Failure Mode and Effects Analysis (FMEA) is a risk analysis method aimed at identifying potential failures in systems, products, or processes, analyzing the causes and effects of these failures, and systematically defining the necessary preventive measures. It was first developed by the U.S. military in 1949 and later adopted by the aerospace, automotive, healthcare, and manufacturing industries. FMEA is designed to detect errors before they occur and has been integrated into international standards as a component of quality management systems.

Definition and Implementation Steps

FMEA is applied to identify potential failure modes for each component in a system, analyze the effects of these modes on the system, and plan corrective actions to prevent failures. The implementation steps are as follows:

1. Defining the scope of the analysis
2. Identifying the components of the system or process
3. Detecting potential failure modes for each component
4. Analyzing the causes and effects of failures
5. Assigning scores for Severity (S), Occurrence (O), and Detection (D)
6. Calculating the Risk Priority Number (RPN): RPN = S × O × D
7. Planning corrective actions for risks with high RPN values
8. Recalculating the RPN after corrective actions are implemented

This analysis allows for the quantification of risks and the identification of critical points. Its application is mandatory or recommended within quality systems such as ISO 9001, IATF 16949, and similar standards.

^{Engineers Performing Analysis at the Machine (Created with Artificial Intelligence)}

Sectoral Applications

FMEA is used across many industries in the fields of system safety, quality, and maintenance management:

Automotive Industry: Applied to part design, manufacturing processes, and final products. It serves as a quality assurance tool under the ISO/TS 16949 standard.

• Aerospace and Aviation: Used on critical components to improve flight safety and system reliability.
• Healthcare Services: Applied through Process FMEA (PFMEA) to enhance the safety of clinical processes and prevent patient errors.
• Defense Industry: Utilized to prevent failures in weapon systems, radar, and command-control components.
• Energy and Manufacturing: Implemented in industrial facilities to prevent equipment failures, optimize maintenance plans, and ensure operational continuity.
• Software and Information Systems: Used to identify failure risks such as code errors, data loss, and security vulnerabilities.

FMEA is one of the fundamental risk management tools in engineering for systematic analysis and the development of preventive strategies.

^{Application of FMEA in an Industrial Facility (Created with artificial intelligence)}

Technical Limitations and Advanced Applications

Although FMEA works with numerical values, it has certain limitations:

• The Risk Priority Number (RPN) calculation method cannot distinguish between failures with different risk levels but the same RPN value.
• In complex systems, the interaction of individual failures is not considered, which can lead to insufficient analysis results.
• Severity, occurrence, and detection scores often rely on subjective assessments, affecting the analysis outcome.

Due to these limitations, various improvement methods have been developed:

• Weighted RPN (WRPN): Increases prioritization accuracy by assigning specific weights to each factor.
• Fuzzy Logic-Based FMEA: Uses fuzzy set theory to reduce uncertainties.
• Model-Based FMEA: Enables more detailed failure analysis by incorporating system dynamics.
• Artificial Intelligence Integration: Automates failure analysis processes by connecting to decision support systems.

In current practice, FMEA is used integratively with other analysis techniques (FTA, HAZOP, RCM) and is conducted digitally.