Developing a new product or improving an existing one starts with an idea. But moving from an idea to reality involves a series of processes, testing, and troubleshooting. One of those processes is taking the product through a design failure mode and effect analysis (DFMEA).
DFMEAs may also be performed on the assets that create these products, and the process of designing them. Here, we’ll explain how a failure mode and effects analysis (FMEA) and DFMEA are related, why DFMEA is important, and how to perform it.
Many businesses use a computerized maintenance management system (CMMS) to manage and track data central to DFMEA. A CMMS centralizes maintenance data, monitors equipment performance, and keeps scheduling and tracking as accurate as possible.
What Is DFMEA? Design Failure Mode and Effects Analysis
DFMEA stands for ‘Design Failure Mode and Effects Analysis’. It’s a method for identifying how a product could potentially fail during the design phase, and what the potential consequences of failure are. The idea is to catch issues before leaving the drawing board stage and entering the production phase.
DFMEA is the process of examining every potential failure that could occur when designing a new product. From making molds to soldering the final connections, a lot can go wrong when building prototypes — which is why it’s important to account for all possible failures before starting large-scale production.
During DFMEA, each failure and its results are assigned a severity rating, an occurrence rating, and a detection rating. Those three numbers are then multiplied together, equaling a risk priority number (RPN):
RPN = Severity x Occurrence x Detection
Failures with the highest RPNs are more severe. Knowing this can help teams mitigate the most critical failures, reducing or eliminating their likelihood during production.
Ideally, companies perform DFMEA prior to launching their product. While they may not eliminate every potential failure, a successful DFMEA will result in a better product design and happier end users.
What Is a Failure Mode?
A failure mode is anything that causes the product or process to perform outside of the expected parameters. It can range from a very minor error that is barely noticeable and doesn’t impact performance in any way, all the way to a major failure resulting in product recalls and a shut-down production line. In the most severe cases, a failure mode could end up causing injury to the end users or even result in lawsuits.
Explaining Failure Mode Effect Analysis (FMEA)
Identifying the failure mode is important, but it’s only the first step in a failure mode effect analysis.
The purpose of FMEA is to determine why the failure happened, how important it is to correct the failure, and then take steps to prevent the failure from repeating in the future. Whether you’re looking at a process, a design, or an entire system, FMEA is a critical component of ensuring maximum uptime, safety, and end-user satisfaction.
The 5 Key Steps of FMEA
In its simplest application, there are 5 basic steps to conducting FMEA.
- Identifying potential failures and effects
- Assessing failure severity
- Predicting failure occurrence likelihood
- Failure detection processes
- Determining risk priority
What Is the Purpose of DFMEA?
The purpose of DFMEA is to identify and resolve any threats to production efficiency, quality, and safety. By doing so, you’ll streamline processes, improve plant safety, increase cost-effectiveness, preserve product quality, and boost customer satisfaction.
That’s why the DFMEA process is an essential risk assessment and risk mitigation tool for a wide variety of industries, including manufacturing, healthcare, utilities, and construction.
Benefits of DFMEA in Product Development
DFMEA is a practical tool for improving product design and reducing long-term costs. Key benefits include:
- Catching design flaws before production, a considerably less expensive option than fixing them down the line.
- Systematically addressing design risks, which ensures more durable, consistent products.
- Facilitating collaboration between engineers, maintenance, and quality teams.
- Support for future audits and iterations via a DFMEA-created record of design logic and mitigation strategies.
Reducing design-related problems, resulting in better user experiences and fewer warranty claims.Industries That Use DFMEA
There’s a lingering idea that DFMEA is limited to the aerospace or automotive industries, but in reality, it has a much larger reach. Any industry that designs complex products or systems can benefit from implementing DFMEA. In manufacturing, for instance, it’s commonly used to evaluate mechanical components, electrical systems, and subassemblies before production begins. In electronics, it helps teams spot flaws in circuit layouts. The medical device industry regularly applies DFMEA to identify specific design issues that could lead to safety hazards, avoiding regulatory review further down the line.
In the energy and utilities sector, DFMEA supports the design of turbines, transformers, and other infrastructure. Consumer products companies rely on it to improve product reliability and reduce warranty claims. Even sectors like agriculture, defense, and construction machinery apply DFMEA principles to reduce failure risk and ensure long-term asset performance.
How Does DFMEA Work?
Design failure mode and effect analysis works by assembling a group of people with expertise across the design being analyzed. Together, these people brainstorm all the ways the design may fail.
Team members can recall past experiences and use their knowledge to think of how failures might happen and what the results of those failures could be. For existing designs, the DFMEA can use past data to help determine the failures and their effects.
Then, the team collaboratively decides on proactive solutions to problems. This could include making changes to the design, parts, materials, or other elements of the design and production process. Tools like a computerized maintenance management system (CMMS)can support this process by centralizing historical failure data and asset performance trends, helping teams reach better-informed design decisions.
For more technical guidance on how large-scale teams use this method, see NASA’s Systems Engineering Handbook on FMEA.
DFMEA Example
Let’s say an engineer develops an asset to be used in packaging a final product. During prototype testing, a DFMEA identifies a failure in the tape dispenser mechanism. It occurs after about 100 hours of use and causes tape to not dispense as needed. In turn, about 50% of the packages are sealed incorrectly and, in some cases, the product spills out of the packaging and becomes unusable.
This is a major problem. During the DFMEA, the team ranks the rate of occurrence at 7, the severity at 10, and the detection a 2. This results in an RPN of 140 and the team determines the issue needs to be addressed.
After examination, the team discovers that the issue is caused by a fault in the bearings which allow the dispenser to spin freely. The team may choose to address this by recommending regular lubrication and maintenance, changing the materials used in the dispenser, or making some other change to reduce the likelihood that the end user of the asset experiences this failure.Scoping a DFMEA: What To Include
Before you start assigning risk scores, you should define the scope of your DFMEA. What parts of the design are you analyzing? Which failure modes are within your control?
A well-scoped DFMEA avoids wasted effort and keeps the focus on risks. You’re making sure you’re not duplicating work already covered in a PFMEA or systems-level analysis. Start by defining the boundaries of the design, the intended function, and any customer-specific requirements. Then, identify interfaces where failures are most likely to happen.
Scoping directly affects the quality and relevance of your results. If the scope is too broad, your team may get lost in low-priority issues. If your scope is too narrow, you might miss important interactions between parts.
Who Will Conduct DFMEA?
DFMEA works best when you bring together professionals who understand the design from different angles. That usually means design engineers, production leads, quality specialists, and perhaps maintenance or field service staff.
Common DFMEA Mistakes To Avoid
DFMEA works best when the process is consistent. But a few common mistakes can hamper its value. One is waiting too long to conduct a DFMEA. If you only start analyzing risks once production is underway, you’ve miss the chance to make any impactful changes. Not involving a cross-functional team is another pitfall. Engineers working alone may miss practical insights that maintenance, operations, or quality teams can bring to the table.
Some teams also stumble into the trap of assigning severity, occurrence, and detection scores without clear definitions. If ratings aren’t agreed upon in advance, the RPNs become less reliable. Others skip documenting recommended actions or fail to follow up after implementation. Also, DFMEAs that are never revisited can quickly become outdated. This peer-reviewed study underlines improvements, citing over 200 journal articles, with techniques to enhance detection, reduce variability and support design reliability.
When Should You Use DFMEA?
DFMEA is most valuable early in the design phase, before prototypes are finalized or tooling is commissioned. However, it’s also useful:
- When introducing major changes to a pre-existing design
- After a significant failure or field issue
- During cost-reduction projects that affect materials or components
- As part of ongoing quality improvement programs
The goal is to prevent design-related problems from cascading into production issues, recalls or safety issues.
DFMEA vs PFMEA
Process failure mode and effect analysis (PFMEA) and DFMEA are both branches of the broader failure mode and effects analysis, or FMEA.
PFMEA looks at the entire process and identifies potential failures in the system. For example, in manufacturing, a PFMEA may look for failures in processes like painting, assembling, or shipping the product.
However, a design failure mode and effect analysis focuses on failures in specific areas of the design. On the product development side, the DFMEA investigates how the product may fail, such as when it’s used in a certain way or exposed to certain temperatures. Assets used in manufacturing these products can also undergo a DFMEA to ensure the assets perform as expected.
How To Perform DFMEA
Performing a DFMEA can be a highly in-depth and time-consuming process, but catching design errors and fixing them before they result in major issues is incredibly important. Here’s how to get started:
1. Choose a design to analyze.
Once you’ve fully integrated the DFMEA process into your product life cycle, you’ll use it with every design. But for now, select a design at any stage in the product development process: one that’s in early development, newly designed, or already in the production phase.
2. Assemble a cross-functional team of experts familiar with different areas of the design.
A well-rounded, diverse team will generate the most comprehensive results. Ideally, your DFMEA analysis team will include quality engineers (product quality, testing analysis, and material engineers), along with teams from production, service, and logistics.
Each team member can identify potential failure modes in their specific areas of focus. They can also review the failure modes discovered by other teams. The full team should assess the causes and consequences of each failure mode and evaluate severity rankings, occurrence rankings, and detection rankings.
3. Identify all possible failure modes.
When identifying potential failure modes, it’s critical to understand that “failure” doesn’t always mean total failure. Potential failures include:
- Intermittent failures: Failure modes that are irregular, intermittent, or otherwise unpredictable
- Functional failures: Failure modes that may inhibit, but don’t fully compromise, an asset’s primary function
- Full failures: Catastrophic system failure modes that cease operations
A wide variety of issues can lead to any one of these failures. That’s why your next step is to determine the root causes of all potential failure modes.
4. Identify the root cause(s) of each failure mode.
Before jumping to solutions, and even before prioritizing the various failure modes your team uncovers, you must understand the failure causes. Root causes include:
- Calculation failures: Incorrect calculations during the design process can lead to cascading failures throughout production.
- Environmental failures: Variations in temperature, humidity, and other environmental conditions can affect design decisions.
- Material failures: Improper material selection can lead to potential risks and damage at any stage of the manufacturing and assembly process.
- Testing failures: Insufficient testing during the design stage can trigger issues at any phase of the product life cycle, including product safety and product reliability failures.
- Degraded failures: Consistent use leads to asset degradation, which can result in degraded failure modes.
- Unintentional failures: When an asset fails due to the failure of another part or asset, it’s considered an unintentional failure.
One failure may have multiple root causes. That’s why it’s essential to include your full cross-functional team in the review and assessment of all potential failure modes.
5. Determine the consequences of each failure mode.
For effective risk management, it’s essential to conduct a full assessment of failure effects. You need to understand minor challenges as well as critical issues, which enables you to create a comprehensive risk mitigation strategy.
Examples of potential consequences include damage to parts, assets, products, packaging, facilities, or worker safety. These consequences can range from minor (such as inexpensive repair or replacement) to severe (such as catastrophic property damage, severe injury, or loss of life).
You need a comprehensive analysis of all potential consequences, because you’ll use that information to rank failure modes and prioritize solutions.
6. Assign severity, occurrence, and detection rankings to each failure.
Start with severity rankings. If this failure mode occurs, how severe are the consequences? Consider factors including equipment damage, property damage, financial loss, and safety concerns. Typically, you’ll rate this on a scale of 1–10. A severity score of 1 indicates a minor issue, while 10 is the most severe.
Next, assign an occurrence rating. This measures the likelihood of each failure mode occurring under normal circumstances. On a scale of 1–10, 1 means the failure is very unlikely to occur, while 10 means the failure will almost certainly occur.
Finally, determine the detection rating. If this failure occurs, is it easy to detect? Assign a detection rating of 1 if the failure is easy to detect, 10 if it’s extremely difficult to detect, or anywhere in between.
For the most accurate results, remember to involve your entire team in the ranking process. For example, a product manager probably won’t understand the ease of detecting an equipment failure. Similarly, your warehouse manager may observe packaging failures but may not have the material or design expertise to assign an occurrence rating.
7. Identify the risk priority number (RPN).
If there are 100 potential failure modes across 27 products, it’s difficult to know where to start. Which solutions are most important, and how do you determine the order of importance?
The answer is your risk priority number (RPN). Instead of scrambling to calculate the right balance of severity, occurrence, and detection at the start of each workday, you’ll assign a single RPN to each potential failure mode.
Thankfully, once you’ve assigned ratings for severity, occurrence, and detection, it’s easy to convert those ratings to your RPN.
RPN = Severity Rating x Occurrence Rating x Detection Rating
Your high-risk failures will have the highest RPNs, while your lower-risk failures will have a lower RPN. With this risk assessment strategy, design teams will start with the highest RPN and work their way down.
8. Implement a systematic approach with an action plan to reduce or eliminate failure risk.
For each potential failure mode, identify an appropriate action plan with concrete, measurable corrective actions. Consider modifications to your existing prevention controls (means of preventing failure) and detection controls (means of detecting failure), along with new action steps and design processes to improve RPN.
You may need additional tools and resources for new risk reduction and corrective action steps. Evaluate budgetary needs, procurement processes, and other essential components of success of your action plan.
9. After implementation, reassess RPN and adopt a continuous improvement approach to DFMEA.
The DFMEA process isn’t a one-time solution. Integrating regular failure analysis into your design and manufacturing process helps ensure optimal efficiency, regulatory compliance with industry standards, quality control, product safety, and customer satisfaction.
By routinely identifying failure modes and implementing a systematic process for addressing any issues, you’ll help reduce and prevent costly failures. When you approach DFMEA as an iterative process, you shift your approach from reactive troubleshooting to proactive, continuous improvement.
A computerized maintenance management program (CMMS) can be the key to increasing reliability and improving RPN scores. By tracking assets and gathering performance data, your team will be well-equipped to perform thorough equipment analyses and boost performance with targeted maintenance.