Failure Mode Effect Analysis (FMEA)

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Failure Mode Effect Analysis (FMEA)

  1. 1. 01/22/11 Michel Akiki FAILURE MODES & EFFECTS ANALYSIS : (FMEA)
  2. 2. Prospective What methods or tools do you use to reduce patient’s safety risk and improve quality ?? 01/22/11 Michel Akiki Retrospective
  3. 3. 01/22/11 Michel Akiki How could thing go WRONG??? Where are the big RISKS??
  4. 4. <ul><li>Systematic, proactive method for: </li></ul><ul><li>Evaluating a process </li></ul><ul><li>Identifying where and how it might fail </li></ul><ul><li>Assessing the relative impact of different failures </li></ul><ul><li>In order to identify the parts of the process that are most in need of change </li></ul>01/22/11 Michel Akiki WHAT IS FAILURE MODES & EFFECTS ANALYSIS : (FMEA)
  5. 5. System/Process : Ex: Water pump Failure Effect Consequence: Answer: Couldn't supply water 3hours What could go wrong Answer: The pump stopped Why the failure happen? Answer: Electricity shutdown Failure Mode 01/22/11 Michel Akiki Failure Cause Desirable Effect or Outcome
  6. 6. <ul><li>Examine the system for failures. </li></ul><ul><li>Try to answer proactively to the question: “How the system/process might fail?” </li></ul><ul><li>Deal with events that could happen </li></ul><ul><li>Propose action to eliminate or reduce the future failure occurrence </li></ul><ul><li>Consequently to improve : productivity, quality, safety and cost efficiency </li></ul>01/22/11 Michel Akiki Why FMEA:
  7. 7. <ul><li>Analysis of complex system or multi-failure system can be difficult </li></ul><ul><li>Successful FMEA requires expertise , experience and good TEAM skills </li></ul><ul><li>Dealing with data redundancies can be difficult </li></ul><ul><li>Can be “Costly” and “Time Consuming”. </li></ul>01/22/11 Michel Akiki Limitations of FMEA
  8. 8. <ul><li>Step 1: Select a process, diagram it </li></ul><ul><li>Step 2: Assemble a team to study it </li></ul><ul><li>Step 2: Brainstorm potential failure modes and their potential effects </li></ul><ul><li>Step 3: Identify the potential causes of failure modes </li></ul><ul><li>Step 4: List the current control </li></ul><ul><li>Step 5: Assign Severity, Occurrence and Detectability </li></ul><ul><li>Step 6 : Calculate Risk Priority Number (RPN) </li></ul><ul><li>Step 7 : Take actions to reduce RPN </li></ul><ul><li>Step 8: Reevaluate the RPN </li></ul>01/22/11 Michel Akiki FMEA steps:
  9. 9. 01/22/11 Michel Akiki
  10. 10. <ul><li>Is the seriousness of the effects of the failure or impact on customers </li></ul>01/22/11 Michel Akiki Severity:
  11. 11. <ul><li>The frequency of the failure or probability </li></ul><ul><li>(based on experience) </li></ul><ul><li>“ How often the failure can be expected?” </li></ul>01/22/11 Michel Akiki Occurrence
  12. 12. <ul><li>Probability to discover a specific failure before it reaches the end </li></ul><ul><li>Evaluate the likelihood of potential occurrences of events identified </li></ul>01/22/11 Michel Akiki Detection: (optional )
  13. 13. <ul><li>An RPN is a measurement of relative risk. </li></ul><ul><li>High Risk Priority Numbers should be selected for Improvement and Action Plans Created </li></ul>01/22/11 Michel Akiki Risk Priority Number (RPN)
  14. 14. Fundamental Major Moderate Minor Insignificant Fundamental 01/22/11 Michel Akiki 10 10 20 30 40 50 60 70 80 90 100 9 9 18 27 36 45 54 63 72 81 90 8 8 16 24 32 40 48 56 64 72 80 7 7 14 21 28 35 42 49 56 63 70 6 6 12 18 24 30 36 42 48 54 60 5 5 10 15 20 25 30 35 40 45 50 4 4 8 12 16 20 24 28 32 36 40 3 3 6 9 12 15 18 21 24 27 30 2 2 4 6 8 10 12 14 16 18 20 1 1 2 3 4 5 6 7 8 9 10   1 2 3 4 5 6 7 8 9 10
  15. 15. <ul><li>It is an actions taken is intended to reduce the RPN by reducing either the severity, the occurrence, the detection ranking, or all three together </li></ul>Corrective Actions 01/22/11 Michel Akiki
  16. 16. <ul><li>After implementation of a corrective action, RE ‘estimate” and record the result of severity, occurrence, detection and the RPN rating in order to evaluate the action taken. </li></ul>Why does we have plenty of time to fix our problems, but never enough time to prevent them? 01/22/11 Evaluation Michel Akiki
  17. 17. <ul><li>Take your time…. </li></ul><ul><li>Ask a lot of questions: </li></ul><ul><ul><li>Can this happen…..? Happen?? Happen??? </li></ul></ul><ul><ul><li>What would happen if ….??? </li></ul></ul><ul><ul><li>Consequences…..?? </li></ul></ul>01/22/11 Michel Akiki Keys for a successful FMEA:
  18. 18. <ul><li>One person is assigned to complete the FMEA. </li></ul><ul><li>Not customizing the rating scales with company specific data, so they are meaningful to other company </li></ul><ul><li>FMEA team not included ALL involved person </li></ul><ul><li>FMEA team member are not trained in the use of FMEA, and become frustrated with the process </li></ul><ul><li>FMEA team becomes bogged down with minute details of design or process, losing sight of the overall objective </li></ul><ul><li>Listing the same potential effect for every failure (ex: customer dissatisfied). </li></ul><ul><li>Stopping the FMEA process when the RPN’s are calculated and not continuing with the recommended actions. </li></ul><ul><li>Not reevaluating the high RPN’s after the corrective actions have been completed </li></ul>01/22/11 Michel Akiki Reasons FMEA’s fail
  19. 19. 01/22/11 Michel Akiki References <ul><li>(n.d.). Retrieved from www.ismp-canada.org. </li></ul><ul><li>Jardali, F. (2009). Quality 105. CPHQ. Beirut: CPHQ Lebanon. </li></ul><ul><li>Jardali, F. (2009). Root Cause analysis. CPHQ. Beirut: CPHQ. </li></ul><ul><li>Latino, R. J. (2009). Patient Safety The PROACT Root Cause Analysis Approach. USA: CRC Press. </li></ul><ul><li>Press, D. (2005). Guideline for Failure Mode and Effects Analysis, For Automotives, Aerospace and General Manufacturing industries. Ontario Canada: CRC Press. </li></ul><ul><li>Press, D. (2005). Guideline for Failure & Effects Analysis For medical devices. Ontario- Canada: CRC Press. </li></ul><ul><li>  </li></ul>
  20. 20. 01/22/11 Michel Akiki

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