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What Is An FMEA

8/16/2012. Quality Support Group, Inc. All rights reserved. 2. Criticisms of FMEA. FMEA often misses key failures (Bednarz et al., 1988)FMEA performed too late does not affect key product/process decisions (McKinney, 1991)The FMEA Process is tedious (Ormsby et al., 1992)The Risk Priori

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What Is An FMEA

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    1. 8/17/2012 Quality Support Group, Inc. All rights reserved 1 What Is An FMEA? Opportunity to Defeat Murphy’s Law Focus on Prevention An assessment of Risk Safety Regulatory Customer Satisfaction Program Coordinated/Documented team effort To determine what can go wrong A method to determine the need and priority of actions

    2. 8/17/2012 Quality Support Group, Inc. All rights reserved 2 Criticisms of FMEA FMEA often misses key failures (Bednarz et al., 1988) FMEA performed too late does not affect key product/process decisions (McKinney, 1991) The FMEA Process is tedious (Ormsby et al., 1992) The Risk Priority Number is not a good measure of Risk (Gilchrist, 1993: Harpster 1999)

    3. 8/17/2012 Quality Support Group, Inc. All rights reserved 3 Timing One of the most important factors for the successful implementation of an FMEA program is timeliness. It is meant to be a “before-the-event” action, not an “after-the-fact” exercise. To achieve the greatest value, the FMEA must be done before the implementation of a product or process in which the failure mode potential exists. Up-front time spent properly completing an FMEA, when product/process changes can be most easily and inexpensively implemented, will minimize late change crises. Actions resulting from an FMEA can reduce or eliminate the chance of implementing a change that would create an even larger concern.

    4. 8/17/2012 Quality Support Group, Inc. All rights reserved 4 OVERVIEW OF THE FMEA PROCESS Define the scope of the study. Scope Definition Worksheet Select the FMEA team. Team Start-Up. Team Start-Up Worksheet. Review Design Intent / Process Function and the process (PFMEA) or product (DFMEA) to be studied. Process: Flowchart or Traveler Product: Blueprint or Schematic

    5. 8/17/2012 Quality Support Group, Inc. All rights reserved 5 OVERVIEW OF THE FMEA PROCESS Identify all failure modes & the corresponding effects. Rate the relative risk of each failure mode and effect. Severity Identify all potential causes Rate the relative risk of each cause. Occurrence Identify all current design/process controls to prevent/detect the failure mode. Rate the relative risk of all controls. Detection/Prevention Prioritize for action. Calculate the RPN (risk priority number). Use the Pareto Principle. Take action. Calculate the resulting RPN.

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    9. 8/17/2012 Quality Support Group, Inc. All rights reserved 9 Potential Failures

    10. 8/17/2012 Quality Support Group, Inc. All rights reserved 10

    11. 8/17/2012 Quality Support Group, Inc. All rights reserved 11 Severity Column

    12. 8/17/2012 Quality Support Group, Inc. All rights reserved 12 Severity Ranking Rating of 1 to 10 with 10 being the most severe impact. Use a scale. Use the same scale throughout. To assign this rating, must assume the failure mode has occurred. Assign severity rating for every possible effect.

    13. 8/17/2012 Quality Support Group, Inc. All rights reserved 13

    14. 8/17/2012 Quality Support Group, Inc. All rights reserved 14 Process Severity Evaluation Criteria

    15. 8/17/2012 Quality Support Group, Inc. All rights reserved 15 Potential Causes

    16. 8/17/2012 Quality Support Group, Inc. All rights reserved 16 Potential Cause(s)/Mechanism(s) of Failure Potential cause of failure is defined as an indication of a design or process weakness, the consequence of which is the failure mode. List, to the extent possible, every potential cause and/or failure mechanism for each failure mode. The cause/mechanism should be listed as concisely and completely as possible so that remedial efforts can be aimed at pertinent causes

    17. 8/17/2012 Quality Support Group, Inc. All rights reserved 17 Occurrence Ranking How often will each cause occur? Ignore the severity of the effect and any possibility that it will be detected. Rating on a 1 to 10 scale with 10 being the most frequent. Define root causes of each failure mode Use data where possible Cpk information. Customer complaints. Defect analysis.

    18. 8/17/2012 Quality Support Group, Inc. All rights reserved 18 Occurrence Evaluation Criteria

    19. 8/17/2012 Quality Support Group, Inc. All rights reserved 19 Current Controls What are the current design or process controls to prevent or detect the potential failure mode? Prevention of cause of failure mode or reduction in occurrence. Detection of cause of failure mode leading to Corrective Actions

    20. 8/17/2012 Quality Support Group, Inc. All rights reserved 20 Current Controls Prevention: Prevent the cause/mechanism of failure or the failure mode from occurring, or reduce their rate of occurrence. Prevention may consist of the mitigation of the failure mode, in that case, the new probability of occurrence should be listed. Detection: Detect the cause/mechanism of failure Detect the cause/mechanism of failure or the failure mode, either by analytical or physical methods, before the item is released to production or shipped to the Customer (FMEA).

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    22. 8/17/2012 Quality Support Group, Inc. All rights reserved 22 Process Detection Evaluation Criteria

    23. 8/17/2012 Quality Support Group, Inc. All rights reserved 23 6. Risk Assessment

    24. 8/17/2012 Quality Support Group, Inc. All rights reserved 24 7. Risk Priority Number (RPN)

    25. 8/17/2012 Quality Support Group, Inc. All rights reserved 25

    26. 8/17/2012 Quality Support Group, Inc. All rights reserved 26 RPN / Risk Priority Number

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    29. 8/17/2012 Quality Support Group, Inc. All rights reserved 29 Example 1000 units returned by a customer for a rust issue $10/unit x 1,000 units x 10 = $100,000 450 RPN# or $100,000 per year What does Mgt understand?

    30. 8/17/2012 Quality Support Group, Inc. All rights reserved 30 Example Reduce RPN of 450 150 Potential savings - $63,000/year Change design dimensions – new materials??? Cost – upfront costs + per part BOM cost (if necessary) What is the payback??? Do we understand the indirect costs as well?

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    35. 8/17/2012 Quality Support Group, Inc. All rights reserved 35 Wrap-up

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