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1、How Is A Paradigm Formed?,Paradigm: A set of assumptions, concepts, values, and practices that constitutes a way of viewing reality for the community.,(Paradigm=Example),A group of scientists placed 5 monkeys in a cage and in the middle, a ladder with bananas on the top.,Every time a monkey went up

2、the ladder, the scientists soaked the rest of the monkeys with cold water.,After a while, every time a monkey went up the ladder, the others beat up the one who tried to go up the ladder.,After some time, no monkey dare to go up the ladder regardless of the temptation.,Scientists then decided to sub

3、stitute one of the monkeys. The 1st thing this new monkey did was to go up the ladder. Immediately the other monkeys beat him up.,After several beatings, the new member learned not to climb the ladder even though it never knew why.,A 2nd monkey was substituted and the same occurred. The 1st monkey p

4、articipated on the beating for the 2nd monkey. A 3rd monkey was changed and the same was repeated (beatings). The 4th was substituted and the beating was repeated and finally the 5th monkey was replaced.,What was left was a group of 5 monkeys that even though never received a cold shower, continued

5、to beat up any monkey who attempted to climb the ladder.,If it was possible to ask the monkeys why they would beat up all those who attempted to go up the ladder. I bet you the answer would be. “I dont know thats how things are done around here” Does it sound familiar?,So the question is How do we k

6、eep from making the same mistakes over and over again?,The “Art Of Perfection” With A Wonderful FMEA,Agenda FMEA Training Suzhou Plant,Day 1 FMEA On team until de-commissioning,Core team defines tasks to complete; Functional Supv. assigns tasks to extended team; On team until assigned tasks are comp

7、leted.,Must attend FMEA,Attend FMEA as required by Core Team,Design Engineer On team until de-commissioning,Core team defines tasks to complete; Functional Supv. assigns tasks to extended team; On team until assigned tasks are completed.,Must attend FMEA,Attend FMEA as required by Core Team,Process

8、Engineer & Launch Team Responsible for all aspects of Process FMEA,Minimum Core Team: Launch Coordinator Plant Quality Engineer Process Engineer Operator,Functional support: Automation engineer Supervisor Environmental Tooling engineer Design engineer,Process FMEA Team Structure,Process FMEA teams w

9、ith members from different areas bring varying degrees of experience and perspective to the problem being analyzed.,Organizing the Team,Team members should have experience working with the process,Process FMEA teams should include members from: Manufacturing or launch coordinator Design Engineer AQP

10、 Engineer Production Supervisor Operator Process Engineering Quality Engineering,Task: Scheduling meetings 2-3 meetings per week. FMEA should not take longer then 8 weeks. Planning the agenda One hour maximum Orienting team Ensuring completion,Facilitator role (preferable Quality/Manu Eng.),Capabili

11、ty Team building Coach, counsel, mentor, continually review the focus of your team members and adjust direction, and manage/direct team members Good written skills Promotes detail and follows up,Understands the process and potential process failures He is the person that manages process expectations

12、 and process performance. Understands process robustness and process flaws Manages and controls all internal aspects of cost, timing, delivery and product expectations Learned from past experience potential failures, occurrences and detections. Discuss opportunities of prevention ,if applicable,Role

13、 of Process/Manufacturing Engineer,Design Engineer Attends For Process FMEA Related To A Product Or Part,Role of Design engineer,Understands critical failure modes from Design FMEA Understands SOR or specifications of the product. Knows fit and function of the part very well and provides potential f

14、ailure modes Provides potential high risk severity,Potential failure modes from daily and hands on experience Provide potential handling defects Has experience and knowledge of failure occurrence Potentially your most valuable team members,Role of Supervisor/ Operator,Role of AQP Engineer,Audits Pro

15、cess FMEA Verifies that failure modes are protected Assures the High Severity, high emphasize actions are complete,1Organizing the team,2Getting Started,Process FMEA,3Analyzing Potential Problems,4Identifying Causes and Controls,5Identifying and Implementing Corrective Actions,6Pitfalls of FMEA,Gett

16、ing Started,Identify Process or function,Review previous FMEAs,Have Design FMEA,Complete process steps/ functions,Conduct Risk Analysis,Getting Started,I start and complete PFMEA at my desk to show Process FMEA to customer for PPAP. Check in the box, FMEA complete for our AQP 6 gate launch process,F

17、MEA is a written document generated by a cross functional team to evaluate the potential failure of a product/ process/ machine and the effects of the failures,All FMEAs focus on design, regardless of whether it is of the product, machine or process,It is against SRG policy to provide a copy of our

18、Process FMEAs to the customer,WRONG !,Process flows include all significant steps and added value on the process/ product,When the risk analysis is performed, the team determines whether each step is a HIGH, MEDIUM, or LOW risk.,1Organizing the team,2Getting Started,Process FMEA,3Analyzing Potential

19、 Problems,4Identifying Causes and Controls,5Identifying and Implementing Corrective Actions,6Pitfalls of FMEAs,1Organizing the team,2Getting Started,Process FMEA,3Analyzing Potential Problems,4Identifying Causes and Controls,5Identifying and Implementing Corrective Actions,6Pitfalls of FMEAs,1Organi

20、zing the team,2Getting Started,Process FMEA,3Analyzing Potential Problems,4Identifying Causes and Controls,5Identifying and Implementing Corrective Actions,6Pitfalls of FMEAs,Process FMEA Considerations,Potential failure modes,Impact on manufacturing plant,Impact on customers,Root Causes of the Pote

21、ntial Failure,Detection On The Root Cause (Not The Effect),Ability to detect root cause,Recommend corrective actions,Effects such as scratch, dirt, nickel show are not failure modes,1) Potential Causes are on the failure mode,2) Detection, Detect the cause, NOT the failure mode or effect of the fail

22、ure mode,PLC stops mold when dryer stops working,3) Prevention: when a potential cause happens, process or machine stops avoiding failure mode,Identifying and Implementing Corrective Actions,We should address corrective actions based on the following criteria:,Improve Design and Process FMEA with To

23、p 5 activity prioritized with previous criteria,Implement our “lessons learned” and “best practice” activity and achieve a continuous improvement culture,(1) High Severity (9 or 10) Operator safety (2) High Impact of Emphasis: Severity= 5 to 8 and Occurrence=4 to 10. (3) High RPN,FMEA,Design FMEA Co

24、mponents Subsystems Systems,Process FMEA Machines Work Stations Tools Production lines Gauges Operator Training,Remember this,1Organizing the team,2Getting Started,Process FMEA,3Analyzing Potential Problems,4Identifying Causes and Controls,Identifying and Implementingcorrective Actions,6Pitfalls of

25、FMEAs,FMEA Pitfalls,Pitfall: Prioritizes Doesnt Correct:,Pitfall: Effects from a failure mode are considered failure modes:,A FMEA does not detect how we can avoid sending a defect to the customer. You make the defect but dont send it to your customer by adding more labor or spectacular detection sy

26、stem. You eat the scrap anyway. A good FMEA avoids making a defect.,The output of a FMEA is prioritizing failure modes, this dont eliminate the failure mode. Additional action are needed to reduce the failure mode,$,FMEA Pitfalls,Pitfall: Only as Good as the team,Pitfall: Time Consuming:,It takes ti

27、me and discipline to get into the details,Identifying failure modes is a team brainstorming process If the team is not detail oriented and forget an important failure, then this failure is waiting to occur,Pitfall: Not Accurate Rating Scales:,Rating scales should be meaningful. Assure that similar r

28、ating scales are always the same thru the FMEA. Visual inspection should be a 8 across the FMEA. Dont cherry pick, with as purpose to keep the RPN low,FMEA Pitfalls,Pitfall: Not starting in the Design phase,Pitfall: To provide this in a PPAP package to customer:,To do a FMEA just to do it is useless

29、. Stop wasting your time Make sure a FMEA has added value and should be completed with a CFT team. Good FMEAs should not be provided to the customer.,The earlier in the design process the FMEA is started, the better A Design FMEA can catch potential failures still when design can be modified,Pitfall

30、: Not including operators,Experience operators should be on the team to use their knowledge Operators often have good information on failure modes and the effectiveness of the controls. They can also provide occurrences,FMEA Pitfalls,Pitfall: Not looking to previous and similar products,Pitfall: Ass

31、ume Detection Controls are better then they are:,Some controls are not robust and not verified for they function Dont test for what we think they test for.,Templates are great but every product has its unique issues or concerns. Use other FMEAs but review with the CFT team that this product doesnt h

32、ave other failure modes,Pitfall: Not linking with Mistake-Proofing,Sometimes failure mode can not be avoided and detection of the failure mode is critical. THE FMEA DOESNT ELIMINATE THE FAILURE MODE OR EFFECTS BY ITSELF, it only DETECTS IT Then we need to apply tools such as mistake-proofing, verify

33、 the robustness of the mistake proofing regularly.,FMEA Pitfalls,Pitfall: Not Tying Into the Control Plans,Pitfall:Failing to Update the FMEA:,As new potential failure modes are identified, they should be added to the FMEA and control plan. These are living documents. Add any QR, PIR, PRR,etc number

34、s to the FMEA,The control plan provides us information on how to react when a failure mode occurs. The FMEA will not be a living document if it is not tied to the control plan,Pitfall: No linkage between Design FMEA-Process FMEA and Control Plan,Severe failure modes from the Design FMEA should be ad

35、dressed in the Process FMEA and for sure mentioned in the control plan,FMEA Example,Previous failure mode: set up sheet was a 4 or 3?,Remember: Flash is an effect from a failure mode,What is the root cause? Clamp pressure to low,Processing, trouble shooting is not a process step,Previous failure mod

36、e: 100% Operator inspection was between a 3 to 7?,Not heated properly is an affect from a failure mode!,Only one root cause: Temperature Anvils not correct:3, Settings not correct:4,Assembly is a process step but is not defined,Previous failure mode: 100% Operator inspection vary from 4 to 7?,Missin

37、g studs is an affect from a failure mode!,root cause is not defined Machine failure or malfunction,Assembly operation is a process step but is not defined,HE,Remember: Severity between 5-8 with combination of occurrence 4-10 are HE failure modes,Previous failure mode: 100% detection was a 7,Remember

38、: Flash is an effect from a failure mode,To much causes: Mold damage=2, Process parameter= 3, New/repaired mold=1,Severity on surface defects should have higher ranking,Similar detections are a 7: Visual inspection should be a 8,Surface defects are effects from a failure mode,To much causes: Padmark=2, Material handling= 4 Rough surface of die= 2,FMEA building block,Building block system,Uses the premises that: Difference from part to part are minimal Molding is molding, plating is plating, paint is paint,etc. Process improvements to part ABC will likely apply to part XYZ Focuses on the

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