The root cause analysis process is applied in my department at work all the time. I work for a occupational testing services, forensic toxicology laboratory. The department screens for drug substances in human specimens, as well as review the data, extract the positive samples, and analyze retention times to calculate the ion ratios for the positive samples. Whenever there is an error for instance, with a drug screening instrument that happens to effect the results of a sample, root cause analysis is performed. We have to document the error and the investigation process. In a step by step process, we must: find out what sample it was, make sure the error didn't effect other samples that were run in the same batch, locate the physical sample if it hasn't been discarded of yet, find out what instrument in ran on, go through the history of error codes on the instrument to assure that there was in fact an error that would've affecting the extraction of the sample, therefore affecting the generated results. 

In my job, I've seen Root Cause Analysis used most often when dealing with CAPAs. CAPA stands for Corrective and Preventive Action, and put simply is a process that is triggered when something goes wrong in order to correct the immediate issue, and implement measures to prevent it from happening again. RCA is an essential phase of a CAPA because it allows you to identify the actual underlying cause of whatever the issue is. The issue may seem obvious from a surface level, but by diving deeper using techniques such as fishbone analysis, you may reveal that there is some fundamental problem with the QMS that caused a domino effect, eventually culminating into the problem at hand.

For example, say a medical device manufacturer runs a certain test on their product before it's ready to ship. However, they notice the test suddenly keeps failing at a much higher rate than normal, which triggers a CAPA. During investigation, the technicians notice something on the device was not installed correctly during the manufacturing process, which ultimately caused the test to failure. The immediate, obvious solution would appear to be a training session with the operators to remind them of the correct installation method. But after Quality engineering performs an RCA, maybe they discover that there is actually no requirement in the company's training policy that the operators need periodic refresher trainings. Thus, the CAPA's action plan would be a procedure update to add that requirement. This example reveals how a thorough RCA during the beginning of a CAPA ensures that the subsequent action plan actually has real value in improving the company's quality system.

I do not work in industry because I am still a graduate student, but as someone who TA's in BME courses, I can see very clearly which student have an instinct for root cause analysis. Many students run into issues where their setup is not working and they proceed in two very different ways. One group will give up and instantly say "mine is broken and I need an new one." This group does not understand that more than half the challenge of the assignment is figuring out why it isn't working. In almost zero cases is something actually broken. The other group of students with great engineering instincts use their own form of basic root cause analysis. They use parts that have been confirmed to work with theirs so they can narrow down what the issue is. By swapping in parts and codes that they know work, they can identify where the issue is. Once they do that, they can see if that part has some small error preventing it from working, or if something is actually just broken. I think these students will make excellent QA/QC engineers once they graduate.

I also do not work in industry yet and my experience is more relevant with creating and executing change notices. However, during my time as an intern doing so, I had to check all documents that referenced the one I was changing and saw different types of files. One that stood out to me that I notice mentioned under most Quality job postings is the FMEA. FMEA stands for Failure Mode and Effects Analysis. Although it is different than RCA, I believe that it is also an aspect that should be mentioned. From my understanding, RCA focuses more on finding the cause of certain effects -- it is a reaction. FMEA is more preventive, focusing on what future effects can be caused by. I think that these two go hand in hand and are equally as important. For example, you can have an FMEA with predictions on what could fail. If something was to fail that didn't align with the FMEA predictions and causes of failure, RCA can be used to find what the unpredictable factor was.

When looking into Root Cause Analysis (RCA) I found that this type of analysis can be applied to a variety of industries and not just the BME sector. I found that there was an overall method that one would use by analyzing a problem, figuring out the causes of that problem, then figuring out the root to the problem by identifying the reason for the causes, and listing solutions and assessing/testing them to see what can fix the issue at hand. I work in a research lab on campus and I have experienced several issue throughout the lab, whether it be our pressurized blast chamber, or our autonomous fluorescence microscope. Over the summer, I had an issue with the blast tube chamber where the chamber was not firing a pressurized air wave as intended. From past experiences I had seen how my mentor would troubleshoot the system and by doing this he essentially created a mental checklist for me to follow whenever something goes wrong with the system. There are several aspects that need to be accounted for prior to firing the blast which also means that there is a large room for error if one is careless. In this specific instance I recall that everything in the system was working, however, air was not filling up and being released as a blast. I followed the mental checklist and I was doing my round, I realized that I had turned one of the knobs and closed the valve instead of opening it. As soon as it was opened the blast worked perfectly. This taught me a lesson that something as small as a valve not being open caused the entire system to malfunction. This was an oversight on my part and was not in the forefront of my mind as a possibility as to why it didn't previously work. It goes to show that even the smallest detail can make the entire system not work, and it is important to review every detail before an experiment.

For my project in the lab I currently work in, I need to fine tune a bioreactor that stretches muscle cells. The bioreactor utilizes multiple mechanical components (stepper motor, threaded rods, a timing belt, and multiple 3D printed components) as well as electrical components. Though I haven't done a formal root cause analysis, I often utilize this technique when troubleshooting my 3D prints or the device itself. For instance the other week, I was having trouble with one of my 3D printed parts consistently getting stuck at the different points as it was moving across the threaded rod. Now I determined that was the problem, but needed to find the root cause of the problem which I determined could be the threaded rod itself, the nuts attached to the 3D printed piece, or the 3D printed piece itself. To determine what the root cause of the problem was, I needed to test each of the components. I tried using a different threaded rod, and the problem still occurred, but when I replaced the nuts in the 3D printed piece, the problem was fixed. This situation could be depicted in a risk tree analysis showcasing what the visible problem was, the "symptom" or what I can tell is occurring due to the problem and then determining what could be causing the problem and which of those being the root cause. 

Currently, I work as a Registered Behavioral Therapist. Root Cause Analysis was used before and during my job because it is super important. Root Cause Analysis is “the process of discovering the root causes of problems in order to identify appropriate solutions.” During my interview, I remember my interviewer asking questions that targeted the idea RCA to see how I would answer and critically think my way through issues. Now, even when I’m working on the floor with the kids, we always want to get to the root of the problem when a child displays behaviors to fix it with the best solution possible. For example, why is my client crying? What is the antecedent? The from there I can help the child in the best way possible.

As a behavioral therapist I utilizing a form of root cause analysis on a daily basis. Change analysis of RCA is an approach where system performance has shifted and one must explore changes in people, equipment, environment, and information in order to find the root cause of the situation. When working with children with intellectual disability / developmental disabilities, My job is to find the antecedent of why an non-socially desirable or aggressive behavior occurred. By identifying the antecedent myself and other staff members are able to put plans into effect that will help the child cope with this stress and respond positively to the same antecedent in the future.    

The first goal of root cause analysis is to discover the root cause of a problem or event. The second goal is to fully understand how to fix, compensate, or learn from any underlying issues within the root cause. The third goal is to apply what we learn from this analysis to systematically prevent future issues or to repeat successes. The analysis is only as good as what we do with that analysis, so the third goal of RCA is important. We can use RCA to also modify the core process and system issues in a way that prevents future problems.

I think the most important skill in Root Cause Analysis, is to understand the 5 Why's and attention to detail. You need to find the underlying root cause. What you think is the root cause, might not be it. You might take a while to find the underlying root cause, but it is important to make sure the issue does not come up again. I think the 5 Why's is an excellent tool, because it really drills at like why something happened. 

During my internship at a pharmaceutical company, I had some exposure to Quality Control investigations, where Root Cause Analysis (RCA) was employed to identify and address issues. While I didn't personally use the Fishbone Diagram method, I did use interviews as a primary tool to identify the root causes of problems in the QC process.

In one particular instance, there were recurring errors in the laboratory results produced by the QC scientists. Instead of jumping straight into the Fishbone Diagram technique, I conducted interviews with the QC scientists involved to gain a deeper understanding of the issues. Through these interviews, it became apparent that the root cause of the errors often stemmed from the scientists not fully understanding certain Standard Operating Procedures (SOPs) and being relatively new to their positions.

My manager also explained the 6M approach to me, which involves considering factors such as man (human resources), machine (equipment), material (raw materials), method (processes), and measurement (data and metrics). In this case, it was clear that the "man" factor, the QC scientists, played a significant role in the errors. However, rather than placing blame solely on the individuals, it was recognized that the existing SOPs were not foolproof and needed improvement.

As a result, our approach was to modify the SOPs to make them more robust and user-friendly. This adjustment aimed to reduce the likelihood of such mistakes occurring in the future, even when employees were relatively new to their roles. The emphasis was on preventing errors at their source rather than relying solely on Corrective and Preventive Actions (CAPA) after the fact.

In the medical device industry as a whole, Root Cause Analysis is a critical component of ensuring product quality and patient safety. Techniques like the Fishbone Diagram, also known as the Ishikawa diagram, are commonly used to visually map out potential root causes across different categories, such as equipment, processes, human factors, materials, and environmental factors. This method allows for a systematic exploration of the underlying causes of issues and helps in devising effective solutions to prevent their recurrence, similar to what was done in my internship experience.

In my experience working in Quality last summer as an intern, Root Cause Analyses were used very frequently. They are used frequently as a starting point for Corrective Actions and Preventive Actions within medical device companies. In order to properly address a nonconformance, and prevent it from occurring again, it is essential to properly identify the true root cause. In some cases, individuals may be focused on addressing an issue that occurred, that they identify a cause that may not be the actual root cause, resulting in the issue occurring again in the future. Therefore, Root Cause Analyses requires critical thinking as well as forward thinking. Typically ways of conducting a Root Cause Analysis may include using the Five Whys, which is a method of digging deep into a cause through coming up with a cause for an event and continuing to question why, five times. Another way of doing so is through a fishbone diagram, which lays out different potential categories and causes in order to find the root cause. 

I don’t have much firsthand experience with root cause analysis (RCA), but I understand its importance in quality management, especially in the medical device industry where safety is a top priority. RCA is about analyzing to find the actual cause of a problem instead of just addressing the surface-level symptoms, which is critical when dealing with problems with processes and projects.

I had not heard of the Fishbone diagram but after doing some research I understood that it separates the problem from its history. It helps improve existing processes and address potential gaps in a process. There’s also the 5 Whys, where you ask “why” until you uncover the root cause. Both seem like effective ways to prevent problems from repeating, which is crucial in something like medical devices where patient safety is at stake. The use of each of these theories depends on how complex the issue is. The 5 whys is considered a quick analysis used for simple problems where there is typically a single cause. On the other hand, the fishbone diagram is utilized for complex problems with multiple potential causes.

I’d love to hear more about how RCA plays out in your daily work and any tips you have for someone new to it!

Root cause analysis is a method that deals with quality management to find the root cause of a problem, rather than just addressing the issues. With a little experience as an engineering coop in a medical manufacturing company, I think it is very important to make sure about the long-term solutions, in the medical devices industry where safety and reliability are top priorities. RCA technique helps break down potential causes segregating them into categories like equipment, materials, processes, human factors, labeling, and damage. If a malfunction occurs, manufacturing companies use tools like a fishbone diagram to put down the failures across various aspects of production. CAPA is one thing I learned during my intern term that are taken during the inspections processes to ensure there are no issues while maintaining device efficacy. I think RCA is not just to keep your problems or defects forward in line but also to improve that there is consistency in maintaining product efficiency and that they meet the regulatory standards and customer expectations