Can Electronic Health Records (EHR) expose quality opportunities in our current Failure Mode and Effects Analysis (FMEA) mapping process? A recent study shows that EHR information can provide significant opportunities to improve FMEA mapping in the quality process. FMEA mapping simply outlines steps in any given process, then identifies and prioritizes the potential opportunities for failure. By using this systematic and prioritized method, teams can make consistent and continuous improvement. Conversely, when information is left unidentified in the FMEA, can real improvement be made?

Quality Opportunities Missed in FMEA

To understand this potential opportunity, researchers recently conducted a study where actual patient data was utilized and provided to a mock quality committee. As with any other FMEA, the committee put together their FMEA mapping based on the information provided to them. The research team then compared the information in the committee’s FMEA mapping the actual data identified in the EHR. The results were enlightening. The study showed that 35% of the processes completed were not identified in the committees FMEA mapping. More illuminating was the fact that people from 12 different categories or positions were involved in the discharge process, and not in the original FMEA mapping. Further, what the original FMEA mapping identified as one activity in their map, EHR data showed it was actually a multi-stepped process, involving completely different people.

EHR Strengthens FMEA Mapping

This study clearly shows the potential EHR has to strengthen and extend the reach of current FMEA mapping processes. Significant amounts of data previously undiscovered in EHR could have a dramatic effect on the success of FMEA mapping. Lean Six Sigma professionals should look to EHR as an untapped resource that could expose significant opportunities for success in your quality improvement opportunities. Use the EHR to drill down to any quality improvement opportunities that are truly hidden gems of quality.

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When a problem or issue surfaces in quality management the set of tools and techniques used to get to the bottom of it are essentially part of Root Cause Analysis (RCA). Although some people prefer to take a freestyle approach to problem-solving, RCA’s tools make the whole endeavour more structured and methodical. This has been shown to lead to excellent results.

Some of the tools allow you to look past what is obvious to uncover the underlying cause. Others allow you to visualize the problem so you can look at it from a different perspective. And each tool is designed to help you see the real, hidden issue, which will prevent the problem or issue from ever happening again once fixed.

This saves the team a lot of time. Constantly working on surface problems is nothing more than patchwork. If the main cause isn’t fixed, the problem becomes recurring – sometimes it gets worse with each reoccurrence. Furthermore, it prevents the team from focusing on the wrong cause or something that doesn’t need to be fixed at all.

When it comes to RCA, there are many tools that teams can use. Here are the most common ones.

Fishbone Diagram

When the problem being faced is complex in nature, the fishbone diagram is used. It allows the team to categorize possible causes into homogeneous groups and sub-groups. It is especially handy to use in the event the root cause is hidden under various surface problems. Another name for the diagram is the cause-and-effect diagram.

5 Whys

The 5 Whys puts you in the shoes of a detective trying to uncover the root cause of a problem. There’s nothing complicated about it either since all you have to do is ask the question “Why?” five times – as a rule of thumb, not a hard rule – until the underlying cause is revealed. It works best on rudimentary issues, so it might not be the best option if there is a need for quantitative analysis.

Pareto Chart

Causes are 20% responsible for the effects seen 80% of the time. This is the underlying principle behind the Pareto Chart. This visualization tool provides a snapshot of common errors so they can be seen from a glance. It shows their causes in descending order, helping you tackle them in order of relevance and urgency.

Failure Mode and Effect Analysis (FMEA)

When a system encounters a particular failure, the FMEA is the best tool to use to shed light on it. The Failure Mode component of the tool is about brainstorming potential things that can lead to system failure. These are the failure modes. Effects Analysis dives deeper into the effects of each of the failure modes identified in the previous step.

Conclusion

Taking Root Cause Analysis seriously is just one of the many ways organizations achieve Six Sigma. There’s no one way to carry out RCA since every problem is unique to the organization. While other tools can be used to conduct RCA as well, these are ones that successful organizations use from time to time. Each one has proved time and time again to be effective and getting rid of problems and issues once and for all.

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Failure mode and effects analysis or FMEA for short is a solid framework for determining where things went wrong in a situation of failure, and to drill down to the root cause of the problem. It’s of particular use in healthcare, where patient safety is always a top priority and everything has to be coordinated around that factor. Uncovering the causes of problematic situations as quickly and efficiently as possible is a critical skill in this area, and FMEA is the perfect tool to help you achieve that.

Managing Patient Pain Better

A published case study concerning patient pain management during anesthesia recovery seems to point towards very positive results from the application of FMEA for this purpose, and it looks like this is the right direction to look in when investigating issues concerning pain management as a whole. The purpose of the study was to find more optimal ways to manage patient pain during difficult periods, and the results are promising in the sense that it scored a significant improvement statistically.

The main point that seems prevalent across the study’s report is that standardization is key to achieving victory, as it leads to a much better ability to determine where a failure could have potentially occurred. Of course, even in a perfectly standardized environment, some issues may still be too difficult to trace them by just intuition alone. But the important point is that you’re creating a framework where you can follow some actual, workable trail.

Accurate patient reports are critical when it comes to this, and FMEA can also address the problem of communicating with patients more effectively. The sooner you establish some standardized framework through which patients can report on their experience and indicate when there is a potential problem, the better results you’re going to see in the long run.

More Accurate and Efficient Imaging

Radiology is another area that seems to be adopting FMEA at a rapid pace, and it’s been seeing good improvements in the overall performance and success rate of procedures performed on patients. Some surprising findings seem to surface when performing a risk analysis on the different parts of the process for caring for a patient, such as potential issues during transportation and post-screening.

But what’s not surprising is that the actual screening itself seems to show the biggest potential for errors, requiring special attention and a very organized approach in order to ensure that failures are kept to a minimum. A checklist is a good first step in that direction, but a lot more can arguably be done to improve the situation.

It’s also worth pointing out that radiology tends to see some rapid developments as a field in general, not just in terms of optimizing its processes but as a whole. It makes sense in that context that this field sees some of the fastest adoption rates for FMEA, and it’s a great example of how effective the methodology can be for realizing serious improvements.

Conclusion

FMEA is seeing more and more applications in the healthcare sector, and we wouldn’t be surprised if the number of such reports keeps growing. There is a lot to gain from using the methodology effectively, and the numerous case studies in this area all show the same thing the sooner a healthcare facility adopts FMEA and makes it an integral part to all of their procedures, the better results it’s going to see in terms of patient satisfaction and wellbeing in the long run, and the safer its procedures are going to be for everyone involved.

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Failure mode and effects analysis is a solid framework for studying the reliability of system, and understanding its intricacies better. It does require a special approach in order to use it correctly though, and you’ll additionally want to make sure that you’re paying attention to some factors that people commonly get wrong. Avoiding those common mistakes is one of the first steps you’ll want to take when applying FMEA to your operations, and you should take some time to properly study the problems that come up most often.

1. Overcomplicating

In order to run FMEA effectively, you’ll want to make sure that your approach is as simplified and streamlined as possible. Otherwise you’re going to run into severe problems sooner or later, and implementing an FMEA scheme that’s overly complex also defeats the point of running FMEA in the first place. When there are too many potential points of failure, you simply cannot trust the methodology to work correctly, and you’ll want to minimize them and ensure that everything is done as easily as possible.

2. Not taking interfaces into account

You should not only study the behavior of main components; it’s also important to look at how the different interfaces between them are working, as sometimes there will be a lot of potential for failure in those areas. Unfortunately, this is also an area that gets somewhat ignored by companies implementing FMEA in their operations, which can usually lead to significantly incorrect results from the analysis. It’s critical to ensure that every part of the system is taken into consideration and not just the ones that you see first.

3. Running FMEA too late

FMEA has to be applied regularly and in due time in order to ensure that it has an appropriate effect on your operations. If you use it as an emergency post-fix and not as something that was properly planned in advance, you’re setting yourself up for trouble, and you’re probably not going to be very happy with the outcome. The best approach is to set FMEA up in a way that it’s a standard part of your process and something that can be called upon in a standardized way, instead of having to set up each of its iterations separately.

4. Not drawing proper conclusions

The main point of FMEA is to learn something useful from the ordeal it doesn’t make much sense to just run it once and not draw any conclusions from what you see. That’s a huge waste of resources and a good way to set your business on the wrong track as well. It’s important that you pay attention to the way you’re analyzing the results of your FMEA implementation, and prioritize learning from your past mistakes. There will always be a good opportunity to learn something new when using FMEA; the question is if you have the appropriate systems in place to actually draw those conclusions. It can take some time to come up with a well-defined system for that though, so don’t worry if you don’t have it in place right from the start.

5. Relying on inexperienced people

Last but not least, FMEA should be carried out by people who actually know what it’s about, and understand the intricate implications that it has at every step of the way. It’s okay to teach your employees new things and train new people in FMEA, but you should always have someone experienced enough on your team to handle the main parts of the work and to ensure that everyone else is performing their duties correctly. Otherwise, things will devolve into chaos before you even realize it.

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FMEA and cause and effect diagrams (also known as fishbone diagrams) are two commonly used analytical tools in the context of Six Sigma. However, some less experienced leaders often tend to confuse the two and may even use them interchangeably in conversation, despite them being quite different in fundamental application and purpose.

Understanding how the two differ from each other, and what the appropriate use for each is, can make a huge difference in how you approach the analysis of problems occurring in your daily operations. It can also help you spot some common mistakes in the workflow of your team (for example, when you notice someone using the wrong type of tool to analyze a certain situation).

What They Have in Common

Before we dig into the differences between the two tools, it can be useful to get a good idea of why people confuse them in the first place, and what the similarities between them are. The common points are mostly related to the core purpose of the two methodologies that is, what they’re used for and what kind of assistance they can offer you in your analysis of regularly occurring problems.

They are both designed to help you pinpoint exactly what went wrong in a problematic situation, and what factors contributed to the failure that occurred in the end. However, FMEA breaks down the problem into abstract components related to the operational structure of the organization, while cause and effect diagrams tend to be more focused on more substantial concepts, such as specific materials, procedures and so on.

Specific Differences

As we mentioned above, the cause and effect diagram is more closely concerned with how specific components of your organization have contributed to the failure. In addition, it shows a directed graph, with the failure being at the very right, and the distance between it and different components used to indicate how closely they are related to the failure itself. Something at the very end of the graph likely contributed very little to the problem, although its contribution is still non-negligible if it’s on the chart.

In contrast, FMEA groups contributing factors according to which part of the production process they occurred in is it a functional issue, a problem with the fundamental design, with the way the process is carried out, etc. There is some visual grouping in FMEA as well, but it serves a different purpose than in fishbone diagrams. The grouping here is more of a logical tool used to determine the closeness of certain components in a functional sense.

It’s also worth pointing out that cause and effect diagrams tend to look more closely at the root cause of the issue, whereas FMEA is concerned with improving the overall process in a sustainable way which leads to a reduction of flaws in the long run. That’s not to say that FMEA does not deal with root causes in any way but it tends to help you discover them more organically, leading you to the solution by aiding your intuition as it helps you see the big picture.

And to answer the big question that some people inevitably ask in these situations — there is no better tool between the two. Asking which the better one is would be a bit like asking a carpenter if the saw or hammer is the better tool. They both have their own applications in specific situations, and an experienced leader has to learn to realize the appropriate use for both, and know when to apply them.

Conclusion

There are many different tools that can help you gain a better understanding of how certain failures manifest themselves in your organization. Exploring this area and learning when each of those techniques is useful is one of the most important factors for a serious leader, and it’s something you should do as early as possible when implementing Six Sigma in your organization. Understanding what leads to the development of a specific issue is key to ensuring that your company as a whole will run in a sustainable way in the future.

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Failure Mode Effect Analysis (FMEA) is a well-known methodology for analyzing points of failure in various environments, and it’s one of the oldest techniques used to that end. The methodology has seen lots of active developments over the years, and it’s very established in many corners of the industry today.

This includes software engineering, and in fact, FMEA is particularly popular in those circles recently, as people have started to pay more attention to preventing issues in the development of complex software. Indeed, despite being rooted in highly advanced technology and a world of constant innovation, software development continues to be a problematic field when it comes to the manifestation of errors in products. A correct implementation of FMEA can result in dramatic improvements in the productivity of an organization in this field.

How FMEA Works in Practice

The goal of FMEA is to identify and analyze potential failure points in the product, and achieve a design in which those problems are predicted and accounted for. One can look at certain types of issues as unavoidable, problems that are guaranteed to present themselves sooner or later, and in this case, the best thing you can do is to simply design the software in a way that it can fail elegantly.

For example, if a certain component of your application crashes, this doesn’t have to bring the whole system down. An intelligent approach to the high-level design can ensure that problems are isolated and don’t spill over into other areas.

FMEA looks at several specific properties of failures in order to categorize them better. The probability that a problem might occur is one of the most important ones; severity is another factor that has to be considered closely. The two usually have a stronger meaning when evaluated together instead of individually, which is why FMEA attempts to structure your knowledge of a failure in a systematic manner.

It’s also important to know what the consequences of a certain failure can be. This concerns both the immediate impact on the surrounding parts of the system, as well as the long-term implications for the system as a whole. For example, in our case of a failing module from above, it’s important to know how this module’s malfunction will affect the whole system if it’s not brought back up in a reasonable timeframe.

On that note, FMEA also identifies the control frequency for a certain malfunction. This means how often the system runs a periodic check to see if there are any problems. Designing your systems in a way that they can catch issues on their own and run a sort of self-maintenance is important for complex software suites, making FMEA a particularly useful approach here.

Working Closely with FMEA Tools

One of the best benefits software engineers have for working with FMEA compared to other industries is that they have immediate access to various specialized tools that can provide a complete FMEA solution. You may sometimes be able to implement the entire system in an in-house manner, using a common tool like Microsoft Excel. However, using a specialized solution like a model-based tool with intuitive visualization can improve your workflow quite a bit.

Not only that, but if your specific software is one where stability is particularly critical, you may even be able to develop a custom-tailored tool to do the job exactly according to your required parameters. Of course, the viability of such a project can depend on many factors, including the size of the organization as a more critical one.

In most cases, the answer is usually somewhere in the middle. The ideal FMEA solution is likely going to be something that’s developed externally, but customized for the needs of your own specific project. If you can build a good relationship with your vendor, this can go a long way.

Conclusion

Understanding the benefits of FMEA and implementing it in a smart, custom-tailored manner is critical for any large organization dealing with software development. The sooner you put a solution in place and ensure that it captures the situation correctly for your specific needs, the more you will benefit in the long run

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