01
Problem
The MARA Vapor Probe required a controlled final inspection process spanning firmware programming, pressure sensor verification, manual checks, automated leak tests, electrical verification, and packaging readiness.
02
Constraints
- Multiple method statements governed different portions of the inspection workflow.
- Pressure sensor accuracy, balloon integrity, impedance, and thermocouple response were safety-related checks.
- Manual and automated modes both required defined operator workflow.
- Inspection evidence had to support finished-device release.
03
Engineering Decisions
- Integrated FISO EEPROM programming, manual-mode verification, and auto-mode inspection into a coherent workflow.
- Separated pressure verification points from leak and electrical checks.
- Used automated pass/fail steps where operator interpretation created risk.
- Included packaging preparation in the validated end-to-end inspection scope.
04
Validation
- Verified FISO pressure sensor calibration coefficients and programming workflow.
- Validated manual-mode checks at defined pressure points.
- Validated auto-mode leak, impedance, and thermocouple response checks.
05
Risk & Mitigation
- Operator setup errors could cause incorrect final inspection; mitigated with defined sequencing and interlocks.
- Balloon micro-leaks could escape detection; mitigated with controlled pressure decay checks.
- Incorrect firmware or sensor coefficients could affect safety; mitigated with EEPROM verification.
06
Outcome
The final inspection process was structured as a traceable, release-ready workflow covering critical safety and performance checks.