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Prerequisites

  • A project created from the Medical Device Safety Solution template
  • Process steps defined in a Process Steps document (or ready to create them)
  • System elements already created in the System Element Tree

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Step 1: Create a PFMEA Document

  1. Navigate to Risks space in Polarion
  2. Click Create New Document
  3. Select PFMEATemplate as the template
  4. Enter a document title (e.g., “PFMEA - Smart Infusion Pump”)
  5. Click Create
The new document inherits the PFMEA structure including:
  • FMEA header metadata table (Item, Model, Version, Owner, Core Team)
  • Risksheet edit panel with a direct link to open in risksheet
  • Scope checklist covering Manufacturability, Handling, Maintenance, and Custom areas
Review and update the scope checklist to reflect which process areas your PFMEA covers. By default, Manufacturability, Handling, Maintenance, and Custom are checked.

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Step 2: Define Process Steps

Process steps are the foundation of PFMEA analysis. Each process step represents a manufacturing or operational activity.
  1. Navigate to your Process Steps document (or create one in the Requirements space)
  2. Create processStep work items with the following fields:
FieldPurposeExample
TitleProcess step name”Solder PCB Components”
processInputsMaterials entering the step”PCB board, solder paste, components”
processOutputsResults produced by the step”Assembled PCB with soldered components”
processEquipmentTools and machinery used”Reflow oven, pick-and-place machine”
processVerificationQuality control method”Automated optical inspection (AOI)“
linkedSystemElementThe system element this step affectsLink to a systemElement work item
The linkedSystemElement field creates a typed reference that only accepts systemElement work items, enforcing data integrity between process steps and the product decomposition.

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Step 3: Open in Risksheet

  1. Open your PFMEA document in Polarion
  2. Click the Edit Risks with Nextedy RISKSHEET link in the edit panel
  3. The risksheet opens with the three-level PFMEA hierarchy:
Level 1: Process Step (linked via 'assesses' role)
  Level 2: Failure Mode (description field)
    Level 3: Cause (linked cause work items)

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Step 4: Identify Failure Modes

For each process step, identify how the step can fail:
  1. Select a process step row in Level 1
  2. Add a new failure mode at Level 2
  3. Fill in the Failure Mode column (bound to the work item description field)
  4. Describe the Effect of Failure — the downstream consequence of this failure
  5. Link one or more Cause work items at Level 3
The PFMEA risksheet column layout:
ColumnLevelDescription
Component—Parent heading (process area grouping)
Process StepL1Linked processStep work item
Failure ModeL2How the process step can fail
Effect of FailureL2Downstream consequence
CausesL3Linked cause work items (multiItemLink)
Unlike DFMEA, which uses a free-text causeOfFailure field, PFMEA links to dedicated cause work items. This makes causes independently traceable and reusable across multiple failure modes.

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Step 5: Score Pre-Mitigation RPN

For each failure mode, assign three ratings:
RatingFieldScaleDescription
Severity (S)fmSeverity1-5How severe is the effect? (uses failureModeSeverity enum)
Occurrence (O)premitigationFMOccurrence0-5How often might this failure occur?
Detection (D)premitigationDetection0-5How likely is this failure to be detected?
The pre-mitigation RPN is calculated automatically: RPN = S x O x D RPN values are color-coded using three tiers: diagram

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Step 6: Assign Mitigation Tasks

For failure modes with unacceptable RPN scores:
  1. Click the Task column to link a risk control (mitigation task)
  2. The risksheet displays the linked task’s Title and Status
  3. Risk controls are linked via the mitigates link role
The risksheet also shows traceability columns:
  • Requirements — server-rendered column showing linked system and design requirements
  • Verification Evidence — two-hop traversal showing test cases linked to requirements

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Step 7: Score Post-Mitigation RPN

After assigning mitigation tasks, re-evaluate with updated scores:
RatingFieldDescription
Occurrence (O) PostpostmitigationFMOccurrenceNew occurrence rating after controls
Detection (D) PostpostmitigationDetectionNew detection rating after controls
The post-mitigation RPN is calculated as: RPN(new) = S x O(new) x D(new)
Severity remains constant between pre-mitigation and post-mitigation. Risk controls reduce occurrence and improve detection but do not change the inherent severity of a failure effect.

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Step 8: Review and Approve

Once all failure modes are analyzed:
  1. Review the RPN distribution — ensure no High (red) RPN values remain
  2. The document follows the standard risk document workflow: Draft -> In Review -> Approved -> Published
  3. Send the PFMEA for review using the document workflow

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Next Steps

Configuration: modules/RiskTemplates/PFMEATemplate/attachments/risksheet.json | Template: modules/RiskTemplates/PFMEATemplate/module.xml | Process fields: .polarion/tracker/fields/processStep-custom-fields.xml