FMEA stands for Failure Mode and Effects Analysis, a technique for reviewing subsystems, components, and assemblies to identify potential failure scenarios in a system. This tool also allows for the investigation of the causes and effects of these failure modes.

This approach offers a step-by-step paradigm to check for possible defects in the design or assembly process of a product or service. “Failure modes” are the ways something can go wrong. This includes any current or potential defects, especially those affecting customers.

The “effects analysis” is the study of the consequences of these failures. Errors should be prioritized according to the severity of their effects, their frequency, and how easy they are to detect.

The evaluator should document the current knowledge and ongoing projects related to identified failures and risks. This should be used in the organization’s continuous improvement process, assisting in quality control before and after the regular operation of a given process.

Types of FMEA

Due to its flexibility, Failure Mode and Effects Analysis can be used in various contexts, resulting in different types of FMEA. The technique can be categorized in several different ways, but it is generally divided into three main classes: DFMEA, PFMEA, and SFMEA. Below, we explain what each element of this alphabet soup means.

Design FMEA (DFMEA)

Design FMEA (DFMEA) is performed during the product design phase. The goal is to improve the design of this merchandise by discovering potential problems.

To verify this, the following are evaluated:

• Properties of the materials used: lubrication, viscosity, elasticity.
• Product geometry: critical dimensions, interferences, ergonomics.
• Tolerances: assembly compatibility, functional performance, durability, and lifespan.
• Engineering noise: noise sources, noise levels, impact on performance.
• Other elements: safety, reliability, and durability, among others.

DFMEA is generally applied in the automotive and aerospace industries. In the case of automotive, manufacturers evaluate the design of a new vehicle to find potential failure points within critical components. For this, they usually check brakes, engine, and transmission.

In the aerospace industry, Design FMEA is used to analyze the design of an aircraft with a special eye on failure points related to safety and performance. The goal, of course, is to resolve them during the design phase.

Process FMEA (PFMEA)

PFMEA should be applied during the manufacturing or production of a commodity. It determines the search for failures that allow greater reliability and safety of your workforce.

For this, you need to evaluate factors such as human errors, analysis methods, materials, and machines used within your processes. It is also recommended to check your monitoring metrics and explore environmental factors.

PFMEA is generally used in industries where customer satisfaction is a crucial factor, such as the food industry. Food companies often use this process methodology to find potential failure modes in their manufacturing process.

These elements include things like contamination, improper handling, or packaging problems. This way, it is possible to identify the effects of these errors on food quality and consumer safety.

System FMEA (SFMEA)

Finally, we have System FMEA, represented by the acronym SFMEA. This is a more generalized analysis of systematic failures. We can describe it as a Design FMEA but for the entire system.

This technique is applied during the service or maintenance phases. The steps to apply SFMEA are basically the same as DFMEA, including function, failure, and risk analyses.

The main sectors that use system FMEA are:

• Medical device industry: manufacturers of medical and hospital devices use SFMEA to find possible failure modes in the manufacturing or operation of their products. The procedure includes looking for incorrect calibrations and installation errors.
• Telecommunications industry: companies in the communication technology sector seek to find failures in their services. This includes things like network interruptions, billing errors, or customer complaints.

How to Apply FMEA 

Now that you know what FMEA is and what types exist, it’s time to learn how to apply the technique in your organization. It is essential that the analysis is done in the right order and one step at a time, as each new step depends on the result of the previous one.

Step 1: Planning and Preparation

The FMEA study begins with a purposeful and careful definition of the scope. The management team is responsible for defining the study’s objective.

Step 2: Structure Analysis

Structure analysis is used to | into sequential steps, interfaces, and logistical elements. It uses the boundaries stipulated by the scope definition in step 1 to identify each step, interface, and logistical element of the process to be studied.

The goal of structure analysis is to facilitate a complete understanding of the process. Start with the central element of your scope, identify the process it is part of, and point out all elements that have a direct relationship with it.

Step 3: Function Analysis

In the Function Analysis step, you should explore what the product should do, what the overall process (and each of its activities) should perform, and how this functionality is facilitated. Using the Structure Analysis developed in step 2, each element is analyzed separately in terms of functions and corresponding requirements.

Step 4: Failure Analysis

In step 4, the concept of the “failure chain” is used to understand and visualize imperfections in the process. This chain is composed of mode, effect, and cause of failure.

• Failure mode represents any way an item can fail to meet its intended function.
• Failure effect is the consequence of a failure mode.
• Failure cause is an indication of what can make a failure mode happen.

In failure analysis, you identify how the elements detailed in Structure Analysis can present errors in performing the intended functions — which are documented by Function Analysis. A failure mode leads to an effect triggered by a failure cause. Determining possible causes is the central element of an FMEA.

Step 5: Risk Analysis

In step 5, you should evaluate the severity, occurrence, and detection capability of each failure chain. Based on the evaluations, determine the level of action priority between “high, medium, or low.”

Use the Action Priority Tables as a basis. It is worth noting that these tables do not establish a “risk priority,” but a level of priority for the demanded action. This seeks to reduce the risk of functional failure.

If the evaluated level is high, measures must be taken to improve prevention or detection controls. Otherwise, you should at least justify what makes the current controls adequate.

If the level is medium, it is recommended that measures be taken to improve prevention and/or detection controls. If it is low, actions to improve prevention or detection controls can be taken but are not mandatory.

Step 6: Optimization

The main objective of the optimization stage is to develop actions to reduce risks and increase customer satisfaction by improving your processes. Most actions will likely involve reducing the probability of occurrence of failure causes or improving detection controls. Both alternatives lead to a more robust process.

Step 7: Documentation of Results

The results of each FMEA study must be fully documented. An FMEA study will not be complete until Step 7 is finalized.

Conclusion

The implementation of FMEA (Failure Mode and Effects Analysis) is a fundamental step to ensure the quality and safety of products and processes in an organization. By identifying and evaluating potential failure modes, as well as their causes and effects, companies can proactively act to mitigate risks and increase customer satisfaction.

Through its different applications, such as DFMEA, PFMEA, and SFMEA, the technique provides a systematic and detailed approach to failure analysis at various stages of the product or service lifecycle.

Thus, FMEA not only helps identify problems before they occur but also provides a solid foundation for continuous improvement, making it an indispensable tool for any organization seeking operational excellence.

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