Failure Mode(s) and Effects Analysis (FMEA) is one of the most effective analytic tools (methodology) to identify Potential Factors in a system, which is:

  • Product or Design – to achieve the desired Quality
  • Work System – Process Safety and Operational Efficiency
  • Machine – Equipment Reliability and Maintainability, as well as Life Cycle Costs

FMEA was born as a tool to identify Potential Failure and help to improve the system – such as Process, Equipment, and Products in Design Phase, we will call 1st Look FMEA.

On the other hand, the application of FMEA for Root Cause Analysis (RCA) is a tool to analyze Possible Causes and also helps to improve the existing (current) system – 2nd Look FMEA.

Two types of Failures

Analytical Approach

2nd Look Process FMEA Worksheet

  • Step 0 Team Organization (3-5 Cross-Functional Team Members)
  • Step 1 List of All Components of the system – Reliability Functional Block Diagram
    • Visualize Process Functional Flow & Structure (by Component Level)
  • Step 2 Analyze Potential Failure Mode – Deviation from Required Conditions & Verify Failure Mode (Deviation)
  • Step 3 Analyze the effects of system Relationship Between Quality Defect and Failure Mode
  • Step 4 Evaluate “Severity Rating” (1 – 10 pts)
  • Step 5 Analyze (Potential) Causes of Failure Mode (Deviation)
  • Step 6 Evaluate “Occurrence Rating” (1 – 10 pts) by Loss Tree (Daily Production Record)
  • Step 7 Review Current Control System Investigate Current Maintenance Level
  • Step 8 Evaluate “Detection Rating” (1 – 10 pts)
  • Step 9 Calculate Risk Priority Number (RPN)
    • RPN=Verification Criteria x Severity Rating x Occurrence Rating x Detection Rating
  • Step 10 Create Actions for High-Risk Failure Mode
  • Step 11 Assign Who & by When taking Actions & Record Countermeasures by M-P Record
  • Step 12 Evaluate Actions for Reducing Risk of Failure Mode Summarize the Results

Reliability Functional Block Diagram

How to Use 2nd Look Process FMEA Worksheet

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