Prerequisites
- Residual risk evaluated for all risk records (see Evaluate Residual Risk)
- At least one risk record with
postRisk= Investigation - All feasible risk controls already applied (see Assign Risk Controls to Hazards)
When Is Benefit-Risk Analysis Required?
Benefit-risk analysis applies when all three conditions are met:- The residual risk level is Investigation (ALARP zone)
- No additional risk controls are technically feasible
- The device provides a clinical benefit that could justify accepting the residual risk
Step 1: Switch to the Residual Evaluation View
- Open your HARA document in risksheet mode
- Select the Residual Evaluation view — this is the only view that shows benefit-risk columns alongside post-mitigation data
Step 2: Set “Additional Controls Possible” to No
For each risk record requiring benefit-risk analysis:- Locate the Additional Controls Possible column (
additionalControlsPossible) - Set the value to No
If
additionalControlsPossible is anything other than “No”, the finalRisk formula will return Unacceptable. This enforces the ISO 14971 requirement to reduce risk as far as practicable before relying on benefit-risk justification.Step 3: Write the Benefit Description
- Click the Benefit column (
benefit) cell for the risk record - Enter a description of the clinical or functional benefit that the device provides to the patient or user
- Be specific about the therapeutic outcome, diagnostic value, or patient safety improvement
- The specific clinical benefit (e.g., “Continuous infusion monitoring prevents dosing errors that cause 12,000 adverse events annually”)
- Quantitative evidence where available (clinical studies, literature references)
- The patient population that benefits
- The severity of the condition being treated
Step 4: Set the Benefit-Risk Result
- Click the Benefit-Risk Result column (
riskBenefitResult) - Select one of two outcomes:
| Result | Enum ID | Meaning | Effect on Final Risk |
|---|---|---|---|
| Benefit > Risk — acceptable | benefitAcceptable | Clinical benefits outweigh residual risk | Final risk = Benefit-Risk Acceptable (purple) |
| Benefit < Risk — NOT acceptable | benefitNotAcceptable | Residual risk exceeds clinical benefit | Final risk = Unacceptable (red) |
Step 5: Verify the Final Risk
After setting the benefit-risk result, check the Final Risk (finalRisk) column:
| Final Risk | Color | Meaning |
|---|---|---|
| Acceptable | Green | Post-mitigation risk was already acceptable |
| Benefit-Risk Acceptable | Purple | Risk accepted through benefit-risk justification |
| Unacceptable | Red | Risk exceeds tolerance, no adequate justification |
rpn4) is unique to benefit-risk acceptable outcomes, providing immediate visual differentiation from standard acceptance.
The row header also reflects the final risk status through the
rowHeaderRpnNew renderer, giving you an at-a-glance view of each risk record’s final determination.Step 6: Review All Benefit-Risk Decisions
Before finalizing:- Switch to the Residual Evaluation view to see all benefit-risk decisions in context
- Verify that every risk record has a final risk determination
- Confirm that no risk record has
additionalControlsPossibleleft empty or at the default - Review benefit descriptions for completeness and objectivity
Common Scenarios
| Scenario | Action |
|---|---|
| Post-risk is Acceptable | No benefit-risk needed — final risk is automatically Acceptable |
| Post-risk is Investigation, more controls exist | Set additionalControlsPossible = Yes, apply more controls first |
| Post-risk is Investigation, no more controls | Set to No, write benefit justification, set result |
| Post-risk is Unacceptable | Cannot use benefit-risk — must apply additional controls or redesign |
Sources
Sources
HARA risksheet configuration (
HARATemplate/risksheet.json), risk record custom fields (riskRecord-custom-fields.xml), benefit-risk result enumeration (riskBenefitResult-enum.xml), final risk enumeration (finalRisk-enum.xml), HARA top panel riskValueFinal() function (risksheetTopPanel.vm).