"algo-mfg-fmea"

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

IRON LAW: Severity Can NEVER Be Reduced by Design Changes
Severity is determined by the EFFECT on the customer. A brake failure
is always severity 10, regardless of how unlikely or detectable it is.
FMEA reduces risk by: lowering Occurrence (better design/process) or
improving Detection (better testing/inspection). NEVER inflate
Detection scores to lower RPN artificially.

Phase 1: Input Validation

Define scope: Design FMEA (DFMEA) or Process FMEA (PFMEA). Assemble cross-functional team. Prepare: process flow diagram or system block diagram. Gate: Scope defined, team assembled, reference diagrams available.

Phase 2: Core Algorithm

1. List all potential failure modes for each function/process step
2. For each failure mode, identify: effect on customer, root cause(s), current prevention controls, current detection controls
3. Score: Severity (1-10), Occurrence (1-10), Detection (1-10)
4. Classic RPN: RPN = S × O × D. Prioritize high RPNs.
5. AIAG-VDA AP: Use the S-O-D combination matrix to assign Action Priority: High, Medium, Low.
6. Define recommended actions for High-priority items with responsibility and target dates

Phase 3: Verification

Review: are all functions/steps covered? Do severity scores match actual customer impact? Are detection scores realistic (not overly optimistic)? Gate: Complete coverage, realistic scoring, actions assigned for high-priority items.