FMEA (Failure Mode and Effects Analysis)

Overview

FMEA systematically identifies potential failure modes, their effects, causes, and current controls. Each failure is scored on Severity (S), Occurrence (O), and Detection (D) on 1-10 scales. RPN = S × O × D prioritizes which risks to address first. AIAG-VDA FMEA (2019) replaces RPN with Action Priority (AP) matrix.

When to Use

Trigger conditions:

• Designing new products/processes and identifying risks proactively
• Systematically evaluating existing failure modes for prioritization
• Meeting automotive (IATF 16949) or medical device (ISO 13485) quality requirements

When NOT to use:

• For root cause analysis of a known problem (use fishbone/5-why)
• For statistical analysis of defect data (use SPC or Pareto)

Algorithm