Is FMEA Analysis Really the Right Approach for My Company?

Entrepreneurs and software buyers are always looking for a practical solution to make the failures that seem unavoidable in a product development process avoidable. FMEA analysis offers a professional way to do this. It supports the user in a well-founded failure analysis. This means that the defect is found first and its consequences for the production process are analyzed. In the further course of the FMEA, a risk analysis is triggered that evaluates and eliminates the defect. Well positioned against open and hidden defects are those companies that use suitable software for the analysis procedure.

Is FMEA Analysis Really the Right Approach for My Company?

Definition of FMEA and FMEA Analysis

An FMEA provides analysis for companies that manufacture products and want to save costs and time with a trouble-free product development process. FMEA stands for an analysis process that finds, analyzes, evaluates, and eliminates the failures that can negatively impact a production process.

A comprehensive FMEA analysis supports the applying company in two ways. On the one hand, the company benefits from a comprehensive risk and system analysis that is designed to optimize the defect prevention process. On the other hand, the user takes advantage of the integrated knowledge repository to store information about specific defect types. This protective measure serves to ensure that future production processes can be designed with fewer errors right from the start. The advantages are obvious. The company not only saves money, but also time. Two factors that can determine any optimal manufacturing process in either direction.

For the use of FMEA, the company uses suitable software, which can be adapted to the company's individual requirements management with several tools. In this way, troubleshooting can be set in motion in the best possible way.

In Which Areas is the FMEA Used?

Failure analysis is performed in many areas of the process industry. This applies to the chemical industry, for example. Here, the focus is less on the actual product development. It is more important in the chemical industry that the processes run in the right direction. But here, too, the FMEA provides professional support. Other research-intensive areas from the process industry are the food industry, the cosmetics industry and steel construction. They take advantage of the benefits that suitable failure analysis software has to offer in order to produce defect-free, high-quality products.

However, the main beneficiaries of comprehensive risk analysis - which is a standard of FMEA - are companies based in the automotive industry. Here, FMEA supports the harmonization process mandated by AIAG/VDA. In addition, the search for intelligent solutions to support e-mobility, along with the developments of new forms of propulsion and alternative fuels, is another field of activity that the automotive industry must face. Here, too, every product development process must be designed in such a way that the automotive industry has to spend little time and money. This is where the well-founded failure analysis of the FMEA supports them.

Medical technology is another field in which an FMEA service provider is active. Here, it is important for the companies to create high-quality products and to keep to the time schedule until market launch. Every product development process in a medical company is designed to ensure patient safety. FMEA analysis meets this requirement because defects can be detected and verified both before they occur and immediately after they occur.

How is the FMEA Used?

The execution of the FMEA analysis follows a certain scheme. First of all, it must be stated that there are three types of FMEA that build on each other. These are the system FMEA, the design FMEA and the process FMEA.

Each FMEA analysis begins with the System FMEA. Here, all subsystems of the system network are subjected to the analysis. The search for the weak points, in which the errors primarily arise, also refers to the interfaces, which connect the individual steps within a production process with one another.

The Design FMEA (also called Construction FMEA), which follows the System FMEA, is used in the development, design and planning of new products and therefore takes place particularly in the early product planning phase. This analysis step also includes, for example, the materials and raw materials that are to be used in the manufacturing process.

Finally, the process FMEA follows. This summarizes the results of the two previous stages once again and analyzes the complete process.

After the troubleshooting in the process FMEA has been completed, the software offers the user the possibility to subject the product creation process to a detailed risk management with another tool. The scheme of this in-depth risk analysis is composed of two steps. These are the preventive FMEA and the corrective FMEA.

Preventive FMEA focuses on detecting defects early - if possible, right at the beginning - in a production process. To achieve this goal, the start of the FMEA should be identical to the start of the production process. At best, the FMEA service provider starts his work when the first preparations are initiated. The preventive FMEA sees itself as a constant companion. The analysis procedure should not be completed until the production process is also stopped. The more strictly a company adheres to this requirement, the more defects can be detected, verified and eliminated. The company's profit results from the fact that both money and time can be saved.

In corrective FMEA, the analysis takes place in the opposite direction. It starts when the production process has come to a standstill and analyzes in the opposite direction all the phases that a product has passed through. At the end, the preparatory measures are also the subject of the corrective FMEA. It can be used when the company has decided not to apply a preventive FMEA. However, it can also be used as a control instrument, complementary to the preventive FMEA.

What Advantages Does a Software Solution for FMEA Offer?

FMEA analysis offers the user many solution approaches for optimally designing a product development process.

The solution packages for the automotive industry and medical technology provide various tools that can be used to initiate and carry out a well-founded risk analysis.

In addition, the software contains four integrated QM processes that can be used to thoroughly examine every production process. Action management ensures trouble-free project planning. Users can carry out their work in an uncomplicated manner and, if desired, can be supported by an external FMEA service provider. The latter will answer all questions with detailed expert knowledge. To ensure that the users do not miss any deadlines or important actions, they are notified in good time via the software's internal communication system.

The document management system installed by the software for transparency in the knowledge store complies with the requirements of ISO 9001:2015. In addition to fulfilling all contractual obligations, users can transparently present their troubleshooting and document the risk assessment for each error found and eliminated. The documented information is stored in the internal archive (knowledge database). There, it can be retrieved at any time to optimize the next production process.

With the deviation manager and the template management, the user receives two further tools that he can use to carry out a well-founded failure analysis.


FMEA analysis provides companies with a comprehensive risk management tool that enables them to optimize their product development process.

The software used as part of an FMEA analysis supports the FMEA service provider in risk analysis. The defects are already identified and analyzed in the development stage of the production creation process. After evaluating the risk, which in the worst case can negatively affect the entire production process, the software helps to eliminate this defect. The user benefits from the fact that no further damage can be caused by this error.

But the software also performs another service. A document management system is installed in the system's integrated knowledge repository, which documents every single defect and a comprehensive risk analysis and records it for the company's subsequent tasks. If the company triggers the next product development process, an error that has been identified and eliminated once will no longer have any effect.