See the failure before it ships — an AIAG-VDA 2019 pFMEA generator.
Turn a plain-YAML process description into a complete, auditable Process FMEA — exported to Excel, Word, and PDF from a single source of truth. Action Priority and every summary metric are computed, never hand-entered.
One engine, many scenarios. Edit YAML — no Python required.
What every commercial and AI competitor is missing.
No $1.2k–$10k/seat licenses. MIT-licensed, runs offline, no account.
AP is one readable function — reproducible for any FDA/notified-body auditor. AI tools can't answer "why this score?"
One command, three formats. Competitors ship Excel only.
Maps pFMEA → Hazard / Harm / P1 / P2. The gap no tool fills: AIAG-VDA and medical risk.
YAML scenarios + a changelog command = auditable revision history for AIAG-VDA Step 7.
Metrics computed from the same AP call that fills the risk sheet — they can't drift.
Three medical-device manufacturing scenarios. Action Priority shown is exactly what the engine computes.
| Failure mode | S | O | D | AP |
|---|---|---|---|---|
| OD out of tolerance | 8 | 4 | 3 | L |
| Surface roughness Ra>0.8µm | 9 | 3 | 2 | M |
| Fixture slip mid-cycle | 7 | 3 | 4 | L |
| Coolant pressure drop | 9 | 3 | 5 | M |
| Wrong program revision | 8 | 2 | 3 | L |
| CMM step skipped | 7 | 4 | 7 | H |
| Failure mode | S | O | D | AP |
|---|---|---|---|---|
| Flash / fin at parting line | 6 | 4 | 3 | L |
| Footprint / height OOS | 8 | 4 | 5 | M |
| Wrong PEEK grade loaded | 9 | 3 | 7 | H |
| Short shot / incomplete fill | 7 | 3 | 2 | L |
| Gate vestige >0.3mm | 7 | 4 | 4 | M |
| Endplate texture OOS | 8 | 5 | 7 | H |
| Failure mode | S | O | D | AP |
|---|---|---|---|---|
| Channel seal defect | 9 | 4 | 6 | H |
| Pinhole / micro-leak | 10 | 2 | 8 | H |
| Seal temp out of range | 8 | 4 | 5 | M |
| Incorrect dwell time | 8 | 3 | 3 | L |
| UDI label mismatch | 8 | 2 | 4 | L |
| Breach during EtO/transit | 9 | 3 | 5 | M |
From clone to a three-format pFMEA in four lines.
git clone https://github.com/LSaiko/foremode.git && cd foremode pip install -r requirements.txt python foremode.py list # see scenarios python foremode.py generate sterile_packaging --format all --iso14971 # -> pfmea_sterile_packaging.xlsx / .docx / .pdf (+ ISO 14971 bridge sheet) python foremode.py changelog --from old.yaml --to scenarios/cnc_femoral_stem.yaml