is fmea a problem solving tool

Failure Mode and Effects Analysis (FMEA)

– Failure Mode & Effects Analysis –

⇓ Introduction to FMEA

⇓ What is FMEA

⇓ Why Perform FMEA

⇓ When to Perform FMEA

⇓ How to Perform FMEA

FMEA Introduction Video

Introduction to failure mode and effects analysis (fmea).

There are numerous high-profile examples of product recalls resulting from poorly designed products and/or processes. These failures are debated in the public forum with manufacturers, service providers and suppliers being depicted as incapable of providing a safe product. Failure Mode and Effects Analysis, or FMEA, is a methodology aimed at allowing organizations to anticipate failure during the design stage by identifying all of the possible failures in a design or manufacturing process.

Developed in the 1950s, FMEA was one of the earliest structured reliability improvement methods. Today it is still a highly effective method of lowering the possibility of failure.

What is Failure Mode and Effects Analysis (FMEA)

Failure Mode and Effects Analysis (FMEA) is a structured approach to discovering potential failures that may exist within the design of a product or process.

Failure modes are the ways in which a process can fail. Effects are the ways that these failures can lead to waste, defects or harmful outcomes for the customer. Failure Mode and Effects Analysis is designed to identify, prioritize and limit these failure modes.

FMEA is not a substitute for good engineering. Rather, it enhances good engineering by applying the knowledge and experience of a Cross Functional Team (CFT) to review the design progress of a product or process by assessing its risk of failure.

There are two broad categories of FMEA, Design FMEA (DFMEA) and Process FMEA (PFMEA) .

Design FMEA

Design FMEA (DFMEA) explores the possibility of product malfunctions, reduced product life, and safety and regulatory concerns derived from:

Material Properties
Interfaces with other components and/or systems
Engineering Noise: environments, user profile, degradation, systems interactions

Process FMEA

Process FMEA (PFMEA) discovers failure that impacts product quality, reduced reliability of the process, customer dissatisfaction, and safety or environmental hazards derived from:

Human Factors
Methods followed while processing
Materials used
Machines utilized
Measurement systems impact on acceptance
Environment Factors on process performance

Why Perform Failure Mode and Effects Analysis (FMEA)

Historically, the sooner a failure is discovered, the less it will cost. If a failure is discovered late in product development or launch, the impact is exponentially more devastating.

FMEA is one of many tools used to discover failure at its earliest possible point in product or process design. Discovering a failure early in Product Development (PD) using FMEA provides the benefits of:

Multiple choices for Mitigating the Risk
Higher capability of Verification and Validation of changes
Collaboration between design of the product and process
Improved Design for Manufacturing and Assembly (DFM/A)
Lower cost solutions
Legacy, Tribal Knowledge, and Standard Work utilization

Ultimately, this methodology is effective at identifying and correcting process failures early on so that you can avoid the nasty consequences of poor performance.

When to Perform Failure Mode and Effects Analysis (FMEA)

There are several times at which it makes sense to perform a Failure Mode and Effects Analysis:

When you are designing a new product, process or service
When you are planning on performing an existing process in a different way
When you have a quality improvement goal for a specific process
When you need to understand and improve the failures of a process

In addition, it is advisable to perform an FMEA occasionally throughout the lifetime of a process. Quality and reliability must be consistently examined and improved for optimal results.

How to Perform Failure Mode and Effects Analysis (FMEA)

FMEA is performed in seven steps, with key activities at each step. The steps are separated to assure that only the appropriate team members for each step are required to be present. The FMEA approach used by Quality-One has been developed to avoid typical pitfalls which make the analysis slow and ineffective. The Quality-One Three Path Model allows for prioritization of activity and efficient use of team time.

There are Seven Steps to Developing an FMEA:

FMEA Pre-Work and Assemble the FMEA Team
Path 1 Development (Requirements through Severity Ranking)
Path 2 Development (Potential Causes and Prevention Controls through Occurrence Ranking)
Path 3 Development (Testing and Detection Controls through Detection Ranking)
Action Priority & Assignment
Actions Taken / Design Review
Re-ranking RPN & Closure

The Steps for conducting FMEA are as follows:

FMEA Pre-Work and Assembly of the FMEA Team

Pre-work involves the collection and creation of key documents. FMEA works smoothly through the development phases when an investigation of past failures and preparatory documents is performed from its onset. Preparatory documents may include:

Eight Disciplines of Problem Solving (8D)
Boundary/Block Diagram (For the DFMEA)
Parameter Diagram (For the DFMEA)
Process Flow Diagram (For the PFMEA)
Characteristics Matrix (For the PFMEA)

A pre-work Checklist is recommended for an efficient FMEA event. Checklist items may include:

Requirements to be included
Design and / or Process Assumptions
Preliminary Bill of Material / Components
Known causes from surrogate products
Potential causes from interfaces
Potential causes from design choices
Potential causes from noises and environments
Family or Baseline FMEA (Historical FMEA)
Past Test and Control Methods used on similar products
Path 1 Development- (Requirements through Severity Ranking)

Path 1 consists of inserting the functions, failure modes, effects of failure and Severity rankings. The pre-work documents assist in this task by taking information previously captured to populate the first few columns (depending on the worksheet selected) of the FMEA.

Wants, needs and desires translated
Specifications of a design
Government regulations
Program-specific requirements
Characteristics of product to be analyzed
Desired process outputs
Full function failure
Partial / degraded function failure
Intermittent function failure
Over function failure
Unintended function failure
Recommended Actions may be considered that impact the product or process design addressing Failure Modes on High Severity Rankings (Safety and Regulatory)
Path 2 Development – (Potential Causes and Prevention Controls through Occurrence Ranking)

Causes are selected from the design / process inputs or past failures and placed in the Cause column when applicable to a specific failure mode. The columns completed in Path 2 are:

Potential Causes / Mechanisms of Failure
Current Prevention Controls (i.e. standard work, previously successful designs, etc.)
Occurrence Rankings for each cause
Classification of Special Characteristics, if indicated
Actions are developed to address high risk Severity and Occurrence combinations, defined in the Quality-One Criticality Matrix
Path 3 Development- (Testing and Detection Controls through Detection Ranking)

Path 3 Development involves the addition of Detection Controls that verify that the design meets requirements (for Design FMEA) or cause and/or failure mode, if undetected, may reach a customer (for Process FMEA).

Detection Controls
Detection Ranking
Actions are determined to improve the controls if they are insufficient to the Risks determined in Paths 1 and 2. Recommended Actions should address weakness in the testing and/or control strategy.
Review and updates of the Design Verification Plan and Report (DVP&R) or Control Plans are also possible outcomes of Path 3.

The Actions that were previously determined in Paths 1, 2 or 3 are assigned a Risk Priority Number (RPN) for action follow-up.

RPN is calculated by multiplying the Severity, Occurrence and Detection Rankings for each potential failure / effect, cause and control combination. Actions should not be determined based on an RPN threshold value. This is done commonly and is a practice that leads to poor team behavior. The columns completed are:

Review Recommended Actions and assign RPN for additional follow-up
Assign Actions to appropriate personnel
Assign action due dates

FMEA Actions are closed when counter measures have been taken and are successful at reducing risk. The purpose of an FMEA is to discover and mitigate risk. FMEAs which do not find risk are considered to be weak and non-value added. Effort of the team did not produce improvement and therefore time was wasted in the analysis.

Re-Ranking RPN and Closure

After successful confirmation of Risk Mitigation Actions, the Core Team or Team Leader will re-rank the appropriate ranking value (Severity, Occurrence or Detection). The new rankings will be multiplied to attain the new RPN. The original RPN is compared to the revised RPN and the relative improvement to the design or process has been confirmed. Columns completed in Step 7:

Re-ranked Severity
Re-ranked Occurrence
Re-ranked Detection
Re-ranked RPN
Generate new Actions, repeating Step 5, until risk has been mitigated
Comparison of initial RPN and revised RPN

FMEA Document Analysis

Deciding when to take an action on the FMEA has historically been determined by RPN thresholds. Quality-One does not recommend the use of RPN thresholds for setting action targets. Such targets are believed to negatively change team behavior because teams select the lowest numbers to get below the threshold and not actual risk, requiring mitigation.

The analysis of an FMEA should include multiple level considerations, including:

Severity of 9 / 10 or Safety and Regulatory alone (Failure Mode Actions)
Criticality combinations for Severity and Occurrence (Cause Actions)
Detection Controls (Test and Control Plan Actions)

When completed, Actions move the risk from its current position in the Quality-One FMEA Criticality Matrix to a lower risk position.

RPN Action Priority

When risk is determined to be unacceptable, Quality-One recommends a priority of action to be applied as follows:

Failure Mode (Only Severity of 9 or 10)
Causes with High Occurrence
Increase Tolerance (Tolerance Design)
Reduce Variation of the Process ( Statistical Process Control and Process Capability)
Mistake Proofing of the tooling or process
Improve the inspection / evaluation techniques

FMEA Relationship to Problem Solving

The Failure Modes in a FMEA are equivalent to the Problem Statement or Problem Description in Problem Solving . Causes in a FMEA are equivalent to potential root causes in Problem Solving. Effects of failure in a FMEA are Problem Symptoms in Problem Solving. More examples of this relationship are:

The problem statements and descriptions are linked between both documents. Problem solving methods are completed faster by utilizing easy to locate, pre-brainstormed information from an FMEA.
Possible causes in an FMEA are immediately used to jump start Fishbone or Ishikawa diagrams. Brainstorming information that is already known is not a good use of time or resources.
Data collected from problem solving is placed into an FMEA for future planning of new products or process quality. This allows an FMEA to consider actual failures, categorized as failure modes and causes, making the FMEA more effective and complete.
The design or process controls in an FMEA are used in verifying the root cause and Permanent Corrective Action (PCA).
The FMEA and Problem Solving reconcile each failure and cause by cross documenting failure modes, problem statements and possible causes.

FMEA Example

This FMEA Example has one item with a progression through multiple recommended Actions. With each instance, the revised RPN has improved. The final RPN of 10 indicates the issue has been mitigated successfully. The new state should be captured as Standard Work.

Learn More About Failure Mode and Effects Analysis (FMEA)

Quality-One offers Quality and Reliability Support for Product and Process Development through Consulting, Training and Project Support. Quality-One provides Knowledge, Guidance and Direction in Quality and Reliability activities, tailored to your unique wants, needs and desires. Let us help you Discover the Value of FMEA Consulting , FMEA Training or FMEA Project Support .

Additional resources: FMEA

(248) 280-4800 | [email protected]

Remember Me

RCA 101 – 5-Why Analysis (Free Training)
RCA201 – Basic Failure Analysis
RCA 301 – PROACT® RCA Certification
RCA401 – RCA Train The Trainer
Other Trainings
5 Whys Root Cause Analysis Template
RCA Template
Chronic Failure Calculator

Guide to Failure Mode and Effects Analysis (FMEA)

By Sebastian Traeger

Updated: June 1, 2024

Reading Time: 7 minutes

What is Failure Mode and Effects Analysis (FMEA)?

An example of failure mode and effects analysis, why perform fmea, when to perform fmea.

How to perform FMEA

Criteria for FMEA Analysis

Final thoughts.

With over two decades in business – spanning strategy consulting, tech startups and executive leadership – I am committed to helping your organization thrive.

At Reliability, we’re on a mission to help enhance strategic decision-making and operational excellence through the power of Root Cause Analysis, and I hope this article will be helpful!

Our goal is to help you better understand Failure Mode and Effects Analysis (FMEA) by offering insights and practical tips based on years of experience. Whether you’re new to doing root cause analyses or a seasoned pro, we trust this will be useful in your journey towards working hard and working smart.

Dealing with potential failures and mitigating their impacts forms the core of reliability engineering. A systematic tool known as Failure Mode and Effects Analysis (FMEA), is a method that provides a path to improved reliability and enhanced performance.

Failure Mode and Effects Analysis, commonly abbreviated as FMEA, is a structured, step-by-step, proactive approach to identifying and analyzing all the conceivable failures in a product, process, design, or service. Conceived during the 1950s within the aerospace industry, this technique has since become a valuable tool across multiple industries.

A ‘failure mode’ in FMEA refers to the way in which a component, subsystem, system, process, or design could potentially fail to meet the expected performance standards. These failure modes are then evaluated for their potential effects on the system or end-users, establishing a comprehensive understanding of the potential risks associated.

The ultimate objective of FMEA is to quantify and prioritize the risks associated with these identified failure modes to guide the improvement efforts. It does this by assessing three key metrics for each failure mode: severity (the potential impact of the failure), occurrence (the likelihood of the failure happening), and detection (the ability to discover the failure before it becomes an issue).

An integral part of FMEA is the calculation of the Risk Priority Number (RPN), which is a numerical value derived from the severity, occurrence, and detection ratings. This RPN allows for the ranking of failure modes in terms of their potential risk, assisting in the prioritization of improvement actions.

FMEA, empowers organizations to anticipate potential problems and implement corrective measures before any failure occurs. This makes it a powerful technique in enhancing the reliability, safety, and quality of products or processes, ultimately leading to better customer satisfaction and cost savings.

Imagine an automotive manufacturer planning to release a new car model. An FMEA could be performed on the braking system:

In this case, the Risk Priority Number (RPN) is high, indicating a high-priority issue that needs to be addressed immediately to reduce the potential risk.

FMEA isn’t just another item on a checklist; it’s a stepping stone towards excellence. Performing an FMEA brings reliability into focus, helping teams to understand potential failures and their impacts. The technique turns hindsight into foresight, allowing for proactive measures and solutions. It builds a culture of anticipation and prevention rather than reaction.

FMEA can be seen as a beneficial tool to deploy in a variety of scenarios. Essentially, anytime a proactive, systematic approach to risk management and failure prevention could be beneficial, that’s a suitable moment to perform an FMEA.

Typically, FMEA is conducted during the design phase of a product, system, or process to spot potential failure modes and address them proactively. For instance, in the product development lifecycle, it is often employed during the early design phases where changes can be made without significant cost or time penalties.

However, FMEA isn’t confined to the early stages. It can be used throughout the entire lifecycle of a product or process to identify failures and their causes, including during the manufacturing phase, upon receipt of customer feedback, or even when a product or process undergoes significant changes.

Moreover, FMEA is crucial in industries where the cost of failure is very high, such as aerospace, automotive, healthcare, and nuclear energy. It’s also employed when there’s an introduction of new technologies or when modifications are made to design codes, standards, or regulations.

How to perform FMEA

Let’s unfold the FMEA Process Step-by-Step. FMEA is an exhaustive process, designed to identify potential product or process failures and anticipate their implications.

It presents a structured way to identify what could go wrong (failure modes), understand the consequences (effects), and estimate the gravity (severity). Here’s a step-by-step guide to performing an FMEA:

Select a Process for Analysis

Begin by choosing a process that has exhibited problems or is typically troublesome in your organization or industry. This selection lays the groundwork for the analysis to follow.

Formulate the FMEA Team

Organizational leadership should offer a clear project charter, setting the stage for the analysis. The team, led by a facilitator appointed by the leadership, consists of individuals directly involved in the process under analysis. This team should include representatives from diverse areas like design, manufacturing, quality control, sales, customer service, and more.

Outline the Process

Delineate the process steps in a way that ensures everyone on the team fully comprehends the process under scrutiny. This clarity sets the stage for a thorough analysis.

Identify Potential Failures

With the process clearly defined, have the team brainstorm potential failure modes for each step. The people working closely with the process are often best placed to spot these possible issues.

Prioritize the Problems

Not all problems are created equal. Some issues might occur frequently or have a more substantial impact on product quality or safety. These issues warrant priority in your improvement efforts.

Plan and Implement Remedial Measures

The team then devises strategies to reduce the likelihood of failure modes or mitigate their effects. These changes could relate to design alterations, process adjustments, or enhancement of detection mechanisms.

Evaluate the Effectiveness of Changes

Like any improvement initiative, it’s crucial to measure the success of the implemented actions. The team should assess whether the changes made have effectively reduced the risk of failure or its impact.

Once the team completes the analysis, they create an FMEA table detailing potential failures, their effects, and associated severity, occurrence, and detection rankings. These rankings range from 1 to 10, with 1 indicating a low impact and 10 showing a high impact.

By multiplying these rankings (Severity x Occurrence x Detection), the team obtains a Risk Priority Number (RPN), which serves as a guide to prioritize work based on the severity and likelihood of failure. Any recommended actions should then address these prioritized risks.

The living FMEA document, continually updated, serves as an invaluable resource for the development of derivative products and a repository of organizational knowledge. Critical characteristics, regulatory compliance needs, process controls, and other relevant data are also recorded here, offering a comprehensive view of potential risks and their mitigation strategies.

In a comprehensive FMEA study, every potential failure is assessed and evaluated based on three fundamental criteria. These criteria allow the team to grasp the significance of each failure mode, how frequently it’s likely to surface, and how readily it could be detected before resulting in any adverse impact.

Severity: This measures the gravity of the potential impact on the customer or end-user if the failure were to occur. It could be a minor inconvenience, a significant disruption, or a serious safety issue. Each failure mode is scored on a scale from 1 to 10, with 1 indicating a negligible effect and 10 indicating a catastrophic or critical outcome.
Occurrence: This gauges the likelihood of the failure mode occurring. It takes into consideration the frequency at which the problem is likely to transpire during the life of the system, product, or process. The team assigns a score from 1 to 10, where 1 suggests a rare event and 10 signifies a nearly certain occurrence.
Detection : This reflects the ability to identify or predict the failure before it manifests itself in an operational scenario. The aim here is to evaluate how robust the current controls are in catching or preventing the failure. A score between 1 and 10 is assigned, with 1 denoting an extremely high likelihood of detection and 10 representing a situation where the failure is almost certain to go undetected.

The team participating in the FMEA study must reach a consensus on the ranking for severity, occurrence, and detection for every failure mode. While the FMEA process is primarily qualitative in nature, it is beneficial to utilize any available data to substantiate the decisions regarding these rankings. This makes the analysis more precise and helps to mitigate any potential biases or assumptions. Remember, the ultimate goal of FMEA is to prioritize risks and facilitate the development of effective strategies to manage them.

Failure Mode and Effects Analysis (FMEA) is a robust and systematic approach to anticipate, prioritize, and mitigate risks. It helps organizations preemptively address possible hitches in their processes or products, paving the way for higher safety, improved quality, and increased customer satisfaction. Despite its complexity, the returns it offers in risk mitigation are invaluable, making FMEA a tool of choice for organizations keen on proactive problem-solving and continuous improvement. It’s not just about solving problems – it’s about predicting and preventing them. That is the power of FMEA.

At Reliability, we’re here to help guide your journey through such complex yet rewarding methodologies. Empower your organization by learning more about Root Cause Analysis, as well as other valuable tools and strategies for achieving and maintaining quality and reliability. Get in touch with us today to see how we can facilitate your journey to improved reliability and heightened business performance.

I hope you found this guide to Failure Mode and Effects Analysis insightful and actionable! Stay tuned for more thought-provoking articles as we continue to share our knowledge. Success is rooted in a thorough understanding and consistent application, and we hope this article was a step in unlocking the full potential of Root Cause Analysis for your organization.

Reliability runs initiatives such as an online learning center focused on the proprietary PROACT® RCA methodology and EasyRCA.com software. For additional resources, visit Reliability Resources .

Root Cause Analysis /

Guide: Failure Modes and Effect Analysis (FMEA)

Author: Daniel Croft

Daniel Croft is an experienced continuous improvement manager with a Lean Six Sigma Black Belt and a Bachelor's degree in Business Management. With more than ten years of experience applying his skills across various industries, Daniel specializes in optimizing processes and improving efficiency. His approach combines practical experience with a deep understanding of business fundamentals to drive meaningful change.

Failure Mode and Effects Analysis (FMEA) is a structured methodology used to identify and mitigate risks caused by system or process failures.

With this guide we will explain how to identify failure modes, assess their severity, determine causes and effects, estimate occurrence, evaluate existing controls, calculate Risk Priority Numbers (RPNs), develop action plans, and monitor and review the effectiveness of implemented measures, beginning with defining the scope and assembling a cross-functional team.

Screenshort of FMEA Template in Microsoft Excel - Ful Size

Why use FMEA?

Expert opinion by michael anleitner.

Michael Anleitner, a veteran in industrial engineering with 50 years of experiance, emphasizes that while FMEA can be labor-intensive, its value lies in identifying critical failure points and mitigating significant risks. He underscores the importance of appropriate scope, focusing on new, unique, or difficult (NUD) elements to ensure efficiency. Anleitner’s extensive experience, particularly in HVAC systems at Lennox, demonstrates that a well-scoped FMEA can uncover and address crucial issues, ultimately preventing costly failures and enhancing product reliability ( Livonia Technical Services ) .

Watch the FMEA Video Guide

Get the FMEA Template

Want exclusive templates, tools and guides?

Join our email list below and for the next 28 days, we will send you exclusive tools, templates and guides unavailable on the website. We developed a short and simple 28-day program designed to develop your ability to implement Lean and Six Sigma methods daily.

Types of FMEA:

Design fmea ( dfmea ) :.

Targets potential failures in product design.
Ensures that products meet design and functional specifications.

Process FMEA ( PFMEA ) :

Examines the manufacturing and assembly processes.
Aims to identify and correct potential process-related failures.

System FMEA (SFMEA) :

Analyze the entire system’s potential vulnerabilities.
Ensures that all components of a system work harmoniously, preventing system-wide failures.

These three types of FMEA offer an approach to risk management at various stages of product development and system integration.

Free Lean Six Sigma Templates

Improve your Lean Six Sigma projects with our free templates. They're designed to make implementation and management easier, helping you achieve better results.

Step-by-Step Guide to Performing FMEA (With Examples)

Step 1: assemble a cross-functional team.

The complexity of most processes, products, or systems often means that no single person has a complete understanding of all aspects. Therefore, a cross-functional team brings together different perspectives and expertise, leading to a more complete analysis.

How to Implement :

Identify key stakeholders and experts from various relevant departments.
Include representatives from design, engineering, quality assurance, operations, and any other relevant department.
Choose a team leader, preferably someone experienced with FMEA, to guide the process and ensure it stays on track.
Ensure that team members are trained on the basics of FMEA so everyone starts with a foundational understanding.

Step 2: Define the Scope

To ensure that the FMEA remains focused and manageable, it’s crucial to clearly define what will be analyzed. This prevents the process from becoming too broad or overlooking critical areas.

Determine if the FMEA will focus on a product, a process, or an entire system.
Define boundaries by clarifying what is included and what isn’t. For instance, if analyzing a manufacturing process, decide which specific stages or components will be the subject of the FMEA.
Document any known assumptions or constraints that could influence the analysis.

Step 3: List Potential Failure Modes

At this stage, the goal is to identify all the potential ways the subject (be it a process, product, or system) might fail. This is the foundation of the FMEA, as understanding these failure modes is key to addressing them.

Conduct brainstorming sessions with the cross-functional team to list potential failures. Encourage open communication and ensure every idea is considered without immediate judgment.
Review past data, including incident reports, customer feedback, or warranty claims, to identify historical failure modes.
For products or systems, consider using techniques like fault tree analysis or component testing to identify potential failure modes.
Document each failure mode with a clear description. For instance, instead of just noting “motor failure,” specify “motor overheating leading to failure.”

Step 4: Evaluate the Potential Failure Effects, Potential Causes, and Current Controls

This step aims to further break down each identified failure mode by understanding its impact, root causes, and existing preventive measures.

Potential Failure Effects : Determine what the consequences of each failure mode are. This can range from minor inconveniences to safety hazards.
Potential Causes : Identify the root causes leading to the failure mode. This is essential for preventive action.
Current Controls : Determine existing processes or measures that are in place to either detect or prevent the failure mode from occurring.

Step 5: Evaluate Severity, Occurrence, and Detection

The aim here is to quantify the risk associated with each failure mode. These three criteria help in understanding the magnitude of the problem and in prioritizing corrective actions.

Severity (S) : Rate the seriousness of the consequences if the failure occurs. Typically rated on a scale of 1 (least severe) to 10 (most severe).
Occurrence (O) : Assess the likelihood of the failure mode occurring. Again, this is usually on a scale of 1 (least likely) to 10 (most likely).
Detection (D) : Evaluate the likelihood that the current controls will detect the failure mode before it reaches the end customer. This is rated on a scale where 1 means it’s very likely to be detected and 10 means it’s very unlikely.
Note: You can find the full classification of scoring within our FMEA Template .

Step 6: Calculate RPN and Prioritize

The Risk Priority Number (RPN) provides a numerical value that represents the overall risk of each failure mode. It helps in prioritizing which failure modes should be addressed first.

Calculate RPN : For each failure mode, multiply the Severity, Occurrence, and Detection ratings:

Prioritize : Once RPN values are calculated for all failure modes, sort them in descending order. Those with the highest RPNs should be given priority for corrective action since they represent the highest risk.

Step 7: Develop Action Plans

The aim of this step is to design and plan corrective actions for the identified failure modes, particularly those with the highest RPN values. Addressing these failure modes will have the most significant impact on improving the process or product.

Prioritize Failure Modes : Start by focusing on the failure modes with the highest RPNs. These represent the highest risks and should be addressed first.
Brainstorm Solutions : Convene the cross-functional team to brainstorm potential solutions to the identified failure modes. Consider redesigning the process, adding inspections, or implementing new technologies.
Assign Responsibility : For each action item, assign a responsible person or team. This ensures accountability and clarity on who will drive the corrective action.
Set Deadlines : Establish a timeline for implementing the corrective actions. This helps in tracking progress and ensuring timely completion.
Document Everything : Maintain a detailed record of the planned actions, responsibilities, and timelines. This documentation is vital for tracking progress and future audits.

Step 8: Implement and Monitor

After developing action plans, this step ensures that the corrective measures are put into practice and that their effectiveness is monitored over time.

Execute the Action Plans : Implement the corrective actions as planned. This might involve training staff, purchasing new equipment, redesigning processes, or any other required change.
Monitor Continuously : Regularly check the effectiveness of the implemented actions. Use metrics, inspections, or tests to evaluate whether the corrective actions are reducing or eliminating the failure modes.
Feedback Loop : Create a feedback mechanism where frontline staff can report on the effectiveness of the corrective actions. Their insights are invaluable as they work directly with the process or product.
Adjust as Necessary : If a corrective action isn’t yielding the desired results, don’t hesitate to modify it or try a different approach.
Update FMEA : As corrective actions are implemented and processes change, the FMEA should be updated to reflect the current state. This might lead to changes in RPN values and further refinements.
Celebrate Successes : Recognize and celebrate when corrective actions lead to significant improvements. This fosters a positive culture of continuous improvement.

FMEA Template

To support you with your FMEA implementation feel free to download our free FMEA template from the template section.

Real-World Applications

Case Study: Automotive Industry In a major automotive company, FMEA was applied to the manufacturing process of brake systems. The analysis identified potential failure modes, such as brake fluid leakage and sensor malfunction. By implementing corrective actions, the company reduced defect rates by 40% and enhanced product reliability, leading to a significant drop in warranty claims.

Case Study: Healthcare Sector A hospital used FMEA to improve the medication administration process. The team identified risks like incorrect dosage and administration delays. After addressing these risks, medication errors dropped by 25%, improving patient safety and care quality.

Conclusion:

FMEA is a useful tool that allows businesses to identify, assess, and address potential failures in processes, products, or systems.

By systematically evaluating each failure mode’s severity, occurrence, and detection, teams can quantify risks and prioritize corrective actions. Our guide walked through the essential steps of FMEA, from assembling a cross-functional team to calculating the RPN. We also illustrated the process with a tangible example from the plastic water bottle manufacturing industry.

Mikulak, R.J., McDermott, R. and Beauregard, M., 2017. The basics of FMEA . CRC press.
Lipol, L.S. and Haq, J., 2011. Risk analysis method: FMEA/FMECA in the organizations . International Journal of Basic & Applied Sciences , 11 (5), pp.74-82.

A: FMEA stands for Failure Mode and Effects Analysis.

A: FMEA is a systematic and proactive method used to identify and analyze potential failures, their causes, and their effects in a system, product, or process.

A: Using FMEA offers several benefits, including:

Early identification and prevention of potential failures
Improved product or process design by addressing failure risks
Enhanced product reliability and safety
Reduction in costs associated with failures and rework
Increased customer satisfaction through improved quality

A: The key steps in conducting an FMEA are as follows:

Select the system, product, or process to be analyzed.
Assemble a multidisciplinary team.
Identify potential failure modes and their causes.
Evaluate the severity, occurrence, and detection of each failure mode.
Calculate a Risk Priority Number (RPN) to prioritize failure modes.
Develop and implement actions to reduce or eliminate high-risk failure modes.
Monitor and review the effectiveness of the actions taken.

A: The Risk Priority Number (RPN) is a numerical value calculated by multiplying the severity, occurrence, and detection rankings assigned to each failure mode during the FMEA process. It is used to prioritize failure modes for further analysis and action.

A: Yes, FMEA can be applied to various industries and fields, including manufacturing, healthcare, automotive, aerospace, software development, and many others. It is a versatile tool for risk assessment and mitigation.

A: Yes, there are different types of FMEA, including:

System FMEA (SFMEA): Analyzes failures at the system level.
Design FMEA (DFMEA): Focuses on failures associated with product design.
Process FMEA (PFMEA): Analyzes failures in manufacturing or process operations.
Software FMEA (SWFMEA): Specifically addresses failures in software development.

Daniel Croft

Hi im Daniel continuous improvement manager with a Black Belt in Lean Six Sigma and over 10 years of real-world experience across a range sectors, I have a passion for optimizing processes and creating a culture of efficiency. I wanted to create Learn Lean Sigma to be a platform dedicated to Lean Six Sigma and process improvement insights and provide all the guides, tools, techniques and templates I looked for in one place as someone new to the world of Lean Six Sigma and Continuous improvement.