Failure Modes and Effects Analysis Methodology

What is FMEA?

FMEA stands for Failure Modes and Effects Analysis.

It is a structured approach to identifying and preventing potential problems and failures in a product, process, or system. FMEA is commonly used in industries such as automotive, aerospace, and manufacturing, where even minor issues can have serious consequences.

The process involves identifying potential failure modes, determining the severity of the effects of those failures, and then identifying the likelihood of the failure occurring and detecting it before it causes harm.

This is typically done by a cross-functional team that includes design engineers, quality engineers, production personnel, and subject matter experts.

The FMEA process helps to identify potential problems early in the development process, allowing for corrective action to be taken before the product or process is released. It can also be used to improve existing products and processes by identifying areas for improvement and potential failure modes that were not previously considered.

FMEA is a valuable tool for risk management and can help organizations to reduce costs associated with quality issues, reduce the likelihood of failures occurring, and improve overall product and process performance.

Define Failure modes and Effects analysis

Failure Modes and Effects Analysis (FMEA) is a structured methodology used to identify and prioritize potential failures of a product, process, or system, and to determine the effects of those failures.

Here are definitions of the two key elements of FMEA:

Failure modes: A failure mode is the way in which a product, process, or system could potentially fail to meet its intended function or performance requirements. It is a specific type of potential failure that can occur. For example, a failure mode in an automobile engine might be a cracked piston, while a failure mode in a medical device might be a malfunctioning sensor. Failure modes are typically identified through brainstorming or other analysis techniques.
Effects analysis: The effects analysis part of FMEA involves assessing the potential effects of each failure mode on the system, product, or process, as well as on the end-user or customer. Effects analysis considers the severity of the effects, the likelihood of the effects occurring, and the detectability of the effects. This information is used to prioritize which failure modes require the most attention and which mitigation actions should be taken.

A tool for identifying and addressing potential failures early in the development process, improving product or process quality, reliability, and safety.

By using FMEA, organizations can prioritize and mitigate potential failures, resulting in better products and processes that are more dependable and safer for users.

When to use FMEA?

Product development: FMEA can be used during the product development phase to identify potential failure modes and take corrective actions before the product is released to the market. This can help to improve the quality and reliability of the product.
Process improvement: FMEA can be used to improve manufacturing or other processes by identifying potential failure modes that can lead to defects or other quality issues. By addressing these potential failures, processes can be optimized to reduce waste and improve quality.
Risk assessment: FMEA can be used to assess the risks associated with a product or process, and to prioritize actions to mitigate those risks. This is especially useful in industries where failure can have serious consequences, such as the medical device, aerospace, or energy industries.
Compliance requirements: FMEA can be used to demonstrate compliance with regulatory requirements or industry standards that mandate the use of risk analysis and mitigation techniques.
Continuous improvement: FMEA can be used as part of a continuous improvement process to continually identify and mitigate potential failures in products, processes, or systems.

Steps involves in FMEA analysis

The exact steps involved in an FMEA (Failure Modes and Effects Analysis) analysis can vary based on the specific industry or application, but here are the general steps that are typically followed in a traditional FMEA process:

Define the scope and purpose of the analysis: This involves defining the product, process, or system that will be analysed, identifying the key stakeholders and their roles, and establishing the objectives of the analysis.
Form a cross-functional team: The team should be made up of experts from various disciplines, including design, engineering, manufacturing, quality assurance, and safety, among others.
Define the product or process functions: This involves identifying the intended functions or uses of the product or process.
Identify potential failure modes: The team should brainstorm potential failure modes for each function of the product or process. Failure modes are the ways in which the product or process may fail to perform as intended.
Assess the severity of the failure modes: The team should assess the severity of each failure mode by considering the potential impact of the failure on the user, environment, or the business.
Assess the likelihood of occurrence: The team should assess the likelihood of each failure mode occurring. This involves considering the root causes of the failure modes, and how often they are likely to occur.
Assess the ability to detect failure modes: The team should assess the ability of the detection systems to identify the occurrence of each failure mode before it reaches the end-user.
Calculate the risk priority number (RPN): The RPN is calculated by multiplying the severity, likelihood, and detection scores for each failure mode. This helps to prioritize which failure modes require immediate attention.
Develop and implement actions to mitigate the high RPN failure modes: This step involves developing and implementing actions to address the high RPN failure modes. This can include modifying the product design, changing the manufacturing process, or implementing new testing procedures.
Monitor and review: Finally, the team should continuously monitor and review the product or process performance, and update the FMEA analysis as necessary.

FMEA is a systematic and structured process that helps organizations identify and address potential failures early in the development process, ensuring that products and processes are safe and reliable for users.

3 / 5 / 7 - Steps in FMEA

FMEA (Failure Modes and Effects Analysis) can be conducted using different numbers of steps, depending on the level of detail and complexity required.

3 / 5 / 7 step FMEA are common methods used in different industries.

Three-step FMEA: This method is the simplest FMEA approach and involves the following steps:

Identify potential failure modes
Determine the severity of each failure mode
Determine the likelihood of each failure mode occurring

Five-step FMEA: This method adds two additional steps to the three-step FMEA and involves the following steps:

Identify potential failure modes
Determine the severity of each failure mode
Determine the likelihood of each failure mode occurring
Determine the ability to detect each failure mode before it occurs
Calculate the risk priority number (RPN) for each failure mode based on the severity, likelihood, and detectability scores

Seven-step FMEA: This method adds two more steps to the five-step FMEA and involves the following steps:

Identify the functions of the product, process, or system
Identify potential failure modes
Determine the severity of each failure mode
Determine the likelihood of each failure mode occurring
Determine the ability to detect each failure mode before it occurs
Calculate the risk priority number (RPN) for each failure mode based on the severity, likelihood, and detectability scores
Identify and implement actions to mitigate or eliminate the high RPN failure modes

The seven-step FMEA is the most detailed and comprehensive approach and provides a more thorough analysis of potential failure modes and associated risks. However, it also requires more time and resources to complete.

NOTE : The choice of the FMEA approach depends on the specific needs and goals of the project or organization.

FMEA Practical example

Here is an example of how FMEA can be used to identify and mitigate potential failures in a product or process:

Let’s say a company manufactures and sells a new type of electronic device that is intended to be used in outdoor environments. The company decides to use FMEA to identify potential failure modes and take corrective actions before the product is released to the market. Here are the steps the company might take:

Assemble a cross-functional team: The company assembles a team of experts from various departments, such as engineering, quality, and marketing, to work on the FMEA analysis.
Identify potential failure modes: The team uses brainstorming and other analysis techniques to identify potential failure modes. Some examples might include damage to the device from exposure to moisture or extreme temperatures, malfunction due to dust or debris, or a failure of the device’s battery.
Rate the severity of the effects: The team assesses the potential severity of each failure mode on a scale of 1 to 10, where 1 is minor and 10 is catastrophic. For example, a failure mode that could cause injury or death might be rated as a 10, while a failure mode that could cause minor inconvenience might be rated as a 1.
Rate the likelihood of occurrence: The team assesses the likelihood of each failure mode occurring on a scale of 1 to 10, where 1 is highly unlikely and 10 is almost certain. For example, a failure mode that is very unlikely to occur might be rated as a 1, while a failure mode that is almost certain to occur might be rated as a 10.
Rate the detectability of the effects: The team assesses how easy it would be to detect the effects of each failure mode on a scale of 1 to 10, where 1 is easy to detect and 10 is difficult to detect. For example, a failure mode that is easy to detect might be rated as a 1, while a failure mode that is difficult to detect might be rated as a 10.
Calculate the Risk Priority Number (RPN): The team calculates the RPN for each failure mode by multiplying the severity, likelihood, and detectability ratings. For example, if the severity is rated as an 8, the likelihood is rated as a 5, and the detectability is rated as a 3, the RPN would be 120 (8 x 5 x 3).
Prioritize actions: The team prioritizes actions based on the RPN. The highest RPN scores indicate the most critical failure modes and the team should take corrective action to mitigate those risks. For example, the team might decide to modify the design of the device to improve its resistance to moisture or to add an external case to protect it from debris.
Monitor and review: The team monitors the effectiveness of the corrective actions and regularly reviews the FMEA analysis to identify and address any new potential failure modes.

The analysis helps the company to identify and mitigate potential failures before the product is released to the market, resulting in a more reliable and safer product for users.

Areas that conduct FMEA analysis

It is widely used in various industries to identify potential failures in products, processes, or systems, and to take preventive or corrective actions. Here are some of the industries where FMEA is commonly used:

Automotive industry: To improve the quality and reliability of vehicles. It is used in the design and development of vehicle components, such as engines, transmissions, and brakes, as well as in the production process.
Aerospace industry: To design and manufacturing of aircraft, engines, and other aviation components. It is also used in the maintenance and repair of aircraft to ensure safety and reliability.
Medical device industry: It is used in the development and manufacture of medical devices to ensure that they are safe and effective for patients, it is also used in the design and implementation of medical procedures.
Electronics industry: To develop electronic components, such as computer chips, printed circuit boards, and electronic devices. It is also used in the manufacturing process to improve quality and reliability.
Manufacturing industry: Implemented in various manufacturing processes, including assembly lines, machining, and welding, to identify potential failure modes and take corrective actions.
Food industry: To identify potential hazards and risks associated with the production, processing, and storage of food products. It is used to ensure food safety and quality.
Energy industry: Identify potential hazards and risks associated with drilling, production, and transportation processes. It is also used in the design and development of energy-related components and systems.

Overall, it is a versatile tool that can be used in any industry where there is a need to identify potential failures and take corrective actions to improve product or process quality, reliability, and safety

Benefits and importance of FMEA

Improves product quality and reliability: By identifying potential failure modes and taking corrective actions early in the development process, FMEA helps to improve the quality and reliability of a product. This can reduce the risk of defects and increase customer satisfaction.
Reduces costs: FMEA can help to reduce costs by identifying potential failure modes before they occur. This can minimize the need for costly repairs or recalls, as well as reduce the risk of lost revenue due to product failures.
Enhances safety and reduces risk: FMEA can help to identify potential safety risks and take corrective actions to reduce those risks. This is especially important in industries where failure can have serious consequences, such as the medical device, aerospace, or energy industries.
Demonstrates compliance: FMEA can help to demonstrate compliance with regulatory requirements or industry standards that mandate the use of risk analysis and mitigation techniques.
Supports continuous improvement: FMEA can be used as part of a continuous improvement process to continually identify and mitigate potential failures in products, processes, or systems. This helps to ensure that an organization is always improving and staying ahead of potential risks.

Loopholes / Disadvantages

Every process can have its own positive and negative point, here are the loopholes / disadvantages in the system where accuracy can be overridden

Lack of buy-in from team members: If team members do not fully buy into the FMEA process or feel that their contributions are not being heard, it can result in incomplete or inaccurate analyses.
Over-reliance on data: FMEA is a data-driven approach, but it is important to recognize that not all potential failures can be predicted through data analysis alone. The team should also take into account expert knowledge, experience, and intuition when assessing potential failure modes.
Failure to update the FMEA: The FMEA should be a living document that is regularly reviewed and updated as new information becomes available. Failure to update the FMEA can result in missed failure modes or incorrect assessments.
Limited scope: FMEA is typically focused on specific products, processes, or systems. It is important to recognize the limitations of FMEA and to consider the broader context in which these products, processes, or systems operate.
Failure to take action: Identifying potential failure modes is only the first step. It is important for the team to take action to mitigate the risks identified through the FMEA. Failure to take action can result in missed opportunities to improve product quality, reliability, and safety.

Ground rules while conducting FMEA

Here are some ground rules to consider when conducting FMEA:

Define the scope: Clearly define the scope of the FMEA analysis, including the product, process, or system being analysed, as well as any boundaries or limitations.
Build a cross-functional team: FMEA should involve a cross-functional team with expertise from different areas of the organization. This ensures that all relevant factors are considered and that the team can collaborate effectively.
Use consistent terminology: Use consistent terminology and definitions to ensure that everyone on the team has a shared understanding of the concepts being discussed.
Be objective: The FMEA process should be objective and data-driven, and not influenced by personal biases or opinions.
Emphasize communication: Effective communication is crucial throughout the FMEA process, from gathering information to presenting and discussing results.
Use a structured approach: Use a structured approach to the FMEA process, including clear steps and guidelines for data collection, analysis, and decision-making.
Document everything: Document all data and decisions made during the FMEA process, as well as any action items resulting from the analysis.
Regularly review and update the FMEA: The FMEA should be reviewed and updated regularly to ensure that it remains relevant and accurate.

Following these ground rules, the FMEA process can be conducted more effectively, leading to more accurate identification and mitigation of potential failures in the product, process, or system being analysed.

Cost involved in conducting FMEA

The cost of conducting can vary depending on several factors, including the size and complexity of the product, process, or system being analysed, the size and expertise of the team, and the resources required for data collection and analysis.

Here are some of the potential costs involved in conducting FMEA:

Personnel costs: The biggest cost associated with FMEA is typically the personnel costs of assembling and training the cross-functional team. The team should have a variety of expertise and include members from various departments, such as design, manufacturing, quality, and engineering.
Data collection costs: Collecting data is a key part of the FMEA process, and it may require additional resources or tools to gather the necessary data.
Software costs: There are many software tools available that can facilitate the FMEA process. These tools can help with data collection, analysis, and reporting, but they can also be expensive.
Meeting and workshop costs: The FMEA process involves a series of meetings and workshops, which may require additional resources such as room rentals, audio-visual equipment, and catering.
Training and certification costs: Depending on the level of expertise required for the FMEA team, additional training and certification may be necessary. This could include training on the FMEA process itself, as well as training on specific software tools or methodologies.

While there are costs associated with conducting FMEA, the benefits of identifying and mitigating potential failures can outweigh these costs. By identifying and addressing potential failures early in the development process.

FMEA can help to improve the quality and reliability of a product or process, ultimately reducing the risk of costly recalls, lost revenue, or damage to the organization’s reputation.

Rating and Ranking for FMEA

In the context of FMEA (Failure Modes and Effects Analysis), rating and ranking are methods used to assess and prioritize potential failure modes based on their severity, occurrence, and detectability.

The rating method involves assigning a numerical score to each failure mode based on its severity, occurrence, and detectability. The scores are typically on a scale from 1 to 10, with higher scores indicating higher levels of severity, occurrence, or detectability.

The scores for each factor are then multiplied together to give a risk priority number (RPN), which is used to prioritize the failure modes for further action. Failure modes with the highest RPNs are given the highest priority for corrective action.

The ranking method involves sorting the failure modes into categories based on their severity, occurrence, and detectability. For example, failure modes may be ranked as high, medium, or low risk based on their severity, occurrence, and detectability. Failure modes that are ranked as high risk are given the highest priority for corrective action.

Both rating and ranking methods can be effective in helping teams to prioritize and focus their efforts on the most critical failure modes. However, it is important to note that these methods are only tools for analysis and decision-making, and should not be used as the sole basis for action.

Teams should also use their professional judgment and experience to evaluate the results and make informed decisions on the appropriate actions to take.