Overview
Process FMEA analyzes potential failures in manufacturing and assembly processes. Unlike Design FMEA which focuses on product design, PFMEA identifies how manufacturing processes can fail and what controls are needed to prevent defects from reaching the customer.
Before You Begin
You need:
- A defined process flow for the manufacturing process you’re analyzing
- Process step definitions (inputs, outputs, equipment, verification methods)
- Access to the Risks space in Polarion
- Permission to create documents and work items
Always create your process flow diagram first. PFMEA analyzes existing manufacturing processes, not theoretical ones. The process flow becomes your Level 1 structure in the PFMEA risksheet.
Step 1: Navigate to Risks Space
- Click Risks in the navigation sidebar
- Click the ➕ Create Document button
- Select document type Risk Specification
- Choose space Risks
Set the following properties:
| Property | Value | Notes |
|---|
| Title | PFMEA - [Product Name] | Example: “PFMEA - AEB Sensor Unit” |
| Document ID | Auto-generated or custom | Use naming convention: PFMEA-ProductName |
| Type | Risk Specification | Required for Risksheet integration |
| Status | Draft | Will advance through workflow later |
The System PFMEA Report automatically discovers PFMEA documents by searching for “PFMEA” or “pfmea” in the document name. If your document ID doesn’t contain this string, it won’t appear in the automated report.
Step 3: Attach PFMEA Risksheet Configuration
- In the document editor, click Attachments
- Click ** Upload Attachment**
- Navigate to
RiskTemplates/PFMEATemplate/attachments/
- Select
risksheet.json
- Upload the file
This configuration provides:
- Three-level hierarchy: Process Step → Failure Mode → Cause
- AIAG-VDA compliant columns (Severity, Occurrence, Detection)
- RPN calculation formulas (before and after mitigation)
- SC/CC special characteristic classification
- Progressive workflow views (Setup, Analysis, Controls, Verification)
Step 4: Open in Risksheet
- Click the ** Open in Risksheet** button (top right)
- The document opens in interactive table mode
- You’ll see the Process Setup view by default
Step 5: Define Process Steps (Level 1)
For each manufacturing or assembly step in your process flow:
- Click ➕ Add Row at Level 1
- Select work item type processStep
- Fill in:
- Process Step (title): Name of the manufacturing operation
- Process Inputs: Raw materials, components, information required
- Process Outputs: Products, assemblies, characteristics produced
- Process Equipment: Machines, tools, fixtures used
- Process Verification: How outputs are checked during manufacturing
Use the Linked System Element field to connect each process step to the component or subsystem it produces. This enables traceability from manufacturing process back to product architecture.
Step 6: Add Failure Modes (Level 2)
For each process step:
- Right-click the process step row → Add Child Item
- Select work item type processFailureMode
- Fill in:
- Failure Mode (description): How could this process fail?
- Effect of Failure: What happens downstream if this failure occurs?
- Severity (1-10): How severe is the effect on the customer?
Example failure modes for “Solder Reflow” process:
- Insufficient solder joint strength (S=8)
- Solder bridging between pads (S=7)
- Component tombstoning (S=6)
Step 7: Identify Causes (Level 3)
For each failure mode:
- Right-click the failure mode row → Add Child Item
- The system creates a Cause entry (uses processFailureMode type)
- Fill in:
- Cause of Failure (causeOfFailure field): Root cause description
- Pre-Mitigation Occurrence (1-10): How often does this cause occur?
- SC/CC Classification: Is this a Special or Critical Characteristic?
- Prevention Control: Controls that prevent the cause from occurring
- Detection Control: Controls that detect the failure before it escapes
When you classify a characteristic as SC (Special) or CC (Critical), it must appear in your Control Plan with defined measurement methods, sample frequency, and reaction plans. The system tracks this coverage automatically.
Step 8: Calculate RPN
The system automatically calculates Risk Priority Number (RPN) for each cause:
RPN = Severity × Occurrence × Detection
- Low: 1-40 (acceptable risk, monitor)
- Medium: 41-100 (action recommended)
- High: >100 (action required)
After implementing controls, update:
- Post-Mitigation Occurrence: New occurrence rating after prevention controls
- Post-Mitigation Detection: New detection rating after detection controls
- Post-Mitigation RPN: Automatically recalculated
Step 9: Use Progressive Workflow Views
Switch between views using the View dropdown:
| View | Purpose | Columns Shown |
|---|
| Process Setup | Define process steps and link to system elements | Process inputs/outputs, equipment, verification |
| Failure Analysis | Identify failure modes and effects | Failure mode, effect, severity, causes |
| Risk Assessment | Set initial rankings | S/O/D ratings, RPN, SC/CC classification |
| Control Definition | Define prevention and detection controls | Current controls, recommended actions |
| Post-Mitigation | Track residual risk after controls | Post-mitigation O/D, RPN, control effectiveness |
| Full PFMEA | See all columns for comprehensive review | All fields visible |
The progressive views guide you through the PFMEA workflow. Don’t jump to Risk Assessment before your process steps are fully defined.
Step 10: Link to Control Plan
For high-risk items (RPN >100) and all SC/CC characteristics:
- Create a Control Plan document (see Create a Control Plan)
- In the Control Plan, create controlPlanItem work items
- Link each control plan item to the corresponding process failure mode
- Define measurement technique, sample size, and sample frequency
The system tracks PFMEA → Control Plan coverage automatically.
Verification
You should now see:
- ✅ PFMEA document appears in Risks space dashboard
- ✅ Process step count shown in document inventory
- ✅ RPN distribution (Low/Medium/High) calculated
- ✅ PFMEA document appears in System PFMEA Report with RPN buckets
- ✅ High-RPN items (>100) trigger alerts in the report
When all process failure modes have post-mitigation RPN <100, your PFMEA shows acceptable residual process risk. High-ASIL components may require tighter thresholds.
See Also
