Process FMEA (PFMEA) Software

A PFMEA analyses how a manufacturing or assembly process can fail, what the effect on the customer is, and which controls catch the failure. The work centres on three columns most teams underestimate: the process step (specific, not generic), the current controls (prevention and detection), and Action Priority. See PFMEA vs DFMEA for scope boundaries.

Most teams start with a spreadsheet template inherited from a previous project. It looks workable for one FMEA, then breaks the moment the team grows or a customer audit is announced. The failure pattern is always the same.

• Version control. "FMEA_final_v3_rev_after_meeting.xlsx" is not an audit trail. There is no reliable way to answer "what did we approve and when".
• Audit traceability. Reviewers cannot see who changed a rating or why. Inputs, controls and decisions are scattered across emails and chats.
• AP calculation mistakes. The AIAG-VDA Action Priority table is not a single formula — most templates fall back to RPN or implement AP partially. A 10-2-2 safety failure ends up as "Low" because the spreadsheet only multiplies.
• Collaboration. Two reviewers cannot edit the same matrix at the same time without overwriting each other. Cross-functional sessions degrade into screen-share marathons.
• Consistency. Severity scales drift between projects. Detection ratings inflate because no one defines what "automated" actually means.

See common FMEA mistakes for the engineering side of the same problem.

1. Inputs. Upload your process flow, drawings or a previous FMEA. Qhubio extracts steps, functions and known controls.
2. AI-assisted draft. The system proposes failure modes, effects and causes as a structured matrix — never as free-form prose.
3. Engineering moderation. The team reviews each row, adjusts wording, removes false positives, and confirms the controls actually in place.
4. Deterministic AP. Severity, Occurrence and Detection are rated once; Action Priority is calculated by the backend using AIAG-VDA 2019 rules. The math is never up to the spreadsheet.
5. Approval. Reviewer and approver sign off; the version is frozen and stored with input and output snapshots.
6. Export. One-click Excel and PDF for the customer file, the audit binder, or the Control Plan handoff.

• 21-column AIAG-VDA matrix with enforced step / function / failure mode structure.
• Prevention & Detection controls consolidated into "Current controls" per the AIAG-VDA model.
• Deterministic Action Priority with a per-row confidence indicator.
• Control Plan handoff — see FMEA → Control Plan.
• Excel export tiers matching engineering, audit and OEM needs.

• Automotive Tier-1 suppliers: PPAP-grade PFMEAs with AIAG-VDA AP, ready for OEM audits.
• CNC machining shops: Tool wear, dimensional drift and inspection capability handled as standard rows. See the worked example.
• Electronics manufacturing: Solder, AOI and ICT controls written as detection-by-design, not as inspection-only.
• Assembly operations: Poka-yoke and torque verification linked to detection rating.
• Medical devices: Risk file alignment between FMEA and ISO 14971 hazard analysis.

Browse complete row-by-row PFMEAs for the processes most teams build first:

• CNC machining PFMEA — drilling, reaming, boring, dimensional control.
• Injection molding PFMEA — drying, fill, cooling, ejection.
• PCB assembly PFMEA — SMT line through ICT and conformal coat.
• Assembly process PFMEA — torque, harness, connectors, functional test.
• Welding PFMEA — robotic MIG/MAG with NDT.
• Stamping PFMEA — progressive die with in-die sensing.
• Browse all on the FMEA examples hub.

PFMEA is an APQP phase-2 deliverable that drives phase-3 Control Plan and phase-4 PPAP outputs. The PFMEA tool has to fit that gate cadence, not fight it. Qhubio is built to map cleanly into each phase.

See FMEA → Control Plan and the automotive FMEA pillar for the OEM-specific overlays.

• AIAG-VDA 7-step process — the methodology applied end-to-end.
• Action Priority guide — how the AP decision actually works.
• Severity, Occurrence and Detection rating guides.
• FMEA → Control Plan linkage — what flows downstream.
• PFMEA CNC example and more worked examples.
• Audit readiness checklist.