Objectives and Basic Concept

The central idea of FMEA is simple:

Do not wait for a failure to happen before understanding its consequences.

The method systematically examines how a product, system or process could fail and determines what should be done to prevent the failure or reduce its impact.

The analysis connects:

Functions → Failure Modes → Effects → Causes → Controls → Risks → Actions

This creates transparency regarding technical risks and allows engineering resources to be focused on the areas where preventive action provides the greatest value.

FMEA therefore supports the fundamental principle of preventive quality planning: identify and manage risk before the failure reaches production or the customer. Your automotive APQP source describes this directly as taking a proactive approach to what can go wrong and managing the associated risks.

Method in Detail
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FMEA follows an inductive, bottom-up approach: individual elements and their potential failures are investigated to determine their effects on the higher-level system.

Function

What is the product, component or process step expected to do?

A clear understanding of intended function provides the basis for identifying meaningful failures.

Failure Mode

How could the function fail?

Examples include:

• No function
• Partial function
• Incorrect function
• Intermittent function
• Unintended function

Failure Effect

What happens if the failure occurs?

Effects should be considered from the perspective of subsequent processes, the customer, the end user and, where relevant, safety or regulatory requirements.

Failure Cause

Why could the failure occur?

Causes describe the mechanisms or conditions that could create the failure mode.

Prevention Controls

What currently prevents the cause from occurring?

These can include design principles, process controls, specifications, simulations or established engineering practices.

Detection Controls

How would the failure or cause be detected before reaching the customer?

Examples include testing, inspection, monitoring and verification activities.

Risk Evaluation

The identified risks are evaluated using the applicable FMEA methodology so that critical topics can be distinguished from lower-priority risks.

Optimization

Actions are defined to:

• prevent the cause,
• reduce the probability of occurrence,
• improve detection,
• or reduce the consequences through design changes where possible.

After implementation, the risk is reassessed.

Application

1. Define Scope and Planning

Define the product, system, subsystem or process to be analyzed and establish the cross-functional FMEA team.

2. Perform Structure Analysis

Break the analysis object into its relevant system elements, components or process steps and understand their relationships.

3. Perform Function Analysis

Determine the intended functions and requirements of each relevant element.

4. Perform Failure Analysis

Identify potential failure modes, their effects and their underlying causes.

5. Perform Risk Analysis

Evaluate the identified failure chains using the applicable severity, occurrence and detection criteria.

6. Define Optimization Actions

Prioritize risks and define preventive or detection-oriented measures with clear responsibilities and deadlines.

7. Document Results and Reassess

Implement the measures, reassess the resulting risk and maintain the FMEA as the product or process evolves.

Tips

Treat FMEA as an engineering process, not a form-filling exercise.

The value of FMEA comes from the technical discussion behind the entries, not from completing the document itself.

Use a genuinely cross-functional team and involve specialists who understand the design, manufacturing process, testing, field behaviour and customer requirements.

Start FMEA early enough that identified risks can still influence the design or process.

Use actual engineering evidence, test results, lessons learned, warranty information, process data and previous failures, rather than relying only on assumptions.

Finally, update the FMEA after design changes, process changes, new failures or significant new knowledge. It should remain a living risk document.

Pitfalls
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Typical mistakes significantly reduce the effectiveness of an FMEA:

• Performing the FMEA only to fulfil a customer or audit requirement.
• Starting the analysis after major design or tooling decisions are already fixed.
• Using vague failure modes such as „bad quality“ instead of technically precise descriptions.
• Confusing failure modes, effects and causes.
• Allowing one person to complete the entire FMEA without cross-functional input.
• Focusing excessively on numerical ratings rather than understanding the actual technical risk.
• Copying an old FMEA without validating whether its assumptions remain applicable.
• Defining actions without responsibilities, deadlines or subsequent verification.
• Failing to update the FMEA when the product or process changes.

Strengths and Limitations
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When does the method provide particular value?

+ Preventive risk identification
Potential problems can be addressed before they become field or production failures.

+ Structured engineering knowledge
Functions, failures, causes, controls and actions are documented systematically.

+ Cross-functional understanding
Different engineering disciplines evaluate risks together rather than in isolation.

+ Supports APQP
FMEA provides important risk information for downstream quality-planning activities. For PFMEA specifically, your MSA source states that its outcome is transferred to the Control Plan.

What are the limitations of the method?

~ Quality depends on team knowledge
Unknown failure mechanisms cannot automatically be discovered simply by completing an FMEA.

~ Resource intensive
Complex products can create very large analyses requiring substantial engineering effort.

~ Individual-failure orientation
Traditional FMEA primarily investigates individual faults. Complex combinations of faults may require complementary techniques such as FTA.

~ Requires continuous maintenance
An outdated FMEA can create false confidence instead of useful risk transparency.

Result​

At the end of the FMEA process, a structured risk analysis is available containing:

Functions → Potential Failures → Effects → Causes → Existing Controls → Risk Evaluation → Improvement Actions → Responsibilities

The result provides a documented basis for preventive engineering decisions and supports subsequent activities such as Control Plan development, validation planning, design optimization and process improvement.

For PFMEA, the documented risk analysis should directly support the Control Plan

Alternatives
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Templates, Documents and Downloads

Access practical FMEA templates and supporting documents for structured risk analysis and documentation.

Moderation and Consulting

Need support with a complex FMEA?

7SIGMA supports organizations in FMEA preparation, moderation, risk evaluation, optimization and implementation within product and process development.

Workshops and Training

Build practical FMEA competence within your engineering and quality teams through application-oriented workshops and training.

From understanding failure chains to conducting structured DFMEA and PFMEA sessions, the focus is on applying FMEA effectively in real engineering environments.

Our References in This Area
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