FMEA stands for Failure Mode and Impact Analysis. It is a risk analysis method used in many sectors, including healthcare, automotive and aviation, to identify potential risks in a product or process and the consequences that may arise from them. Failure mode (FM) indicates potential errors that may occur in a product or process. Effective analysis (EA) shows the consequences of these mistakes. This makes it possible to detect all faults and to understand which faults occur and how often, and to identify issues that need to be prioritized. With FMEA, organizations evaluate the severity, causes and probability of failures related to risks that may occur in the future. In this way, organizations proactively eliminate potential problems, increasing product, process or service quality and customer satisfaction. What are FMEA Types? There are basically three FMEA modes: design, process and functional. Design FMEA (DFMEA) As the name suggests, DFMEA allows to identification potential failure modes, their causes and effects, that a product or process may encounter while it is still in the design phase. Design FMEA prevents a product or process from being much more costly by identifying areas of failure before it is released to the market. In short, it aims to detect and eliminate pre-production errors. Process FMEA (PFMEA) PFMEA is used to identify, prioritize and assess the risks associated with potential process-related failures that could adversely affect product or service quality. Process FMEA enables to improve process designs, correct deficiencies, prevent defects and reduce the risk of failure. Service FMEA Service FMEA is a risk analysis method used in the service industry to identify potential failures and their impact on the customer. This analysis aims to increase customer satisfaction and service quality by evaluating the errors that may occur in service processes, the causes and possible consequences of these errors. Functional FMEA (FFMEA) Functional FMEA is the forerunner of the design and process FMEA modes. Its purpose is to focus on avoiding failures by identifying potential errors at the very beginning of a product or process development. When to Benefit from FMEA (Failure Mode and Impact Analysis)? There are several situations where FMEA should be performed: When a novel product, service, or process is devised When an existing process is planned to be performed in a different way, When quality improvement is targeted in a particular process, FMEA is needed to understand the failures of a process and how to improve these failures. How to Conduct an FMEA? FMEA is run by a team of experts, including engineers, production staff and designers. The team conducting the FMEA identifies the failure modes, the causes and potential effects of these failures, and the corrective actions that need to be taken to eliminate them. The team then documents these findings in the FMEA report, which includes identification details and an assessment of the failure, severity level, and recommended corrective action. The steps involved in conducting an FMEA are as follows: Defining the Scope of FMEA: Which product, process or system needs to be analyzed? Identifying Possible Failure Modes: What could go wrong? Identifying Causes of Error Modes: Why might these errors occur? Assessing the Severity of the Error: How bad would it be if this error occurs? Estimating Probability of Error: What is the probability that this error will occur? Calculating RPN: RPN is a measure of the severity and probability of each fault. Developing Corrective Actions to Mitigate RPN: What can be done to prevent or mitigate each error? The last two steps are to Implement Corrective Actions and monitor the Effectiveness of Corrective Actions . Failure Types Encountered in FMEA Analysis Design Errors These errors usually occur during the project design phase. They adversely affect the characteristics and performance of the product. Manufacturing Defects Manufacturing defects occur when the project moves into the production phase and have a negative impact on product quality. When product parts are not assembled correctly, this causes a production error. Operating Errors Operating errors occur during the operational phase of the project and affect the reliability of the product. Such errors can degrade the performance of the product, damage the product or lead to a ban on its use. What Are the Benefits of FMEA? The most important advantage of FMEA is its ability to anticipate potential problems in production and prevent errors. In addition, there are many other advantages FMEA provides to organizations: FMEA improves customer satisfaction by improving product and process reliability and quality to reduce the risk of failure. This is very important for organizations to meet customer demands and have a say in competitive markets. Failure Mode and Effect Analysis enables to identify failure modes and related causes by querying on questions such as why, how and what happens. This helps organizations identify and prevent the root cause of the problem before it even occurs. Identifying and addressing potential issues before they occur helps improve quality by preventing costly returns. FMEA helps identify safety hazards that may arise due to product design. This helps make fixes early in the development process, making products safer to use. FMEA helps improve product reliability by reducing the possibility of manufacturing and design defects. Quality Management System
