All fields on Failure Mode work items are read-only in the standard Polarion work item form. Editing is only possible through Nextedy risksheet. This ensures RPN formula integrity and structured data entry.
Custom Fields
Failure Description Fields
| Field ID | Display Name | Type | Default | Description |
|---|
failureMode | Failure Mode | Rich Text | — | How the function or component fails to perform as intended |
effectOfFailure | Effect of Failure | Rich Text | ”Undetermined” | Downstream consequence on the system, user, or patient |
causeOfFailure | Cause of Failure | Rich Text | ”Undetermined” | Root cause or mechanism producing the failure |
Human Factors Fields (IEC 62366)
| Field ID | Display Name | Type | Default | Description |
|---|
cognitionError | Cognition Error | Rich Text | ”Undetermined” | Cognitive errors (misunderstanding, misinterpretation) contributing to failure |
perceptionError | Perception Error | Rich Text | ”Undetermined” | Perceptual errors (failure to notice, misreading) contributing to failure |
Pre-Mitigation Scoring
| Field ID | Display Name | Type | Enumeration | Description |
|---|
fmSeverity | Failure Mode Severity | Enum | failureModeSeverity (1-5) | Severity of the failure effect, color-coded |
premitigationFMOccurrence | Pre-Mitigation Occurrence | Enum | fmOccurrence (0-5) | How often the failure is expected to occur |
premitigationDetection | Pre-Mitigation Detection | Enum | detection (0-5) | Likelihood of detecting the failure before it reaches the user |
premitigationRPN | Pre-Mitigation RPN | Integer | — | Computed: S x O x D (set by risksheet formula) |
Post-Mitigation Scoring
| Field ID | Display Name | Type | Enumeration | Description |
|---|
postmitigationFMOccurrence | Post-Mitigation Occurrence | Enum | fmOccurrence (0-5) | Occurrence after mitigation controls |
postmitigationDetection | Post-Mitigation Detection | Enum | detection (0-5) | Detection after mitigation controls |
postmitigationRPN | Post-Mitigation RPN | Integer | — | Computed: S x O_new x D_new (set by risksheet formula) |
Severity (fmSeverity) is shared between pre-mitigation and post-mitigation RPN. Only Occurrence and Detection change after mitigation — Severity remains constant per failure mode.
RPN Calculation
RPN = Severity (S) x Occurrence (O) x Detection (D)
| RPN Range | Tier | Color | Cell CSS |
|---|
| 1 - 10 | Low | Green (#4CAF50) | rpn1 |
| 11 - 30 | Medium | Amber (#FF9800) | rpn2 |
| > 30 | High | Red (#F44336) | rpn3 |
Severity Scale
| Value | Label | Color | Description |
|---|
| 1 | Negligible (Acceptable) | #58FF59 | No mitigation beyond standard design controls |
| 2 | Low (Tolerable) | #ADFF59 | Tolerable under standard monitoring |
| 3 | Moderate (Undesirable) | #FFFF59 | Requires verification or mitigation plan |
| 4 | High (Unacceptable) | #FFB359 | Unacceptable without corrective actions |
| 5 | Critical (Intolerable) | #FF5959 | Intolerable until fully mitigated |
Occurrence Scale
| Value | Label | Range |
|---|
| 0 | Unanalyzed | Default |
| 1 | Never | < 5% |
| 2 | Seldom | 5 - 25% |
| 3 | Sometimes | 25 - 75% |
| 4 | Often | 75 - 95% |
| 5 | Always | > 95% |
Detection Scale
| Value | Label |
|---|
| 0 | Unanalyzed (default) |
| 1 | Never |
| 2 | Seldom |
| 3 | Sometimes |
| 4 | Often |
| 5 | Always |
Higher detection values mean the failure is more likely to be detected before reaching the user. A detection rating of 5 (“Always”) indicates near-certain detection, while 1 (“Never”) means the failure will almost certainly escape detection.
Link Roles
| Role | Direction | Target Type | Description |
|---|
assesses | Outgoing | function, systemElement, processStep | What this failure mode analyzes |
hasCause | Outgoing | cause | Root cause of the failure |
analyzedIn | Outgoing | riskRecord | HARA risk records linked to this failure mode (DFMEA-to-HARA bridge) |
mitigates | Incoming | task, riskControl | Tasks or controls that mitigate this failure mode |
allocatedTo | Outgoing | systemElement | System element this failure mode is allocated to |
tracks | Incoming | changeRequest | Change requests tracking this failure mode |
DFMEA Risksheet Hierarchy
In the DFMEA risksheet, failure modes are organized in a 3-level tree:
| Level | Entity | Column |
|---|
| L1 | Function | Item/Function link (via assesses role) |
| L2 | Failure Mode | failureMode text field |
| L3 | Cause | causeOfFailure text field |
HARA Cross-Reference
The DFMEA risksheet includes a HARA Reference column that shows backlinks to risk records via the analyzedIn role. This provides bidirectional traceability between DFMEA failure modes and HARA risk records, linking design-level failure analysis to the ISO 14971 hazard analysis.
- All fields are read-only in the default hat (
@all fields locked for _default status)
- Failure modes can only be edited through the DFMEA risksheet view
- RPN fields (
premitigationRPN, postmitigationRPN) are computed by risksheet formulas — not manually entered
- All text fields default to “Undetermined” rather than empty, providing explicit tracking of unanalyzed items
Related Pages
