What is Failure Modes & Effects Analysis (FMEA)?
Failure Modes and Effects Analysis (FMEA) is a systematic and proactive approach used to identify and analyze potential failures or problems in a system, process, or product. It is commonly employed in various industries, including engineering, manufacturing, automotive, aerospace, and healthcare.
The primary goal of FMEA is to anticipate and prevent failures or errors from occurring by identifying their potential causes and effects. By thoroughly examining the system or process, FMEA helps in identifying weak points and areas that are susceptible to failure, allowing organizations to take preventive measures to mitigate or eliminate these risks.
FMEA is a valuable tool for proactive risk management, quality improvement, and reliability enhancement. It helps organizations identify and address potential failures early in the development or operational stages, leading to increased product safety, customer satisfaction, and overall process efficiency.
What is an FMEA Template?
An FMEA template is a pre-designed document or form that provides a structured framework for conducting an FMEA. It serves as a tool to guide the FMEA process and helps ensure consistency and completeness in identifying and analyzing potential failures and their impacts.
An FMEA template typically includes the following sections and information:
System or Process Information: This section provides an overview of the system, process, or product being analyzed. It includes details such as the system name, identification number, version, and relevant specifications.
Team Members: List the names and roles of the individuals involved in the FMEA analysis, including team leaders, subject matter experts, and other stakeholders.
Functional Analysis: Break down the system or process into its functional components or steps. This section helps in understanding the functions and interactions of various elements within the system.
Failure Modes: Identify and document potential failure modes for each component or step. Failure modes describe the specific ways in which a component or step can fail or deviate from its intended functionality.
Effects of Failure: Describe the potential consequences or effects of each failure mode. This section highlights the impact of failures on safety, performance, reliability, customer satisfaction, and other relevant factors.
Severity Rating: Assign a severity rating to each failure mode based on the potential consequences. A rating scale is typically provided, ranging from 1 to 10, where 1 represents low severity and 10 represents high severity. You may also use a 1, 3, 9 format so there is less arguing about whether something is an 8 or a 9. While you get less granularity than the 1-10 scale, you will be able to complete your analysis faster.
Causes of Failure: Identify and document the potential causes or sources that could lead to each failure mode. This section helps in understanding the underlying reasons behind the failures.
Occurrence Rating: Evaluate the likelihood or probability of each cause leading to its associated failure mode. Use a rating scale, often from 1 to 10, to assess the occurrence, with 1 representing low likelihood and 10 representing high likelihood.
Detectability Rating: Assess the detectability or the ability to identify each failure mode before it reaches the customer or end-user. Assign a rating to each failure mode, typically on a scale from 1 to 10, where 1 represents high detectability and 10 represents low detectability. This is based on the degree that there are currently controls in place to prevent failures from happening.
Risk Priority Number (RPN): Calculate the RPN for each failure mode by multiplying the severity, occurrence, and detectability ratings. The RPN helps prioritize the failure modes based on their overall risk level.
Recommended Actions: Based on the RPN and prioritized list of failure modes, suggest appropriate preventive actions to mitigate or eliminate the identified risks. Describe the actions in detail, including proposed solutions, modifications, tests, training, or any other relevant steps.
Action Owners and Due Dates: Assign responsibility for each recommended action to specific team members or departments. Set due dates for completion to ensure accountability and timely implementation.
Recalculated RPN: To determine if your actions have had an impact, you should recalculate your RPN. If the major cause has been reduced, then you can start working on the next highest original RPN.
Our Free FMEA Template
Please go to https://www.sixsigmatrainer.com/templates to download your free FEMA Template.
How to Use Our FMEA Template
Column of FMEA Instructions Desired result of process step.
List the key outcomes or results that you need to consider this process step properly completed. Focus first on the high impact critical results.
What is the specific operational definition of that desired result? It needs to be clear to anyone what is meant by that result.
Using a 1-10 scale, make a judgment as to the current effect or impact that existing process controls are having with 1 being high impact of existing controls and 10 being little impact. Note the reversal in the scaling of the numbers. Less of a problem if the current controls are being effective. Much more so if they are not having an impact so a new control strategy may need to be employed.
How will you measure the result? You need to describe how, when, where, who and any requirements or expectations associated with the result.
What specific process steps are you analyzing? List them in sequential order. The degree of detail can vary depending on the extent of the process.
Potential failure mode
In the event the process step is not properly executed, list what kinds of things could go wrong with regards to the results.
Potential failure effects
If the potential failure mode occurs, list what negative impacts would there be on the process.
Using a 1-10 scale make a judgment on the severity of the effect on the process step with 1 being negligible and 10 being severe.
List the possible causes that could lead to the potential failure mode.
Using a 1-10 scale make a judgment on the likelihood of the cause occurring with 1 being not likely and 10 being very likely.
Identify what process controls may exist already that could prevent the failure mode or potential cause from occurring.
RPN (Risk Priority Number)
This is the multiplication of SEVERITY, OCCURRENCE and DETECTION. A large number indicates that the Potential Failure Modes may have a severe impact on the desired results combined with a high frequency of Occurrence and the likelihood that there is not a good existing Control strategy in place, makes this step critical for the successful outcome of the process.
Have the Team recommend actions that would eliminate or mitigate the negative impact of the process step. While it is unlikely you can change the severity of a potential failure mode, you can reduce the frequency of occurrence and implement stronger controls.
Identify who will be responsible for developing and executing the appropriate recommended actions to change the results.
List the specific steps and activities that were taken to execute and deploy the actions.
SEVERITY, OCCURRENCE, CONTROLS and RPN
Recalculate the values of the three descriptors and compute the revised RPN. Hopefully there is some combination of reduced severity, reduced occurrence and increased control that will result in improved achievement of the desired results.
Types of FMEA
There are several types of FMEA, each serving a specific purpose and applied in different stages of product development, manufacturing, or operational processes. Here are four common types of FMEA:
System FMEA (SFMEA) focuses on analyzing failures and their effects at the system level. It is used to identify potential failure modes and their consequences within complex systems, such as large-scale manufacturing processes, supply chains, or integrated product systems. SFMEA helps understand how failures in one component or subsystem can impact the overall system's performance, safety, or reliability.
Design FMEA (DFMEA) is conducted during the design phase of a product or system development process. It focuses on evaluating potential failures and their effects on individual components or subsystems within the design. DFMEA aims to identify and address design weaknesses, improve reliability, and ensure that the product meets its intended functionality, performance, and safety requirements.
Process FMEA (PFMEA) is performed during the manufacturing or production phase of a product's lifecycle. It aims to identify potential failures and their effects related to specific manufacturing or operational processes. PFMEA analyzes process steps, equipment, materials, and personnel involved to identify potential risks and develop preventive measures. The focus is on improving process reliability, efficiency, and reducing defects or errors.
Software FMEA (SFMEA) specifically focuses on failures and their effects related to software systems or applications. It is applied in software development projects to identify potential software failures, such as errors, bugs, crashes, or security vulnerabilities, and their potential impacts on the overall system performance or user experience. SFMEA helps ensure the reliability, stability, and security of software systems.
These are just a few examples of the most common types of FMEA. However, depending on the industry and specific application, there may be other variations or specialized types of FMEA, such as Manufacturing FMEA (MFMEA), Service FMEA (SFMEA), or Healthcare FMEA (HFMEA). The choice of FMEA type depends on the context, objectives, and the specific area or phase of analysis within an organization's processes.
FMEA Success Factors
Achieving successful implementation of FMEA requires attention to several key factors. Here are some critical success factors for conducting FMEA effectively:
● Clear Objectives: Clearly define the objectives and scope of the FMEA analysis.
● Cross-functional Team: Form a multidisciplinary team with diverse expertise and knowledge related to the system, process, or product being analyzed.
● Management Support: Obtain support and commitment from management at all levels within the organization.
● Adequate Training: Provide training to the FMEA team members to ensure they understand the FMEA methodology, tools, and techniques.
● Thorough Data Collection: Gather and analyze relevant data and information about the system or process under analysis.
● Systematic Approach: Follow a structured and systematic approach during the FMEA process.
● Collaboration and Communication: Foster effective communication and collaboration within the FMEA team and with relevant stakeholders.
● Risk Prioritization: Prioritize failure modes based on their severity, occurrence, and detectability ratings (RPN). Focus on high-priority failure modes that pose significant risks.
● Follow-up and Review: Continuously monitor the effectiveness of recommended actions and follow up on their implementation.
● Continuous Improvement: Integrate the lessons learned from FMEA into the organization's processes, design guidelines, quality management systems, and risk mitigation strategies.
SafetyCulture (formerly iAuditor) as your FMEA Tool
SafetyCulture (iAuditor) is a mobile-first application that allows you to digitize all the elements of your operations. As an inspection management software, SafetyCulture lets your team capture consistent data, identify areas of improvement, share reports and collaborate across working teams, all from one easy-to-use app.
While SafetyCulture is primarily known for its inspection capabilities, it can be customized and utilized as a tool to support the FMEA process. Here's how SafetyCulture can be leveraged for FMEA:
SafetyCulture provides a template builder that allows users to create customized FMEA templates specific to their industry or application.
Digital Data Collection
Enables users to perform FMEA assessments digitally using mobile devices or tablets.
Allows users to attach multimedia files, such as photos or videos, to FMEA assessments.
Collaboration and Workflow
Facilitates collaboration among team members involved in the FMEA process. Multiple users can access and contribute to FMEA assessments simultaneously, enabling efficient teamwork and real-time communication.
Data Analysis and Reporting
Offers analytics and reporting features that allow users to analyze FMEA data and generate insightful reports.
Integration and Automation
Integrates with other software tools and platforms, such as data management systems or project management tools, allowing seamless data transfer and automation of workflows.
While SafetyCulture provides a versatile platform for digital inspections and assessments, it's important to note that FMEA is a specific methodology and requires customization of the tool to align with the FMEA process steps and requirements. SafetyCulture can serve as a valuable tool for digital data collection, collaboration, and reporting, but it's necessary to design and configure the templates and workflows to suit the FMEA methodology and specific organizational needs.
When to Use FMEA
FMEA is a valuable tool that can be used in various stages of a product's lifecycle or operational processes. Here are some key situations where FMEA can be applied:
● Product development
● Process improvement
● New technology or system implementation
● Supplier evaluation
● Regulatory compliance
● Continuous improvement
● Incident or failure investigation
It's important to note that the application of FMEA depends on the specific industry, organizational needs, and the stage of the product or process being analyzed. FMEA can be tailored and applied in various contexts to address specific risks and improve overall performance, reliability, and safety.
FMEA Criteria for Analysis
During an FMEA, certain criteria are typically used to assess and analyze failure modes and their impacts. The following criteria are commonly considered in FMEA analysis:
● Severity refers to the potential consequences or impact of a failure mode on the system, process, or product. It evaluates the seriousness of the effect that the failure mode could have on safety, customer satisfaction, compliance with regulations, environmental impact, or other critical factors. Severity ratings are often assigned on a scale from 1 to 10, where higher ratings indicate more severe consequences.
● Occurrence assesses the likelihood or probability of a specific cause leading to its associated failure mode. It measures the frequency with which the failure mode is expected to occur, considering historical data, experience, expert judgment, or other relevant information. Occurrence ratings are typically assigned on a scale from 1 to 10, where higher ratings indicate higher likelihood.
● Detectability evaluates the ability to identify a failure mode before it reaches the customer or end-user. It considers the effectiveness of existing detection methods, quality control processes, inspections, tests, or other means of identifying the failure mode. Detectability ratings are often assigned on a scale from 1 to 10, where higher ratings indicate a lower ability to detect the failure mode.
These three criteria—severity, occurrence, and detectability—are used to calculate a Risk Priority Number (RPN) for each failure mode. The RPN is determined by multiplying the severity, occurrence, and detectability ratings together. The higher the RPN, the higher the priority for addressing the failure mode.
What are the steps of the FMEA process?
The FMEA process is a systematic and structured approach used to identify, analyze, and mitigate potential failures or risks in a system, process, or product. The following steps outline the typical FMEA process:
1. Define the Scope
Determine the scope of the FMEA analysis, including the system, process, or product to be analyzed. Clearly define the boundaries and identify the specific components or steps that will be included in the analysis.
2. Assemble the Team
Form a multidisciplinary team consisting of individuals with relevant expertise and knowledge related to the system or process being analyzed. Include representatives from different departments or disciplines to ensure a comprehensive analysis.
3. Functional Analysis
Conduct a functional analysis to understand the intended functions, interactions, and requirements of the system or process under analysis. Identify the functions of each component or step and establish the relationships between them.
4. Identify Failure Modes
Identify potential failure modes for each component or step. Failure modes are specific ways in which a component or step can fail or deviate from its intended functionality. Brainstorm potential failure modes based on historical data, experience, expert knowledge, or other sources of information.
5. Assess Failure Effects
Determine the effects or consequences of each failure mode. Analyze how each failure mode can impact safety, performance, reliability, customer satisfaction, regulatory compliance, or other critical factors. Document the effects in a clear and concise manner.
6. Assign Severity Ratings
Evaluate the severity of each failure mode's effects on the system or process. Assign a severity rating on a predefined scale, typically ranging from 1 to 10, where higher ratings indicate more severe consequences. This helps prioritize failure modes based on their potential impact.
7. Identify Causes and Detectability
Determine the potential causes or sources that could lead to each failure mode. Analyze the underlying reasons behind the failures. Additionally, assess the detectability or the ability to identify each failure mode before it reaches the customer or end-user. Assign ratings to causes and detectability using predefined scales.
8. Calculate Risk Priority Number (RPN)
Multiply the severity, occurrence, and detectability ratings for each failure mode to obtain the Risk Priority Number (RPN). The RPN helps prioritize failure modes based on their overall risk level. Higher RPN values indicate higher priority for mitigation actions.
9. Prioritize Actions
Prioritize the identified failure modes based on their RPN values. Focus on high-priority failure modes that pose significant risks. Develop and prioritize actions to mitigate or eliminate the identified risks. Consider implementing preventive measures, design modifications, process improvements, training, or other appropriate actions.
10. Implement Actions
Assign responsibility for implementing the recommended actions to the relevant individuals or departments. Set target dates for completion and track the progress of the actions. Ensure that appropriate resources are allocated for implementing the actions effectively.
11. Review and Update
Regularly review and update the FMEA analysis as new information becomes available or changes occur in the system or process. This ensures that the analysis remains relevant and effective over time. Consider conducting periodic reviews to validate the effectiveness of the implemented actions.
How to Create an FMEA in Excel
Creating an FMEA template in Excel can be done by following these steps:
Open Microsoft Excel and start a new workbook.
Determine the necessary columns for your FMEA template. Common columns include "Input/Process Step," "Potential Failure Mode," "Potential Effects of Failure," "Severity," "Potential Causes," "Occurrence," "Current Controls," "Detectability," and "Risk Priority Number (RPN)." You can customize these columns based on your specific needs.
Label each column header in the first row of your Excel sheet with the corresponding information. For example, in cell A1, enter "Input/Process Step," in cell B1, enter "Potential Failure Mode," and so on.
Format the headers and cells as desired, such as applying bold formatting, centering the text, adjusting column widths, and adding borders to enhance readability and organization.
Set up dropdown lists or data validation for certain columns to provide predefined options. For example, you can create a dropdown list in the "Severity," "Occurrence," and "Detectability" columns to select ratings from a predefined scale.
Create formulas to calculate the Risk Priority Number (RPN) automatically. In the "RPN" column, use a formula that multiplies the severity, occurrence, and detectability ratings for each failure mode. For example, in cell I2, enter the formula "=D2*F2*H2" if the severity rating is in column D, occurrence rating is in column F, and detectability rating is in column H.
Apply conditional formatting to highlight high-risk failure modes. You can set up conditional formatting rules based on specific RPN thresholds, so cells with RPN values above a certain threshold are highlighted in red or any other desired formatting.
Add any additional columns or sections based on your organization's requirements. This could include columns for recommended actions, responsible parties, due dates, status, or any other relevant information.
Save the Excel file as an FMEA template for future use. You can save it as a template (.xltx) file so that you can create new FMEA worksheets based on this template without modifying the original file.
Start populating the template with the relevant information for your specific FMEA analysis.
Other FMEA Templates
Learn more about FMEA
You can learn more about FMEA by checking out these sources:
Get Certified in Lean Six Sigma
To get certified in Lean Six Sigma, you can follow these general steps:
● Familiarize yourself with the concepts, principles, and tools used in Lean Six Sigma.
● Determine the level of certification that aligns with your goals and experience. Yellow Belt is the entry-level certification, while Green Belt and Black Belt certifications are more comprehensive and require a deeper understanding of Lean Six Sigma.
● Select a certification provider. There are several organizations that offer Lean Six Sigma certifications, such as the American Society for Quality (ASQ), the International Association for Six Sigma Certification (IASSC), and private training companies such as https://www.sixsigmatrainer.com/courses-and-certifications
● Research different providers, compare their programs, and choose one that suits your needs and budget.
● Lean Six Sigma certifications typically require completing a training program that covers the relevant concepts, methodologies, and tools.
● Once enrolled in a training program, dedicate time to study and understand the Lean Six Sigma principles and tools.
● After completing the training program, you'll need to pass a certification exam to become certified in Lean Six Sigma. The exam may consist of multiple-choice questions, case studies, or a combination of both. Check the certification provider's guidelines for specific details on the exam format, duration, and passing criteria.
● Some Lean Six Sigma certifications require ongoing professional development or renewal to maintain the certification status. Ensure you understand the requirements for maintaining your certification and plan to fulfill them accordingly.
Frequently Asked Questions About FMEA
Is FMEA Lean or Six Sigma?
Failure Modes and Effects Analysis (FMEA) is a methodology that is commonly associated with both Lean and Six Sigma practices. While FMEA is not exclusive to either Lean or Six Sigma, it is often utilized as a tool within these methodologies to support their objectives.
It's important to note that while FMEA is utilized in Lean and Six Sigma, it can also be applied independently as a standalone methodology for risk assessment and management. The flexibility of FMEA allows it to be used in various industries and organizational contexts, aligning with different quality improvement frameworks or initiatives.
What phase of Six Sigma is FMEA in?
FMEA is typically associated with the Analyze phase of the Six Sigma DMAIC (Define, Measure, Analyze, Improve, Control) methodology. The Analyze phase is the third phase of the DMAIC framework, which follows the Define and Measure phases and precedes the Improve and Control phases.
In the Analyze phase, the focus is on identifying the root causes of problems or inefficiencies in a process. FMEA is a tool utilized during this phase to analyze potential failures, their effects, and their underlying causes.
While FMEA is primarily associated with the Analyze phase, it can also be applied in other phases of the DMAIC framework. For example, FMEA may be used during the Measure phase to identify potential failure modes that can affect data accuracy or measurement systems. Additionally, FMEA can be revisited during the Control phase to ensure that the implemented improvements effectively address the identified risks and prevent future failures.