Process FMEA (PFMEA)

Is your manufacturing process documented step by step?

Level 1 → 5World class at level 4

1. 1Process is in people's heads — not documented
2. 2Rough process description exists
3. 3Process flow diagram exists but may be out of date
4. 4Current, accurate process flow with inputs and outputs per stepWorld class
5. 5Live process documentation linked to PFMEA and control plan

For your most critical process steps, have you listed what can go wrong?

Level 1 → 5World class at level 4

1. 1No formal failure mode analysis
2. 2Informal knowledge of common problems
3. 3Some problem history documented but not structured as FMEA
4. 4Failure modes documented for high-risk process stepsWorld class
5. 5Comprehensive PFMEA covering all process steps

Do you use Severity, Occurrence, Detection ratings to prioritise your quality risks?

Level 1 → 5World class at level 4

1. 1No formal risk prioritisation
2. 2Informal severity ranking
3. 3Basic high/medium/low classification
4. 4SOD scoring with RPN calculation for significant risksWorld class
5. 5Full PFMEA with RPN matrix, regularly reviewed and updated

For your highest-risk failure modes, do you have verified controls in place?

Level 1 → 5World class at level 4

1. 1Controls are informal or unknown
2. 2Some controls exist but not linked to specific failure modes
3. 3Controls documented but not verified as effective
4. 4Controls linked to failure modes in a control plan; verifiedWorld class
5. 5Controls verified through measurement data; PFMEA updated when controls change