAre Error P

24、roofing verification checks complete?Are Error Proofing devices, gages and fixtures used properly?Are all gages(required by the Control Plan)availble at the workstation? Are the gages numbered, calibrated and mathch the Control Plan? Are significant process events recorded?Containment/ReworkContainm

25、ent/ReworkIs containment information documented when the product is nonconforming?Is in-plant rework/teardowns completed per instrctions with proper identification?Are out-of spec conditions recorded and corrective actions documented?P.M.ActivitiesP.M.ActivitiesAre QNPM/TPM activities verified as co

26、mplete?Section #2Workplace Organization &Environment第二部分-工作场所组织安排和环境DateAuthor7Disclosure or duplication without consent is prohibited分层审核检查表分层审核检查表设置设置u Confirm that current Confirm that current setup documentation setup documentation was usedwas used确认现行的设置确认现行的设置文件被使用文件被使用u Make sure that Mak

27、e sure that changeover instructions changeover instructions were usedwere used确保切换指令的确保切换指令的使用使用u Verify that control plan Verify that control plan requirements are requirements are followedfollowed确认控制计划要求确认控制计划要求被执行被执行Error Proofing / Gauging / Masters used防错/仪表/标准样件使用Visual aids available有视觉器具Cor

28、rective action for any item found to be out of specification on set-up针对任何设置超标项的纠正措施All previous stock purged from cell / line所有来自单元/线先前的闭箱存货LAYERED AUDIT CHECKLISTLAYERED AUDIT CHECKLISTAUDITOR:_ DEPT:_ DATE:_AUDITOR:_ DEPT:_ DATE:_LINE/MACHINE/CELL:_ SHIFT:_LINE/MACHINE/CELL:_ SHIFT:_Process Eleme

29、ntProcess ElementY YN NCommentsCommentsDate CorrectedDate CorrectedCommunicationCommunicationAre employees aware of any recent PRRs/quality issues? Is a Quality alert posted for any recent WFCCs/quality isssues?Any observations from operator interviews or other input communicated?Workplace Organizat

30、ion & EnvironmentWorkplace Organization & EnvironmentIs in-process & outgoing material properly IDd?Any mix or wrong material found in process?Is FIFO used?Is nonconforming or suspect product identified and placed in a designated area?Are proper containers used?Is material in containment

31、 properly identified & segregated?Are working and environmental conditins suitable?Set-UpSet-UpAre Masters being run if required by the Control Plan?Are Visual Aids (required by the Control Plan)available?Is Set-Up current per routing?Are Change Over instructions followed?Operator Certification/

32、Standardized WorkOperator Certification/Standardized WorkAre Operators following standardized work?Are Operators certified on the job?Control PlanControl PlanAre control plan checks made at the proper frequency, with the correct sample size and on the correct form?Are product/process checks with in

33、specification? If not, are reaction plans being followed?First Time QualityFirst Time QualityAre alarm limits being adhered to?Measurement SystemsMeasurement SystemsAre Error Proofing verification checks complete?Are Error Proofing devices, gages and fixtures used properly?Are all gages(required by

34、the Control Plan)availble at the workstation? Are the gages numbered, calibrated and mathch the Control Plan? Are significant process events recorded?Containment/ReworkContainment/ReworkIs containment information documented when the product is nonconforming?Is in-plant rework/teardowns completed per

35、 instrctions with proper identification?Are out-of spec conditions recorded and corrective actions documented?P.M.ActivitiesP.M.ActivitiesAre QNPM/TPM activities verified as complete?Section #3-Set-Up第三部分-设置DateAuthor8Disclosure or duplication without consent is prohibited分层审核检查表分层审核检查表-操作工资质操作工资质/

36、/作业标准化作业标准化u Are Operators and Are Operators and Supervisors following Supervisors following standardized work?standardized work?操操作工和主管执行标准作作工和主管执行标准作业吗业吗? ?u Are Operators Are Operators certified on the job?certified on the job?操操作工胜任工作吗作工胜任工作吗? ? How do you know?你怎么知道?u Are there operators in Are

37、 there operators in training?training?操作工有培训操作工有培训吗吗? ? Is there a training plan? ?有培训计划吗有培训计划吗? ? What are the requirements for certification on a job胜任工作的要求是什么?LAYERED AUDIT CHECKLISTLAYERED AUDIT CHECKLISTAUDITOR:_ DEPT:_ DATE:_AUDITOR:_ DEPT:_ DATE:_LINE/MACHINE/CELL:_ SHIFT:_LINE/MACHINE/CELL:_

38、 SHIFT:_Process ElementProcess ElementY YN NCommentsCommentsDate CorrectedDate CorrectedCommunicationCommunicationAre employees aware of any recent PRRs/quality issues? Is a Quality alert posted for any recent WFCCs/quality isssues?Any observations from operator interviews or other input communicate

39、d?Workplace Organization & EnvironmentWorkplace Organization & EnvironmentIs in-process & outgoing material properly IDd?Any mix or wrong material found in process?Is FIFO used?Is nonconforming or suspect product identified and placed in a designated area?Are proper containers used?Is ma

40、terial in containment properly identified & segregated?Are working and environmental conditins suitable?Set-UpSet-UpAre Masters being run if required by the Control Plan?Are Visual Aids (required by the Control Plan)available?Is Set-Up current per routing?Are Change Over instructions followed?Op

41、erator Certification/Standardized WorkOperator Certification/Standardized WorkAre Operators following standardized work?Are Operators certified on the job?Control PlanControl PlanAre control plan checks made at the proper frequency, with the correct sample size and on the correct form?Are product/pr

42、ocess checks with in specification? If not, are reaction plans being followed?First Time QualityFirst Time QualityAre alarm limits being adhered to?Measurement SystemsMeasurement SystemsAre Error Proofing verification checks complete?Are Error Proofing devices, gages and fixtures used properly?Are a

43、ll gages(required by the Control Plan)availble at the workstation? Are the gages numbered, calibrated and mathch the Control Plan? Are significant process events recorded?Containment/ReworkContainment/ReworkIs containment information documented when the product is nonconforming?Is in-plant rework/te

44、ardowns completed per instrctions with proper identification?Are out-of spec conditions recorded and corrective actions documented?P.M.ActivitiesP.M.ActivitiesAre QNPM/TPM activities verified as complete?Section #4第四部分Operator Certification/Standardized Work操作工资质/作业标准化DateAuthor9Disclosure or duplic

45、ation without consent is prohibited分层审核检查表分层审核检查表 - -控制计划控制计划u Verify required control Verify required control plan checksplan checks验证要求的验证要求的控制计划检查控制计划检查 Frequency频率 Sample size样本大小 Fixtures / tooling置具/模具 Form形式u Confirm that checks Confirm that checks are within specificationare within specifica

46、tion确认检查在规范之内确认检查在规范之内u Make sure that Make sure that reaction plans are reaction plans are being followedbeing followed确保反应确保反应计划的跟踪计划的跟踪LAYERED AUDIT CHECKLISTLAYERED AUDIT CHECKLISTAUDITOR:_ DEPT:_ DATE:_AUDITOR:_ DEPT:_ DATE:_LINE/MACHINE/CELL:_ SHIFT:_LINE/MACHINE/CELL:_ SHIFT:_Process ElementP

47、rocess ElementY YN NCommentsCommentsDate CorrectedDate CorrectedCommunicationCommunicationAre employees aware of any recent PRRs/quality issues? Is a Quality alert posted for any recent WFCCs/quality isssues?Any observations from operator interviews or other input communicated?Workplace Organization

48、 & EnvironmentWorkplace Organization & EnvironmentIs in-process & outgoing material properly IDd?Any mix or wrong material found in process?Is FIFO used?Is nonconforming or suspect product identified and placed in a designated area?Are proper containers used?Is material in containment pr

49、operly identified & segregated?Are working and environmental conditins suitable?Set-UpSet-UpAre Masters being run if required by the Control Plan?Are Visual Aids (required by the Control Plan)available?Is Set-Up current per routing?Are Change Over instructions followed?Operator Certification/Sta

50、ndardized WorkOperator Certification/Standardized WorkAre Operators following standardized work?Are Operators certified on the job?Control PlanControl PlanAre control plan checks made at the proper frequency, with the correct sample size and on the correct form? Are product/process checks with in sp

51、ecification? If not, are reaction plans being followed?First Time QualityFirst Time QualityAre alarm limits being adhered to?Measurement SystemsMeasurement SystemsAre Error Proofing verification checks complete?Are Error Proofing devices, gages and fixtures used properly?Are all gages(required by th

52、e Control Plan)availble at the workstation? Are the gages numbered, calibrated and mathch the Control Plan? Are significant process events recorded?Containment/ReworkContainment/ReworkIs containment information documented when the product is nonconforming?Is in-plant rework/teardowns completed per i

53、nstrctions with proper identification?Are out-of spec conditions recorded and corrective actions documented?P.M.ActivitiesP.M.ActivitiesAre QNPM/TPM activities verified as complete?Section #5第五部分Control Plan控制计划DateAuthor10Disclosure or duplication without consent is prohibited分层审核检查表分层审核检查表-一次通过率一次

54、通过率u Is FTQ data being Is FTQ data being collected at all reject collected at all reject points in the system?points in the system?一一次通过率的数据是从系统次通过率的数据是从系统的所有拒收点收集吗的所有拒收点收集吗? ?u Are alarm limits Are alarm limits visually displayed?visually displayed?警报警报极限有目视化展示吗极限有目视化展示吗? ?u Are alarm limits being

55、Are alarm limits being adhered to?adhered to?警报极限有警报极限有被遵从吗被遵从吗? ? How would you know?你怎么知道?u Is FTQ data posted?Is FTQ data posted?一一次通过率有否公示次通过率有否公示? ?u Are rejected parts Are rejected parts properly identified?properly identified?拒拒收件有适当标识吗收件有适当标识吗? ?LAYERED AUDIT CHECKLISTLAYERED AUDIT CHECKLIST

56、AUDITOR:_ DEPT:_ DATE:_AUDITOR:_ DEPT:_ DATE:_LINE/MACHINE/CELL:_ SHIFT:_LINE/MACHINE/CELL:_ SHIFT:_Process ElementProcess ElementY YN NCommentsCommentsDate CorrectedDate CorrectedCommunicationCommunicationAre employees aware of any recent PRRs/quality issues? Is a Quality alert posted for any recen

57、t WFCCs/quality isssues?Any observations from operator interviews or other input communicated?Workplace Organization & EnvironmentWorkplace Organization & EnvironmentIs in-process & outgoing material properly IDd?Any mix or wrong material found in process?Is FIFO used?Is nonconforming or

58、 suspect product identified and placed in a designated area?Are proper containers used?Is material in containment properly identified & segregated?Are working and environmental conditins suitable?Set-UpSet-UpAre Masters being run if required by the Control Plan?Are Visual Aids (required by the C

59、ontrol Plan)available?Is Set-Up current per routing?Are Change Over instructions followed?Operator Certification/Standardized WorkOperator Certification/Standardized WorkAre Operators following standardized work?Are Operators certified on the job?Control PlanControl PlanAre control plan checks made

60、at the proper frequency, with the correct sample size and on the correct form?Are product/process checks with in specification? If not, are reaction plans being followed?First Time QualityFirst Time QualityAre alarm limits being adhered to?Measurement SystemsMeasurement SystemsAre Error Proofing verification checks complete?Are Error Proofing devices, gages and fixtures used properly?Are all gages(requ

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