When is FMEA done? Who will do it?

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FMEA – Proactive Prevention

Under what circumstances do we need to do FMEA? Some friends said that it was during the customer review. It sounds like no problem, but FMEA should not be done just for audit, and it should not be regarded as a tool for passive output, but should be regarded as a tool for active prevention.

When is prevention necessary?

● The first case: the emergence of new designs, new technologies, and new processes.

During these processes, you will encounter many problems that you have not encountered before. The risks and uncertainties are the most. Therefore, we need to use FMEA to reduce the risk.


● Second case: New application to an existing design or process.

A factory built in the north, in order to expand business, also built a factory in the south. The production process and design of the two factories are the same. Does it mean that the FMEA can be copied directly? of course not. There may be huge differences in the environment and site in different regions, especially for processes or technologies that have certain requirements for the production environment, and slight changes in temperature and humidity will affect the machine parameter settings.


Therefore, we need to re-do FMEA analysis based on the impact of the new environment and new site on the existing design or process.


● Case 3: Engineering changes to existing designs or processes

In design or process engineering, there must be new production requirements, and it is bound to be inaccurate to continue to make judgments based on previous designs or processes. Therefore, we have to re-do the FMEA analysis.


● The fourth case: the enterprise establishes FMEA database

Enterprises want to make mature FMEA experience into a standardized knowledge base, to extend existing technologies, or to pave the way for the development of subsequent new products, new technologies, and new processes, so FMEA analysis naturally needs to be constantly updated iterative.


Today is the era of digital transformation for enterprises and the pursuit of innovation. 5G, big data, artificial intelligence, and cloud technologies are gradually emerging. As technology is constantly updated, FMEA naturally needs to be constantly updated. Therefore, it is more necessary for us to actively initiate FMEA and make it an effective proactive prevention tool.


FMEA – Teamwork

Now that the start time of FMEA is clarified, let’s take a look at the people who determine the success or failure of FMEA.


First of all, it must be clear that if you want to do a good job in FMEA, you cannot do it alone. Personal knowledge and experience are important, but they are absolutely inseparable from the help of the team.


Especially work like FMEA requires all-round, multi-angle, and distributed considerations, and no matter how strong an individual is, it is impossible to cover everything. Therefore, the importance of the FMEA team needs to be emphasized here. Since it is teamwork, there must be a division of labor, and everyone performs their duties.

Generally speaking, we generally divide the FMEA team into two parts: core members and extended members.


● The core members are essential, they are resident personnel, and their work needs to be from the beginning to the end of the FMEA.


● Extended members are members who provide some help only when needed. For example, when encountering some specific problems related to production line employees, equipment maintenance, or even customers and do not know what to do, they often need to rely on the help of these extended members.


Whether it is DFMEA or PFMEA, its core members need a FMEA moderator, also known as a coordinator (Moderator). As the name suggests, it is the person who leads and coordinates the team members to carry out the FMEA work smoothly, and is able to grasp the overall direction and output rhythm of the FMEA. The FMEA moderator can guide the team members correctly in terms of methods and ideas, as well as manage and control the process reasonably. The method and thinking are correct, and what the rest of the staff need to do is to fill in the content, that is, the inputter (Input) of our FMEA content.

The FMEA host is the leader of the method, good at FMEA thinking logic, commonly known as FMEA expert. We can see that in the FMEA team, not everyone has to be an expert in FMEA.


As the saying goes, there are specializations in the art industry, we only need a person with clear thinking to lead everyone. The FMEA host is responsible for all FMEA updates, changes, etc., and the rest of the members do not need to output a separate FMEA, but only need to provide their own experience. This is the correct division of labor of an FMEA team, and it is possible to output a valuable FMEA.


When is FMEA done? Who will do it?

It can be seen that when we are doing FMEA, we must regard FMEA as a tool for active prevention. When there are new designs, new applications, engineering changes, etc., we must start to do FMEA.


In addition, if you want to do a good job in FMEA, you must establish an FMEA team. Only with teamwork can FMEA proceed smoothly.

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