1. Failure Mode & Effect AnalysisPHILIPPINES :: MALAYSIA :: VIETNAM :: INDONESIA :: INDIA :: CHINA
2. Learning Bites • Understand the concept of FMEA • Identify the terminologies of FMEA • Determine steps in measuring and analyzing the potential failure modes • Define steps in measuring the critical points of failure. • Deploy the concept in your workplace to reduce the potential failures.
3. What is FMEA• FMEA stands for Failure Mode & Effect Analysis.• An Advanced Quality Planning Tool used to evaluate Potential Failure Modes and their Causes.• Prioritizes potential failures according to their risk and drives action to eliminate or reduce their likelihood of occurrence• Provides a disciplined methodology for documenting this analysis for future use and continuous process improvement• By itself, an FMEA is NOT a problem solver. It is used in combination with other problem solving tools.
4. Role of FMEA in Quality System Quality Process Business Improvement Objectives QFD QOS Problem Problem Solving Prevention FTA RFTA 8-D DOE Control APQP Plan FMEA SPC Tools Special Characteristics
5. Design & Process FMEA Design FMEA Involves study of product DFMEA is an analytical technique utilized primarily to ensure potential failure modes and their associated causes are identified, considered, and addressed in the design phase. FMEA Process FMEA Involves study of processes PFMEA is an analytical technique utilized primarily for continuous analysis of potential failure modes and their associated causes during the processes.
6. Important Terms in FMEA • CAUSE - cause of a failure mode is a deficiency that results in a failure mode. It is description of how the process could result in a failure. • SEVERITY - is an assessment of the seriousness of the effect of the potential failure mode to the customer. Severity applies to the effect only. • OCCURRENCE - the number of times the cause has resulted in the failure mode before any additional process control are applied. • DETECTION - is rating corresponding to the likelihood that current process will detect the failure mode before it gets to the customer. • RPN (Risk Priority Number) - is a measure of process risk and should be used to rank order the risks/concerns. RPN = SEVERITY x OCCURRENCE x DETECTION
7. FMEA Roadmap POTENTIAL FAILURE MODE EFFECT DETERMINE SEVERITY CAUSE DETERMINE OCCURRENCE CURRENT CONTROLS DETERMINE DETECTABILITY ACTIONS LEADING TO DETERMINE RPN CONTINUOUS IMPROVEMENT
8. FMEA Priority Actions Changing design Eliminating SEVERITY (material, failure geometry, etc) mode Preventing or Changing design reducing OCCURRENCE occurrences of or process one or more causes Improving Adding/improving ability DETECTION controls/methods to detect the failure mode
9. FMEA Process Steps Step 10: Calculate Resulting RPN Step 9: Take Actions Step 8: Develop Action Plan Step 7: Calculate RPNs Step 6: Assign Detection Ranking Step 5: Assign Occurrence Ranking Step 4: Assign Severity Ranking Step 3: List Potential Effects of Failure Step 2: Brainstorm Potential Failure Modes Step 1: Review the Process
10. Potential Causes & their Effects POTENTIAL CAUSES POTENTIAL EFFECTS METHODS MACHINERY FAILURE NEXT DOWNSTREAM MATERIALS MODE OPERATION USER PEOPLE ULTIMATE CUSTOMER ENVIRONMENT
11. Standard PFMEA Detection Ranking Detection Criteria: Likelihood of Detection by Process Control Rank Almost No known Controls available to detect Failure Mode or Cause 10 Impossible Very Remote Very remote likelihood current Controls with detect Failure Mode or Cause 9 Remote Remote likelihood current Controls with detect Failure Mode or Cause 8 Very Low Very low likelihood current Controls with detect Failure Mode or Cause 7 Low Low likelihood current Controls with detect Failure Mode or Cause 6 Moderate Moderate likelihood current Controls with detect Failure Mode or Cause 5 Moderately Moderately high likelihood current Controls with detect Failure Mode or Cause 4 High High High likelihood current Controls with detect Failure Mode or Cause 3 Very High Very high likelihood current Controls with detect Failure Mode or Cause 2 Current Controls almost certain to Failure Mode or Cause. Reliable detection controls are Almost Certain 1 known with similar processes.
12. FMEA Worksheet
13. Summary • FMEA is created to satisfy a customer or third party requirement, NOT to improve the process. • FMEA is developed too late in the process and does not improved the product/process development cycle. • The FMEA is perceived either as too complicated or as taking too much time.
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