Risk Analysis Domain
Work item types used in HARA and DFMEA risk assessment. Risk records and failure modes are read-only in Polarion forms — editing is only possible through Nextedy risksheet.- Risk Record (riskRecord) — Central HARA entity combining hazard, use step, cause, harm, and P1xP2 risk parameters
- Failure Mode (failureMode) — DFMEA entity describing how a function or system element can fail, with SxOxD RPN scoring
- Hazard (hazard) — Potential source of harm per ISO 14971 (energy, motion, software malfunction)
- Harm (harm) — Specific injury, damage, or adverse effect with severity classification (Negligible to Catastrophic)
- Risk Control (riskControl) — Risk mitigation measure following the ISO 14971 three-tier hierarchy
- Cause (cause) — Root cause or mechanism producing a failure mode
Requirements Domain
Work item types forming the V-Model traceability chain from user needs through design requirements.- User Need (userNeed) — Customer, business, or stakeholder need at the top of the requirements hierarchy
- System Requirement (sysReq) — System-level requirement derived from user needs
- Design Requirement (desReq) — Technical implementation requirement derived from system requirements
Product Structure Domain
Work item types representing the physical and logical decomposition of the medical device.- System Element (systemElement) — Physical or logical component classified by type (System/Subsystem/Assembly/Subassembly/Component)
- Function (function) — Operational capability or behavior of a system element, assessed by failure modes in DFMEA
- Use Step (useStep) — Operational step or use scenario for HARA risk identification
- Process Step (processStep) — Manufacturing or process step for PFMEA analysis
Verification and Change Management
- Test Case (testCase) — Verification and validation test linked to requirements via
verifiesandvalidatesroles
Type Summary Table
| Type ID | Label | Domain | Custom Fields | Editing Mode |
|---|---|---|---|---|
riskRecord | Risk Record | HARA | 13 fields (P1, P2, risk, benefit-risk, final risk) | Risksheet only |
failureMode | Failure Mode | DFMEA | 12 fields (S, O, D, RPN, human factors) | Risksheet only |
hazard | Hazard | HARA | Standard fields + 4-level taxonomy | Form or risksheet |
harm | Harm | HARA | Severity (5-level scale) | Form or risksheet |
riskControl | Risk Control | Risk Control Plan | riskControlType (multi-enum) | Form or risksheet |
userNeed | User Need | Requirements | Standard fields | Form or powersheet |
sysReq | System Requirement | Requirements | Standard fields | Form or powersheet |
desReq | Design Requirement | Requirements | subType enum | Form or powersheet |
systemElement | System Element | Structure | elementType enum | Form |
function | Function | Structure | Standard fields | Form |
useStep | Use Step | HARA | Standard fields | Form |
processStep | Process Step | PFMEA | 5 fields (inputs, outputs, equipment, verification, linked element) | Form |
cause | Cause | DFMEA | Standard fields | Form |
task | Task | Actions | Standard fields | Form |
changeRequest | Change Request | Change Mgmt | Standard fields | Form |
defect | Defect | Quality | Standard fields | Form |
testCase | Test Case | Verification | Standard fields | Form |
Related Pages
- Data Model and Work Item Types — Conceptual overview of the entity taxonomy
- Link Roles and Traceability Relationships — How work item types connect through link roles
- Enumerations — All enumerated values used by custom fields