FMEA risk assessment: How does it work?

FMEA risk assessment is an excellent way to identify and address potential process or product failures. I’ve applied this strategy many times to help manufacturing plants prevent expensive errors and optimize their processes.

You’ll learn how FMEA operates, how you can use it, and why it’s essential for any business focused on improving quality and reliability.

Understanding FMEA Risk Assessment

FMEA risk analysis is a systematic approach to identify and mitigate potential process or product failures. I’ve personally leveraged FMEA risk analysis many times throughout my career. It’s an excellent tool for predicting problems before they happen.

FMEA stands for Failure Mode and Effects Analysis. At its core, FMEA risk analysis is designed to identify potential failure modes, assess their impact, and then prioritize actions to mitigate the risk. Taking this proactive stance will save you time, money, and headaches in the future.

The history of FMEA is really interesting:

• It originated in the 1940s.
• The U.S. military developed it.
• It was initially used in the aerospace and defense sectors.
• It was later adopted by the automotive and manufacturing industries.
• And now it’s prevalent among all industries.

FMEA has several main elements. You’ll need to identify potential failure modes, evaluate their severity, likelihood of occurrence, and detectability. These data points will roll up into a risk priority number that informs where you should focus your improvement efforts.

FMEA is applicable across industries. I’ve personally had success using it in manufacturing, healthcare, aerospace, and even software. It’s a versatile framework that you can really use in any industry where managing risk is important.

FMEA isn’t just about preventing failures, though. It’s a structured framework to improve processes and products. You’ll find it particularly helpful if you’re designing a new product or revamping an existing process.

The FMEA Process: Step-by-Step Guide

Let’s go through the FMEA process step by step. I’ll provide some key insights from my experience using this framework in various industries.

1. First, identify potential failure modes. This step requires your team to get creative and leverage their past experience. Essentially, you brainstorm all the possible ways a process or product could fail. Don’t limit yourself – even the most improbable events should be considered.

2. Next, you’ll assess severity, occurrence, and detection ratings, typically on a scale of 1-10. Here’s a basic example:

1. Now, calculate the Risk Priority Number (RPN), which is simply the severity × occurrence × detection. Each factor is rated on a scale of 1-10, so your RPN can range from 1 to 1000.

2. Once you have RPNs, you can prioritize your list of risks. Start with the highest RPNs and work your way down. These are the most critical potential failures.

3. The next step is taking action to correct each failure. This is where the real work of FMEA happens. You develop a plan to reduce the severity, occurrence, or improve the detection of your highest RPN items. This might involve redesigning a component, adding a sensor as a fail-safe, or improving a quality control checkpoint.

4. Remember, FMEA is an iterative process. You should revisit your list of risks at regular intervals, especially after making a change. This continuous improvement aspect is really the key to maximizing the value of FMEA.

Key Elements of FMEA Risk Assessment

So, let’s break down the most important components of FMEA risk analysis. These are the building blocks of the analysis and what you’ll use to mitigate the risks.

1. Assessing severity is key. You’re essentially evaluating the severity of the failure you’re analyzing. This could be anything from a slight annoyance to a catastrophic failure. One tip I always give teams is to think about both the immediate and long-term impact.

2. The Occurrence assessment looks at how likely the failure is to occur. This is where historical data and engineering judgment come into play. You might talk about things like historical component data or process inputs.

3. The Detectability assessment evaluates if you can detect the failure mode. This is often overlooked, but it’s an important one. A failure that has high severity becomes a lower risk if you can detect it early.

4. The RPN calculation combines all of these assessments. Remember the RPN equation: RPN = Severity × Occurrence × Detectability. This calculation gives you a quantitative metric to prioritize your risks.

5. Another great assessment is the criticality assessment. This is simply Criticality = Severity × Occurrence. This is helpful if you want to just focus on the severity and likelihood without considering detectability.

All of these assessments work together to give you a solid understanding of your risks. They should guide your decision-making process and resource allocation to reduce the risk.

FMEA Templates and Worksheets

FMEA worksheets are the best way to ensure that you conduct a comprehensive risk assessment. They also provide a framework and ensure that your analysis is consistent.

The basic components of an FMEA worksheet are:

• What you’re analyzing (product or process)
• Potential failure mode
• Potential effect(s) of the failure
• Severity
• Potential cause(s)
• Occurrence
• Current controls
• Detection
• RPN calculation
• Recommended actions

There are also different types of fmea:

• Design (DFMEA)
• Process (PFMEA)
• System (SFMEA)
• Service FMEA

You can find industry-specific FMEA templates. I’ve even used some custom FMEAs designed for industries like automotive or even healthcare processes. The key is to make it your own while still following the basic FMEA principles.

The advent of digital FMEA tools and software has transformed the process. These tools can automatically calculate the RPN and have other features like real-time collaboration and historical tracking. Popular options include Minitab, Quality Companion, and Reliasoft Xfmea, but there are plenty of other software solutions. Any of these tools can make your FMEA process much more efficient.

Best Practices for Conducting FMEA Risk Assessment

These are the major lessons I’ve learned about how to do an FMEA effectively over the years. Here are some best practices you can apply to improve your FMEA.

1. Creating a cross-functional team is key. You need a variety of different perspectives to catch all potential failure modes. Invite people from design, manufacturing, quality, and sometimes customer service.
2. Establish clear guidelines and scope for the FMEA. You can easily get lost in the details, so define basic parameters for what you’re analyzing. This will ensure your team stays on track and completes the FMEA in a reasonable amount of time.
3. Use brainstorming to identify potential failure modes. Allow people to think freely without criticism. Even if a failure mode is unlikely, write it down. You can always discard it later.
4. Record your assumptions and limitations. This will provide continuity for your analysis. It’s particularly helpful in highly complex systems or when you have limited information.
5. Continuously reviewing and refining the FMEA is a requirement. The FMEA is never a one and done because processes change and more information becomes available. Therefore, you need to continuously refine the FMEA.
6. Remember, the FMEA is simply a tool. It’s not the answer itself. It’s most effective when you integrate it into your broader quality system.

FMEA Standards and Guidelines

FMEA standards and guidelines ensure a consistent high quality of risk assessments. These are necessary to guarantee your FMEA meets industry standards.

There are various industry specific FMEA standards and guidelines.

1. SAE J1739, for example, is the automotive industry standard for FMEA. It offers detailed guidelines on how to perform FMEAs in automotive design and manufacturing.
2. IEC 60812 is an international standard for FMEA techniques across industries.

ISO 9001:2015 also made a significant shift to risk based thinking. It eliminated preventive action from previous versions and incorporated a more proactive risk mitigation strategy. FMEA fits perfectly within this framework making it an excellent tool for ISO 9001 compliance.

You’ll also need to adapt FMEA to meet various regulations within your industry if yours is heavily regulated.

1. For example, if you work in medical device manufacturing, you’ll need to ensure your FMEA meets FDA regulatory requirements.
2. In aerospace, AS9100 may be a standard you have to comply with.

While these standards offer excellent guidelines, don’t hesitate to make them your own. The goal is to keep the core principles of FMEA intact while making it relevant to your specific risk landscape.

Keep in mind standards change. Stay current on the most recent revisions to ensure your FMEA process is still relevant and effective.

In Summary

I’ve leveraged my experience in lean management and process improvement to help you navigate FMEA risk assessment. This is a great tool to help you identify potential failures and take action to mitigate risks. Just make sure you select a diverse team, set a clear scope, and that the FMEA templates are standardized.

Regularly reviewing and updating the FMEA is critical. FMEA is not just a concept, but a step-by-step strategy you can use to make your processes and products much more reliable and safe. Use these takeaways, and you’ll notice real improvements in reliability and safety.