Traceability Overview
V-Model Traceability Links
These link roles implement the requirements decomposition and verification/validation chain:
| Role ID | Forward Label | Reverse Label | From | To | Cardinality |
|---|
refines | Refines | is Refined by | sysReq, desReq | userNeed, sysReq | many-to-many |
verifies | Verifies | is Verified by | testCase | sysReq, desReq | many-to-many |
validates | Validates | is Validated by | testCase | userNeed | many-to-many |
address | Address | is Addressed by | useStep | userNeed | many-to-many |
The distinction between verifies and validates implements the ISO 14971 V&V separation: verification confirms a requirement is correctly implemented, while validation confirms a user need is met under real-world conditions.
Risk Analysis Links
These link roles create the risk assessment traceability graph connecting hazards, harms, risk records, failure modes, and risk controls:
| Role ID | Forward Label | Reverse Label | From | To | Cardinality |
|---|
hasHazard | has Hazard | is Hazard in | riskRecord | hazard | many-to-one |
hasHarm | has Harm | is Harm in | riskRecord | harm | many-to-one |
hasCause | has Cause | is Cause in | riskRecord, failureMode | cause | many-to-many |
assesses | Assesses | is Assessed by | failureMode | function, systemElement, processStep | many-to-many |
assesses | Assesses | is Assessed by | riskRecord | function, systemElement, useStep, processStep | many-to-many |
analyzedIn | is Analyzed in | Analyzes | failureMode | riskRecord | many-to-many |
mitigates | Mitigates | is Mitigated by | task, riskControl | failureMode, riskRecord | many-to-many |
assesses Link — Multi-Rule Structure
The assesses link role has the most complex type constraint. It supports two distinct patterns:
- DFMEA pattern:
failureMode assesses function, systemElement, or processStep
- HARA pattern:
riskRecord assesses function, systemElement, useStep, or processStep
analyzedIn — DFMEA-to-HARA Bridge
The analyzedIn link role bridges DFMEA failure modes to HARA risk records, enabling cross-referencing between the two risk analysis methodologies. In risksheet configurations, this appears as the FMEA Reference / HARA Reference columns.
Structural Links
These link roles manage the product structure and requirement-to-control traceability:
| Role ID | Forward Label | Reverse Label | From | To | Constraint |
|---|
parent | has parent | is parent of | Any type | Same type | sameType='true' |
allocatedTo | is Allocated to | has Allocated | function, failureMode, riskRecord, processStep | systemElement | Typed |
implements | Implements | is Implemented by | task | sysReq, desReq, riskControl | Rule 1 |
implements | Implements | is Implemented by | sysReq, desReq | riskControl | Rule 2 |
The parent link enforces sameType='true', meaning only items of the same type can be hierarchically nested. A sysReq can be a child of another sysReq, but not of a userNeed. Cross-type hierarchy is handled by the refines link role instead.
implements — Two-Rule Structure
The implements link has two rules:
- Tasks implement requirements or controls:
task —> sysReq / desReq / riskControl
- Requirements implement controls:
sysReq / desReq —> riskControl
This creates bidirectional requirement-to-control traceability, visible in the HARA risksheet’s Requirements and Verification Evidence columns.
Change Management Links
These link roles support defect tracking, change control, and follow-up actions:
| Role ID | Forward Label | Reverse Label | From | To |
|---|
detectedBy | is Detected by | Detects | defect | testCase |
tracks | Tracks | is Tracked by | changeRequest | sysReq, desReq, riskRecord, failureMode, task, defect |
followsUp | Follows up | is Followed up by | task | defect, task, changeRequest |
Generic Links
These link roles have no type constraints and apply to any work item type:
| Role ID | Forward Label | Reverse Label | Constraints |
|---|
branched_from | is Branched from | has Branch | None |
derived_from | is Derived from | has Derived | None |
Link Role Usage in Risksheet
The following table summarizes how link roles appear in risksheet column configurations:
| Risksheet | Column Type | Link Role | Target Type |
|---|
| HARA | itemLink (L1) | assesses | useStep |
| HARA | itemLink (L2) | hasHazard | hazard |
| HARA | itemLink (L4) | hasHarm | harm |
| HARA | multiItemLink (FMEA Ref) | analyzedIn (backLink) | failureMode |
| HARA | taskLink | mitigates | riskControl |
| DFMEA | itemLink (L1) | assesses | function |
| DFMEA | multiItemLink (HARA Ref) | analyzedIn | riskRecord |
| DFMEA | taskLink | mitigates | task |
| Risk Control Plan | multiItemLink | mitigates | riskRecord |
Related Pages
