FMEA Process and How to Perform an FMEA? FMEA Series Chapter 2

7-step FMEA process 

The AIAG & VDA FMEA handbook recommends a 7-step process to create FMEA, which is illustrated in the figure below. 

Figure 1: Overview of the AIAG & VDA FMEA process 

1. Step 1 – Planning and Preparation involves defining the purpose of performing the FMEA, assembling a cross-functional team, selecting appropriate tools, establishing a timeline, and setting guidelines for the analysis. The first task is to determine the type of FMEA to be conducted, whether it is a System FMEA, Design FMEA, Software FMEA, or Process FMEA. Once the type is selected, suitable tools should be chosen to support the process. For example, SLIKWORKS offers AI-powered features that assist users in performing FMEAs efficiently. Guidelines provide a standardized framework for evaluating failure modes, including rating severity, occurrence, and detectability. 

   Recommended Reading: Read Chapter 1 - Functional Safety Analysis using FMEA - it provides an overview on FMEA, the different types of FMEA, and when to consider each of the types.
   

2. Step 2 – Structure Analysis involves defining the boundaries of the product or process and identifying the corresponding sub-components or sub-processes. A boundary diagram is created to visualize these elements and their relationships. This diagram can be developed using XML-based tools, Visio, draw.io, or other system architecture software. The boundary diagram should clearly illustrate all interfaces between components or processes, highlighting how the system interacts with other elements. 
   

3. Step 3 - Function Analysis focuses on identifying the functions and interfaces for each component or process. Each element in the boundary diagram is analyzed to determine its specific functions. A function should define a particular action, task, or process that the system performs to achieve a desired outcome. Importantly, a function describes what needs to be done, not how it is performed. Since a function represents an action, it is recommended to start the description with a verb. This approach makes it easier to systematically identify potential failure modes and their effects. 
   

4. Step 4 - Failure Analysis involves identifying failure modes, their effects, and underlying causes. Failure modes can be determined using state-of-the-art methods such as HAZOP, component datasheets, reliability databases, or engineering experience. Similarly, the effects of failures can be identified through HAZOP, lessons learned from previous projects, or engineering judgment. Causes of failure can also be derived from databases, datasheets, or expert knowledge. The relationship between cause, failure mode, and effect forms the foundation for assessing risk in the subsequent step. 
   

5. Step 5 - Risk Analysis evaluates the severity, occurrence, and detectability of each failure mode to determine its action priority. Severity reflects the impact of a failure mode on system performance, safety, or availability. Occurrence indicates the likelihood of the failure’s cause occurring, while detectability measures the ability of existing controls to identify the failure before it reaches the customer or system. Each of these factors is typically rated on a scale from 1 to 10. Based on these ratings, the Action Priority is calculated, representing the overall risk associated with the failure mode and guiding mitigation efforts. 
   

6. Step 6 - Optimization focuses on improving or redesigning preventive and detection measures to reduce risk. If the original risk is deemed too high, modifications are implemented to lower it. The goal is to minimize risk as much as possible, ensuring the system, component, or process achieves the highest level of safety and reliability. 
   

7. Step 7 – Documentation is the final step in the FMEA process. It involves reviewing the analysis and summarizing the identified risks, ensuring that all findings, mitigation measures, and decisions are clearly recorded for traceability and future reference. 

FMEA using SLIKWORKS 

SLIKWORKS is an AI powered tool that helps engineers perform safety analyses. An example of SLIKWORKS to perform FMEA is shown in the example below

Summary

Performing an FMEA involves systematically identifying potential failure modes, their causes, and effects across a system or a process. Each failure mode is evaluated for severity, occurrence, and detectability to determine its associated risk and prioritize mitigation actions. The process concludes with implementing improvements and documenting findings to ensure safety, reliability, and continuous traceability throughout the product lifecycle.