Many organizations rely on Failure Mode and Effects Analysis (FMEA) to uncover and prevent failures in production systems. FMEA helps companies enhance the quality and reliability of their operations, ultimately saving time and money while improving customer satisfaction and corporate reputation. In this post, we’ll share how and when to apply FMEA and explore a step-by-step guide on how to utilize this tool.
What is FMEA?
Failure Mode and Effects Analysis (FMEA) is the process of assessing and prioritizing the ways failure can occur in a production system. When conducting FMEA teams thoroughly examine possible failure scenarios and their impacts enabling them to mitigate risks and enhance output.
FMEA originated in the 1940s within the U.S. Military for evaluating equipment reliability and has become a favored risk mitigation practice in sectors like automotive, aerospace, healthcare, and manufacturing.
Depending on the goal of your FMEA analysis, you may choose to use a specific type such as:
- DFMEA (Design Failure Mode and Effects Analysis): An analysis performed early in the product development process, focused on identifying potential failures that result from the product’s design.
- PFMEA (Process Failure Mode and Effects Analysis): An analysis performed after the design phase, focusing on potential failures in the production process.
- FMECA (Failure Mode and Effects Criticality Analysis): A similar process to FMEA, FMECA evaluates potential failures but adds a ranking of those failures based on the criticality of the system or component being assessed.
Benefits of performing FMEA analysis
FMEA is more than just a quality control tool; it’s a strategic asset that can help companies unlock a wide array of benefits beyond fixing flaws or defects.
1. It systematically uncovers hidden problems
FMEA is like a detective that investigates each component and subsystem to find hidden failure modes. Armed with this knowledge, teams can develop targeted strategies to lower these risks, ultimately creating a more robust and reliable product or process.
2. FMEA prioritizes risks
FMEA helps you classify risks by assessing three key factors:
- Severity of the failure’s impact
- Likelihood of occurrence
- Ease of detection
Teams assign a rank for each factor in order to calculate a Risk Priority Number (RPN) that helps guide decisions and resource allocation. Essentially, you learn the riskiest problems you’re facing and which you should tackle first.
3. Reduces product development time and costs
One of the main benefits of using FMEA is that it helps determine the biggest liabilities for your budget before you devote too much money and resources to larger-scale production. The goal is to avoid redesigns, delays, or even having to start over again.
4. It makes a more collaborative work environment
FMEA breaks down barriers and brings experts together from different departments like design, engineering, manufacturing and quality control. When you take a collaborative approach like this you build a culture of continuous learning in your organization.
5. FMEA boosts customer satisfaction
The ultimate goal of relying on FMEA is to eventually gain a competitive edge in the market by making customers happy. By using this tool to create a higher quality product, you increase customer satisfaction and provide a path to greater success.
6. It facilitates continuous Improvement
You don’t use this methodology just once. It must be regularly reviewed and updated in order to improve failure prevention and explore new failure scenarios. It’s a continuous improvement tool that helps evaluate the production process and optimize it as you learn more and more.
7. It helps you meet legal and regulatory requirements
FMEA is often required in many industries if you want to comply with legal and regulatory standards. This type of failure analysis is a form of proactive risk management and quality assurance that helps companies avoid legal and financial issues.
When should you perform Failure Mode and Effects Analysis (FMEA)?
Performing an FMEA analysis at the right point is crucial to its effectiveness and ensures that possible failures are addressed at the most opportune time. Here’s when performing this risk assessment is particularly beneficial:
- During the design phase of a new product or process: Identifying and preventing potential failures before they become embedded in your final design helps you save significant time, resources, and effort that cost you more if done later in the product lifecycle.
- When modifying an existing product or process: It is essential to analyze for the probability of failure during the change management process to ensure modifications don’t introduce new risks or make existing ones worse.
- Before developing control plans: FMEA is key for developing the steps you’ll use to prevent failures from happening. Doing the FMEA before creating process control plans ensures you tackle the biggest problems and that you allocate the proper resources.
- When planning improvement goals for an existing product/process: When trying to make an existing process or product better, FMEA shows which areas need the most attention.
- When analyzing failures of an existing product or process: If you’re already experiencing failures, perform FMEA to help find the root causes and effects of these issues. Auditing the failures helps you create better corrective actions to prevent recurrence.
- Periodically Throughout the Life of a Product or Process: Regularly update and review FMEA throughout the life of your product to identify new potential failure modes and assess whether you’re dealing with them the right way.
Steps in the FMEA process
By systematically following key steps, you and your team can deliver a comprehensive analysis that improves the reliability of your products and processes.
1. Assemble a cross-functional team
Begin by bringing together experts from various departments like customer service, manufacturing, engineering, design, and others. It’ll be easier to identify failure modes when you have people with different perspectives providing input.
2. Identify the scope of the FMEA
Lay out clearly what you want to accomplish with the FMEA as well as the boundaries of the analysis. Define which product or process you’re evaluating as well as the level of detail you’ll need. This step should help keep the team focused and the FMEA manageable and effective.
3. Identify functions and potential failure modes
Itemize the key components of the product or process and the functions they serve. For each of those functions or components, rely on your multidisciplinary team to brainstorm the possible failures that could occur. Then consider how they may cause failure of the overall system or end product.
4. Determine the potential effects of each failure mode
Once you’ve found possible failure modes, identify how they will affect your system or the end product. Deliberate over just how bad these failure mode effects will be. Know whether you’ll need to shut down operations, deal with safety hazards, or contend with customer dissatisfaction. This information will help you prioritize failure modes based on impact.
5. Assign severity, occurrence, and detection ratings
Evaluate each failure mode based on three criteria:
- Severity: The seriousness of the failure’s impact
- Occurrence: The likelihood of the failure occurring
- Detection: The ease of detecting the event before it causes product or full system failure
Assign number ratings for each on a scale from 1 to 10. Higher numbers indicate a bigger problem.
6. Calculate risk priority numbers (RPN) and prioritize failure modes
At this point, it’s time to calculate the RPN for each failure mode by multiplying the severity, occurrence, and detection ratings. The issues with the highest score theoretically should get more of your attention. You’ll use the scores to determine which problems to address and the amount of resources you’ll need.
7. Develop and implement corrective actions
For the high-risk failure scenarios, lay out how you want to address the situation so you can avoid the problem in the future or improve your ability to detect it. Options may include design changes, improvements in your process, or better testing and inspection. Assign responsibilities and deadlines for each solution.
8. Reevaluate and update the FMEA when appropriate
Once you’ve set your corrective actions in motion, you will eventually need to reassess to determine whether your actions are working. In addition, performing FMEA again when processes or designs change, or at regular intervals to continue improving risk mitigation efforts over time.
A key to unlocking organizational potential
FMEA isn’t just a tool but a philosophy that empowers you to be better at your job by getting ahead of the game and taking on problems before they happen. It can unlock a wealth of benefits that help organizations do much more than simply manage the effects of failure. It can drive innovation, bring team members closer together, and transform problem-solving abilities.
As the business world evolves and customers expect more and more from you, FMEA remains indispensable for staying ahead of the curve and delivering amazing value.
