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FMEA and PFMEA risk assessment
Build an FMEA, PFMEA or DFMEA from your records: failure modes scored for severity, occurrence and detection, ranked by RPN, classed Critical to Low, with mitigation actions and residual RPN for every Critical and High risk, exported to Excel.
In the portal: /app/intelligence
Build an FMEA
Ask Q Intelligence, for example: "Build a PFMEA for the aseptic filling process from our deviations, investigations and SOPs, with mitigation actions for the critical risks." It reads the records first and puts the record or document reference on each row.
- Person
1. Ask for the FMEA
Process, product or equipment and scope
- AI drafts
2. Read the records
Steps, deviations, complaints, CAPAs, SOP controls
- AI drafts
3. Score S, O, D
1 to 10 scales, each row referenced
- System
4. Rank by RPN and class
Refused until Critical/High rows have actions
- Person
5. Review and edit scores
Ranking and residuals update at once
- Person
6. Export or save
Excel workbook, CSV, Generated charts
- Person
7. Team approval
Under your ICH Q9(R1) procedure
Scoring and classes
RPN = Severity × Occurrence × Detection (1 to 1,000). Rows are ranked by RPN, then severity, then occurrence.
| Class | Rule (defaults) | Mitigation |
|---|---|---|
| Critical | RPN ≥ 200, or severity ≥ 9 whatever the RPN | Required |
| High | RPN ≥ 100 | Required |
| Medium | RPN ≥ 50 | Optional |
| Low | Below 50 | Optional |
Every Critical and High risk needs a specific action aimed at the cause (eliminate the cause, reduce occurrence, improve detection, or reduce severity), an owner role, a due date and the revised S, O and D expected after it. The residual RPN and class follow; a severity of 9 or 10 stays Critical unless a design change lowers the severity itself.
Views and exports
- Register: the ranked table with scores, RPN bar, class, controls, mitigation, revised scores and residual RPN; scores and actions are editable.
- RPN Pareto: RPN by failure mode with the cumulative percentage; severity-critical risks are called out.
- Risk matrix: severity by occurrence, each failure mode coloured by its class.
- Rating scales: the S, O and D criteria.
- Excel: register (RPN, class and residual columns are live formulas), summary and rating scales sheets. CSV. Save to Generated charts and the dashboard.
Rule: An FMEA from Q Intelligence is a draft for the cross-functional team to review, score and approve. Q Intelligence does not accept risks.