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How is a DFMEA structured in risksheet?

The DFMEA risksheet organizes failure analysis in a three-level hierarchy:
LevelContentWork Item Type
Level 1Item / Functionfunction (linked via assesses role)
Level 2Failure ModefailureMode (text field + severity)
Level 3Cause of FailurecauseOfFailure (root cause text)
Functions are scoped to a specific subsystem using the queryFactory mechanism. The top panel resolves the document’s subsystem custom field and injects a component JavaScript variable that filters available functions to only those linked to that subsystem. For full column definitions, see the DFMEA Risksheet Configuration Reference.

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How is the Risk Priority Number (RPN) calculated?

The RPN is computed as the product of three factors: RPN = Severity x Occurrence x Detection Each factor uses a defined scale:
FactorScaleEnumDescription
Severity1—5failureModeSeverity1 = Negligible (green) through 5 = Critical/Intolerable (red)
Occurrence0—5fmOccurrence0 = Unanalyzed, 1 = Never (<5%) through 5 = Always (>95%)
Detection0—5detection0 = Unanalyzed, 1 = Never (<5%) through 5 = Always (>95%)
The risksheet computes the RPN automatically using the commonRpn formula. Both pre-mitigation and post-mitigation RPNs are calculated — the pre-mitigation RPN uses premitigationFMOccurrence and premitigationDetection, while the post-mitigation RPN uses postmitigationFMOccurrence and postmitigationDetection. Severity remains constant across both evaluations.
The risksheet applies three-tier color coding to RPN cells and row headers:
  • Green (1—10): Low risk — acceptable
  • Amber (11—30): Medium risk — requires attention
  • Red (>30): High risk — immediate action required

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What is the difference between DFMEA and HARA?

DFMEA and HARA are complementary risk analysis techniques with distinct scopes and scoring methods:
AspectHARADFMEA
FocusPatient harm from hazardsComponent/function failure modes
Hierarchy4 levels: Use Step > Hazard > Hazardous Situation > Harm3 levels: Function > Failure Mode > Cause
Scoring5x5 risk matrix (Probability x Severity)RPN = Severity x Occurrence x Detection
Risk levelsAcceptable / Investigation / UnacceptableLow / Medium / High (numeric RPN)
Benefit-riskYes (ISO 14971 Clause 7.4)No — uses RPN thresholds only
Final risk3 outcomes: Acceptable, Unacceptable, Benefit-Risk AcceptableRPN-based classification only
Views5 predefined viewsSingle default view
The two analyses are linked through the HARA Reference column in DFMEA (analyzedIn link role) and the FMEA cross-reference column in HARA, creating bidirectional traceability between failure modes and risk records. For details on HARA workflows, see the HARA Workflow Questions.

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How do I scope a DFMEA to a specific subsystem?

Each DFMEA document is scoped to a subsystem through the document’s subsystem custom field. When you create or configure a DFMEA document:
  1. Set the Subsystem field to the target system element
  2. The top panel resolves the subsystem and displays it in the header alongside the parent system element
  3. The queryFactory automatically filters the function picker to show only functions linked to that subsystem
If no subsystem is configured, the risksheet falls back to the root system element and displays a yellow warning: “Subsystem is not configured. Used default system item.” See Create System Elements for setting up the system element hierarchy.

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How do mitigation tasks work in DFMEA?

Risk mitigation in DFMEA uses task work items linked via the mitigates role. The risksheet displays four task-related columns:
  1. Task ID — link to the mitigation task work item
  2. Task Title — name of the mitigation action
  3. Task Status — current workflow status
After mitigation tasks are implemented, you re-evaluate occurrence and detection to calculate the post-mitigation RPN. The row header color updates to reflect the new RPN value, providing at-a-glance mitigation effectiveness.
The risksheet includes two server-rendered traceability columns that automatically resolve downstream links:
  • Requirements — traverses from task items to linked system requirements (sysReq) and design requirements (desReq)
  • Verification — performs a two-hop traversal from task to requirements to test cases (testCase), showing verification evidence

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How does the DFMEA Summary Report work?

The DFMEA Summary Report provides an executive-level overview with:
  • Executive summary cards showing pre-mitigation and post-mitigation RPN distribution (Low / Medium / High) with color-coded status indicators
  • Module-level breakdown table listing each DFMEA document with subsystem, total failure modes, and RPN distribution columns
  • Action items section (conditional) listing all modules with post-mitigation RPN > 30 that require immediate attention
The report auto-discovers all DFMEA modules in the Risks space matching the pattern DFMEA* or FMEA*, so new DFMEA documents appear automatically without configuration changes.

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What human factors fields are available in DFMEA?

Beyond standard DFMEA fields, the solution includes two IEC 62366 usability engineering fields on failure mode work items:
FieldPurpose
Cognition Error (cognitionError)Cognitive human factors errors such as misunderstanding or misinterpretation that contribute to the failure mode
Perception Error (perceptionError)Perceptual human factors errors such as failure to notice or misreading that contribute to the failure mode
Both fields default to “Undetermined” to explicitly track items that have not yet been analyzed, rather than leaving them blank.

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Can I export a DFMEA to PDF?

Yes. The DFMEA template includes a dedicated PDF export configuration that generates a multi-section document:
  1. Cover page with document properties (Model, Item, Owner, Core Team, Version, Last Update)
  2. Main risk records table (task columns hidden for readability)
  3. Prevention controls sub-table showing risk items with prevention controls
  4. Mitigations task list with Task ID, Title, and Status
The export also supports revision comparison mode — when comparing two document revisions, only the changes between them are exported. For step-by-step instructions on working with DFMEA, see the DFMEA Analysis Workflows section.
DFMEA risksheet configuration (DFMEATemplate/risksheet.json), failure mode custom fields (failureMode-custom-fields.xml), DFMEA severity/occurrence/detection enums, DFMEA Summary Report (System DFMEA Report/page.xml), DFMEA top panel (DFMEATemplate/risksheetTopPanel.vm), PDF export template (DFMEATemplate/risksheetPdfExport.vm).