Overview
| Property | Value |
|---|
| Type ID | riskControl |
| Sort Order | 6 |
| Domain | Risk Analysis (Risks space) |
| Managed In | Risk Control Plan risksheet document |
| ISO Standard | ISO 14971 — Risk Control Measures |
Custom Fields
Risk control work items have a single custom field that classifies the type of risk reduction measure:
| Field ID | Display Name | Type | Enum | Multi-valued |
|---|
riskControlType | RiskControlType | enum | riskControlType | Yes |
riskControlType Values
The field supports multiple selections, allowing a single control to span more than one tier. Per ISO 14971, controls should be applied in priority order:
| Priority | Enum ID | Display Name | Description |
|---|
| 1 (highest) | InherentSafetyDesign | Inherent Safety by Design | Eliminate the hazard entirely through design choices |
| 2 | ProtectiveMeasure | Protective Measure | Physical barriers, guards, interlocks, or automatic shutoffs |
| 3 (lowest) | InformationForSafety | Information for Safety | Labels, warnings, instructions for use, training |
Standard Fields
In addition to the custom riskControlType field, risk control work items use these standard Polarion fields:
| Field | Type | Description |
|---|
title | String | Name of the risk control measure |
description | Rich text | Detailed description of the control implementation |
status | Enum (status) | Lifecycle state: Draft, In Review, Pending Approval, Approved, Rejected, Obsolete |
severity | Enum (severity) | General severity classification (Blocker through Trivial) |
priority | Enum (priority) | Priority level (Highest through Lowest) |
Link Roles
Risk control work items participate in three link roles:
| Link Role | Direction | Connected Type | Purpose |
|---|
mitigates | Forward | riskRecord, failureMode | Identifies which risk records and failure modes this control addresses |
implements | Reverse (from sysReq, desReq) | sysReq, desReq | Tracks which requirements implement this control |
implements | Reverse (from task) | task | Tracks which tasks implement this control |
Risksheet Behavior
Risk controls appear in two risksheet contexts:
Risk Control Plan Document
The dedicated Risk Control Plan risksheet has a flat, single-level layout with three columns:
| Column | Binding | Description |
|---|
| Risk Control | title | Name of the control measure |
| Risk Control Type | riskControlType | ISO 14971 control tier classification |
| Risk Records | mitigates (multiItemLink) | Linked risk records this control addresses |
HARA and DFMEA Documents
In HARA and DFMEA risksheets, risk controls appear as task link columns. The HARA sheet references controls from the Risks/RiskControlPlan document via the mitigates link role, showing the control ID, title, and type alongside each risk record.
Risk control work items are created and edited only in the Risk Control Plan risksheet document. HARA and DFMEA sheets reference them via task link columns but do not create new control records.
ISO 14971 Context
Per ISO 14971:2019, the manufacturer shall implement risk control measures in the following order of priority:
- Inherent safety by design — Eliminate or reduce the hazard by changing the design
- Protective measures — Add physical safeguards (guards, interlocks, automatic shutoffs)
- Information for safety — Provide warnings, labels, instructions for use, or training
The multi='true' attribute on the riskControlType field allows a single control to be tagged with multiple tiers simultaneously, though ISO 14971 typically treats these as a priority hierarchy.
Related Pages
