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Severity is defined on the Harm work item type (not on the risk record itself). In risksheet, the harmSeverity column resolves severity from the linked harm item via the cross-item binding harm.severity.
Severity level descriptions align with ISO 14971:2019 Annex E guidance on estimating severity of harm. The scale uses patient-outcome language consistent with medical device regulatory expectations.

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Severity Scale

LevelIDNameDescriptionDefaultColor
11NegligibleTemporary discomfort; no injury or medical intervention required—
22MinorTemporary injury not requiring medical interventionGray #95A5A6
33SeriousInjury requiring medical interventionGreen #2ECC71
44CriticalPermanent impairment or life-threatening conditionYesBlack #000000
55CatastrophicPatient deathRed #E74C3C

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Default Value Rationale

The default severity is Critical (level 4), not Catastrophic. This implements a conservative-but-practical risk management strategy:
  • Conservative: unassessed harms are treated as life-threatening until explicitly evaluated, preventing underestimation of risk
  • Not maximally alarming: defaulting to Catastrophic (level 5) would be dismissed as overly pessimistic, discouraging meaningful analysis
Any harm item without an explicitly assigned severity will appear as Critical in the risk matrix and risksheet. Always assign severity during the hazard identification phase to ensure accurate risk evaluation.

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How Severity Feeds Into the Risk Matrix

Severity occupies the vertical axis (rows) of the 5x5 risk acceptability matrix. It is combined with the calculated composite probability P (derived from P1 x P2) on the horizontal axis. 
                  Probability (P)
                  1     2     3     4     5
Severity    1   [ A ] [ A ] [ A ] [ A ] [ I ]
            2   [ A ] [ A ] [ I ] [ I ] [ U ]
            3   [ A ] [ I ] [ I ] [ U ] [ U ]
            4   [ I ] [ I ] [ U ] [ U ] [ U ]
            5   [ I ] [ U ] [ U ] [ U ] [ U ]

A = Acceptable   I = Investigation   U = Unacceptable
Higher severity shifts the risk classification toward Unacceptable, particularly when combined with probabilities of 3 or above.

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Configuration Details

PropertyValue
Source file.polarion/tracker/fields/harm-severity-enum.xml
Enum typeharm-severity
Applied toHarm work item type
Referenced in risksheet asharm.severity (cross-item binding)
Used by reportsRisk Matrix Report, ISO 14971 HARA Report (Section 2 methodology, Section 5/6 matrices)
Code: harm-severity-enum.xml, risksheetTopPanel.vm, Hara Risk Matrix Report page.xml, iso-14971-hara-report page.xml