Creating FMEA Entries

Learn how to create and configure FMEA entries in your project.

Creating an FMEA Entry

1. Navigate to FMEA

   • Open your project
   • Click "FMEA" in the sidebar

2. Click "New FMEA Entry"

   • Opens the FMEA creation form

3. Fill in Required Fields

   • See FMEA Fields below

4. Save

   • Click "Create" or "Save"
   • Entry appears in FMEA table

FMEA Fields

Required Fields

Item/Function

The component, subsystem, or process step being analyzed.

Examples:

• "Engine cooling system"
• "Battery charging circuit"
• "Welding process - Step 3"

Potential Failure Mode

Specific way the item can fail to meet requirements.

Format: "Item + may/can + failure"

Examples:

• "Coolant pump may fail to circulate"
• "Battery may overcharge"
• "Weld may not penetrate fully"

Tips:

• Be specific (not just "doesn't work")
• One failure mode per entry
• Use consistent language

Potential Effect(s) of Failure

What happens when the failure occurs (customer perspective).

Examples:

• "Engine overheats, vehicle stalls"
• "Battery catches fire, safety hazard"
• "Weld fails under load, product recall"

Severity (S)

How severe is the effect? (1-10 scale)

• 10: Hazardous without warning
• 7-9: Very high impact
• 4-6: Moderate impact
• 1-3: Minor impact

See: FMEA Ratings Guide

Potential Cause(s)

Why does the failure occur?

Examples:

• "Pump bearing wear"
• "Charge controller malfunction"
• "Insufficient heat input"

Occurrence (O)

How likely is the cause? (1-10 scale)

• 10: Very high (>50%)
• 7-9: High (10-50%)
• 4-6: Moderate (1-10%)
• 1-3: Low (<1%)

See: FMEA Ratings Guide

Current Controls

What prevents the failure or detects it?

Prevention Controls:

• "Pump preventive maintenance every 50k miles"
• "Charge controller redundancy"

Detection Controls:

• "Temperature sensor with alarm"
• "Visual weld inspection (100%)"

Detection (D)

How likely are controls to detect the failure before delivery? (1-10 scale)

• 10: No detection method
• 7-9: Low likelihood of detection
• 4-6: Moderate likelihood
• 1-3: High likelihood

See: FMEA Ratings Guide

RPN (Risk Priority Number)

Automatically calculated: RPN = S × O × D

Range: 1 to 1000

• Critical (125-1000): Immediate action required
• High (50-124): Action required
• Medium (10-49): Action recommended
• Low (1-9): Monitor only

Optional Fields

Recommended Action(s)

What should be done to reduce risk?

Focus on reducing:

1. Severity (change design to reduce effect)
2. Occurrence (prevent cause from happening)
3. Detection (improve testing/inspection)

Examples:

• "Add temperature sensor with automatic shutoff"
• "Redesign bracket with 2X safety factor"
• "Implement 100% automated inspection"

Responsibility

Who is responsible for implementing the action?

Examples:

• "John Doe (Design Engineer)"
• "Manufacturing Team"
• "QA Department"

Target Date

When should the action be completed?

Action Taken

What was actually done?

Examples:

• "Added redundant temperature sensor - Part #12345"
• "Updated design spec - Rev B"
• "New inspection procedure - QA-001-R2"

Status

Current state of the action:

• Open: Not started
• In Progress: Work underway
• Closed: Complete

Resulting S, O, D

After mitigation, what are the new ratings?

Example:

Before mitigation:
S=9, O=6, D=7 → RPN=378

Action: Add temperature sensor with auto-shutoff

After mitigation:
S=9, O=2, D=3 → RPN=54

RPN Calculation

IntelliSE automatically calculates RPN:

RPN = Severity × Occurrence × Detection

Example:
S = 8 (very high impact)
O = 5 (moderate likelihood)
D = 6 (moderate detection)

RPN = 8 × 5 × 6 = 240 (Critical - immediate action!)

Priority Guidelines

RPN Range	Priority	Action
125-1000	Critical	Immediate action required
50-124	High	Action plan needed
10-49	Medium	Action recommended
1-9	Low	Monitor, no immediate action

Focus on High RPN

Prioritize mitigation for RPN > 100. Small reductions in S, O, or D can dramatically reduce RPN.

Examples

Example 1: Design FMEA

Item: Battery Pack
Failure Mode: Battery may overheat during fast charging
Effect: Fire, injury to user
Severity: 10 (hazardous)

Cause: Inadequate thermal management
Occurrence: 4 (1 in 500 charges)
Current Controls: Temperature monitoring
Detection: 6 (manual review of logs)

RPN: 10 × 4 × 6 = 240 (CRITICAL)

Recommended Action: Add automatic charging cutoff at 45°C
Responsibility: Battery Engineering Team
Target Date: 2025-12-01

Example 2: Process FMEA

Item: Welding Process - Step 5
Failure Mode: Weld may not fully penetrate joint
Effect: Joint fails under load, warranty claim
Severity: 7 (high impact)

Cause: Insufficient heat input
Occurrence: 5 (1 in 100 welds)
Current Controls: Visual inspection (spot check 10%)
Detection: 8 (remote chance of catching)

RPN: 7 × 5 × 8 = 280 (CRITICAL)

Recommended Action: Implement 100% automated ultrasonic testing
Responsibility: QA Manager
Target Date: 2026-01-15

Best Practices

Writing Clear Failure Modes

✅ Good:

• "Fuel pump may fail to deliver required pressure"
• "Software may crash when memory exceeds 4GB"
• "Bearing may seize due to lack of lubrication"

❌ Poor:

• "Pump broken" (too vague)
• "System doesn't work" (not specific)
• "Bad quality" (no failure mode)

Describing Effects

Focus on customer impact, not internal effects.

✅ Good:

• "Vehicle stalls in traffic, safety hazard"
• "User loses unsaved work, frustration"

❌ Poor:

• "Component fails" (what happens to customer?)
• "Error logged" (customer doesn't care about logs)

Assigning Ratings

Severity:

• Customer perspective only
• Worst-case scenario
• Based on effect, not cause

Occurrence:

• Use data when possible
• Current design, current controls
• Be realistic, not optimistic

Detection:

• Before customer receives product
• Current test methods only
• Don't assume future improvements

Troubleshooting

RPN Seems Too High

Check if:

• Severity rating is worst-case (correct)
• Occurrence reflects current controls (may need to update)
• Detection considers all test methods

If RPN is truly high → This is a real risk that needs mitigation!

Can't Reduce RPN

Try reducing:

1. Occurrence (easiest):

   • Improve design robustness
   • Add redundancy
   • Prevent cause

2. Detection (moderate):

   • Add tests
   • Improve inspection
   • Automate checks

3. Severity (hardest):

   • Redesign to reduce effect
   • Add safety features
   • Change architecture

What's Next?

• FMEA Ratings Guide - Detailed rating scales
• Actions and Mitigation - Implement corrective actions
• Link to Requirements - Traceability (coming soon)