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1、Cayman Systems Revision N 980815 (513) 777-3394 Potential Failure Mode and Effects Analysis Slide 1, Printed: 10/12/98 Failure Mode and Effects Analysis Cayman Systems Revision N 980815 (513) 777-3394 Potential Failure Mode and Effects Analysis Slide 2, Printed: 10/12/98 Dont Let This Happen To YO
2、U! Cayman Systems Revision N 980815 (513) 777-3394 Potential Failure Mode and Effects Analysis Slide 3, Printed: 10/12/98 Potential Failure Mode and Effects Analysis Process Failure Mode And Effects AnalysisLow - High Process: Outside Suppliers Affected:Engineer:1 - 10 Primary Process Responsibilit
3、y:Model Year/Vehicle(s):Part Number: Other Div. Or People Involved:Scheduled Production Released:PFMEA Date:Rev. Approvals:Quality Assurance ManagerQuality Assurance Engineer Operations ManagerSenior Advisor Part Name Operation NumberProcess Function Potential Failure Mode Potential Effects Of Failu
4、rePotential Cause Of FailureCurrent Controls Occured Severity Detection RPN Recommended Actions And Status Actions Taken Occured Severity Detection RPN Responsible Activity SIRTake TPPEWrong MaterialFragmented ContainerInsufficient Supplier ControlMaterial Certification 19218 ContainerMaterial Held
5、InUnpredictable DeploymentImproper HandlingRequired With Each 1Storage AreaMisidentified MaterialShipment Release Verification Out Of SpecFragmented ContainerSupplier Process ControlPeriodic Audit Of 310390 MaterialUnpredictable DeploymentSupplier Material ContaminatedFragmented ContainerOpen BoxesV
6、isual Inspection 19763 MaterialUnpredictable Deployment MaterialFragmented ContainerEngineering ChangeRelease Verification 110770 CompositionUnpredictable DeploymentSupplier ChangeGreen “OK“ Tag ChangeCustomer Notification 2Move ToUnreleasedFragmentationUntrained LTOCheck For Green “OK“ 510150 Appro
7、vedUntrained PersonnelTag At Press StorageTrace Card Check List Training Cayman Systems Revision N 980815 (513) 777-3394 Potential Failure Mode and Effects Analysis Slide 4, Printed: 10/12/98 Potential Failure Mode and Effects Analysis Cayman Systems Revision N 980815 (513) 777-3394 Potential Fail
8、ure Mode and Effects Analysis Slide 5, Printed: 10/12/98 Course Goals To understand the role and function of the FMEA To understand the concepts and techniques of Design FMEA and how to apply it To understand the concepts and techniques of Process FMEA and how to apply it To understand the role and
9、function of FTA To understand the concepts of Zero Quality Control or Mistake-Proofing (e.g. Poka-Yoke) and its implications for FMEA Cayman Systems Revision N 980815 (513) 777-3394 Potential Failure Mode and Effects Analysis Slide 6, Printed: 10/12/98 Liability Issues Cayman Systems Revision N 980
10、815 (513) 777-3394 Potential Failure Mode and Effects Analysis Slide 7, Printed: 10/12/98 How FMEA Fits With Elements of TQM Customer Requirements Engineering Specifications System and Components Specifications Process and Supplier Requirements and Control Develop System Design and Process FMEA Eli
11、minate Potential Failures Improve Upon Design and Process Design is The Critical Element Cayman Systems Revision N 980815 (513) 777-3394 Potential Failure Mode and Effects Analysis Slide 8, Printed: 10/12/98 What Is An FMEA? An Advanced Quality Planning tool used to evaluate potential failure modes
12、 and their causes. Prioritizes Potential Failures according to their Risk and drives actions to eliminate or reduce their likelihood of occurrence. Provides a discipline/methodology for documenting this analysis for future use and continuous process improvement. By its self, an FMEA is NOT a problem
13、 solver. It is used in combination with other problem solving tools. The FMEA presents the opportunity but does not solve the problem. Cayman Systems Revision N 980815 (513) 777-3394 Potential Failure Mode and Effects Analysis Slide 9, Printed: 10/12/98 FMEAs Have Failure Modes? The team developing
14、 the FMEA turns out to be one individual. The FMEA is created to satisfy a customer or third party requirement, NOT to improve the process. The FMEA is developed too late in the process and does not improve the product/process development cycle. The FMEA is not reviewed and revised during the life o
15、f the product. It is not treated as a dynamic tool. The FMEA is perceived either as too complicated or as taking too much time. Cayman Systems Revision N 980815 (513) 777-3394 Potential Failure Mode and Effects Analysis Slide 10, Printed: 10/12/98 Origins FMECA Failure Mode Effects and Criticality
16、Analysis 1950s Origin - Aerospace person who uses the product Use Failure This can help in Repair manuals person who uses the product More in the DFMEA section herein. Cayman Systems Revision N 980815 (513) 777-3394 Potential Failure Mode and Effects Analysis Slide 51, Printed: 10/12/98 CAUTION! Do
17、 NOT mix up: Design Failures or there is no Design Control. 10 Very Remote Very remote chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. 9 Remote Remote chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. 8 Very
18、Low Very low chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. 7 Low Low chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. 6 Moderate Moderatechance the Design Control will detect a potential cause/mechanism an
19、d subsequent failure mode. 5 Moderately High Moderately high chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. 4 High High chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. 3 Very High Very high chance the Desi
20、gn Control will detect a potential cause/mechanism and subsequent failure mode. 2 Almost Certain Design Control will almost certainly detect a potential cause/mechanism and subsequent failure mode. 1 Cayman Systems Revision N 980815 (513) 777-3394 Potential Failure Mode and Effects Analysis Slide 6
21、8, Printed: 10/12/98 Design Controls Design controls are those actions taken as a normal part of the development process that are designed into the process to minimize the occurrence of failure or to detect specific failure modes. Design controls should directly relate to the Prevention and/or Detec
22、tion of specific causes of failures. Cayman Systems Revision N 980815 (513) 777-3394 Potential Failure Mode and Effects Analysis Slide 69, Printed: 10/12/98 Design Control Examples Reliability Tests / Prototype Testing Design Reviews Worst Case Stress Analysis Robust Design Environmental Stress Tes
23、ting Designed Experiments Finite Element Analysis Variation Simulation FT Analysis Component Derating (60% to 80%) 100,000 Mile Pilot Test Consider Interpretation of Data Cayman Systems Revision N 980815 (513) 777-3394 Potential Failure Mode and Effects Analysis Slide 70, Printed: 10/12/98 Recommen
24、ded Actions When the failure modes have been ranked by their RPN, corrective actions should be first directed at the highest ranked concerns and critical items identified. The intent of any recommended action is to reduce one or more (or all) of the occurrence, severity and/or detection rankings. On
25、ly a design revision can bring about a reduction in the severity ranking. If no actions are recommended for a specific cause, this should be indicated. A reduction in the occurrence ranking can only be effected by removing or controlling one or more of the causes of the failure mode through a design
26、 revision. An increase in design verification actions will result in a reduction in the detection ranking ONLY. Design FMEA doesnt rely on process controls to overcome potential weaknesses in the design; however, it does take technical and physical limitations of a process into consideration (Design
27、 Rules) Cayman Systems Revision N 980815 (513) 777-3394 Potential Failure Mode and Effects Analysis Slide 71, Printed: 10/12/98 Process FMEA Cayman Systems Revision N 980815 (513) 777-3394 Potential Failure Mode and Effects Analysis Slide 72, Printed: 10/12/98 The Process FMEA Identifies Critical
28、and Significant Characteristics and is therefore the Starting Point for the Control Plan Sample Sizes Evaluation Frequency Method of Evaluation Out-of-Control Action Plan (OCAP) Cayman Systems Revision N 980815 (513) 777-3394 Potential Failure Mode and Effects Analysis Slide 73, Printed: 10/12/98 U
29、se a Process Flow Chart! Because: You want to understand your current process You are looking for opportunities to improve You want to illustrate a potential solution You have improved a process and want to document the new process Lets Try A Process Flow Chart Cayman Systems Revision N 980815 (513)
30、 777-3394 Potential Failure Mode and Effects Analysis Slide 74, Printed: 10/12/98 Creating a Process Flow Chart 1. Identify the process or task you want to analyze. Defining the scope of the process is important because it will keep the improvement effort from becoming unmanageable. 2. Ask the peop
31、le most familiar with the process to help construct the chart. 3. Agree on the starting point and ending point. Defining the scope of the process to be charted is very important, otherwise the task can become unwieldy. 4. Agree on the level of detail you will use. Its better to start out with less d
32、etail, increasing the detail only as needed to accomplish your purpose. Cayman Systems Revision N 980815 (513) 777-3394 Potential Failure Mode and Effects Analysis Slide 75, Printed: 10/12/98 Creating a Process Flow Chart 5.Look for areas for improvement Is the process standardized, or are the peop
33、le doing the work in different ways? Are steps repeated or out of sequence? Are there steps that do not ad value to the output? Are there steps where errors occur frequently? Are there rework loops? 6.Identify the sequence and the steps taken to carry out the process. 7. Construct the process flow c
34、hart either from left to right or from top to bottom, using the standard symbols and connecting the steps with arrows. 8. Analyze the results. Where are the rework loops? Are there process steps that dont add value to the output? Where are the differences between the current and the desired situatio
35、n? Cayman Systems Revision N 980815 (513) 777-3394 Potential Failure Mode and Effects Analysis Slide 76, Printed: 10/12/98 Early Process Flow Diagram Inspection Points Inspection Frequency Instrument Measurement Scale Sample Preparation Inspection/Test Method Inspector Method of Analysis Cayman Sys
36、tems Revision N 980815 (513) 777-3394 Potential Failure Mode and Effects Analysis Slide 77, Printed: 10/12/98 GM Example Process Flow Chart Process Flow DiagramApproved By: Part Number: Date:4/5/93QA Manager Part Description: Rev. :COperations Manager Prepared By: Senior Advisor QA Engineer Step Fa
37、brication Move Store Inspect Operation DescriptionItem # Key Product Characteristic Item #Key Control Characteristic 1Move “OK“ Vinyl Material1.0Material Specs1.0Material Certification Tag From Storage Area and Load Into Press. 2Auto Injection Mold Cover2.0Tearstrip In Cover2.1Tool Setup In Tool #2.
38、2Machine Setup 3.0Hole Diameter In Cover2.1Tool Setup 2.2Machine Setup 4.0Flange Thickness In Cover2.1Tool Setup 2.2Machine Setup 5.0Pressure Control Protrusions2.1Tool Setup Height2.2Machine Setup 3Visually Inspect Cover6.0Pressure Control Protrusions2.1Tool Setup Filled Out2.2Machine Setup Cayman
39、Systems Revision N 980815 (513) 777-3394 Potential Failure Mode and Effects Analysis Slide 78, Printed: 10/12/98 Basic Flow Chart Example Start Manufactured Parts Purchased Parts Receive Raw Materials InspectInspect Receive Parts Move to Production Move to Production Process Material Disposition St
40、art Inspect Bad Bad BadBadBad Cayman Systems Revision N 980815 (513) 777-3394 Potential Failure Mode and Effects Analysis Slide 79, Printed: 10/12/98 Basic Flow Chart Example Assemble Functional Test Package Ship Disposition Bad Cayman Systems Revision N 980815 (513) 777-3394 Potential Failure Mod
41、e and Effects Analysis Slide 80, Printed: 10/12/98 How To Use The Flow Chart Use to help determine who should be involved by identifying all the work areas in a process Use as a job aid to remind people about process standards Use as a check list to collect data on where problems occur Use to invest
42、igate why rework is occurring at a certain place in the process Use the ideal process flow chart data to communicate your proposed solution Cayman Systems Revision N 980815 (513) 777-3394 Potential Failure Mode and Effects Analysis Slide 81, Printed: 10/12/98 Flow Chart Tips If a process step or bo
43、x has two output arrows, consider whether a decision box is needed Remember that the people closest to the work know it best. Make sure people are involved in developing the flow chart Software packages make flow chart production easy. Cayman Systems Revision N 980815 (513) 777-3394 Potential Failu
44、re Mode and Effects Analysis Slide 82, Printed: 10/12/98 The Process Potential FMEA Identifies potential product-related failure modes Assesses the potential customer effects of the failures Identifies the potential internal and external manufacturing or assembly process causes and identifies proces
45、s variables on which to focus controls for occurrence reduction and/or detection of the failure condition(s) Develops ranked list of potential failure modes, thus establishing a priority system for corrective action considerations Documents the results of the manufacturing or assembly process Cayman
46、 Systems Revision N 980815 (513) 777-3394 Potential Failure Mode and Effects Analysis Slide 83, Printed: 10/12/98 Process Potential FMEA A Process Potential FMEA is an analytical tool utilized by a Process FMEA team as a means to ensure potential failure modes and their associated causes are identi
47、fied, considered and addressed. Teams should be run by the owner of the process or someone who understands the process well. Defines reasons for rejection at specific operations. In preparation for the FMEA, the assumption should be made that the incoming parts and materials are correct. A compariso
48、n of similar processes and a review of customer claims relating to similar components is a recommended starting point. A knowledge of the purpose of the design is necessary. It can be cause-associated with a potential failure mode in a subsequent operation or an effect associated with a potential failure in a previous o