FMEA Overview

Failure Mode and Effects Analysis (FMEA) is a systematic method for identifying potential failures in products or processes and assessing their impact.

What is FMEA?

FMEA helps engineering teams:

• 🔍 Identify Failure Modes - Find potential ways systems can fail
• ⚠️ Assess Risk - Calculate severity, occurrence, and detection ratings
• 📊 Prioritize Actions - Focus on high-risk failure modes first
• ✅ Mitigate Risks - Define and track corrective actions
• 🔗 Link to Requirements - Trace failures back to requirements (coming soon)

FMEA Modes

NirmIQ offers Simple FMEA (quick start) and Advanced FMEA with the AIAG-VDA 7-Step Wizard for full industry compliance.

Simple FMEA vs Advanced FMEA

Feature	Simple FMEA	Advanced FMEA
Setup Time	2 minutes	10-15 minutes
Structure	Flat list	Hierarchical tree
Priority	RPN only	Action Priority (AIAG/VDA)
Analytics	None	Heatmap, Trending
Best For	Quick assessments	Regulatory compliance

Recommended for Safety-Critical Industries

For automotive, aerospace, medical devices, and other regulated industries, use the AIAG-VDA 7-Step Wizard for full compliance with industry standards.

AIAG-VDA 7-Step Wizard

The 7-step wizard guides you through the complete FMEA process:

1. Planning & Preparation - Define scope using the 5T's (InTent, Timing, Team, Task, Tool)
2. Structure Analysis - Build system hierarchy (P-Diagram)
3. Function Analysis - Define what each element should DO
4. Failure Analysis - Identify failure modes, effects, and causes
5. Risk Analysis - Rate Severity, Occurrence, Detection → Action Priority
6. Optimization - Define and track corrective actions
7. Documentation - Export compliant reports

Learn more about the AIAG-VDA 7-Step Wizard →

Learn more about Advanced FMEA →

FMEA Types

NirmIQ supports three main types:

Design FMEA (DFMEA)

Focus: Product design weaknesses

Used for:

• New product development
• Design changes
• Component selection

Example failure modes:

• "Bracket may fracture under load"
• "Battery may overheat during charging"
• "Software may crash with invalid input"

Process FMEA (PFMEA)

Focus: Manufacturing process issues

Used for:

• Production planning
• Process improvement
• Quality control

Example failure modes:

• "Weld may be incomplete"
• "Paint may not adhere properly"
• "Assembly may be reversed"

FMEA-MSR (Monitoring & System Response)

Advanced FMEA Only

FMEA-MSR is available in Advanced Mode.

Focus: System monitoring and failsafe responses

Used for:

• Safety-critical systems
• Autonomous vehicles
• Medical devices
• Real-time monitoring

Example failure modes:

• "Collision sensor does not detect obstacle"
• "Emergency braking system delayed"
• "Patient alarm does not trigger"

Key Concepts

Failure Mode

What can go wrong?

A specific way in which a component or process can fail to meet requirements.

Examples:

• Engine overheats
• Door latch fails to engage
• Software crashes unexpectedly

Effects

What happens when it fails?

The impact of the failure on the customer or next operation.

Examples:

• Vehicle stalls (safety issue)
• Door opens while driving (critical safety)
• User loses unsaved data (inconvenience)

Causes

Why does it fail?

Root causes that lead to the failure mode.

Examples:

• Coolant leak
• Manufacturing defect
• Unhandled exception

RPN (Risk Priority Number)

How risky is it?

RPN = Severity × Occurrence × Detection

Rating	Range	Priority
Critical	125-1000	Immediate action required
High	50-124	Action required
Medium	10-49	Action recommended
Low	1-9	Monitor only

Severity (S)

How bad is the effect?

Rating	Description	Examples
10	Hazardous without warning	Death, serious injury
9	Hazardous with warning	Injury, system damage
7-8	Very high	Loss of primary function
4-6	Moderate	Reduced performance
2-3	Low	Minor inconvenience
1	None	No effect

Occurrence (O)

How often does it happen?

Rating	Probability	Frequency
10	Very high	> 1 in 2
9	High	1 in 3
7-8	Moderate	1 in 8 to 1 in 20
4-6	Low	1 in 80 to 1 in 2,000
2-3	Remote	1 in 15,000 to 1 in 150,000
1	Nearly impossible	< 1 in 1,500,000

Detection (D)

How likely are we to catch it?

Rating	Likelihood	Detection Method
10	Absolute uncertainty	No detection method
9	Very remote	Random inspection
7-8	Remote	Manual inspection
4-6	Moderate	Automated inspection
2-3	High	Error-proof design
1	Almost certain	Defect cannot occur

FMEA Workflow

Typical Process

1. Define Scope - What are you analyzing?
2. Identify Failure Modes - What can go wrong?
3. Assess Effects - What happens?
4. Determine Causes - Why does it happen?
5. Assign Ratings - S, O, D scores
6. Calculate RPN - Prioritize risks
7. Define Actions - Mitigation plans
8. Implement - Execute actions
9. Re-evaluate - New S, O, D after mitigation

Features

✅ Current Capabilities

• Create FMEA entries (Simple and Advanced modes)
• Assign S, O, D ratings
• Auto-calculate RPN and Action Priority (AP)
• AIAG-VDA 7-Step Wizard for structured analysis
• System Structure Tree (P-Diagram) builder
• Failure mode libraries with industry templates
• Industry starter templates (Automotive, Aerospace, Medical, etc.)
  Template Restrictions

  FMEA templates cannot be applied to sample projects. Sample projects have pre-built traceability links that would be broken. Create a new project from the template instead.

• Define actions and responsibilities
• Track status (Open, In Progress, Closed)
• Export to Excel (.xlsx)
• Risk heatmaps and RPN trending
• DTC (Diagnostic Trouble Code) library for automotive

🚧 Coming Soon

• AI-powered FMEA import from documents
• AI-generated failure mode suggestions
• Collaboration and comments
• PDF export with custom templates

Best Practices

Conducting Effective FMEA

1. Assemble Team: Include design, manufacturing, quality experts
2. Start Early: Conduct in design phase, not after problems occur
3. Be Specific: Clear, detailed failure mode descriptions
4. Focus on High RPN: Prioritize actions for RPN > 100
5. Document Actions: Clear owners and due dates
6. Follow Through: Track and verify mitigation effectiveness
7. Update Regularly: FMEA is a living document

Rating Guidelines

Severity:

• Based on worst case scenario
• Customer perspective
• Cannot be reduced (inherent to design)

Occurrence:

• Based on current controls
• Use data when available
• Can be reduced via design changes

Detection:

• Based on current test methods
• Before delivery to customer
• Can be improved via better testing

Integration with Requirements

Coming soon: Link FMEA entries to specific requirements.

Benefits:

• Trace failures to requirements
• Ensure all requirements have FMEA coverage
• Impact analysis when requirements change
• Complete traceability matrix

What's Next?

• AIAG-VDA 7-Step Wizard - Industry-standard structured FMEA process
• Creating FMEA - Add your first FMEA entry
• Advanced FMEA - DFMEA, PFMEA, and FMEA-MSR
• FMEA Ratings - Learn how to assign S, O, D
• Actions and Mitigation - Define corrective actions