What is the FMEA
The FMEA Model is a risk management tool used to identify and manage risks within projects and across entire departments and organisations. It can be a process FMEA (where the risks are process failures) or a design FMEA (where the risks are product or system-related failures).
Failure Mode and Effects Analysis (FMEA) is a systematic approach used to identify potential failures in a process, product, or service. Developed by the U.S. military in the 1940s, FMEA is used to identify potential failure modes and their associated effects on the system as well as the likelihood of occurrence and severity of each failure mode. This helps organizations anticipate problems before they occur, allowing them to take preventive measures to reduce risk and improve quality. FMEA involves analyzing all components, assemblies, and subsystems of a process or product to identify potential failure modes and their effects on the system. The analysis also considers each failure mode’s likelihood of occurrence and severity so that appropriate corrective actions can be taken. By proactively identifying potential problems before they occur, organizations can minimize defects and ensure high-quality products or services are delivered to customers.
How to use the FMEA within your Lean Six Sigma Projects
Failure Modes and Effects Analysis (FMEA) is a powerful tool in Lean Six Sigma methodology, designed to identify and prevent process or product failures before they occur. By proactively identifying potential failure modes, their causes, and the effects of these failure occurring before failures, FMEA offers a structured approach to risk management that aligns closely with the continuous improvement goals of Lean Six Sigma. This post will guide Lean Six Sigma practitioners through incorporating FMEA into their projects for enhanced process efficiency and quality.
Understanding the Purpose and Benefits of FMEA
FMEA is utilized to anticipate and identify potential failure modes prevent defects in manufacturing or other business processes. By systematically evaluating the processes through which products are made or business decisions are implemented, FMEA helps to identify weak points in a system, machinery, or operation. The benefits of using FMEA are numerous:
- Enhanced product and process safety
- Reduced development cycle time and costs
- Improved quality and reliability
- Lower warranty and field service costs
- Increased customer satisfaction
- Supports compliance and regulatory requirements
“Risk comes from not knowing what you are doing”.
What are the Failure Mode or Failure Modes?
Failure modes refer to the various ways in which a process, component, system, or product can fail to meet its intended function. These can range from complete malfunction to a reduction in operational efficiency or quality. Identifying failure modes is a critical step in the FMEA process as it lays the groundwork for understanding the potential weaknesses in the system. By analysing different failure modes, teams can gain insights into the root causes of these process failures and their potential impact on the overall system. This proactive identification and assessment help prioritise issues based on their severity, occurrence, and detectability, thereby enabling more effective risk management strategies.
What is the Risk Priority Number (RPN)?
The Risk Priority Number (RPN) is a crucial element within the FMEA framework that quantifies the level of risk associated with each identified failure mode. It is calculated by multiplying three factors for each failure mode: Severity (S), Occurrence (O), and Detectability (D). The severity factor evaluates how serious the effects of a failure are, the occurrence factor assesses how frequently these failures are likely to happen, and the detectability factor estimates the probability of detecting the failure before it reaches the customer. The resulting RPN, a numerical value, helps teams to prioritise failure modes, focusing on reducing the risks of failure mode and effects those with the highest RPNs first. This prioritisation is instrumental in guiding corrective actions and resource allocation within Lean Six Sigma projects, aiming at the most impactful improvements.
What is the Effects Analysis?
The Effects Analysis in the FMEA process is the assessment of the consequences of the identified failure modes. It involves evaluating the impact of each failure on the system, the end-user, and any associated processes or products. This analysis is crucial for understanding the severity of each potential failure and can range from minor inconvenience to the user, to catastrophic outcomes affecting safety and compliance. It allows teams to quantify or qualitatively describe the potential harm, loss of functionality, or degradation in product or process quality that could result from each identified failure mode. Through the Effects Analysis, prioritisation becomes more accurate, focusing efforts on mitigating failures that would have the most significant impact.
| Mode of Failure | Cause | Effect | Frequency | Severity | Detection | PRN |
| Card Printed Incorrectly | Incorrect information provided | Card must be reissued | 3 | 8 | 5 | 120 |
| Information incorrectly entered in database | Card must be reissued | 5 | 8 | 5 | 200 |
Steps to Perform FMEA in Lean Six Sigma Projects
- Identify the Process or System to Analyse: The first step is defining the process or system you intend to analyze. This could be any stage of the manufacturing process, a service delivery system, or an administrative process. It should be something that, if improved, will significantly impact your key performance indicators (KPIs).
- Create a Cross-functional Team: FMEA is most effective when performed by a team representing a cross-section of the organisation. This ensures that all potential risks are identified from various perspectives. Team members should include those with direct experience with the process under evaluation.
- List Potential Failure Mode: Brainstorm with your team to list all the potential failure modes of the process. A failure mode is when a process fails to meet the requirements.
- Evaluate the Severity, Occurrence, and Detection of Each Failure Mode: With the team, assess the severity of the effect if the failure mode were to occur, the likelihood that it will happen, and the ability to detect it before it reaches the customer.
- Calculate the Risk Priority Number (RPN): The RPN is a numerical value calculated by multiplying the severity, occurrence, and detection scores. This prioritizes which failure modes to address first. Those with the highest RPN should be given the most attention.
- Develop and Implement Mitigation Strategies: For high RPN failure modes, develop action plans to reduce severity and occurrence and/or improve detection. Ensure these strategies integrate with your existing management and quality systems.
- Re-evaluate and Monitor the Effectiveness of Mitigation: After implementing the strategies, reassess the process to see if the risk has been effectively reduced. You may need to revisit the FMEA periodically to ensure new risks are also identified and managed.
What is the Risk Priority Number (RPN)
The RPN (risk priority number) is the product of the frequency, severity and detection values. In other words:
RPN = Frequency x Severity x Detection
In this example, the frequency is representing how likely is it that the error will take place. You can see that the fact that the information is incorrectly entered in the database happens more frequency than the incorrect information is provided at the beginning.
The severity refers to how significant the impact is. In this case, both examples scored an 8 and the cards will need to be reissued. The final section measures how likely is that this mistake will be detected internally. The number 5 shows that we have a 50/50 chance of detecting this internally. For the other 50% of the times, it will be the customer who notifies us.
In this example, the PRN value clearly indicates that “information incorrectly entered into the database” should be given priority for improvements.
At this stage, keep in mind that for the FMEA to be effective the categories must have reliable measures or a clear matrix to score the Frequency, Severity and Detection levels the same. Generally speaking, most companies:
Develop their own measures for the three categories (frequency, severity and section) or
They use standard values that have been developed within their industry.
100% Free Fundamentals of Lean COURSE
Using the FMEA Risk Assessment
Once you have reviewed the potential reasons why a process, product or service may fail and the impact on the business, you can begin to reduce and improve the overall risk management. The FMEA acts as both a tool to conduct a risk assessment, but also drive improvements to reduce the overall risk
So the first step is to take the highest PRN score and begin as a team to identify potential ways to reduce the risk if the risk is deemed too high. You can:
> Highlight actions to reduce the risk
> Identify the person who will lead the activity and when they will deliver it
> Record the actions that are taken
> And then, you can update the Severity, Occurrence and Detection scores to calculate a new RPN
This process can continue until you have levels of risk that you are happy with.
Download: FMEA Tool Template (Excel)
Download the FMEA Excel template now and get started on achieving your business goals. Click here to download.
Learning How to Use the FMEA
If you want to learn how to use the FMEA, join our Lean Six Sigma Green Belt Course and get an in-depth understanding of identifying potential failure modes and their effects on a system. Discover how to anticipate problems before they occur and take preventive measures to reduce risk and improve quality. Our instructors are here to help you master the tools of the trade and become a successful FMEA practitioner. Sign up today!
What is the goal of the FMEA
The primary goal of FMEA (Failure Modes and Effects Analysis) is to proactively identify and address potential problems in products, processes, or systems before they occur. By systematically analysing potential failure modes and their impacts, the approach aims to enhance the reliability, safety, and quality of the output while minimizing risks and potential failures. Ultimately, FMEA seeks to prevent defects, reduce time and costs associated with development and warranty claims, and improve customer satisfaction through a structured process of risk assessment, detection rating and mitigation.
Process FMEA and Criticality Analysis
Process Failure Modes and Effects Analysis (PFMEA) is a systematic, step-by-step approach for identifying all possible failures in a manufacturing or assembly process. Criticality analysis, often integrated with PFMEA, evaluates the significance of those failures, prioritising them based on their severity, frequency, and detectability. This combined process helps to focus attention on the most critical issues that could affect product quality and safety.
By applying PFMEA and criticality analysis, teams can identify process deficiencies and implement improvements, leading to higher operational reliability and efficiency. This method helps enhance product quality and significantly reduces costs and downtime associated with failures.
Common Mistakes to Avoid in FMEA
- FMEA can only be as effective as the process with which it’s conducted. Some common mistakes to avoid include:
- Not involving a broad enough range of stakeholders can lead to missed potential failure modes. The FMEA Team is critical
- Using incorrect or inconsistent criteria for evaluating failure modes
- Failing to follow through with the mitigation strategies or not monitoring their effectiveness
- Overreliance on software tools without the appropriate checks and balances
- Not using the insights to conduct through. root cause analysis on existing processes often caused by human errors
Real-life Examples of FMEA in Lean Six Sigma Projects
Automotive Industry
In automotive manufacturing systems engineering, FMEA is used to identify potential hazards in a vehicle that can cause harm to someone. These hazards could be physical (such as sharp edges), chemical (such as toxic materials), or environmental (such as excessive noise).
Healthcare
In the healthcare sector, FMEA is leveraged to meticulously evaluate high-risk processes, such as medication administration, surgical procedures, and patient care protocols. By applying this analytical method, healthcare professionals can proactively identify and address possible failure modes within these processes. The ultimate aim of failure analysis is to enhance patient safety by significantly reducing or completely preventing incidents of medical errors. This proactive approach aligns with the industry’s commitment to delivering high-quality healthcare services and ensuring the well-being of patients.
Conclusion and Next Steps
FMEA is an integral part of Lean Six Sigma, bringing structure and clarity to the improvement process. Proactively addressing risks can improve product and process quality, reduce costs, and increase customer satisfaction. I encourage you to apply the principles of FMEA to your ongoing and future Lean Six Sigma projects and continuously refine your approach.
To enhance your expertise in FMEA and Lean Six Sigma, consider further training or consulting with practitioners experienced in these methodologies. Numerous courses, workshops, and certifications are available to bolster your knowledge and application of FMEA. Remember, the goal is to identify risks and take purposeful steps to mitigate them effectively.
