What is the difference between DFMEA and PFMEA?

DFMEA focuses on product design risks, while PFMEA focuses on manufacturing and assembly process risks.

How often should FMEA be updated?

Update FMEA after any product or process change, after significant defects, and during periodic reviews.

Is FMEA mandatory for IATF 16949?

Yes. IATF 16949 requires FMEA as part of automotive core tools for risk management.

What are common outputs of FMEA?

Prioritized action plans, updated Control Plans, and improved detection or prevention controls.

How does FMEA link to Control Plans?

High-risk failure modes in PFMEA must be addressed with specific controls in the Control Plan.

Definition

Failure Mode and Effects Analysis(FMEA)

FMEA is a structured method for identifying potential failure modes in a product or process, assessing their impact, and prioritizing actions to reduce risk.

What is Failure Mode and Effects Analysis?

FMEA helps teams proactively prevent defects by analyzing how a product or process could fail and what the consequences would be. It is a core automotive quality tool required by IATF 16949 and is used throughout APQP.

There are two main types: Design FMEA (DFMEA) for product design risks and Process FMEA (PFMEA) for manufacturing and assembly risks.

Key Points

FMEA identifies failure modes, causes, and effects before they occur
Risk prioritization guides where to focus improvement efforts
PFMEA must align with the Control Plan and real process controls
FMEA is a living document that should be updated after changes
Effective FMEA reduces warranty risk and customer escapes

Implementation Guide

Steps:

1Define the scope and assemble a cross-functional team
2Break down the product or process into steps or functions
3Identify potential failure modes for each step
4List effects, causes, and current controls
5Assess risk and prioritize actions to reduce it
6Implement actions and verify risk reduction
7Update the Control Plan and work instructions

Best Practices:

Use real defect history and field data to inform failure modes
Validate that current controls are actually used in production
Focus on prevention controls before detection controls
Review and update FMEA after any process change
Link high-risk items to 8D corrective actions

Common Mistakes to Avoid

• Treating FMEA as a one-time launch document
• Copying generic failure modes without process-specific detail
• Listing controls that do not exist on the shop floor
• Not updating FMEA after corrective actions
• Ignoring escape causes and customer detection gaps

Qualiteh's Approach to Failure Mode and Effects Analysis

Qualiteh builds PFMEAs that reflect actual production risk, then aligns Control Plans and 8D corrective actions to close high-risk gaps. We also train teams to maintain FMEAs as living documents.