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Unlike the HARA harm severity scale which uses patient-outcome language, the failure mode severity scale combines numeric ratings with risk acceptability qualifiers, bridging FMEA methodology with ISO 14971 risk language.

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Severity Scale

RatingIDNameRisk QualifierIconColor
11NegligibleAcceptableRPN_green#58FF59
22LowTolerableRPN_lightgreen#9AFF59
33ModerateUndesirableRPN_yellow#FFFF59
44HighUnacceptableRPN_orange#FFA959
55CriticalIntolerableRPN_red#FF5959
The color palette follows a traffic-light gradient from green (acceptable) to red (intolerable), providing immediate visual risk communication in risksheet views.

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Dual Labeling System

Each severity level carries two labels:
  1. Numeric severity name (Negligible through Critical) — standard FMEA rating language
  2. Risk acceptability qualifier (Acceptable through Intolerable) — ISO 14971 risk evaluation language
This dual labeling enables the DFMEA to communicate in both FMEA practitioner language and ISO 14971 regulatory language simultaneously.
A failure mode rated as 4 - High (Unacceptable) tells the FMEA team that the effect is high-severity, and tells the regulatory reviewer that this severity level is considered unacceptable by the organization’s risk criteria.

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Where This Enumeration Is Used

FieldIDWork Item TypePurpose
Failure mode severityfmSeverityFailure ModeSeverity rating for the failure mode effect
Unlike occurrence and detection, severity is assigned once per failure mode and does not have separate pre/post-mitigation values. The severity of the failure mode effect does not change with mitigation — only the likelihood (occurrence) and detectability change.

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RPN Calculation

Severity is multiplied with occurrence and detection to produce the Risk Priority Number: 
RPN = Severity (S) x Occurrence (O) x Detection (D)
         (1-5)          (1-5)            (1-5)

Minimum RPN:  1 x 1 x 1 =   1
Maximum RPN:  5 x 5 x 5 = 125
The RPN value is computed automatically by risksheet formula columns:
FieldIDStage
Pre-mitigation RPNpremitigationRPNS x pre-O x pre-D
Post-mitigation RPNpostmitigationRPNS x post-O x post-D

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Comparison: FM Severity vs. Harm Severity

PropertyFailure Mode SeverityHarm Severity
Used inDFMEA / PFMEAHARA
Scale1-5 with risk qualifiers1-5 with patient outcomes
DefaultNoneCritical (4)
Color codingTraffic-light gradient iconsSemantic colors
Role in risk evaluationS factor in RPN = S x O x DRow axis in 5x5 risk matrix
Applied toFailure Mode work itemHarm work item

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Configuration Details

PropertyValue
Source file.polarion/tracker/fields/failureMode-failureModeSeverity-enum.xml
Enum typefailureModeSeverity
Applied toFailure Mode (fmSeverity)
IconsProject path /polarion/icons/project/IDC_2512/RPN_*
Used in reportsDFMEA Summary Report
The color-coded RPN icons are stored in the IDC_2512 project icon library. This is a hardcoded dependency — if the icon project is unavailable, severity cells will display without color indicators.
Code: failureMode-failureModeSeverity-enum.xml, failureMode-custom-fields.xml, DFMEATemplate risksheet.json