FMEA analysis is an excellent method to improve processes and minimize risks. I’ve personally applied it many times to identify obscure failure modes in sophisticated systems. You’ll be amazed at how many failure modes it can uncover. FMEA also helps you determine where to focus your process improvement efforts and avoid expensive mistakes. So, let’s discuss how this framework can optimize your processes.
Understanding FMEA Analysis
What is FMEA?
FMEA analysis, or Failure Mode and Effects Analysis, is a systematic method to identify potential failures within a system, process, or product. And why should you care? Well, I’ve worked as an engineer and have seen countless projects succeed and fail. And one of the main reasons projects fail? They didn’t complete an FMEA analysis.
FMEA has been around since the 1940s. It was originally developed by the U.S. military to evaluate the reliability of equipment and identify potential failures. In the 1970s, FMEA analysis migrated to other industries, including the automotive, food, and environmental industries. Ford Motor Company introduced FMEA to the automotive industry in the mid-1970s. This transition significantly expanded the applications of FMEA analysis.
There are two primary types of fmea:
- Design FMEA focuses on the product design, while Process analyzes the manufacturing and assembly processes. However, both types of FMEA are designed to enhance reliability and reduce risk.
The industries using FMEA analysis are diverse:
- Aerospace
- healthcare
- manufacturing
- software development
are just a few examples. I’ve personally witnessed its use in small startups and large multinational companies. This versatility makes it one of the most powerful tools across various industries.
The goal of FMEA analysis is simple:
- identify potential failures,
- determine the severity of the impact,
- take action to reduce the risk.
It’s a proactive process that will in turn save you time, money, and heartache. And trust me – you’d rather identify these issues during planning than after a product is already on the market.
Key Components of FMEA Analysis
Severity ratings: Severity ratings are used to assess the impact of a failure. These ratings typically range from I (no effect) to V (catastrophic). Here’s a simple breakdown:
- I: No effect
- II: Minor effect
- III: Moderate effect
- IV: Major effect
- V: Catastrophic effect
Occurrence ratings: Occurrence ratings are used to estimate how often a failure will occur. A simplified version might look like this:
- 1: Remote (1 in 1,000,000)
- 3: Low (1 in 100,000)
- 5: Moderate (1 in 10,000)
- 7: High (1 in 1,000)
- 10: Very High (1 in 100)
Detection ratings: Detection ratings assess how likely the current controls are to catch the failure. You might use:
- 1: Almost Certain
- 4: High
- 7: Low
- 10: Almost Impossible
The Risk Priority Number (RPN) is the most important calculation. The RPN is calculated as the product of the Severity, Occurrence and Detection ratings. A higher RPN indicates a more critical issue that requires immediate attention.
FMEA worksheets, These are the FMEA documents that you’ll fill out. They typically have columns for the failure mode, effect, cause, current controls and recommended actions. These worksheets have been incredibly helpful to organize thoughts and prioritize efforts.
FMEA originated in the 1950s and was one of the earliest structured methods for improving reliability. Some of the components of FMEA have changed over time, but the basic principles remain the same. The components give you a structured approach to analyze and improve a process or product.
Failure Mode Evaluation Procedure
The FMEA process is a seven step methodology. I’ve walked many teams through it, and it’s quite effective when executed properly.
- Form team
- Define scope and boundaries
- Identify potential failure modes
- Determine effects of failure
- Identify causes of failure
- Assess current controls
- Calculate RPN and prioritize actions
Team selection is key. You want a variety of perspectives, so select a cross functional team. This includes engineers, quality experts, operators, and any other team members who can provide valuable insights. In one project, including a maintenance technician uncovered failure modes we had missed entirely.
Identifying potential failure modes is half art and half experience. You can’t just list obvious issues. You also need to think through the unlikely scenarios. I’ve even encountered seemingly minor failure modes that resulted in significant problems.
Determining effects of failure is helpful for understanding how it relates to the rest of the system. This frequently uncovers surprising interdependencies between different parts of your system or process. This also is helpful to prioritize where you’ll focus your time.
Identifying causes of failure is where the expertise of your team shines. You’re really getting into the essence of potential issues. Typically, this section yields a number of insights about your process or design.
Assessing current controls is the process of determining what safeguards you already have in place. You may discover that some controls you thought were working well actually aren’t. This realization can drastically improve your system.
FMEA Analysis Tools and Techniques
- FMEA worksheets and templates are basic, yet essential, tools.
- They offer a structured way to document your analysis.
- I’ve used everything from a simple Excel spreadsheet to dedicated software.
- The key is to use whatever tool your team and process will actually execute.
- Software tools can streamline FMEA analysis.
- They often have functionality like automatic RPN calculation and trend analysis.
- However, don’t get too caught up in fancy software features.
- I’ve seen teams spend more time figuring out how to use software to complete FMEA analysis than actually analyzing.
Brainstorming:
- Brainstorming is the best way to identify failure modes and causes.
- I like the 6-3-5 method.
- Six people write down three ideas in five minutes then pass it to the next person.
- It’s a great way to generate a lot of ideas quickly.
Cause and effect diagrams:
- Cause and effect diagrams (Ishikawa or fishbone diagrams) are helpful to visualize potential causes of failure.
- They help bring order to chaos and ensure you’re considering every factor.
- Fault tree analysis is another effective option.
- It’s particularly helpful for complex systems.
- You start with the top level failure and work downwards to identify all potential causes.
- I’ve used it to identify subtle interactions between different components of a system that weren’t immediately obvious.
Failure Mode Evaluation for Effective Troubleshooting
FMEA and problem-solving methodologies are closely related – and they also happen to work beautifully together. The failure modes in FMEA are the equivalent of problem statements in problem solving. The causes in FMEA are potential root causes in Problem Solving. The effects of failure in FMEA are the problem symptoms in problem solving.
Using FMEA with other quality tools makes it more effective. I frequently use it in conjunction with Six Sigma tools or lean principles, which makes it a more comprehensive approach to quality improvement.
The data from FMEA is a gift that keeps on giving for continuous improvement activities. It tells you exactly where your process or product needs help, and you can then use it to make targeted improvements.
In root cause analysis, FMEA is extremely useful. It gives you a structured way to think about what could be causing the problem. I’ve leveraged information from an FMEA to direct a Root Cause Analysis, which saved a lot of time and resources.
Advantages and Drawbacks of Failure Mode Evaluation
FMEA has many benefits:
- Improved reliability and safety
- Cost savings from preventing failures
- Higher customer satisfaction
- Increased cross-functional teamwork
- Documented proof of your team’s due diligence
However, it’s not without its drawbacks. It is a resource-intensive tool, particularly for complex systems. Teams sometimes struggle to accurately rank each factor, leading to incorrect prioritization. There’s also a risk of overanalyzing if you try to account for every potential failure mode.
The cost-benefit analysis is key. While FMEA requires some upfront time and resources, the cost savings potential from preventing a critical failure more than justifies the initial investment. In fact, I’ve seen instances where a single prevented failure paid back the investment in conducting FMEA many times over.
FMEA offers numerous advantages:
- Improves reliability and safety
- Reduces costs by preventing failures
- Enhances customer satisfaction
- Promotes cross-functional collaboration
- Provides documented evidence of due diligence
The overall impact of FMEA on product and process quality is significant. It forces you to take a step back and think critically about the weaknesses in your system, which you might have missed without this tool. By taking a proactive approach, you’ll design a much more robust system. In my experience, any product or process that has been through a tough FMEA just performs better in the long run.
A Few Last Words
FMEA analysis is an excellent method to improve reliability and safety. It originated from the military and is now widely used in industry. The process evaluates the severity, occurrence, and detection of potential failures. It’s an excellent tool for general troubleshooting and continuous improvement. However, FMEA isn’t without its drawbacks. It takes time, resources, and a competent team to execute it effectively. I’ve found that the benefits of FMEA far exceed the drawbacks when done correctly.
