Skip to main content

​
Prerequisites

​
Understanding the Risk Control Hierarchy

ISO 14971 requires risk controls to be considered in a specific priority order: diagram
Control TypeEnum IDExamples
Inherent Safety by DesignInherentSafetyDesignMaterial change, geometry redesign, eliminating sharp edges
Protective MeasureProtectiveMeasurePhysical guards, software interlocks, pressure relief valves
Information for SafetyInformationForSafetyWarning labels, IFU instructions, training materials

​
Step 1: Open the Measures View

  1. Open your HARA document in risksheet mode
  2. Switch to the Measures view — this shows all columns except detailed probability values, giving you a clear view of risk controls alongside risk records
The default No Risk Records and Reqs Link view also shows risk control columns. The Measures view uses @all minus probability columns for a focused layout.

​
Step 2: Create or Select a Risk Control

In the Risk Control column (task link), you can either link an existing risk control or create a new one: To link an existing control:
  1. Click the risk control cell for the target risk record
  2. Use the picker to search the Risk Control Plan document (Risks/RiskControlPlan)
  3. Select the appropriate risk control
To create a new control:
  1. Click the risk control cell
  2. Select Create new — a new riskControl work item will be created in the Risk Control Plan document
  3. Enter the risk control title and save
Risk controls live in the Risk Control Plan document (Risks/RiskControlPlan), not in the HARA document. The risksheet uses the mitigates link role to connect risk controls to risk records across documents.

​
Step 3: Set the Risk Control Type

After linking the risk control, set its type in the Risk Control Type column (riskControlType):
  1. Click the Risk Control Type cell
  2. Select one or more types from the ISO 14971 hierarchy:
    • Inherent Safety by Design — the most effective type
    • Protective Measure — physical or software barriers
    • Information for Safety — least effective, used when design controls are exhausted
The riskControlType field supports multiple values. A single risk control can span multiple tiers (for example, a redesign that also includes a warning label). However, ISO 14971 expects controls to be applied in priority order — document your rationale if relying primarily on lower-priority types.

​
Step 4: Verify Traceability Columns

The risksheet automatically populates two server-rendered traceability columns:
ColumnShowsTraversal Path
RequirementsSystem and design requirements implementing the controlRisk Control —> sysReq / desReq (back-links)
Verification EvidenceTest cases verifying the requirementsRisk Control —> Requirements —> testCase (two-hop)
These columns update automatically when requirements and test cases are linked to the risk control in Polarion.

​
Step 5: Assign Multiple Controls (If Needed)

A single risk record can have multiple risk controls. To add additional controls:
  1. Click the risk control cell on the same risk record row
  2. Link or create another risk control
  3. Each control appears as a separate entry in the task column
Review whether higher-priority controls are feasible before relying on information-for-safety measures. ISO 14971 Clause 7.1 requires demonstrating that the control hierarchy was followed.

​
What Happens Next

After assigning risk controls:
  1. Evaluate residual risk — re-assess probability with controls in place. See Evaluate Residual Risk (Post-Mitigation).
  2. Review the Risk Control Plan — verify all controls are documented in the Risk Control Plan with proper type classifications.
  3. Check requirements traceability — ensure controls are traced to design requirements and verification tests via the PowerSheet RTM views.
HARA risksheet configuration (HARATemplate/risksheet.json), Risk Control Plan configuration (RiskControlPlanTemplate/risksheet.json), risk control custom fields (riskControl-custom-fields.xml), risk control type enumeration (riskControlType-enum.xml), UI walkthrough (risksheet-views.md).