In a world that constantly strives for quality, dependability, and customer satisfaction, preempting errors before they occur is a business imperative. Enter FMEA—Failure Mode and Effects Analysis—a structured approach for identifying potential failures in a product, process, or system, and taking proactive steps to mitigate them. This analytical method is a cornerstone in industries like automotive, aerospace, medical devices, and even the food and beverage sector. The purpose? To magnify quality, minimize costs, and elevate customer satisfaction by methodically pinpointing vulnerabilities and prioritizing them for corrective action.
In this comprehensive guide, we will demystify FMEA and walk you through its foundational pillars—from assembling a cross-functional team to calculating the Risk Priority Number (RPN). You’ll learn how to define the scope, identify failure modes, evaluate consequences, and implement corrective actions. Whether you’re a seasoned quality manager or a novice stepping into the realm of continuous improvement, this guide will equip you with the tools and know-how to make your FMEA process a resounding success.
Table of Contents
What is an FMEA? (Failure Mode and Effect Analysis)
FMEA (Failure Mode and Effects Analysis) is a method for detecting and analysing potential failure modes in a product, process, or system. It consists of identifying all potential failure modes, analyzing the potential consequences of each failure, and calculating the likelihood of each failure occurring.
FMEA’s purpose is to identify and prioritise potential failure modes so that corrective actions can be implemented to prevent or mitigate their occurrence.
FMEA is widely used in a variety of industries, including as automotive, aerospace, medical devices, and food and beverage, to improve product quality and dependability, increase customer satisfaction, and reduce costs associated with product recalls and warranty claims.
Why is FMEA Important?
FMEA is important because it helps organisations in identifying and addressing potential failure modes in a systematic and proactive manner. Organizations may improve the overall quality and dependability of their goods and processes by identifying and assessing potential failure modes and taking steps to prevent or limit their occurrence.
Furthermore, by assessing the potential consequences of each failure mode, companies can prioritise corrective efforts depending on the failure’s potential impact. This allows them to focus their attention on the most significant concerns and ensure that the most serious threats are addressed first.
FMEA can help firms reduce expenses associated with product recalls and warranty claims, in addition to increasing product quality and reliability. Organizations can avoid the costly and time-consuming process of recalling and repairing faulty items by detecting and addressing probable failure modes before a product is distributed.
FMEA is a great tool for firms that want to continuously improve their products and processes while also ensuring that their customers receive high-quality and dependable products and services.
Benefits of Using FMEA
There are many benefits to using FMEAs to identify and resolve potential failure modes including:
Improved quality and reliability: An FMEA can assist businesses in improving the overall quality and reliability of their products and processes by identifying and resolving potential failure modes in a systematic and proactive manner.
Reduced costs: Organizations can avoid the costly and time-consuming process of recalling and fixing faulty items by detecting and addressing potential failure modes before a product is released. This can assist firms in reducing the cost of product recalls and warranty claims.
Enhanced customer satisfaction: Organizations can boost customer happiness and loyalty by providing high-quality and reliable products and services.
Improved safety: Organizations may lower the risk of accidents and injuries and improve the overall safety of their products and processes by identifying and addressing potential failure modes that could affect safety.
Continuous improvement: Organizations can identify and address potential failure modes in a continuous improvement process by conducting an FMEA on a regular basis, which can help them continuously improve the quality and reliability of their products and processes.
How To Complete an FMEA
Identify the scope of the FMEA
Defining the scope of the FMEA is a critical stage in the FMEA process. It entails identifying the product, process, or system to be examined, as well as the boundaries and assumptions that will guide the study.
Some questions to consider while defining the scope of the FMEA include:
- What is the product, process, or system being studied?
- What are the primary functions or qualities of the product, process, or system?
- What are the potential failure modes being considered?
- Who are the customers or users of the product, process, or system?
- What are the potential consequences of each failure mode for the product, process, or system, as well as for customers, users, and the organisation?
- What are the constraints and assumptions?
- What are the boundaries and assumptions that will guide the analysis?
By clearly defining the scope of the FMEA, you can ensure that the analysis is focused and relevant to the product, process, or system being analysed. This will assist you in identifying and prioritising the most essential failure modes, as well as taking necessary remedial steps to improve the product, process, or system’s quality and reliability.
Assembling A Cross-Functional Team
Assembling a cross-functional team is an important step in the process of completing an FMEA. It involves assembling a team of experts from various departments and functions who are knowledgeable about the product, process, or system under consideration.
Involving a cross-functional team in the FMEA process has various advantages:
- A diversified team with a range of perspectives and expertise can give a more thorough analysis of potential failure modes and their consequences.
- Involving many stakeholders can help ensure that the FMEA considers the interests and concerns of various groups within the company.
- A cross-functional team can increase the overall effectiveness of the FMEA process by facilitating communication and collaboration across departments and functions.
When forming a cross-functional team for an FMEA, keep the following points in mind:
- Finding team members who have suitable knowledge and experience.
- Assuring that the team is representative of the various departments and roles involved in the product, process, or system under consideration.
- Defining clear roles and duties for the team to ensure that the FMEA process is organised and efficient.
By involving a cross-functional team in the FMEA process, you can ensure that the analysis is thorough and comprehensive and that the resulting corrective actions are effective and supported by the necessary stakeholders.
Identify Potential Failure Modes
Identifying potential failure modes is a critical stage in the FMEA process. It entails brainstorming and listing all possible failure modes that could occur in the product, process, or system under consideration.
- There are various approaches for identifying probable failure modes, including:
- Gather a cross-functional team and use a systematic brainstorming process to discover probable failure modes.
- Failure mode and effects analysis: Employ a systematic approach to identifying and analysing potential failure modes and their consequences.
- Root cause analysis: Identify the root causes of previous failures and utilise this information to predict future failure patterns.
- Expert judgement: To identify potential failure modes, consult with experts or subject matter specialists.
When identifying probable failure modes, it is critical to be thorough and complete. Starting with a broad list and then narrowing it down to the most relevant and significant failure modes can be beneficial.
Once the various failure modes have been determined, you can proceed to the following stage of examining the potential implications of each failure mode. This will assist you in prioritising failure modes and determining the most effective corrective steps to take.
Evaluate the consequences
Evaluating the effects of each failure mode is a crucial phase in the FMEA process. It entails evaluating the potential effects of each failure mode on the product, process, or system, as well as on customers, users, and the business.
To assess the consequences of each failure mode, utilise a standardised scale (e.g., low, medium, high) to rate the severity of the probable consequences. Consider the following considerations when assessing the intensity of the effects:
- The severity of the failure mode’s damage or harm.
- The impact of the failure mode on the product, process, or system’s performance or functionality.
- The potential consequences of the failure mode on customers, users, or the organisation.
You can prioritise failure modes and choose the most significant issues to address by evaluating the severity of the potential repercussions of each failure mode. This will allow you to focus your resources on the most effective corrective actions and guarantee that the most serious hazards are addressed first.
In addition to analysing the severity of the impacts, you may want to examine additional aspects that can impact the total risk of each failure mode, such as the likelihood of the failure occurring and the effectiveness of current measures in place to avoid or detect the failure.
Determine the likelihood that each failure mode will occur
Determining the likelihood of each failure mode occurring is a crucial stage in the FMEA process. Based on historical data, testing, or expert assessment, it determines the likelihood of each failure mode occurring.
To rate the possibility of each failure mode occurring, you can use a standardised scale (e.g., low, medium, high). Consider the following considerations while assessing the possibility of each failure mode occurring:
- Historical data: If the failure mode has occurred in the past, it can be used to predict the likelihood of it occurring in the future.
- Testing: If the failure mode has been tested and found to be likely to occur, this can be used to predict how likely the failure mode will be in the actual world.
- Expert opinion: Consult with experts or subject matter specialists to determine the possibility of each failure mode occurring.
You can have a better picture of the overall risk of each failure mode by estimating the likelihood of each failure mode occurring. This data can be used to rank the failure modes and identify the most effective corrective steps to take.
Determine the current Controls
Determining the current controls in place involves identifying the current measures in place to prevent or detect each failure mode.
To determine the current controls in place, you can review the design and operational processes for the product, process, or system being analysed. Some questions to consider while assessing current controls include:
- What preventative measures are in place to avoid the failure mode?
- What monitoring systems are in place to detect the failure mode if it occurs?
- How successful are the existing preventive and detection measures?
By evaluating the current controls in place, you can get a better understanding of the overall risk of each failure mode and identify any gaps or weaknesses in the current controls. This data can be used to rank the failure modes and identify the most effective corrective steps to take.
When prioritising failure modes and selecting the most effective corrective steps, it is also crucial to evaluate the potential effects of each failure mode as well as the likelihood of the failure mode occurring.
Calculate the RPN
Calculating the risk priority number (RPN) for each failure mode is an essential step in the FMEA process. The RPN is a measure of each failure mode’s severity, occurrence, and detection ratings. It is calculated by adding together the severity, occurrence, and detection scores.
The RPN is used to rank failure modes and identify the most significant issues to fix. Higher RPN levels suggest a greater likelihood of failure and a larger need for corrective action.
You can use the following formula to determine the RPN for each failure mode: RPN = severity rating multiplied by incidence rating multiplied by detection rating
For example, if the severity rating for a failure mode is 8, the occurrence rating is 5, and the detection rating is 3, the RPN for the failure mode would be 8 x 5 x 3 = 120.
Calculating the RPN for each failure mode allows you to readily assess the relative risks of various failure modes and prioritise them based on their RPN values. This will allow you to focus your resources on the most significant issues and solve the most pressing concerns first.
When deciding the most effective remedial steps to take, it’s vital to examine the potential effects of each failure mode as well as the current controls in place, in addition to calculating the RPN for each failure mode.
Prioritize Failure Modes
Prioritizing the failure modes involves sorting the list of failure modes by RPN in descending order, starting with the most critical failure modes.
By prioritising the failure modes, you can ensure that you are focusing your resources on the most critical issues and taking the most effective corrective actions. It can be helpful to set a threshold RPN value to determine which failure modes require immediate attention and which can be addressed later.
In addition to prioritising the failure modes based on their RPN values, it’s also important to consider the potential effects of each failure mode and the current controls in place when determining the most effective corrective actions to take.
Developing and Implementing Corrective Actions
The final phase in the FMEA process is to develop and implement corrective actions. It consists of identifying and documenting potential corrective measures for the most significant failure modes, as well as putting such corrective actions into action.
You can brainstorm and identify viable solutions for addressing each failure mode to generate corrective actions. Some things to think about when creating remedial actions are:
- The failure mode’s root cause: Identify and address the failure mode’s root cause to avoid it from occurring in the future.
- The failure mode’s potential consequences: Consider the failure mode’s potential impact on the product, process, or system, as well as on customers, users, and the organisation.
- The cost and feasibility of corrective action: To choose the most effective option, evaluate the feasibility and cost of taking each corrective action.
Once potential corrective steps have been identified, you can apply the most effective options and monitor the results to ensure that the risk of the failure mode is effectively mitigated. It is critical to reevaluate the FMEA on a regular basis to ensure that corrective actions are effective and to detect any new or emerging failure modes.
Ultimately, the purpose of planning and implementing corrective measures is to improve the product, process, or system’s quality and reliability while lowering the risk of failure.
Types of FMEA
There are four different types of FMEA that can be used, depending on the needs and goals of the organisation. FMEAs that are commonly used include:
- Design FMEA (DFMEA): A Design FMEA (DFMEA) is used in the design of a product or process to identify and assess potential failure modes. It is usually used early in the design phase to detect and fix potential difficulties before developing the product or process.
- Process FMEA (PFMEA): A Process FMEA (PFMEA) is a tool for identifying and analysing potential failure modes in a manufacturing or production process. It is often used to identify and address potential issues that may impact the product’s quality, reliability, or safety.
- System FMEA (SFMEA): A System FMEA (SFMEA) is used to identify and analyse potential failure modes in a complex system that is made up of several components or subsystems. It is often used to identify and address possible faults that may impact the system’s overall performance or functionality.
- Service FMEA: A Service FMEA (SeFMEA) is used to identify and analyse potential failure modes in a service process or system. It is often used to identify and address possible issues that may impact the service’s quality, reliability, or safety.
Example of FMEA in action
To help you understand the process of completing an FMEA we have created an example of how the process could go with a failure mode of a device dispensing an incorrect dosage of medication.
To begin an FMEA, the team identifies the potential failure modes that could occur in the product, process, or system. In this example, the potential failure mode is the device dispensing an incorrect dosage of medication.
Next, the team evaluates the effects of each failure mode. In this case, the potential effects of the device dispensing an incorrect dosage of medication include the patient experiencing adverse side effects or inadequate treatment of their condition, and the potential for serious injury or death.
The team then determines the likelihood of each failure mode occurring. To do this, they might consider factors such as historical data, testing results, and expert judgment.
The team also identifies the current controls in place to prevent or detect the failure mode. In this example, the current controls include regular calibration and maintenance of the device and the use of sterile techniques during medication administration.
Next, the team calculates the risk priority number (RPN) for each failure mode by multiplying the severity rating, occurrence rating, and detection rating together. The RPN is used to prioritize the failure modes and determine the most critical issues to address.
Finally, the team develops and implements corrective actions to address the most critical failure modes. In this example, potential corrective actions might include implementing additional user training on proper medication administration, redesigning the device to include additional safeguards against calibration errors and contamination, and considering adding a feature to alert users to potential dosage errors.
To visualise how this might look on an FMEA template see the image below. Don’t be afraid to evaluate multiple corrective actions to see which will result in the lowest RPN. As you can see in the example below three options were considered and scored, with varying levels of risk reduction.
Download FMEA Template
To help you successfully implement an FMEA, we have created a free Excel template that you can use as a tool to assist with the process. In addition to the template, we have also provided a guide on how to score the severity, occurrence, and detection of potential failure modes. The template will automatically calculate the risk priority number (RPN) based on the severity, occurrence, and detection scores that you input.
Using the template, you can easily identify and analyze potential failure modes in a product, process, or system. By completing the severity, occurrence, and detection scores for each failure mode, you can determine the relative risks of different failure modes and prioritize the failure modes based on their RPN values. This will help you focus your resources on the most critical issues and take the most effective corrective actions.
Conclusion
FMEA is a valuable tool for organisations to use in actively identifying and addressing potential failure modes. Organizations may improve the overall quality and reliability of their goods and processes by identifying and assessing potential failure modes.
FMEA also assists businesses in prioritising corrective actions based on the potential consequences of each failure mode, allowing them to focus their efforts on the most pressing problems and ensuring that the most serious threats are handled first.
FMEA can help organisations decrease costs related to product recalls and warranty claims, improve customer happiness, and improve safety, in addition to increasing quality and reliability.
To complete an FMEA, organisations should define the scope of the analysis, assemble a cross-functional team, identify potential failure modes, evaluate the effects of each failure mode, determine the likelihood of each failure mode occurring, identify current controls in place, calculate the RPN for each failure mode, prioritise the failure modes, and develop and implement corrective actions.
References
Mikulak, R.J., McDermott, R. and Beauregard, M., 2017. The basics of FMEA. CRC press.
Chiozza, M.L. and Ponzetti, C., 2009. FMEA: a model for reducing medical errors. Clinica chimica acta, 404(1), pp.75-78.
