Root Cause Analysis & Corrective Actions: A Short Course

LeAnn Chuboff: Good afternoon or good morning or good evening wherever you're from and welcome to the next SQF365 webinar. This webinar is on root cause analysis and corrective action. so we're really happy to have Arlen Keller join us here today. But before we begin, we just have some housekeeping. I want to remind you because we are joined by competitors of SQF and FMI's antitrust statement. So discussions around price fixing, boycotting of markets are to be avoided. if we feel that you are that the conversation is headed in that direction, we will speak up and I hope you do the same. This is the antitrust statement in front of you. If you would like a copy, please let us know and we'll be happy to send one to you. Next, is about Eagle, our sponsoring certification body. So, Eagle has been an SQF certification body for us for over boy for almost 15 years, I believe, but they have been in business since 1994\. And they are one of our top performing certification bodies. and we are really pleased that they are able to sponsor this webinar. And then today's presenter.

So this is my last slide before we hand it over to the expert on corrective and preventive action. But today we are joined by Arlen Keller and Arlen is a well-known and seasoned food safety and quality expert. More than 45 years of industry experience. Right now he is the president of Food Safety and Quality Consultants for over 14 years. He supported companies with consulting, auditing, training, prep preparation for SQF certifications or other GFSI benchmarked programs, FSMA, preventive controls, HACCP, regulatory quality systems. Arlen has a tremendous background. He has worked at companies such as the Hershey Company, Cadbury, Coca-Cola, all in food safety and quality. And what I know about Arlen, widely respected for his expertise in food safety, internal auditing, supplier auditing, training, preventive controls, and strategic planning. So Arlen, we are very thrilled to have you here and presenting on root cause and corrective action, a very important piece of the SQF program. So Arlen, I'm going to take it away. Let you take

Arlen Keller: Okay. Well, thank you, LeAnn. I appreciate both Eagle certification sponsoring this webinar and SQF having me here to do the presentation. So we're going to get right into it. We got a lot of information to cover in a short period of time. So, today's agenda, we're just going to have some discussions around the corrective and preventive action process and root cause analysis. And the real focus of today's presentation is going to be on root cause analysis. and we'll talk about that more as we go through this. But, just so the discussion points that we're going to have today, we're just going to do a quick overview of what a corrective and pre preventive action process is and the importance of, and I'm going to call this CAPA, CAPA, as shortened for the corrective and preventive action process. we're going to talk about the importance of CAPA.

We're going to look at conducting an effective CAPA, where the problems lie. getting an understanding of the components in CAPA so you can relieve those problems, alleviate those problems, understanding the root cause, and then a six-step CAPA process that you can use to go through the process, document it, and we'll also do an overview of some of the CAPA methods and tools that are out there you can use. And this isn't going to be an exhaustive presentation on the methods and tools. It's just going to be a quick overview just to kind of present to you what options are out there and how some of them are used and then we'll have time for question and answers. So we're going to start with what is a the CAPA process the corrective and preventive action process. And essentially CAPA's the CAPA process has been around for a long time.

It was started as a quality management system tool. as far back as the 1940s, it was officially documented in some military programs and today we know it through ISO and some of the other standards, the GFSI-benchmarked standards and things regulations and things that all require corrective and preventive action process in place. But really what it was intended to do, number one, it's a continuous improvement tool. It has a corrective component to it and a preventive component to it. So it's really intended to help improve your processes. when something goes wrong, there's a corrective component to it and there's also a component to it that's that's proactive. It helps to prevent things from happening in your systems. You do some work to determine where you have possible issues that you might need to address and you do and it's also really intended to eliminate causes of problems from your systems.

So the CAPA approach from the way CAPA is typically set up is there's a root cause analysis that is conducted to get to the root cause of the problem that you're dealing with in your system or even a potential cause that you haven't had to deal with yet and you want to get preventive actions in place. So the root cause analysis helps you to conduct a process of finding where your problems are and implementing corrective actions and preventive actions. corrective action to eliminate a cause that's already occurred or preventive action again is proactive to prevent a potential cause from occurring. So I talked about the CAPA came around as early as the 1940s officially documented in some publications but today and we know CAPA and some different things and the importance of CAPA today is really because it is an industry expectation and it's also regulatory expectation. So things like the ISO standards or the GFSI-benchmarked standards such as SQF all have components in it where they require a corrective and a preventive action process and as well as regulations the FDA, the USDA, OSHA, other regulatory bodies out there.

But they all have processes in place and regulations defined for conducting a corrective and preventive action process if you have an issue that you have to deal with or planning for food safety or safety in your processes, those types of things. CAPA is also very important to your processes because it's cost effective and it improves efficiencies. It helps to stop errors, excuse me. it helps you to avoid the cost of errors when they occur and downtime that's associated with it. And it also improves customer satisfaction because as you conduct your corrective actions, eliminate root causes, do preventive actions, you're reducing and eliminate issues in your systems, in your products, and you reduce and eliminate potential customer complaints. And then from a regulatory standpoint, as I mentioned, it also satisfies regulatory requirements and regulatory findings. So we're going to talk a little bit about what you need to do to conduct an effective cast CAPA.

So let's start with the problem and essentially what we're going to be focusing on here today is the basic underlying problems that you face when you're trying to conduct a CAPA is it comes down to really misunderstanding some of the CAPA process. So there's always a lot of questions and if you go out and search on the web, you do a Google search, you'll find a hundred different articles and white papers out there asking questions like well what is a corrective action versus a preventive action? What is a corrective correction? what is root cause? How do I know I found root cause? All those things. So there are some misunderstandings about the CAPA process and how it works. So because of that misunderstanding then companies find themselves not sure how to effect effectively implement the c the CAPA process. So again it comes down to things like they're not sure that they're actually identifying the proper root cause. Did they eliminate the root cause with their corrective action? Are they implementing the appropriate correctives actions?

And again they always have questions such as is this a preventive or is this a corrective action. So there is some confusion in the industry as to how to effectively go about doing that. So what we plan to do here today is we want to give you an understanding of the CAPA process and the components in CAPA so you can put together the pieces of how CAPA process actually works and have a better understanding of it so you can be more effective at actually carrying it out. And I want to just give you a simple concept here up front that comes into play with the CAPA process and that is understanding the difference between a system and a process. So when we talk about a system, every manufacturing company, everybody who's on this webinar, you're doing something, you have a company that's making something. there's a system in place and that system is made up of a group of interacting interrelated or independent processes that all work together to form a complex hole that's all working together towards the same goal.

So your company has the goal of selling a product, a product that's a quality product to consumers that consumers will want and that's what that system is intended to do. But that system is made up of a bunch of independent processes and those processes are different parts and activities actions and things that happen and occur in that proc that in that system to make it function as a whole and produce that desired end outcome. So for example in your company you may have a procurement process, you may have a sanitation process, you might have a maintenance process, you may have a manufacturing process. Each of those processes are designed to do something different, but they all work together as a whole to reach the end result that we're talking about within the system of producing that product. So, it's important to just have a good understanding of the differences between those two. So, what is the CAPA process intended to do? Well, at the top level, we talked about earlier, it's really it's it's really a continuous improvement tool and a risk management tool. It has a corrective process in it, a preventive process in it.

But when it comes down to the more granular level of it, when you're conducting your CAPA pro your CAPA process, what you're actually doing is and this most of this presentation is going to focus on a problem that has already occurred and you're you're addressing that through a corrective and preventive action process. We will also talk about the prevention portion of it, but most of this is going to focus on a problem that already occurred. So what you're typically doing with the cast CAPA process is you had a problem that's already occurred. You want to contain that problem. You want to limit the impact of that problem. You don't want that problem getting to your customer. And you want to eventually bring control back to your system so you can continue to make good product. And in that process, you have to have a process an action in place to find the root cause and fix it and address that. So you got to correct whatever went wrong in the system. It has to be addressed and you want to get to that root cause so that you can get the system back into operation and making product a good product or whatever it is.

I say product but a CAPA doesn't even necessarily have to apply to product. It can be to different processes, practices anything that you deal with in your manufacturing industry. So understanding the components of CAPA, there are some basic components that you'll see when you're going through a CAPA process. These are things that come up you'll deal with. So obviously there's a non-conformance. Something failed somewhere in a system. you got a non-conformance that shows up and you're wondering what's going on? Where does non-conformance come from? And then there's a correction process. And we're going to talk about these in just a little bit more detail, but corrections are things you're going to do to address that non-conformance again to limit the impact of it. There will be deficiencies that you identify in the system that contribute to the cause of that non-conformance. And then there's an underlying root cause that allows that deficiency to occur.

You'll also be conducting a root cause analysis to find those things that we just talked about to find the underlying root cause so you can eliminate the deficiency and do away with the non-conformance. And once you find that root cause that's done, you do that through a corrective action process. The corrective action process is what you're going to do. The actions you're going to take to eliminate that root cause from the system and bring control back to the system and get to a place where you prevent that nonconformity from happening again. And then there's also a preventive action component to a preventive action component to the process which is where you're going to do proactive things where you there might not there may have been a non-conformance that occurred and you might do something proactively to look at different processes where there may be a similar thing that could occur but hasn't occurred yet and you're going to address it there. And there might be things in your process where you're just looking to improve the system and you identify places where you can improve it and you'll do a preventive action.

And then at the end of all this you all there's a verification step that's being taken to look at what you've done in the way of the corrective actions that you implemented preventive actions that you may implemented and determine that they have been properly implemented and they're effective at controlling the cause. So just to go through these quickly, I'm going to give just a little bit more detail on this. So a non-conformance that we talk about is typically something it's a failure to conform to a standard or requirement and it's a manifestation of a problem that you have in the system somewhere. so it's an indication that there's been some deviation in some variation in one of your systems or system processes and it's resulting in un it's resulting in a non-conformance or an output that doesn't meet the standard or requirement. The correction that we talk about is an action that you take to eliminate a detected nonconformity. So you have a non-conformity, it shows up, you want to control the impact that had. It's a fix that you want to put in place to relieve that non-conformance.

So that correction that you do is really intended to address the non-conformance and control the impact of that non-conformance and eliminate it from the system. When we talk about a deficiency, as you're going through the process of a root cause analysis, as you go through that process, you're going to, in the process likely identify somewhere in your system processes where there's a variation that's occurring that's creating that unacceptable outcome or that non-conformance. And that variation is typically going to be directly related to the non-conformance. And we'll talk about that a little bit. But that variation is again allowing some function in the system. Some process is not functioning like it should and it's resulting in a nonconformity. Then we're going to look at root cause. And the root cause is a basic fundamental breakdown in the system. It's the basic underlying cause of the non-conformance. It's what allows that variation in your system processes to occur that result in that deficiency.

So somewhere in that system there is some basic underlying failure or breakdown in that system that's allowing a variation in processes to occur that results in a deviation. To find that root cause, you're going to go through root cause analysis. And the root cause analysis is really going to be a systematic method that you use to really dig into the process and the and the system and the causes that you're seeing the nonconformities and trying to get to the cause of that non-conformity in the system. The basic underlying cause. So the basic underlying cause again as we said the root cause is a basic breakdown in the system that's allowing deviations in system processes to occur. So the root cause analysis is really intended to get to that basic fundamental breakdown in the system because that's what you have to fix to keep a non-conformance from recurring or occurring again. If you don't fix that basic underlying cause, you're going to put yourself in a position where that nonconformity ends up recurring again and you get frustrated. And the way you fix that again is with a corrective action.

A corrective action is the action that you're going to take to eliminate that root cause, that basic fundamental underlying cause. It's the cause that you found that was detected through a non-conformity that manifested itself. is creating an undesirable situation. And the corrective action is intended to be the long-term fix. It's intended to address the root cause and prevent the problem from recurring again. It's really going to take that cause out of the system and eliminate the problem. As I said, preventive actions are actions that you're going to take there to eliminate potential non-conformances. Again, a preventive action is addressing things that have not occurred already or it might be related to something that has already occurred. As I said, maybe you had something occur on line one and you went through the process and found the root cause for that and now you're thinking, well, what if that could happen on line two and line three?

So then you start working on line two and line three, even though a problem hasn't occurred there yet, you're putting actions in place to prevent that problem from occurring before it does occur. So preventive actions are used in this process to address potential non-conformities that could occur or undesirable situations before they actually occur. And then the verification process again are actions that you're going to take to make sure that your corrective and preventive action processes have been properly implemented and that if they've been properly implemented that they actually are effective at controlling and removing and eliminating the root cause from the system and you have the system back under control and you've prevent the recurrence of those actu nonconformities. So just quickly here to kind of illustrate this two of those actually I'm going to back up a step here in the components of a corrective action process that we talked about. Three of those components actually are components that produce results when you're dealing with an issue and trying to conduct a corrective and preventive action process.

And those are correction that you do. So those are correction or actions that you're going to take to try to eliminate the non-conformity and contain it to limit its impact on your product and your processes. So the correction something that you're going to do it's an action that you take. So will the corrective action be the corrective action that you take is going to be intended to address the root cause that you find and eliminate that root cause from the system. It's a long-term solution. It prevents recurrence of it. and then preventive actions are an action that you're going to take because you're going to look for potential nonconformities and address them before they occur. So these three things are all action steps, but in this process, two of them are really related to something that's already recur occurred. So if a you have an issue that's already occurred and you're going through your corrective and preventive action process, you're going to conduct corrections to contain that nonconformity to limit its impact. that correction is going to be done because something has already occurred. So, it's reactive.

Same way with a corrective action. A corrective action, you're going to be addressing a the root cause of a nonconformity that you found through your root cause analysis. You had some nonconformity occur. You've done your root cause analysis. You found a root cause. Now, you're going to put a corrective action in place to eliminate that root cause and prevent that nonconformity from occurring again. That's a long-term solution, but it's also reactive because you had an event that's already occurred, a non-conformity that's already occurred. The preventive action, on the other hand, though, is a preventive step. It's a proactive step. it's not based on necessarily something that a non-conformity that has occurred. It's really intended to prevent potential nonconformities from occurring. And again, you might do a preventive action related to a nonconformity that you had. Like the example I gave, line one, you had a failure, but line two and three you didn't. Maybe you look at line two and three to make sure you don't have the same or similar process. So, it's a preventive step as opposed to a reactive step.

So, I'm going to try to help demonstrate for you how these elements of a corrective and preventive action process actually work. Excuse me. And to do that, I'm going to use a what I'm going to call a practical application. I'm going to go through a process that's not a manufacturing process that you're used to, but it's something that everybody can relate to. And I'm going to show you how the CAPA process and all the its components apply to any situation regardless of the industry, the product, whatever it is you're making. and that these elements are present in the CAPA process when you go through it. so to kind of take you through a practical application, let's start with something that everybody can relate to. I'm sure everybody's familiar with this. Somebody's had somebody go through this, maybe you've gone through it yourself, but somebody goes to the emergency room and they have chest pain and shortness of breath. What's happening here is there's a non-conformance. it's an indication that there's some deficiency in one of the system processes that there a nonconformity has occurred.

And that nonconformity is basically a manifestation of an underlying problem. So somebody shows up in the emergency room with chest pain and shortness of breath. There's a non-conformance there. It's a manifestation of an underlying problem. What happens when they show up there with shortness of breath and chest pain? Well, the staff at the hospital, the doctor, they're going to react immediately. They're going to do some things to try to contain the symptom, the non-conformity. They're going to try to bring it back under control. they're going to try to eliminate some of the symptoms of nonconformity, if you will. So they might do things like administer nitroglycerin, blood pressure medicine, pain medicine, oxygen, those types of things. So what's happening here is a correction process. They're there. It's a reactive measure intended to eliminate and contain the impact of the non-conformance that's happening.

So as they're addressing the nonconformity, then once they have some control over the symptoms, the non-conformity a little bit, they start an investigation to why the patient is experiencing the pain and the shortness of breath. So they start conducting some tests. They might do a stress test, an angio, ECG, some of those things. So what this is really is the start of the root cause analysis. So this patient showed up, there's a non-conformance that's manifested itself. Now they're starting a root cause analysis and the intent of this root cause analysis is to really find a root cause of that non-conformance. So that's why they start the testing and things that they're going to do. And in that testing, the doctor might find a blocked artery that's causing the pain and shortness of breath. so at this point, the doctor's identified a deficiency. And this is important here. I want we'll talk about this a little bit more. but the deficiency may not be the root cause.

And at this point, the root cause analysis led to a deficiency, a deviation in the system processes that resulted in an unacceptable outcome. so it's a deficiency in the system that's been identified and the doctor will address that deficiency by in this case they place a stent in the artery to return blood flow to the system eliminate the chest pain reduce the shortness of breath. So again this is another correction that's a step that's being taken. It's a reactive measure aimed at eliminating the nonconformity that's occurring. Okay. So, it's eliminating the non-conformance, but keep in mind at this point it may not be the root cause yet. And then and this is where this is going to become important. We'll talk about this coming up here. But the doctor continues investigation at this point. He just doesn't stop there. He continues the investigation. He starts examining potential causes for the blocked artery. So, he wants to know why the blocked artery was there in the first place. So, he's digging deeper. And this is what's going to be important about root cause. root cause.

When you're conducting a root cause and you stumble upon a deficiency through the investigations and examinations that you're doing, the analysis that you're doing, don't just stop at the deficiency. You don't want to just scratch the surface. You want to dig deep and get to the underlying fundamental cause. And that's what the doctor's going to do here. They're going to continue investigating. So, they might start interrogating the patient about eating habits and exercise and conduct blood tests and looking for things that could be related to why a blocked artery would occur. And this is a continuation of the root cause analysis. It started when the symptoms occurred and they came in, they started doing testing and started the root cause analysis. They found a deficiency. They continue with the examination and continue the root cause analysis because really what they're doing is they're they're doing a more systematic analysis. They're digging in deep to find that fundamental that fundamental underlying cause, that root cause that allowed that nonconformity to occur in the first place. So it's a detailed examination.

They're really trying to understand more about the entire system, not just the one portion that they saw that was related to the nonconformity. So they continue with the root cause. So what the doctor finds in this investigation that the patient's cholesterol is high and the patient's diet is high in fat and low in fiber. They don't exercise. So now the doctor's getting to the point of a root cause. He's found something more fundamental underlying in the process that allow in the system I should say that allowed one of the processes in the system to deviate and cause a nonconformity. So when you think about the nonconformity, the shortness of breath and the pain they were having related to the blocked artery, that's one system in the body that's that has a variation that's causing that nonconformity. The whole body is not failing, but there is something deeper in the system that allowed that process to fail. And what the doctor found through his root cause investigation was their diet was not good for it caused high cholesterol and things like that and they ended up with a blocked artery. So he found the basic underlying root cause.

So what the doctor does at this point is he changes the diet. He gets the patient on a low-fat high-fiber diet, implements an exercise routine, things like that. So now a corrective action is being t taking place. This action is implemented to address the fundamental the fundamental underlying root cause for the nonconformity that was detected that alerted everybody that there was a problem in the system but the root cause analysis took them to the fundamental underlying root cause and that's what's being addressed now through the corrective action. Then the doctor checks to see what other potential risks the patient might have. Now that he knows they about their diet and things and he knows they had a blocked artery, he might be concerned about other things. He might start looking at blood pressure. He might be concerned about diabetes or other diet related ailments that could occur in other systems or processes within the system. so what he's doing at this point then is he's starting in on preventive action.

He's looking at for actions to take to eliminate a cause of a potential non-conformity that hasn't yet occurred. he knows that there's a potential for things to occur. So he's looking for potential non-conformities that haven't occurred yet. So it's a preventive action. It's a proactive action. He's conducting a preventive action at this point. And then the doctor scheduled follow-up visits with the patient, checks to see that the diet's being followed. He might interrogate them about their diet or exercise routine, do more tests and things like that. And at this point this is verification. Now the doctor's in the process of actions that he's taken to make sure the corrective actions and the preventive actions that he has put in place have been properly are being properly implemented and that they are containing and are effective at addressing the root cause and have eliminated it from the system. So that's just a simple example just using an ailment that everybody's familiar with how this all applies and the same things the same process would apply within your company and the processes you have in your company.

And coming up here in a few minutes, I'm going to show you some examples of things that happen within manufacturing processes in the food industry that use the same concepts and the same applications that led to a finding of a root cause, a corrective action and preventive actions and things like that. So, okay. So, we talked about the focus of this is really going to be on root cause. And this is what I really want you to understand about root cause from the example we just gave with the doctor. the doctor had to understand the difference between a deficiency in a system a process in the system and the underlying root cause of what's going on with the system. And the doctor could have easily got to the point where he found the blocked artery and said, "Ah, there's the root cause, put the stent in as a correct and call that a corrective action and then release the patient and then never get to that fundamental underlying root cause which was the diet and the patient would probably likely be back in somewhere between two to five years with the same issue.

So the doctor had to understand the difference between the deficiency and the root cause. So when he found a deficiency, he didn't mistake that for root cause. He went on to find the actual root cause and kept digging. So it's important to in a an effective corrective and preventive action process to understand the difference between root cause and deficiency. Again, the root cause is that fundamental breakdown in the system that allows a deviation or variation in system processes that result in a nonconformity. the deficiency is that variation in that process where that process is kind of not doing what it's supposed to do now and creating a nonconformity a symptom that you can see it manifests as a nonconformity. so make sure you understand the difference between root cause and a deficiency in the system so that you don't stop at the deficiency, you move on to root cause. And the entire point here is dig deep. Don't just scratch the surface. dig deep to make sure you found the root cause. A root cause analysis really helps you define the deviations in the process that might cause an a deficiency that results in a non-conformity.

So in the doctor's case, he started a root cause analysis that led him to that deficiency, but you got to continue the root cause analysis to make sure you get to the root cause. So the root cause helps you to find that deficiency, but it also takes you to the underlying basic fundamental root cause. And that deficiency is going to be important in helping you to determine that. And I'm going to show you an example coming up here how that works. and then once you get to that underlying root cause, then you can implement effective corrective actions. So to do that, to get to that root cause, it really takes a root cause analysis. And when you look at the definition for the term analysis, it means examining something in detail. And really you're examining it in detail in order to find out and discover more about that process that system that you're looking at. So it takes a root cause analysis to go through that process to understand where failures are occurring and what the fundamental root cause is and address that root cause. So an effective CAPA process has to have an effective root cause.

If you don't have an effective root cause, you're not going to address the root cause and eliminate the problem from occurring. An effective root cause eliminates a problem because it eliminates the root cause from the system and the problem doesn't recur. If you have an ineffective captive CAPA and you're not addressing the root cause, you're going to be doing probably some corrections and containment activities to address the nonconformity because if you have a non-conformity, you're running your line, something, you have some non-conformity that shows up, you're going to do things to address it. You might put things on hold, you might resort things, you might repack things, you might re, whatever it is that you're going to do. but if you don't get to the root cause, you'll never do a corrective action or an effective corrective action. And what happens is the problem continues because you didn't address and eliminate the root cause. The problem continues and then it just results in frustration for you because you're always going back looking at the same thing saying, "We had this problem. I thought we fixed this.

It's back again." And it's probably because you didn't get to the root cause. So that comes to the question is why do failures in root cause analysis and capital processes typically occur? It comes down to a couple things. Not understanding the difference between a deficiency in the system and the root cause and a company stops at the deficiency thinking they found the root cause. So in the example of the doctor, he found a blocked artery, he puts in a stent. He thinks the blocked artery is the root cause. Puts in the stent thinks he's conducted a corrective action. and he never addressed the fundamental underlying basic root cause. So it's going to return again. So not understanding that difference is one reason why root cause analysis and corrective action processes fail. U because essentially what it comes down to is you're misinterpreting the deficiency in the system for the root cause. So don't stop at the deficiency. Get to the basic underlying root cause. Dig deep.

So when we're talking about a CAPA process, there are three things that are going to be important in the CAPA pro process that the CAPA process revolves around when it comes to finding the root cause in your system so you can address it and eliminate the nonconformity and those are the non-conformance itself, the deficiency that we talked about in the system and the root cause itself. so you'll always have all three of those in a in a in a process to different degrees and you may have more than one. There may be more than one deficiency that results in a nonconformity and there may be more than one root cause. So you have to make sure again that you dig deep. But understanding that these three things in their relationship is important in conducting an effective root cause analysis and corre corrective and preventive action process. And this diagram helps to illustrate that.

So what happens in the system is there's this fundamental underlying root cause this fundamental system failure somewhere there's been some variation that has occurred in the system that impacts the processes that are taking place in that system and those processes then start varying and they result in a nonconformity something that you see. So there's always a root cause that leads to whatever the deficiency, the variation in the system is that causes the nonconformity. And to eliminate that nonconformity altogether and keep it from recurring, you got to get back to the root cause. You got to get rid of the root cause. And the reason this relationship is important is because it's linear. And what that means is because it's linear, it's what you can use through your root cause analysis process and start with the nonconformity. The nonconformity shows itself. So you have a line that's running. You have a product that starts, some non-conformity comes up. It might be underweights or some defect like that and you think, oh, what's going on here?

And you start, scrambling to figure out what's going on and you start adjust making machine adjustments and checking things. So some of those things you're starting to do some corrections and containment activities, but that's where the root cause is going to start. Once a nonconformity manifests itself, you got a problem in the system. You're going to start a root cause analysis. And what you want to do is because that root cause led to a deficiency that resulted in a nonconformity. You want to take that nonconformity and start evaluating and tracing back trying to figure out what's going wrong in the system and its processes. and it's eventually going to take you back to a deficiency in one of the system processes that now can help point you to where the root cause may be. If you understand, excuse me, what the failure is in the process that's resulting in the non-conformance, that failure gives you some indication of what might be happening in the system as a root cause to allow that failure to occur.

So in the in the example what we gave with the patient when the doctor found the blocked artery then he started thinking about what are the things that could be causing that deficiency that's why he started looking at their diet and things like that. So it gives a clue as to where you might need to go. but make sure you're doing a thorough evaluation. But the key here is you can use this process to work your way back to the root cause and use each of these the nonconformity the nonconformity the deficiency to get to the root cause. And don't stop at the deficiency because if you stop at the deficiency you don't get to root cause. Use the deficiency as a springboard to root cause. Make sure you find the underlying basic fundamental problem and address that root cause through a corrective action and eliminate it from the system so the nonconformity doesn't recur. I'm just going to go through this table quickly because I know we have a time constraint here. but this table basically shows kind of the differences and I'm just going to talk about the differences between root cause and deficiency. Non-conformity is listed on here too.

I'll get into some of that but not all that. But a root cause is a fundamental breakdown in the system and it's usually some subtle variation in normal system processes that really doesn't appear and jump out in front of you. It's usually because it's a subtle variation. It's very vague and ambiguous and not obvious. So, it doesn't show itself. and it's typically going to be directly related to the deficiency that you eventually will find that resulted in the nonconformity. But to get to root cause, it requires a thorough examination of the system and its processes. You can't just stop at, the deficiency, scratch the surface and think you found it. You really got to dig deep. The deficiency on the other hand in the process because the root cause has allowed this process deviation to occur then there's a failure and unintended variation in the process because of that root cause and it's a specific failure. so that specific failure is typically in an identified process like in a patient's example it was a blocked artery. and it's typically distinctive and detective. So they detectable so they could find that when they found it.

It was very distinct what was going on there. and it is directly related to the root cause and to the deviation. That's the bridge between the two. but every it requires a root cause analysis too. And in that root cause analysis it requires this focused inspection of processes and things in the system to identify that deficiency. But you got to continue with a deep dive into it to get to the root cause. So make sure you again the point here is to get to the root cause. Don't stop at the deficiency. So there's a six-step process that basically is used in the corrective and preventive action process. And what it starts with is you start with your problem. and you're going to a problem that occurs your non-conformity occurs. You're going to start with the problem. You're going to describe what the problem is. and the non-conformity in detail, those types of things. You're going to gather data related to that problem to help you evaluate and start your root cause analysis.

You're going to conduct the root cause analysis to identify the root cause and the failure in your system. and then you're going to identify actions that you can take against that root cause. And then you're going to implement those actions against that root cause. And then once they're implemented, you're going to do a verification where you're going to look and make sure that they've been properly implemented and that they're effective. So again, with the problem, you're going to describe the problem in detail. And remember, it's the starting point. This is where everything that you have a non-conformity that's occurred. Now that tells you there's it's a manifestation that there's an underlying problem in the system. That's the starting point. So make sure you describe the problem in detail, what's going on, so you have good information to start working on your root cause analysis. And then your root cause analysis. You're going to gather any pertinent information.

It might be production records, maintenance records, sanitation records. it could be non-conformance, anything that you need to help you investigate and work through the pro problem that you're having. And then the root cause analysis, as I said, is the root cause analysis is going to be starting with all that information, knowing what the problem is, and you're going to start doing a deep dive into the system processes. you're going to really do a systematic evaluation looking for that fundamental basic underlying root cause and continue till you've identified the root cause. don't stop at the deviation and then once you def identify the root cause you're going to determine what actions are appropriate for that and there may be again more than one root cause or one deficiency. make sure what actions you're going to take against them and don't stop at the deficiency. And once you identify the actions that you're going to take, you identify all those actions for things like corrections that you might need to do.

You're going to identify what the proper action appropriate actions are to take for your corrective action to eliminate the non-conformity, the root cause and eliminate from the system to prevent the non-conformity from recurring. and then preventive actions that you might take to address nonconformities that haven't occurred, but there are potential non-conformities that could. So, you're going to go through that process and corrections might be things like stopping production, holding product, you might sort, inspect those kind of things. Corrective actions could be anything. It could be repairing equipment, changing procedures, whatever. But it's really intended to address the root cause and eliminate the root cause from the system to prevent the non-conformity. And then again, preventive actions are actions that you'll take that are proactive. And then veric verification again is going through the process of making sure that the actions have been implemented properly and they're effective. And then this is just an example of a simple form for doing a the six-step process because when you do this process, document it.

You have to document your corrective and preventive action process. So make sure you document all those steps. What was the problem? What data did we have related to the problem? What was the root cause analysis? and what were our findings, what actions were identified that need to be taken either for corrections, corrective action or preventive action and what actions were implemented and then verification of were they effective or not. So document it's important to document it. I'm going to go through these quickly because I want to get to the examples we have from manufacturing.

So you have several tools available out there at tool I'm say tool it's actually a method the 8D process a team oriented approach a discip disciplined approach and it's a deep dive and it's really a very formal method for going through that process that we just described and it kind of takes you through that process where you prepare you gather the information you form a team you describe the problem you conduct your containment or interim containment actions or corrections, you do a root cause analysis and you conduct preventive and corrective actions from that root cause analysis. you make sure they get implemented and validated and then you do your prevention preventive actions to make sure that if there's anything that potential root cause you need to address is addressed. so it's it's a very detailed process. 5 Whys tool is very simple. I like to use this as team oriented. It's simple. It's quick and effective. It's just simply a process where you start with the question you have a non-conformity. why? Why did this occur? And the answer to that becomes an X Y. The answer to that becomes an X Y.

And typically till you get to about the fifth Y, you have the answer, but you go beyond the fifth Y. If you don't have the answer, do six 78 Ys if you have to. And if you don't find it through the 5 Whys, then bring in other tools or other methods like the AD or some other tools that are available. We talk about the fishbone. Everybody, I think, is probably familiar with the fishbone diagram. It's been around for a long time. It's team oriented, easy to use, captures a lot of information. It's a deep dive, and what it does is helps you to see relationships between processes. and it typically looks at six things: machines, methods, materials, measurements, manpower, and the environment. and it's all mapped out on a diagram where you're do looking at those things and documenting why is this happening? How could this be contributing to it? Is/Is Not is a favorite tool of mine. It's team oriented. It's also easy to use. It captures a lot of information from different disciplines, but what it does is highlight anomalies in the system that can help point you to the root cause.

So that's a deep dive. so again, basically Is/Is Not is just looking at the what, when's, where, who's, how of what is happening and what is not happening. What did happen, when did it happen, when did it not happen? those types of things. and you start putting together a document that shows where anomalies are occurring. So I want to show you some basically a case study here. These are actual examples that I worked through with clients I had. So in this particular example, I had a client that had an issue with employees not washing their hands and they were getting frustrated. They were getting written up in audits. they were having things written up against them in regulatory inspections and stuff like that and they tried everything to fix it. they did dis training of retraining of employees, they did discipline and all that kind of stuff but it still people weren't washing their hands. So they asked me to come and help. So, what I did is I went in and did a simple 5 Whys.

And what I did is I went out to the where the break room is at a break and I waited for the break to end and watched people come out through the hand wash station to go back to the workstations. And as they were going through I saw a couple people not washing their hands. So, I stopped them and asked questions. And the first question is, why aren't you washing your hands? And the common response I got is there not enough time before they have to report to their workstation. So in this particular scenario, there's a bell that rang. When the bell rang, they had two minutes to get to their workstation. Okay. So the next question becomes, why isn't there enough time? And the common answer was, there are always long lines at the sink. So next question becomes, why are there long lines at the sink? And everybody's response was there aren't enough sinks for everybody in the department basically to get through in that two-minute time period and get back to their workstation. So they were skipping washing their hands to make sure they got back to their workstation and not get docked.

So the next question becomes why aren't there enough sinks? And that's not a question for employees. So this I went to management said why aren't there enough sinks? And they said well we had six sinks scheduled to be installed but maintenance was only allowed to install two. So the question becomes why was maintenance only allowed to stall install two. And the answer was that sinks were cut from the maintenance budget as a as a cost savings measure. So in this process here you can see at the third why we basically got to a deficiency in the system but it's not really the root cause yet. The root cause was in when we got to number five and maybe even a little bit beyond that because there were more questions that came up but just for the sake of this example and that it was documented this way. So the real root cause was that senior management did not have a process in place for eval evaluating the impact the GMPS in the food safety program for budgetary changes that they made.

So what they did is they implemented a process where any budgetary changes were submitted to the food safety director and he determined whether they had an impact or food safety or not and if they did then there's a next steps that had to be taken and if not then the budgetary method went on through. So that's an example of how a 5 Whys can be used and how that the whole process of corrective and preventive action comes into play because we had a non-conformity that occurred. We eventually through a root cause analysis got to a deficiency in the system and then we got to the fundamental underlying root cause. So for the deficiency they installed some more sinks as a correction and action in the containment measure. They actually started splitting break time so not all the employees were going to break at the same time so they had time to wash their hands. Now, the last one I want to go through here with you quickly is this was one for a manufacturing process where they had production line that was making a chocolatecoed coated cookie and they're having weights that were varying outside the acceptable limits.

So, the question becomes, why are weights varying outside the acceptable limits? And through investigation again, now this took time. I say 5 Whys are easy and quick, but this one actually took about 3 days to get to the pro the answer that we were looking for here to finally resolve this issue. But when we asked why are weights varying we noticed through investigation that deposit depositor was heavy on half the strokes. So the question becomes why is the depositor heavy on half the strokes and in that investigation we found out that the stroke of the depositor was varying beyond its acceptable limits. So the stroke was not staying within its control limits. So why was the stroke varying? well we found the bearing on a stroke rod on the depositor was worn. That's why the stroke was varying. so there is again we what we did is a correction here. We fixed the bearing in the system and that got the wake back under control. It eliminated the nonconformity but it wasn't the root cause yet. So the question becomes why did that bearing fail? So as we started with that process, we said why is the bearing worn?

Well, what we found out is that bearing was rated for 500 hours and it's been service for 800 hours. So the question becomes why was it in service for 800 hours? And what we found out the answer was that when there's one mechanic trained to perform that activity and he's out on medical leave. So basically the root cause here was they didn't have a process in place to make sure they had adequate contingency personnel trained in key activities to keep the processes functioning. So again the third why we found the deficiency. The fifth why we got to the root cause. And you can go deeper. It could be more than Whys. You can go deeper. Go as deep as you have to get to the root cause, but don't stop at the deficiency. Continue on. That's the whole point. This is just a quick example of Is/Is Not. I'm not going to go through this, but basically what this did is look at that depositing line we were talking about. And a good example of the Is/Is Not. If you look at the second line here, it says it was heavy on line 37, but not on line 38s and 39. So, right away, that points to equipment. That tells us something's going on in line 37.

I could go through all this. I'm not going to take the time to do I don't want to leave time for questions, but that's how you use these tools. Also, a fishbone diagram. Same thing. we map that out. You can see that we have things under machine, materials, methods, manpower, measurements. we discussed all those things. Again, I'm not going to get into all the detail. but these are tools that you can use. And this fishbone diagram again shows you relationships between the different processes that are occurring. So in that sixstep process, this is kind of how that would look that right up. we defined what the problem was, all the data that was gathered, the root cause analysis and what we found there is the root cause, the actions that were identified, the actions that were taken and then verification of those actions. So making sure you document all that is important. So with that said, I think we have some time here for some questions.

LeAnn Chuboff: Hey, well, thank you for all of that information. That was fantastic. And we did have questions come in. So, I'll just start with this question. So, in your experiences, what's the most common mistake that sites and organizations make when conducting root cause analysis? And how can like what can the site do to avoid that?

Arlen Keller: In my experience, the most common mistake that's made is getting to a deficiency in the system and identifying it as the root cause. they misidentify the deficiency that they found as a root cause. and to me the way around that is I always with the clients I work with is when they identify a deficiency in the system and they think it's the root cause, I always encourage them to continue on with the root cause analysis to find out why that thing you found as a deficiency is occurring because let's face it, everybody's pressed for time. And in the example, the depositor I showed with the bearing, they're scrambling trying to figure out what's going on. So, we go through this process of root cause. We find the bearing that's bad and we replace the bearing. And once you replace the bearing, now the system's back up functioning. Your weights are back in control and everything looks good. And because everybody's pressed for time, then they say, "Oh, that was the root cause. We're good to go.

Let's move on." and they need to continue to dig deeper to make sure they find that underlying cause why that bearing went bad because in that case if they would have stopped there it would just occurred again.

LeAnn Chuboff: Yeah. And if they would really look to see if there was a change in the process or the equipment or whatever to know to understand better understand why that bearing wasn't reflected in the entire process. So that kind of goes into even change management and getting people involved. So that's a webinar for another day. But somebody had posted as you were talking about root cause that isn't the most fundamental root cause of any deficiency ultimately a failure of senior site management to properly manage the system or communicate or whatever. Do you do you find that I know that was a talking point for a long time as to here's the issues that we have and it always goes to food safety culture. What's your opinion on that one?

Arlen Keller: I think that it's there are issues the fundamental underlying root causes that can be traced back to management of the system but not every fundamental root cause goes back to management of the system. it's it's when I go through these processes with companies like the two examples I gave both of those kind of came back to processes the root cause was in a procedural process basically. So for the handwashing one that was management they were doing things to cut budgets and not really understanding how it impacted food safety. So it does relate to food safety culture, that kind of thing. But in the bearing example that I gave, it came back to not having the right people trained and from a management standpoint, the processes that were in place were intended to have the people trained. but what they didn't understand is that there were key processes that need to have people trained and contingency personnel on. So it's indirectly related to management, not directly related to management. But so I would say in my experience, there are things that are related to management, but not everything is.

You will find things that are not directly related to management.

LeAnn Chuboff: So then what happens if you cannot identify the root cause?

Arlen Keller: That's a good question and that's basically the issue that everybody deals with when they go through a root cause analysis and don't find a root cause. In that case, what I always do with my clients is you have to put some process in place to start monitoring things about the system that are important to the deviation that occurred to try to build information to eventually get to a root cause. because I'd say that I would say that probably 90 98% of the processes that I work with, we eventually get to a root cause. There's probably about 2% where it's a struggle to find that. But if you put a good program in place to start monitoring things tracking things that kind of stuff for the weight example if we wouldn't have found a root cause there we would have started tracking weights more frequently evaluating statistical process information on that. trying to get some information that points us in a direction. because quite frankly there are times where you do not find a root cause and you need to be prepared to put a plan in place to help you monitor that system and track what's going on.

So when a root cause does if that particular non-conformity does occur again now at least you have some pertinent information pointed geared towards that nonconformity.

LeAnn Chuboff: Maybe what you're saying is like look at other data collection points that you can do to support that. couple more questions. what are some of the advantages and disadvantages to some of the root cause analysis methods and tools? And is it a good idea to have more than one method to determine that root cause? is that more efficient than using only one? So maybe in your, the previous example as to what if we couldn't find a root cause, are you just going to switch to a different method? Are there better methods to start off with or, what would be your suggestion there?

Arlen Keller: So my suggestion there is you use whatever methods you need to get the root cause accomplished. So, for example, when we talked about the root cause methods and the different tools that are out there with the example of the depositor that wasn't depositing correctly, we started with a 5 Whys on that, but we ended up doing an 8D on that. We also had an Is/Is Not on that. so, when we got to a point where we had some things that we ran into that we weren't sure which way to go, excuse me, we brought in other tools. I can't say that there's one tool out there that's better than another tool or one method that's better than another. If you go search on, like I said, Google corrective preventive action methods or tools, you'll find a thousand different things out there. there are a lot of tools available to you. So, my advice is to get familiar with all of them and use the ones that are appropriate to what the issue is that you're dealing with. and just I'm sorry. Go ahead.

LeAnn Chuboff: Oh, go ahead. Just to just to interject a little going back to the bearing, did you start off with the 5 Whys and then go to the fishbone or did you start off with a fishbone because it was equipment and you felt that a fishbone would be a better tool. So using that as an example, you gave the same deficiency and problem but use two different methods. So did you use both methods?

Arlen Keller: We used the 5 Whys initially just a quick because the 5 Whys is easy to go through 5 Whys questions. We did a quick 5 Whys and it pointed us in certain directions with the 5 Whys. So then we took the fishbone and the Is/Is Not and used those to develop correlations between processes and things and define where anomalies were occurring. And then when we had all that information we put it together in an 8D. Oh okay. Wow. All right. Yeah. So, you did use that was an example of where you use multiple tools and methods in order to better identify where the problem was and to better understand that problem, not just to fix it in the corrective action, but put forth that preventive action as well. So, yeah. And from a from a preventive action standpoint, it highlighted that something was going wrong with personnel and maintenance and training.

So we had four other lines that we went and looked at for the same issues on those four other lines and we also took a preventive action step of looking at all the other key processes in the manufacturing process to make sure that the personnel were properly trained for key issues in those other areas. So you could continue to go on and say there was perhaps maintenance or engineering or whoever wasn't on the table when there was a processing or product change. Yeah. Excellent. one more question and I know we're two minutes over, but one more question and then we've answered all the questions that are out there. Actually, two more just came in, but we'll put those we'll parking lot those for another day. how do you differentiate between a minor mishap and something needed of a full-blown root cause analysis? But does everything every non-conformance is everything a nonconformance? Does that need to be documented? Does that root cause analysis for every non-conformance? So, can you just put a correction and walk away or do you root cause analysis on everything?

I'm going I'm I'm going to present it this way. there are times where you have a non-conformance that occurs where it's probably appropriate just to do a correction. And I'll give you an example. if I'm out in a facility and I'm walking through the facility and I see let's just say I see a utensil that's not properly stored. it's laying on a machine or something say a sanitation brush. I might take that sanitation brush and take it over the sanitation wash area and put it up to be cleaned and tell somebody, "Hey, that brush was over there." And that's a correction. I took care of the nonconformity, addressed it. But if I come through there and every week I find a brush laying on that equipment out of place and I'm starting to see a trend, then I'm going to do a corrective action.

So my rule of thumb is and this is I think probably relatively common through the industry is if I see a trend of deviations occurring against a standard of some type then I'll do a corrective action or if there's a non-conformance that occurs against a standard that has a food safety issue related to it or a customer quality issue related to it I will do a corrective action. Yeah. So yeah that makes sense. Yep. So those are but there are times simple things where you might just do a correction and it and that's a isolated incident but if you see the trends you need to do a corrective action. Yeah, that's why it's so important like all those requirements in the SQF code that talk about trending and analysis and change management and it's all interrelated and that's how you build your food safety system and it's all based off of continuous improvement doing root cause analysis putting in preventive action and providing an enhancement to that food safety system. So it goes to that we're never in a destination of food safety.

It's always that journey and it's something you just me mentioned there is important and we talked about it briefly in the beginning of the presentation but think of corrective and preventive action as a continual improvement process too because that's really what it does. Oh yeah. It's really a continuous improvement of your processes and systems. Yeah. This is how we get better. Absolutely. So well Arlin thank you very much and for everybody that stayed the extra four minutes. We appreciate it. and if you want to know when our next 360 webinar is, go to our website at sqfi.com under the training tab. It'll list the next 360 webinar. I also, and we don't have a slide, want to invite everybody to squnites. SQFunites is in St.

Louis this year. again go to sqfi.com and your and just go right to the training and you'll see a tab to sqfunites and coup if you can put that in the a link to that in the chat that would be great but if you guys want to come we have a whole session on root cause analysis and corrective and preventive action we also have more information on edition 10 so edition 10 if you haven't received our newsletter will be posted in the beginning of March right before the conference and we are dedicating really many sessions on edition 10 and learning about the changes of edition 10 and good sharing of knowledge and learning. So hopefully I get to see you at unites go to our website and look for more opportunities to learn. So Arlin again many thanks for your time today and for sharing your knowledge all about root cause analysis and corrective action. Any questions? I just say just reach out to Arlen. I think he'll get back to you pretty soon. Okay. Thank you. Appreciate it. Thank you everybody. Thank you everybody. Have a great day.