What is FMEA (Failure Mode and Effects Analysis)?
0
8
0
TL;DR
FMEA (Failure Modes and Effects Analysis) helps identify potential failure points before they occur.
Commonly used in Six Sigma during the Measure and Analyze phases
Assesses risk through Severity, Occurrence, and Detection rankings
Enables early problem-solving and reduces product defects
Complements tools like Root Cause Analysis and Control Plans for stronger outcomes
FMEA in Six Sigma: Improving Process Reliability and Quality
Failure Mode and Effects Analysis (FMEA) is a proactive risk management tool that evaluates possible ways a process, product, or system might fail. It also examines the effects of each failure mode on the overall outcome. This approach allows teams to identify critical issues and implement risk mitigation strategies early.
FMEA plays a key role in the Six Sigma methodology, especially during the Measure and Analyze phases of the DMAIC process. It is often applied as Process FMEA (PFMEA), Design FMEA (DFMEA), or Functional FMEA, depending on the use case.
Teams score three important factors:
Severity ranking (S) – Measures the impact of a failure
Occurrence ranking (O) – Measures how frequently it may happen
Detection ranking (D) – Measures the ability to detect the failure before it reaches the customer
The product of these scores results in the Risk Priority Number (RPN), a metric that helps prioritize recommended actions.
Using a structured FMEA process improves reliability, strengthens quality assurance, and reduces the likelihood of adverse events.
How to Perform an Effective FMEA in a Six Sigma Project
Step 1: Map the Existing Process
Break down the process into smaller steps. Each step is examined for potential failure modes.
Step 2: Identify Failure Modes
List how each step could fail. Failure modes might include human error, equipment malfunction, material defects, or software issues.
Step 3: Analyze Effects and Assign Scores
For each failure mode, conduct a detailed effect analysis and assign severity, occurrence, and detection ratings.
Step 4: Calculate the RPN
Multiply the three scores to calculate the Risk Priority Number. High RPN values indicate areas of critical concern.
Step 5: Recommend Corrective Measures
Prioritize issues based on RPN. Create a plan with recommended actions, such as design improvements or additional process controls.
Step 6: Implement and Monitor
Apply the corrective measures and monitor improvements using FMEA software or manual documentation. Reassess regularly.
FMEA Example: Automotive Case Study
An automotive company applied Process FMEA to an airbag deployment system. One failure mode was a wiring defect with high severity and occurrence but low detection. The team redesigned the wiring and added current controls like pressure testing. This prevented costly recalls and improved system performance.
Real-World FMEA Application in Six Sigma Projects
Problem: A home appliance manufacturer faced a surge in warranty claims.
DMAIC Approach:
Define: 20 percent rise in warranty claims for refrigerators
Measure: Frequent compressor failures identified
Analyze: Conducted FMEA on compressor assembly
Findings:
Severity: High due to customer dissatisfaction
Occurrence: Medium due to a known supplier issue
Detection: Low because of missing quality checks
Substandard compressor seals were flagged with a high RPN. The team switched to a new supplier and added leak detection tests.
Result: Warranty claims dropped by 50 percent within 12 months.
This case illustrates how the FMEA process improves product quality, reliability, and overall customer satisfaction.
Benefits of FMEA
1. Early Risk Assessment
Identifies hazardous situations and enables preventive action before failures impact customers or operations.
2. Structured Analysis
FMEA transforms complex system reviews into data-driven decision-making using clear scoring and prioritization.
3. Improved Product Design and Reliability
FMEA is especially useful in product design and manufacturing processes where small failures can lead to significant losses.
4. Compliance and Audits
FMEA is often a requirement in industries such as automotive and medical devices. It provides documentation for inspections and supports regulatory compliance.
Best Practices for Implementing FMEA
Include cross-functional teams for comprehensive analysis
Combine FMEA with Root Cause Analysis to trace underlying issues
Use FMEA software to track changes and updates efficiently
Continuously update the analysis as processes evolve
Document current controls to validate detection and mitigation efforts
Conclusion
FMEA is more than just a checklist. It is a critical component of any robust risk management and quality improvement system. Whether you are optimizing product design, evaluating a manufacturing process, or enhancing system reliability, FMEA provides a structured way to identify and mitigate risk.
Applying FMEA alongside tools such as Criticality Analysis, Root Cause Analysis, and Control Plans ensures a complete risk assessment framework. By using Severity, Occurrence, and Detection rankings, organizations can focus on the most pressing issues and create action plans that lead to measurable improvements.
For more insights, explore examples of FMEA case studies or download our FMEA template to get started.
