What is FMEA and How to Use it in Manufacturing?

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What is FMEA and How to Use it in Manufacturing?

August 22, 2024

Did you know that nearly 80% of product defects occur because of issues with product design during the product development phase? So, it only makes sense if manufacturers evaluate these risks beforehand and mitigate them before they turn into serious issues. The best way to identify issues is through a systematic method called Failures Modes and Effects Analysis (FMEA)

FMEA has been long used by industrial engineers to pinpoint any sources of failurers. Traditionally, FMEA is conducted by listing down the potential risks or failures along with their effects on a paper or spreadsheet. These failures are then evaluated and ranked according to their severity. While this method is prevalent, there are software in the market that make FMEA easier and quicker.

In this article, we will discuss everything you need to know about implementing FMEA in manufacturing.

What is FMEA in Manufacturing?

FMEA was first launched in the US military in the 1950s. Initially, it was used to find out and solve quality-related and reliability issues of military products. In the 1960s, FMEA was used as a formal design methodology by the aviation industry to cater to their reliability and safety requirements. Then in the 1970s, the Ford Company introduced FMEA in the automotive sector. Ford not only used FMEA for safety and regulatory considerations, but also utilized it to improve the design and production.

Since then, the manufacturing industry has embraced FMEA and it is widely used in aerospace, military, automobile, electricity, mechanical, and semiconductor industries. Various research has been conducted on the use of FMEA in the manufacturing and assembly process. Some of the developments are discussed as follows:

Dale and Shaw conducted a study in 1990, in which they surveyed 78 organizations in the UK motor industry related the use of FMEA. Many companies stated that at first, they only used FMEA as a part of a contractual requirement. However, after using it for some time they began to understand the benefits of FMEA and started using it effectively to improve their quality issues.

Arvanitoyannis and Varzakas demonstrated a practical application of FMEA in the food industry, specifically in the potato chips manufacturing. FMEA was used to analyze the potential risks involved during the potato chips production. Through FMEA, they were able to identify critical control points (points that are located at any step where hazards can be either prevented, eliminated, or reduced to acceptable levels) during the process to improve quality.

Another research was conducted by Potente and Natrop to improve the quality of a plastic welding process. Plastics were joined by a hot welding tool and then the finished product was inspected. The method led to high scrap rates, as defects were only inspected after production. After a thorough study, FMEA was implemented before mass production to identify potential failure modes and their effects in advance.

The examples highlight the potential application of FMEA in various manufacturing sectors and its contribution to improving the overall process. They demonstrate that, when implemented properly, FMEA can improve product quality, reduce risk, and enhance efficiency of a manufacturing process.

Types of FMEA in Manufacturing

There are different types of FMEAs. While the purpose of all FMEAs is the same i.e. to identify and mitigate failures. However, they are used in different stages. Based on their nature of application, FMEAs can be classified into three basic types as shown in the figure below:

Concept FMEA: Concept FMEA is used in the early stages of a product or system development. It focuses on potential failures associated with the proposed function of a concept.
Design FMEA: Design FMEA identifies and prevents failures of a product related to their design. The aim of design FMEA is to pinpoint any failures in early stages of design development to eliminate their effects, and select the optimal design variant.
Process FMEA: Process FMEA focuses on the potential failure of the process that is caused during the manufacturing or assembly of the product. It can be of two types that is Manufacturing FMEA and Process FMEA. Manufacturing FMEA primarily deals with failure modes related to visual defects in the production process, such as incorrect sizes, shapes, or surface finishes. On the other hand, Assembly FMEA concentrates on issues that can occur during the assembly of components.

Benefits of Using FMEA in Manufacturing

The major benefits of using FMEA in manufacturing industry is:

Early identification of design flaws: FMEA allows manufacturers to evaluate potential failures in a product during the design phase. It reduces the cost required to modify a product later in the development phase.

For example: In the automotive industry, using FMEA in the design phase of a new engine could point out a potential issue with a cooling system component and hence save the cost to modify thousands of vehicles later or save the manufacturer from recalls.

Improved product quality and reliability: FMEA can identify risks and failures at an early stage of the product leading to a more reliable and good quality product. In this way, product performance and customer satisfaction are also improved.

For example: The electronics industry can implement FMEA in their production lines, which may lead to the discovery of a weakness in a phone’s casing design.

Reduced overall costs: Overall cost can be significantly reduced after the implementation of FMEA. Products are less reworked and modified if the failure is already assessed during the design phase.

For example: A medical device manufacturer used FMEA during the development of a new insulin pump. By identifying and addressing potential failure modes early, they reduced prototype iterations, saving the overall development cost.

Enhanced process efficiency: By identifying critical points during FMEA and working on them, the overall efficiency can be increased. FMEA helps to streamline the process by focusing on high-risk areas.

For example: A food processing plant applied FMEA to its production line and identified several critical control points. By focusing on these areas, they can increase their overall production.

Decoding FMEA

Now that you know what FMEA is used for, let’s discuss how you can conduct FMEA. There are some basic requirements that you should know of such as:

Step 01: Preparation

To prepare for FMEA, you need to create key documents that outline any investigation of past failures.
To investigate past failures, you can perform root causes analysis of past failures through block diagrams or process flow diagrams, etc.
After that form a cross-functional team and discuss the scope of the project.
Now, fill all this information in an FMEA sheet.

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Step 02: Assigning Severity Number and Class

List down your process step or function in the FMEA sheet.
Now analyze potential failures associated with that step or function and write it in the potential failure mode.
Evaluate the effect of that failure and assign a severity number to it.
Severity number ranges from 1 to 10, with 1 being the least and 10 the most hazardous one. Usually, severity numbers 9 and 10 require immediate action.
There are two types of classes: critical and special. Critical class characteristics deal with government regulations, and safe operations of equipment while special deals with product features and customer satisfaction.

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Step 03: Potential Causes and their Occurrence

Write down potential causes which contribute to failure mode.
Assign occurrence ranking to these causes based on their failure rates.

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Step 04: Identifying Detection Control through Detection Ranking

Identify current process control to mitigate or prevent these causes. These controls can be in the form of tests, procedures, and mechanisms.
Assign detection ranking to these . The ranks are from 1 to 10, 1 is assigned to the cause which is very unlikely to detect failure while the control with a ranking of 10 is highly likely to identify the failure.

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Step 05: Action Priority

Calculate the Risk Priority Number (RPN) with the following formula:
RPN = Severity × Occurrence × Detection
The RPN helps prioritize which failure modes need attention urgently for improvement efforts. A high RPN number indicates higher risk and priority of action.
Note down recommended actions for failures along with the person responsible and target date to complete an action.
You can also use the following matrix of occurrence and severity to detect the highest-priority and lowest priority risks:

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Step 06: Actions Review

Write down the actual action taken for these failures.
Again, calculate the RPN according to the new severity number, occurrence, and detection ranking after the preventive action. This will ensure the effectiveness of the action.

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Challenges in Conducting FMEA Manually

The FMEA process that we just discussed is the traditional way of conducting FMEA. It was easier to use when processes were simpler. However, today processes are more complicated and there are machines, devices and robots involved as well. So, traditional FMEA can be challenging because:

Time-consuming process: Manually entering data in paper or spreadsheet and calculations can be slow and labor-intensive. Plus, it takes time to update data across multiple documents.
Error-prone: There are chances of error in calculating Risk Priority Number (RPN), which can lead to inaccurate risk assessments and wrong priorities.
Difficult Collaboration: Sharing FMEA across different departments or people can be a difficult process, especially for geographically dispersed teams. Version control becomes an issue when multiple people work on the same analysis.
Lack of Standardization: Different teams may use different formats or interpretations of FMEA. Inconsistent terminologies across different teams can lead to confusion.

These challenges can affect effectiveness of FMEA, reduce the accuracy of the process and make it difficult to maintain up-to-date FMEA documentation, potentially leading to outdated risk assessments.

Easily Implement FMEA with Kaizen Copilot

Kaizen Copilot is an AI-powered continuous improvement software that comes with various capabilities. Industrial engineers can use Kaizen Copilot to conduct rapid time and motion studies, design safer workstations with ergonomics module and easily conduct process FMEA.

All users have to do is enter details of a process and the software evaluates the process and predicts potential failures. It also allows users to re-generate failures multiple times until they are satisfied with the results. Moreover, Kaizen Copilot leverages the AI technology to detect causes for each failure. It also makes it easier to manage and share across different teams since the process is standardized. With easier access to traceability and easier revisions, Kaizen Copilot not only simplifies FMEA but also enhances it by identifying and preventing potential failures of the product.

Conclusion

FMEA is a powerful technique that empowers manufacturers to proactively identify and address potential failures throughout the product development and manufacturing process. By pinpointing potential failures early in the design and production stages, FMEA helps identify weaknesses before they cause costly problems, which translates into higher quality, more reliable products, and fewer rework needs.

Ready to transform your FMEA process? Book a free demo.