What is FMEA and how to apply it to improve processes and products

Looking to understand what FMEA is? Regardless of the field a company or industry works in, we know quality is always tied to results. After all, whoever does it better than the competition has a huge competitive edge.

But what happens when processes are not running in line with what was originally defined? And when products start to show failures? In some cases, this kind of problem can even compromise the safety of the end consumer.

One of the methodologies used to deal with this kind of problem and to identify causes and effects is FMEA.

Do you know what FMEA is? It may be the first step toward reducing failures and improving the quality of your products. In turn, this directly affects customer satisfaction and trust.

FMEA is a methodology used to reduce failures in processes. Another way to do that is with management software that brings all the important information together in a single place.

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Read on and discover the two types of FMEA, their benefits, and where and how to apply it!

What is FMEA?

FMEA (Failure Mode and Effects Analysis) is a systematic methodology that identifies and analyzes the possible points of failure in equipment, processes and products, as well as the impacts those failures can cause. By examining in detail the causes and effects of each failure, this technique makes it possible to prioritize corrective and preventive actions, contributing significantly to improved safety, reliability and efficiency in industrial environments.

Its use began in military operations in the late 1940s. Since then, FMEA has been used to assess the reliability of systems and failures in the equipment used. The logic was to reduce the occurrence of those failures, thereby increasing product reliability.

From NASA to Ford, this methodology is used today in many industries. That is because FMEA became popular as a useful tool for ensuring safety and efficiency in its two possible types:

• Products: FMEA applied to the failures that can appear in products that fall outside the standard and the specifications defined in a project;
• Processes: process FMEA is applied to failures in activities from their planning stage, and they are generally observed after nonconformities in products have been identified.

What are the benefits of FMEA?

When we talk about what FMEA is, it is important to highlight that its great advantage is the ability to reduce the frequency of failures or even eliminate them. Products and processes, as a result, become more accurate, always focused on superior quality.

Another major benefit of understanding what FMEA is and applying it is the financial savings for the company. In an industry, for example, reducing failures in a manufacturing process is directly tied to reducing the raw material used.

Using less material means spending less and only on the essentials, avoiding any waste and reducing company costs.

For the end consumer, it means the product will rarely have a manufacturing problem. The result is product quality, customer satisfaction and brand trust.

After all, as consumers, we know that when a failure occurred in a company’s product and could have been avoided, we tend to look for another company to keep the problem from happening again. In that case, winning the market’s trust back takes a lot of marketing work, time and money.

Where and how to apply it?

FMEA is always used to improve processes or products, whether based on failures that may occur, pre-existing ones, or to prevent potential problems from happening.

In projects for new processes or products, for example, it can also be useful to define in advance the likelihood of failures appearing and avoid different kinds of problems.

See also: How to implement a quality system in organizations?

FMEA step by step

First, you will need to identify the possible failure modes. The data should be as real as possible, coming from engineering or the field.

Next, you will analyze the risks of each failure mode. But how?

For each potential failure mode identified in the previous step, you will assign a value on a scale of 1 to 10 for:

• Severity of the problem (S): where 1 is “never” and 10 is “always”
• Probability of occurrence (O): where 1 is “never” and 10 is “always”
• Probability of detecting the failure (D): starts where 10 is “never” and 1 is “always”

Note on the scale (model below used for “S” and “O,” only inverted for “D”):

The three numbers are then multiplied to generate a risk priority number (RPN). The RPN becomes the priority value, the one that ranks the failure modes.

The higher the number, the more critical that failure is and the faster a measure or action should be taken to prevent it.

In short, the calculation helps prioritize possible defects based on their severity, frequency and probability of detection. The highest number resulting from the calculation will require the most urgent improvement activity.

Looking to understand what FMEA is? Invest right now in your team’s continuous improvement! Download our material and take advantage of it!opens in a new tab (in Portuguese)

What is FMEA and a calculation example

To calculate, the formula for this “risk score,” following the previous explanations, is:

S x O x D = RPN

In the example below, shared by the platform MoreSteamopens in a new tab, we see more details about a seat belt installation process at an automaker.

Consider that:

• “A) Severity” is our “S,” the severity, where 10 is the most severe;

• “B) Probability of Occurence” is the “O,” probability of occurrence,

  where 10 is the highest probability;

• “C) Probability of Detection” is the “D,” probability of detecting the failure, where 10 is the lowest probability.

We see that three different potential failure modes were identified for the front left seat belt. The first relates to the wrong belt color, the second to the clasp/screw that is not fully tightening, and the third to the misalignment of the part.

Doing the math S x O x D = RPN, the highest number observed was for the second failure mode, with a result of 144. That is, 9 x 2 x 8 = 144.

In this analysis of failure modes and their effects, that is, FMEA, the number 144 showed that the second failure mode should currently be the company’s highest priority for process improvement.

So, whether in this or another example, the conclusion is that once potential failures and the priority level for fixing them have been identified, it is easier to work on preventive or corrective actions and create an action planopens in a new tab.

Next steps

Did you understand what FMEA is? Remember that the focus should always be on quality, whether in a process or a product! This will let your company stay competitive in the market, always focused on quality and on the continuous improvementopens in a new tab of processes.

If you want to go deeper into what FMEA is, watch this video on the quality indicators you need to measure (in Portuguese):

Stratwsopens in a new tab is a corporate performance management software with specific features for tracking KPIs. This way, you can monitor teams and projects in real time, with full transparency. That makes it much easier to make sure your processes are of high quality.

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Frequently asked questions

What are the 4 types of FMEA?+−

Although our text highlights Product and Process FMEA as the most common, in practice the methodology can be adapted to many contexts. The 4 types most often cited in the literature are: Design (or Product) FMEA: assesses possible failures during development and in the product's functionality. Process FMEA: identifies potential failures in manufacturing or service delivery processes. System FMEA: analyzes the interaction between the components of a system to avoid failures resulting from that integration. Service FMEA: focuses on identifying and mitigating failures in service delivery, aiming to raise customer satisfaction.

How to calculate risk in FMEA?+−

Risk in an FMEA is quantified by the Risk Priority Number (RPN). This number is obtained by multiplying three factors: Severity (S): impact of the failure if it occurs; Occurrence (O): probability of the failure happening; Detection (D): chance that the failure goes unnoticed before causing problems. The formula used is: RPN = S x O x D

When should FMEA be done?+−

FMEA should be carried out: In the planning and development phase of new products or processes: to anticipate and mitigate failures before they occur; In existing processes or products: to identify, prioritize and fix failures, contributing to continuous improvement and risk reduction.