Failure Mode and Effects Analysis (FMEA)

What is FMEA?

Failure Mode and Effects Analysis (FMEA) is a systematic evaluation of the ways failure can occur in a production system. Industries with complex design and production processes, such as automotive, aerospace, healthcare, and manufacturing, have used FMEA for decades to improve operations and proactively minimize risks. 

Failure modes and effects analysis (FMEA) systematically and thoroughly uncovers:

• Failure modes — the ways an existing process could fail
• Downstream effects of those failure modes on the rest of the production system
• Weak links in the chain of inputs, components, processes, and their interactions

The FMEA process was one of the first ways organizations began to look at risk factors in a production system systematically. It is at the core of engineering for reliability, safety, and quality control. 

The end goal of FMEA is to eliminate or minimize the chances of a system failure or severe breakdown. Knowing the potential weaknesses and their potential effects on the whole system makes it easier to decide which parts can be adjusted to make it more reliable.

Types of FMEA

Over the years, FMEA has evolved and adapted to different applications, industries, and phases of the production process. Depending on the organization and the system being analyzed, teams may choose specialized types of FMEA, such as: 

• Design FMEA (DFMEA) identifies possible failures in a product’s design to improve the reliability of product quality.
• Process FMEA (PFMEA) examines manufacturing and assembly processes to prevent defects and improve quality control.
• System FMEA (SFMEA) addresses failures within complex systems and their interactions, ensuring overall system reliability.
• Service FMEA focuses on processes related to service delivery to enhance its quality and customer satisfaction.
• Failure Mode Effects and Criticality Analysis (FMECA) expands FMEA to include an assessment of failure criticality when prioritizing corrective actions.
• Functional FMEA focuses on the system as a whole rather than individual components to ensure it achieves its intended function, enhancing reliability and safety.

How to perform FMEA

The process of performing FMEA analysis can be incredibly valuable when performed thoroughly. But it does take time. While there are numerous steps involved – each one varying in complexity and time investment –  they can be grouped into three overall phases:

• Identifying failure scenarios
• Evaluating and prioritizing risks using the Risk Priority Number (RPN)
• Taking action to eliminate or minimize risks

Identifying failure scenarios

This initial phase entails brainstorming to compile a list of ways a new product, process, or system’s potential failure modes could prevent it from fulfilling its intended function. It requires an in-depth understanding of the system components and how they interact.

Once identified, the effects and root causes of each failure mode must be documented for further analysis in future steps. In this phase, it is critical to use historical maintenance data on system failures and the expertise of experienced cross-functional team members. 

Evaluating risks using the Risk Priority Number (RPN)

Each identified failure scenario and its effects are then evaluated and assigned a set of ratings based on three factors that will help prioritize corrective actions: 

• Severity of the failure and its effects
• Likelihood of the failure to occur
• Detectability of the failure

These values are multiplied to determine a Risk Priority Number (RPN). The RPN is a value that represents the overall impact of a failure on the system being assessed in the FMEA process. The higher the RPN, the more important it is to prevent or minimize that failure. 

Taking action to fix the issue

Finally, for failure modes that pose the highest risks—represented by the highest RPNs—teams must find ways to adjust the system to prevent the failure or minimize its downstream effects. This proactive approach ensures effective failure prevention and minimizes potential impact on the system’s performance.

Benefits of performing FMEA

FMEA is more than just a quality control tool; it’s a strategic asset that can help companies unlock benefits beyond fixing flaws or defects. Here are some of the ways implementing FMEA can benefit the product development process. 

Uncovers hidden problems

FMEA is like a detective that investigates each component and subsystem to find hidden failure modes. Armed with this knowledge, teams can develop targeted strategies to lower these risks, ultimately creating a more robust and reliable product or process.

Reduces product development time and costs

One of the main benefits of using FMEA is that it helps determine the biggest liabilities for your budget before you devote too much money and resources to larger-scale production. The goal is to avoid redesigns, delays, or even having to start over again.

Makes a more collaborative work environment

FMEA breaks down barriers and brings experts from different departments, such as design, engineering, manufacturing, and quality control, together. When you take a collaborative approach like this you build a culture of continuous learning in your organization.

Boosts customer satisfaction

The ultimate goal of relying on FMEA is to eventually gain a competitive edge in the market by making customers happy. By using this tool to create a higher quality product, you increase customer satisfaction and provide a path to greater success.

Facilitates continuous Improvement

You don’t use this methodology just once. It must be regularly reviewed and updated in order to improve failure prevention and explore new failure scenarios. It’s a continuous improvement tool that helps evaluate the manufacturing process and optimize it as you learn more and more.  

Meets legal and regulatory requirements

FMEA is often required in many industries if you want to comply with legal and regulatory standards. This type of failure analysis is a form of proactive risk management and quality assurance that helps companies avoid legal and financial issues.