I’ve been using Failure Mode and Effects Analysis (FMEA) for over 20 years. The optimization phase FMEA is one of the best product and process reliability tools available. It’s a systematic way to identify and solve likely failures before they happen. You won’t regret incorporating it as a routine part of improving your systems and getting the most out of them.
Understanding Optimization Phase FMEA
The optimization phase FMEA is one of the most important steps in continuous improvement. It’s a systematic way to improve upon your initial FMEA – Failure Mode and Effects Analysis. The main goal with this step? Identify and solve failures that you missed or that have arisen since the initial FMEA.
While the initial FMEA helps you prevent potential failures before the product’s launch, the optimization phase FMEA helps you solve issues that occur during the product’s use or process’ implementation. It’s an ongoing process to make the product more reliable and reduce risks. Why use FMEA in healthcare? Can it help patients? The answer is yes, as FMEA can significantly improve patient safety and care quality in healthcare settings.
Executing the optimization phase FMEA has several benefits:
- Higher product quality and reliability
- Fewer warranty claims and customer complaints
- More efficient processes
- Better resource allocation for problem solving
- A culture of continual learning and improvement
You’ll likely execute the optimization phase FMEA at various intervals through the product’s life. How often you execute it depends on the product’s complexity, industry regulations, and field performance data. Some businesses execute it annually, while others execute it quarterly for critical components or processes.
Many companies struggle with timing. If you execute it too frequently, the optimization FMEA becomes a burden. If you execute it too infrequently, you miss opportunities to make valuable improvements. Find the right cadence for your company. Remember, the goal is to stay proactive instead of reactive.
In my experience, the optimization phase FMEA is where you really see the value of FMEA. Use this step as an opportunity to turn real data and experiences into real improvements. Don’t make the mistake of overlooking this key step in your journey of continuous improvement.
Steps in FMEA Optimization Process
The FMEA optimization process requires several steps. Let’s discuss them:
Review and update failure modes and effects: Start by looking at your original FMEA. What new failure modes have developed since the initial analysis? Update the effects of known failure modes with data from the real world.
Reassess severity, occurrence, and detection ratings: With new data in hand, reevaluate these ratings.
Recalculate RPNs: Once you’ve updated the ratings, recalculate the RPNs to identify the most important areas to focus on.
Identify new potential failure modes: Are there any new potential failure modes based on changes in product use, customer feedback, or process changes?
Evaluate the effectiveness of any actions taken: Determine if the actions you took were effective. If not, why?
Document changes and updates to the FMEA: Make sure to document all changes to the FMEA, why you made the changes, and any new findings. This serves as a historical record for the future.
Remember, optimization is an iterative process. Each cycle improves your understanding and the product or process.
During my consulting career, I’ve seen companies completely change their business by optimizing the FMEA. For example, in just one year, a manufacturer I worked with reduced warranty claims by 30% through consistent optimization of the FMEA.
The key is consistency and not rushing through the process. Each step provides valuable insight to help you make significant improvements to the business.
Prioritizing and Addressing Identified Failure Modes
Prioritizing failure modes during optimization is important because you can’t fix everything at once. Thus, you need to prioritize, so use these criteria:
- Priority order based on updated RPN values
- Customer impact
- Number of times it occurs
- Potential for catastrophic failure
- Cost of the solution
Once you have your list, conduct root cause analysis on the highest risk failure modes. You can use the 5 Whys, Fishbone Diagrams, Fault Tree Analysis, etc., to get to the bottom of why it’s failing.
Create action plans to address each of your failure modes in priority order. Each action plan should include:
- Specific steps you’ll take
- What the change will look like
- Resources required
- Timing to implement
Assign ownership and due dates for each action to resolve the failure mode. This is the only way to ensure it actually gets done in a reasonable timeframe.
Keep track of the progress of the solutions you implement. A simply monthly cadence works well for this, and the key here is that if the solution isn’t working, you need to be willing to adjust course.
One of the teams I consulted with in the past really struggled to execute on this. There initially identified failure modes were adding up to over 100, so we provided a simple framework to score each failure mode based on the above criteria to identify the key 20% of issues that were causing the 80% of customer complaints.
Remember, the point of prioritization is not to forget about the other things. It’s just to start with the highest priority thing while continuing to keep an eye on the rest. Prioritizing in this way will allow you to maximize resources and see faster overall improvements in product or process reliability.
Techniques for Improving Risk Priority Numbers (RPN)
Reducing RPNs is one of the main goals when optimizing an FMEA. Here are some of the most effective strategies:
Lowering severity ratings often requires a product or process redesign, which can be a difficult pill to swallow but it’s the right decision. Alternatively, consider how you can mitigate the impact of a failure.
Reducing occurrence probability comes down to emphasizing prevention. This is often why FMEAs identify opportunities to tighten up a process control, add a quality check, or change a material. Other times, small tweaks can make a massive difference in reducing the probability of an occurrence.
Increasing detection is typically the easiest way to reduce RPNs. However, remember that greater detection isn’t always the best answer. Often, FMEAs reveal opportunities to add a process control, quality check, or test. In other situations, it’s acceptable to inch up the detection.
Optimizing the trade-off between severity, occurrence, and detection is key. You won’t be able to reduce all three, so analyze what’s most important for your product or process. Sometimes, you can’t reduce severity, so increasing detection is the best strategy to reduce RPNs.
Here are a few examples of projects that successfully reduced RPNs:
An automotive supplier reduced RPNs by 40% through automated visual inspections.
A food processing company significantly lowered contamination risks through real-time monitoring.
A software development company decreased critical bugs by 60% through improved code reviews.
In my experience, solving the RPN is about creative problem solving. Don’t just consider obvious solutions – whiteboard ideas with your team. Some of the best RPN reduction ideas I’ve seen have come from a unique source, such as production line operators or customer support.
Lastly, remember RPN reduction isn’t solely about the numbers. Focus on making a tangible, real change to the product or process. Keep this in mind as you optimize your FMEA.
Best Practices for Implementing Corrective Actions
Implementing the corrective actions is key to FMEA optimization. However, it can be challenging. Therefore, the system must have sufficient rigor to effectively implement corrective actions. To accomplish this, start by setting clear objectives for each action. What specifically do you want to improve? If possible, quantify it.
Involve cross functional teams in implementing corrective actions. More diverse perspectives will generate better corrective actions. I’ve seen maintenance technicians solve problems engineers hadn’t considered.
Conduct a pilot on the corrective action before rolling it out across the board. You’ll likely refine the corrective action once you learn from the pilot, and it’s much easier to refine the action on a small scale.
Document successful corrective actions and ensure it becomes a standardized process. This will help store knowledge for future reference and ensure we develop learnings across the organization.
Here are some key takeaways from implementing corrective actions:
- Communicate the why behind the changes effectively.
- Expect pushback. Change is uncomfortable. If your corrective action strategy is meeting at resistance, you don’t have a strong enough why.
- Have a strong follow up system. The biggest assumption in implementing corrective actions is that people will actually do the action.
- Celebrate the wins you generate with your team. This is so important to keep morale high and people invested in the process.
- Learn from your failures. Not all corrective actions will have an ROI, so continue to learn and improve going forward.
One company I worked with was really struggling to implement corrective actions. So we implemented a very simple follow up system. All you had to do was check on the corrective action at 30, 60, and 90 days. This one change doubled the success rate of their corrective actions.
Remember, implementing corrective actions is one of the harder parts of FMEA optimization. Most of the above is also hard, but many of the best companies fail to execute on corrective actions effectively. So stay with it, and you’ll see significant improvement over time.
Tools and Templates for Tracking Optimization Progress
Tracking the progress of FMEA optimization is easier with effective tools and templates. Using tools will keep you organized, streamline communication, and ensure you don’t overlook any key details.
Most people start with an FMEA optimization tracking spreadsheet. This allows you to record updates, RPN changes, and action item progress. Many companies have their own custom Excel sheets for this purpose.
Visual management boards are excellent for monitoring progress. You can then quickly see the status of each optimization. Some of the most effective teams I’ve observed use basic whiteboards with color-coded magnets.
There are now software solutions specifically designed for managing FMEA optimization. These tools often include RPN calculations, real-time collaboration, and integration with other QMS systems.
When evaluating FMEA optimization tools, look for:
- Easy to enter and update data
- Automatic calculations and trend identification
- A clear view of progress and what’s most important
- Ability to create reports for different stakeholders
- Integration with other quality management processes
Be sure to customize the tools to your specific needs. What works for one company may not work for another. Therefore, don’t hesitate to tweak off-the-shelf solutions or build your own tools.
The best FMEA optimization tools are typically the ones that strike a middle ground between being comprehensive and easy to use. Some teams get caught up with overly complex systems. Keep it simple to maximize usability.
Always remember that the tools should enable your optimization process, not the other way around. The real value comes from the insights you gain and subsequent actions you take from optimizing the data in these tools.
To Sum It Up
Optimization FMEA is a great tool for continuous improvement. It takes the initial assessments and helps make the product more reliable and safe. You now know how to do this effectively. From analyzing failure modes to ranking actions and improving RPNs, you can now optimize an FMEA. Just remember, the key to success is using it consistently and working cross functionally. Continue optimizing it to stay one step ahead of potential problems.
