Failure Mode & Effect Analysis (fmea) Worksheet template
A form in the Nonconformity and Corrective Action procedure (PR07), mapped to ISO 15189:2022 clauses 5.6, 8.5, 8.7. Fill it in whenever the task occurs. Used by the quality-management team.
FormISO 15189 · 5.6, 8.5, 8.7As needed
Calculated automatically
Your LaboratoryFailure Mode & Effect Analysis (fmea) Worksheet | YL-QM-FRM-07-F03c v1.0
Form: Failure Mode & Effect Analysis (fmea) Worksheet
Process / System
FMEA Date
RPN = Severity × Occurrence × Detectability | Scale: 1 (low) to 10 (high) | Priority: RPN ≥ 100 = High; 50-99 = Medium; < 50 = Low
| No. | Process Step / Function | Potential Failure Mode | Potential Effect of Failure | S | O | D | RPN (S×O×D) | Current Controls | Recommended Action | Revised S | Revised O | Revised D | Revised RPN |
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Max RPNauto
Mean RPNauto
… 10 more rows continue on the next page
Sign-off
| Role | Name | Signature | Date |
|---|---|---|---|
| Completed by | |||
| Reviewed by |
Shaded cells are calculated automatically.
Controlled document. Printed copies are uncontrolled unless stamped.Page 1
A4 landscape · first page · showing 10 of 20 rowsExactly as LabToolkit Pro prints it — with your logo and colours
What it records
- Process Step / Function
- Potential Failure Mode
- Potential Effect of Failure
- S
- O
- D
- RPN (S×O×D)
- Current Controls
- Recommended Action
- Revised S
- Revised O
- Revised D
- Revised RPN
Instructions on the form
- RPN = Severity × Occurrence × Detectability | Scale: 1 (low) to 10 (high) | Priority: RPN ≥ 100 = High; 50-99 = Medium; < 50 = Low
Sign-off
- Completed by
- Reviewed by
Related templates
- Nonconformity & Corrective Action Form (PR07-F01)
- Corrective & Preventive Action (capa) Form (PR07-F01 (CAPA-FORM))
- Nonconformity Log (PR07-F02)
- CAPA Register & Status Tracker (PR07-F02 (CAPA-LOG))
- 5-why Root Cause Analysis Worksheet (PR07-F03a)
- Fishbone / Ishikawa Cause Analysis Worksheet (PR07-F03b)
- CAPA Effectiveness Review Form (PR07-F04)
- Nonconformity Trend Analysis Dashboard (PR07-F05)
- Guide: ISO 15189 documentation checklist
Clause references are to ISO 15189:2022; check them against your licensed copy of the standard.