What is Failure Modes and Effects Analysis? Understand the Role of FMEA in Management!

Failure Mode and Effects Analysis (FMEA) is a tool that allows you to exponentially increase the reliability of processes and products by identifying, ranking, and preventing potential failures of a product or process.

This new dimension of quality has been increasingly used strategically by organizations, going beyond the old-fashioned concept of being just a guarantee for after-sales.

The FMEA presents itself as not only a tool but a strategy for placing the business on the market as a company that ensures the quality and reliability of the product or process it sells.

This factor weighs heavily in the purchase decision process of any customer.

Now that we know the importance of this powerful tool, check out the topics that we will cover in this article:

• What is an FMEA Process?
• What are the 3 Types of FMEA?
• What are the Benefits of FMEA?
• What are the Main Elements of FMEA?
• Is FMEA a Lean Six Sigma Tool?
• How to Become a Lean Six Sigma Professional?

What is an FMEA Process?

FMEA is a method that uses qualitative variables to carry out possible failure modes analysis that may originate in components and generate an effect on the function of the entire assembly.

With the use of this methodology, it is possible to perform a risk assessment and correct potential failure effects in products and processes. It is a tool that helps to increase reliability and the tracking of control plans necessary to alleviate risks.

This analytical tool is elaborated and revised, in most cases, by manually filling in a matrix in Excel itself - although there are already computerized systems that allow instant revision.

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To proceed with its application, it is first necessary to identify which of the three types of FMEA analysis should be adopted.

What are the 3 Types of FMEA?

Process FMEA analysis

As its name suggests, this type of FMEA considers failure modes and their effects in all stages of a production process, regardless of whether they are new or already in operation.

That is, based on the execution of each sequence of activities within the process, failure possibilities are discussed and improvement points are implemented.

Product FMEA analysis

Unlike the first case, this type of FMEA - also known as design FMEA - considers failure modes and their effects on all functions of a product or project, whether new or existing.

That is, by defining each of these specifications, those responsible can discuss the possible failures that may occur in meeting each of these requirements.

FMEA administrative processes analysis

Like the process FMEA, this type of FMEA also considers all the steps of a process, only this time administrative, whether it is also a new or existing process.

What are the Benefits of FMEA?

The main benefit of FMEA is the concern for our customers' experience and satisfaction with current services and products.

We live in a constant race for great innovations and new technologies, for this, it is necessary to identify the existing failures, study their causes and develop effective solutions through corrective actions.

To help you in this process, today we will teach you how you can use FMEA to do this efficiently. So, keep reading this article and start your continuous improvement process now!

What are the Main Elements of FMEA?

FMEA includes an assertive design process for detecting failure, based on the following elements:

Definition: here the information describing the process or product to be analyzed must be recorded.

Specifications: in this step, if it is a process FMEA analysis, it must contain all the process steps, if it is a product FMEA analysis, it must contain all the product functions.

Failure modes: before each process step or product requirement, the team involved in the FMEA application must note all occurrences already obtained in each specification, as well as discuss all other potential failure modes that have not yet occurred.

Effects per failure: based on each failure mode registered in the form, those responsible must now enter the effects generated by these failures. Each of these effects should be scored concerning the Severity of this occurrence emerging.

Causes for failure: Participants should discuss the causes that cause each failure to appear. Five whys and the Ishikawa diagram are some tools that facilitate this identification. After that, each of these causes should also be scored, now in terms of their occurrence.

Controls by cause: each cause that was identified in the previous step must be analyzed in terms of its level of detection, that is, find out if they exist and what are the prevention and control measures already adopted to eliminate or at least contain each one of the causes.

Risk Priority Number (RPN): the multiplication of the scores obtained for Severity, Occurrence, and Detection will generate a result that will inform the team which main problems must be tackled first: the greater this calculated risk, the greater the need for action priority.

Improvement proposals: after knowing and prioritizing which failure causes should be solved, participants will now be able to discuss solutions to eliminate these causes, or at least control them. Tools like brainstorming can help.

Action plan: define the solutions that will be implemented, an action plan must be prepared, containing the recommended actions, the person responsible for the compliance, and the deadline for completion.

New calculated risk: with the improvement actions identified and implemented, those responsible meet again to issue a new calculated risk, and thus, inform themselves of how much progress has been made in the application of this tool.

Is FMEA a Lean Six Sigma Tool?

Employing an FMEA analysis process within the Lean Six Sigma methodology is an excellent alternative to achieve even more precisely the objectives of this program, which seeks above all the continuous improvement of performance.

Check out 5 reasons to use FMEA in conjunction with Lean Six Sigma:

• It facilitates the identification of potential flaws and deficiencies of a product or process;
• It helps to quantify the Risk in the effect of each failure;
• Recognizes the causes of failures and deficiencies and manages to quantify their frequency;
• I work preventively and focus on eliminating potential problems;
• Facilitates the documentation and traceability of actions.

The FMEA assists in Lean Six Sigma, through a more preventive posture than a more reactive posture.

How to Become a Lean Six Sigma Professional?

Lean Six Sigma is a methodology that seeks to increase the profitability of companies through the improvement of their processes.

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With this course, you will be able to develop small improvement projects within your area of expertise and work with Green Belts and Black Belts in support of the Lean Six Sigma program.

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