Failure mode and effects analysis (FMEA) is a risk-assessment method that anticipates problems before they occur and develops plans to neutralize their impact.

Image illustrates a wooden blocks with words “Failure Modes and Effects Analysis

  • Failure mode and effects analysis (FMEA) is defined as a proactive risk-assessment method used to identify and evaluate potential failure modes and their effects on a product or process.
  • FMEA is widely used in industries such as automotive, aerospace, and manufacturing to improve the quality and reliability of products and processes.
  • This article explains the fundamentals of FMEA, its types, and its importance in modern industries.

What Is FMEA?

Failure mode and effects analysis (FMEA) is a proactive risk-assessment method that helps identify and evaluate potential failure modes and their effects on a product or process. This method finds application in industries such as automotive, aerospace, and manufacturing, where it is used to improve the quality and reliability of products and processes.

FMEA involves a team of experts who analyze a system or product to determine the likelihood of failure modes and their effects. This analysis is done in a step-by-step process, and the results are used to develop corrective actions to mitigate failures.

But what is failure mode? Failure mode refers to an element, component, system, function, or process with a non-zero probability of failure. Let’s understand it with an example of a motorcycle. The motorcycle’s disc brake works due to the friction created between the rotor and the brake pads. Now, several events, such as oil spills on the road or heavy rains, can result in reduced friction, eventually leading to brake failure and an accident. These events are referred to as failure modes.

FMEA identifies failure modes and effects and prioritizes resolving or eliminating them before the product is released.

History of FMEA

In the 1940s–50s, the United States military developed a method called “failure mode and effects analysis” to improve the reliability of weapons systems, airplanes, and missiles. During World War II, the U.S. military encountered numerous weapons system failures, leading to loss of lives and resources.

The military then developed a systematic approach to identify and tackle potential failure modes in weapons systems. This approach involved analyzing each component and subsystem of the weapons to expose potential points of failure and their causes and effects on the system’s performance. The military also developed methods to quantify the probability and severity of each failure mode and prioritize its remediation.

After the war, FMEA was adapted and applied across other industries to improve the reliability and safety of their products and processes. In the 1960s, FMEA was incorporated into the NASA Apollo program, where it was used to determine potential failure modes in the spacecraft and its subsystems.

Since then, FMEA has become widely used as a risk-mitigating tool in several industries, such as electronics, telecommunications, and healthcare.

FMEA standards

FMEA relies on several standards that outline the FMEA process and provide guidance on conducting an FMEA. Let’s look at some of the most widely recognized FMEA standards:

  • AIAG-VDA FMEA Handbook: This is a joint publication from the Automotive Industry Action Group (AIAG) and the German Association of the Automotive Industry (VDA). It provides a common framework for FMEA used by automotive companies and their suppliers worldwide.
  • ISO 9001:2015 Quality management systems: This is a standard that outlines the requirements for a quality management system, including the use of FMEA as a tool to find and mitigate risks to quality.
  • IEC 60812:2018: This standard offers guidance on conducting an FMEA for systems, including electrical and electronic systems.
  • MIL-STD-1629A: This is a U.S. Department of Defense standard that outlines the FMEA process for defense systems.
  • SAE ARP5580: This is a standard from the Society of Automotive Engineers (SAE) that provides guidelines for the FMEA process applied in aerospace systems.

How is FMEA performed?

FMEA uses a structured approach to recognize potential failure modes and develop solutions to prevent those failures. Let’s look at the steps followed in FMEA:

  1. Identify the scope: Define the scope of FMEA, including the product or process being evaluated, the functions and features, and the team responsible for performing the FMEA.
  2. Assemble the team: Form a cross-functional team consisting of subject matter experts from different departments, such as design, engineering, manufacturing, quality, and reliability.
  3. Develop a process flow diagram: Create a process flow diagram that shows the sequence of steps in the process or the flow of materials in the product. This helps to determine potential flaws at each step in the material flow.
  4. Identify potential failure modes: Brainstorm potential failure modes for each step in the process flow. Use past experience, customer complaints, warranty data, and other sources to localize the faults.
  5. Assess the severity of each failure mode: On a scale of 1 to 10, assess the severity of each failure mode, where 1 is minor and 10 is catastrophic. Severity is the measure of the impact of the failure mode on the customer.
  6. Assess the likelihood of each failure mode: Likelihood refers to the measure of the probability that the failure mode will occur.
  7. Assess the detectability of each failure mode: Detectability is the measure of the probability that the failure mode will be detected before it reaches the customer.
  8. Calculate the risk priority number (RPN): Calculate the RPN for each failure mode by multiplying the severity, likelihood, and detectability scores. The RPN is a measure of the risk associated with the failure mode and helps to prioritize corrective actions.
  9. Develop corrective actions: Based on the RPN scores, design solutions to prevent the highest priority failure modes. Assign responsibility and due dates for each corrective action.
  10. Implement corrective actions: Implement and track the effectiveness of corrective actions. Monitor the process or product to ensure that the corrective actions have been effective in mitigating the failure modes.
  11. Review and update FMEA: Review and update FMEA periodically to ensure it remains current and effective.

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Types of FMEA

FMEA is primarily categorized into three types: design FMEA (DFMEA), process FMEA (PFMEA), and system FMEA (SFMEA). Each type focuses on a different stage of the product or process lifecycle and has a different objective.

1. Design FMEA (DFMEA)

DFMEA is performed during the product design phase. DFMEA aims to improve product design by discovering and addressing potential issues before the product is released to the market. This involves assessing the characteristics that can have a safety and regulatory impact on the product. It may include evaluating the properties of materials used (lubricity, viscosity, or elasticity), product geometry, tolerances, engineering noise, and so on.

DFMEA is usually employed in the following industries:

  • Automotive industry: Car manufacturers use DFMEA to analyze the design of a new car model to ascertain potential failure modes in critical components like the engine, transmission, and brakes and determine their effects on the car’s performance.
  • Aerospace industry: Aircraft manufacturers use DFMEA to analyze the design of an aircraft to pin down potential failure modes and their effects on the aircraft’s performance and safety and to address them in the design phase.

2. Process FMEA (PFMEA)

PFMEA is performed during the manufacturing or production process. This involves locating failures that may lead to reduced process reliability, safety of the workforce, and customer dissatisfaction. It also involves assessing human factors or errors, analyzing methods, materials, and machines used in the business process, examining measurement metrics relied upon for product acceptance, and exploring environmental factors affecting the business process.

PFMEA is typically used in the following industries:

  • Semiconductor industry: Semiconductor manufacturers use PFMEA to reveal potential failure modes in the manufacturing process of computer chips, such as defects in the etching, doping, or packaging processes, and determine their effects on the quality and reliability of the chips.
  • Food industry: The food processing industry uses PFMEA to expose potential failure modes in their manufacturing processes, such as contamination, improper handling, or packaging, and determine their effects on the safety and quality of the food.

3. System FMEA (SFMEA)

SFMEA is performed during the service or maintenance phase. The following sectors rely on SFMEA to assess risks:

  • Medical device industry: Hospitals and medical device manufacturers use SFMEA to bring to light potential failure modes in the service or maintenance of medical devices, such as incorrect calibration or incorrect installation, and determine their effects on the performance and safety of the devices.
  • Telecommunications industry: Telecommunications companies use SFMEA to unearth potential failure modes in their service processes, such as network outages, billing errors, or customer complaints, and determine their effects on the quality and reliability of the service.

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Importance of FMEA

In modern industries where the emphasis is on high quality, reliability, and safety, FMEA is a crucial tool to uncover potential failures in products, processes, or systems before they impact the entire system.

According to a 2023 report by Grand View Research, the risk-assessment market had a valuation of $5.98 billion in 2022 and is estimated to grow at a CAGR of 6.1% from 2023 to 2030. The report cites that in 2022, the industrial sector, which relies on machines for production, earned the maximum overall revenue among all verticals (automotive, food & beverages, consumer electronics, industrial, healthcare, and others) with a share of 30.03%.

Risk assessments are performed using several methods, such as hazard analysis, FMEA, and fault tree analysis (FTA). However, the importance of FMEA in modern industries is quantifiable due to the following reasons:

1. Improved product and process quality

FMEA allows companies to resolve possible failures before they adversely affect the business. By addressing issues early on, companies can improve product and process quality, increase customer satisfaction, and reduce the likelihood of costly rework, warranty claims, or product recalls.

2. Enhanced safety

In industries such as aerospace, healthcare, and automotive, where safety is a critical concern, FMEA performs an essential role by tracking down potential safety risks and their causes. Companies can then take actions to eliminate risks and ensure employee and customer safety.

3. Reduced costs

With FMEA, companies can avoid costly repairs, downtime, and rework, resulting in significant cost savings and increased efficiency.

4. Proof of compliance

Many industries are subject to regulatory compliance standards that require using risk management techniques such as FMEA. By using FMEA, companies can ensure compliance with regulatory standards.

5. Competitive advantage

As FMEA improves product and process quality, enhances safety, and reduces costs, companies inevitably gain a competitive advantage over their rivals. They can build a positive reputation for high-quality products, improved safety, and customer satisfaction, leading to increased market share and profitability.

6. Innovation

By understanding the potential risks that FMEA reveals and taking corrective actions, companies can develop innovative products and processes that meet customer needs and expectations.

In addition to these benefits, FMEA has become even more important in modern industries due to the increasing complexity and interconnectivity of products, processes, and systems. The emergence of new technologies such as artificial intelligence (AI), machine learning (ML), and the internet of things (IoT) has added a new dimension to the risk management process, making it more challenging to identify and mitigate potential failures.

FMEA Tools

Today, several modern technologies and tools are used to perform FMEA to improve product and process effectiveness and efficiency. Some of the most common tools used in modern FMEA include:

  • FMEA software: Specialized software tools automate the FMEA process and help analyze and manage large amounts of data. These tools typically provide templates to document failure modes, causes, and effects and can be customized to meet the specific needs of a particular project or organization. Some known examples of FMEA solutions are ReliaSoft XFMEA, Intelex FMEA, DataLyzer FMEA, and Relyence FMEA.
  • CAD and simulation tools: Computer-Aided Design (CAD) and simulation tools can be used to model and analyze complex systems or products, allowing the accurate identification and evaluation of potential failure modes. These tools can also be used to simulate different scenarios and test potential mitigation strategies.
  • Statistical analysis tools: These tools help analyze data from multiple sources, including production lines, quality control systems, and customer feedback. They can help detect patterns and anomalies that may indicate potential failure modes and can be used to evaluate the effectiveness of different failure prevention strategies.
  • IoT and sensor technology: IoT and sensor technology are increasingly being used to collect data on product or system performance in real-time. This data can be used to pinpoint potential failure modes and associated risks accurately.
  • Collaborative tools: Collaborative tools such as online platforms or chat systems enable teams to work together on FMEA projects by allowing team members to share information and communicate in real-time, reducing the need for lengthy meetings and improving collaboration.

As technology continues to advance, we can expect more sophisticated tools and techniques to be developed to enhance the FMEA process further.

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FMEA will continue to evolve as industries adopt new technologies. One potential development is the increased use of AI and ML algorithms to analyze data and determine potential failure modes. This could lead to more efficient and accurate FMEA processes.

Another potential development is the integration of FMEA into the product lifecycle management (PLM) process. This could allow for more comprehensive risk management throughout the product development process, from design to end-of-life. Additionally, as companies prioritize sustainability and environmental impact, FMEA may be used to find potential environmental risks and improve product sustainability.

Did this article help you understand the relevance of FMEA in the risk assessment market? Comment below or let us know on FacebookOpens a new window , X (Twitter)Opens a new window , or LinkedInOpens a new window . We’d love to hear from you!

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Vijay Kanade

Vijay A. Kanade is a computer science graduate with 7+ years of corporate experience in Intellectual Property Research. He is an academician with research interest in multiple research domains. His research work spans from Computer Science, AI, Bio-inspired Algorithms to Neuroscience, Biophysics, Biology, Biochemistry, Theoretical Physics, Electronics, Telecommunication, Bioacoustics, Wireless Technology, Biomedicine, etc. He has published about 30+ research papers in Springer, ACM, IEEE & many other Scopus indexed International Journals & Conferences. Through his research work, he has represented India at top Universities like Massachusetts Institute of Technology (Cambridge, USA), University of California (Santa Barbara, California), National University of Singapore (Singapore), Cambridge University (Cambridge, UK). In addition to this, he is currently serving as an ‘IEEE Reviewer’ for the IEEE Internet of Things (IoT) Journal.