How to conduct an FMEA analysis?

What is an FMEA analysis?

FMEA stands for failure mode and effect analysis. It is one of the quality management methods that involves analyzing the causes and effects of potential failures. The purpose of FMEA is to prevent problems that may occur at the design or production stage.

This method was developed in the USA in the 1850s. Since then, it has been very popular, especially in the space, automotive, aerospace and military industries. However, it is not always used successfully. Learn the most common mistakes that cause FMEA to be ineffective. So how do you conduct an FMEA analysis?

Mistake 1 – FMEA analysis is performed only once

Unfortunately in case of many companies the situation looks as follows: we perform FMEA analysis, we engage a lot of resources (human and financial) in it, and when it is ready, the product goes into serial production and the analysis prepared at that time goes into a binder. Employees forget about it, and the probability that it will be used again someday is small. Of course it is a mistake. The analysis should not only be a document prepared at the stage of designing and implementing the product into production. The purpose of the risk analysis is to ensure that we continuously improve the process of manufacturing the product. And it is hard to do this when the FMEA analysis is “tucked away” and forgotten.

In addition, you should also take into account the fact that during the occurrence of quality problems, or even customer complaints, FMEA is one of the most basic documents to be reviewed and analyzed. So the FMEA analysis – as a document – we will do once, but we work with it, modify and complete it continuously.

Mistake 2: FMEA is for the customer

This mistake is often repeated because of the leading role of the Customer. Often, the organization focuses more on the execution of documents required by the customer than on what these documents summarize and what value they bring to the company itself. In the case of FMEA, the greatest value is the earlier (preventive) prediction of problems and errors in the product manufacturing process and creating an appropriate system of its supervision and control as well as preventive actions. This goal is internal to the company – hence FMEA is intended mainly for the company applying it – the Customer only wants to make sure that such an analysis has been created and is of good quality. This is an element of professional cooperation between the Customer and the Supplier and is a sign of suppliers with high attention to quality, who are able to meet the requirements of the Customer and constantly improve their production process.

Mistake 3: FMEA must be performed for each product

This is another mistake you may encounter. It is largely due to the leading role and influence of the customer on the organization where such analysis is created. Each customer is happier when they have “their” FMEA for each of their products and can put pressure on the supplier to create the FMEA in this way. However, the primary value of FMEA is not the execution of a dedicated document for the Customer, but the determination of risks and actions within the analysis of the product manufacturing process, for which a general (collective) analysis may be better suited, due to its simplicity. Such an analysis can be performed when, despite the diversity of products, they go through the same operations and process stages. Then a collective FMEA analysis can be proposed for a group (family) of products or the entire product line (not necessarily only for a single Customer).

Mistake 4: FMEA can be done by one person

Can an FMEA be done by one person? Yes, it can. However, in order for the analysis to be of sufficient quality and bring value to the company – it should not be done in such a way. The purpose of FMEA is to perform a good risk analysis, not just a quick form filling. It is hard to do a good risk analysis by a single, even the smartest and most experienced person. It is the FMEA team that is one of the greatest values in the analysis. Only multiple viewpoints from different experiences and specialties give the best chance to take into account the existing risk and correctly estimate the coefficients, not to mention plan corrective actions.