GA 458 | Exploring Risk Analysis with Ron Pereira

Hey, everyone. Today's episode is going to be a little different as we turn our attention towards the topic of risk analysis. Well, specifically, we're going to be sharing the audio from three of Gemba Academy's newer courses. At least newer as of the original recording here in January 2023. Now, if you actually want to watch these videos and not just listen to the audio, you can watch them free of charge. We're going to scroll down here on your podcast and you'll find the links and you can also navigate to the Show Notes page over@gembapodcast.com just look for episode 458 and we will. We will link to all of these videos as well. As a reminder, the first video of every Gemba Academy course is is unlocked and free of charge. Okay, well, first up is the course on bow tie analysis. Bow tie. As if. Like what you tie on a shirt. Bow tie analysis. Now, here's the course description. Every workplace comes with hazards. Bow tie analysis is a powerful risk analysis tool used to identify, evaluate and address specific hazards within your organization, whether that be from a chemical spill on a factory floor or medical error in a hospital. Learn how this tool, which combines features of fault tree analysis and event analysis, can shed light on all kinds of potential issues and how you can intervene before these risks cause real damage. Okay, here's the audio from the first video of this course.

Hello and welcome. In any workplace, there are countless things that can go wrong. Part of the goal of continuous improvement is to minimize risk, prevent accidents, optimize efficiency, and keep everyone safe. Bow tie analysis is a highly visual way to introduce risk analysis and can be made as simple or as complicated as you like. The name comes from the distinctive bowtie shape of the diagram. Bowtie analysis is a powerful risk assessment tool used to identify and evaluate potential hazards. It's used to help grasp the impacts of a specific hazardous event and determine the controls that should be put in place to prevent that event from happening. Occasionally, bow tie analysis can also be used to demonstrate positive risk. By positive risk, we mean a particular opportunity that has potential to add value or lead to various benefits. Having originated in the oil and gas industries, bow tie analysis is now used in all kinds of fields, including healthcare, aviation, chemical engineering, and more. Now that we have a general idea of what bow tie analysis is, let's take a look at how it compares to other tools, as well as how it evolved over time. Bowtie analysis is rooted in both fault tree analysis and event tree analysis. Bowtie analysis combines both approaches to create one well rounded analysis the left threat side of a bowtie analysis is essentially a basic version of a fault tree analysis. This is where we focus on the potential failures and identify how a hazardous event might unfold. The right consequences side of a bow tie analysis resembles a simple version of an event tree analysis. This is where we map the outcomes and consequences of a hazardous event. As you can see, bowtie analysis shows where fault tree analysis and event tree analysis merge linked by singular top event. Another method to model the barriers in place to prevent a hazardous event is the swiss cheese diagram. The swiss cheese diagram is similar to a fault tree analysis in the left side of a bot's eye analysis. However, unlike bowseye analysis, a swiss cheese diagram does not illustrate the ways in which the harm and consequences can be minimized once the event has occurred. Another predecessor of bowtie analysis is causal factors charting. The concept of causality mapping is woven into the design of bowtie analysis as we model the relationship between causes, the top event and its consequences. The bowtie diagram also shows the pathway between the controls and their escalation factors. However, in causal factors charting, the emphasis is placed on the incidents that have already occurred and only examines one pathway to a potential hazard. The overall bowtie analysis is designed to be more proactive and prevention oriented than other risk analysis tools. The goal is not necessarily to examine probability and frequency, but to ensure the controls we've put in place are actually working. Now that we've explained how bowtie analysis fits in with other tools, let's discuss the main advantages and disadvantages of utilizing bowtie analysis. The first advantage of bowtie analysis is that unlike cause and consequence diagrams, bowtie analysis displays the full complexity of the situation. This means both sides of the top event are displayed in one diagram as opposed to separately. Like in fault tree analysis and event tree analysis, existing controls and causal relationships are both modeled as well. The second advantage of bowser analysis is that it's a comprehensive tool that can be conducted over and over again to assess what can controls are treating what risks. The third advantage of bot eye analysis is that its visual nature makes it easy to see where there are gaps or deficiencies in the process. This comes in handy when it's time to decide where to invest money, time and labor. While bow tie analysis is an incredibly valuable tool, there are two notable disadvantages or scenarios in which it may not be the best choice for risk analysis. The first disadvantage of bow tie analysis is that it is less suitable when there are multiple causes connected via complicated pathways, for example and or gates. These Gates are logic symbols that connect events and conditions. If two input events must both occur for an output event to occur, they are both connected by an and gate. If only one of the two input events must occur for an output event to occur, they are connected by an or or gait. The second disadvantage of bow tie analysis is that it's less useful when risk and hazards need to be quantified. While it is possible to incorporate some degree of quantification into bow tie analysis, other tools may be more appropriate. In conclusion, bow tie analysis is a versatile tool that can shed light on all kinds of potential hazards in your organization. That wraps up our review of bow tie analysis.

Next up is our course focused on Failure modes and Effects analysis, or fmea. Now, FMEA is a structured approach to identifying the ways that a product or process can fail, what causes a failure, and how this affects the customer. Learn how to apply FMEA to improving the safety, reliability, and performance of performance processes, products and services. And here's the audio from the first video of this course.

Hello and welcome. Failure Modes and Effects Analysis, abbreviated as fmea, is a structured approach for identifying the ways that a product or process can fail, what causes the failure, and how this affects the customer. FMEA is a bottom up inductive analytical method. This means that we study the failure modes of individual components within a system, identify their effects, and trace their causes. After estimating the risk associated with specific failures and causes, the FMEA helps us to prioritize and take actions to reduce the risk. We can benefit from doing failure modes and effects analysis whenever we need to identify and manage risk. These include when we're getting ready to launch a new project, a new process, or develop new products. Also, FMEA helps us when we are planning changes to operating conditions, products or process designs, and when there are new regulations or when we have new customer requirements that we must meet. There are five notable features of FMEA's. First, it's essential to perform failure modes and effects analysis as a team activity. This ensures that we capture as many possible risks as we can, involve stakeholders and interface with technical experts and build consensus on the actions we will implement to reduce risk. Second, FMEA uses a standard format and specific terminology. While these are not difficult to learn, it's important to be familiar with them. Also, some industries, such as the automotive industry, specify an exact format and standard to follow for doing FMEA's. Third, the FMEA follows a structured, step by step process. These steps closely follow the structure of the FMEA template. FMEA is often described as an 89 or 10 step process based on the eight main sections of the template. Fourth, an FMEA is a living document. We must recognize that as we make improvements to the process, we must review and update our FMEA's. This should be done at least once per year. It's often more frequent based on regulatory requirements or based on product, materials, environment or process changes. The fifth point to note is that in many instances the FMEA is considered a legal document that must be validated, controlled, and stored. Accordingly, the findings and actions of FMEA activities may be used to support investigations into accidents or warranty or other contract or performance issues. FMEA can be used to evaluate and mitigate risks across a wide range of applications such as safety products, systems, environmental projects, and others. However, broadly Speaking, there are two types of FMEA's. These are process FMEA's and design FMEA's. The process FMEA, abbreviated PFMEA, investigates the functions and failures of existing processes, services, systems, equipment, etc. The process FMEA is used to analyze new and existing manufacturing processes, to identify deficiencies in our current control plans, to evaluate risks when making changes to our processes, and more. The second type is the Design fmea, abbreviated dfmea. We use this to evaluate the risks related to a product's design. The objective is to thoroughly examine how a product can fail during its useful lifetime. Design FMEA's can be conducted at different phases of the design process such as concept development, prototype, final design, and even to study failure modes of a product currently in production. The overall process for doing a failure modes and effects analysis is the same for products, processes, services, projects, or any other type of risk. However, there are four notable differences between process focused FMEAs and product focused or design FMEAs. First, the nature of the function that each type of FMEA studies is different. Process FMEAs examine how a process may fail to produce a desired function. On the other hand, a design FMEA examines risks of a product being unsafe, unreliable, or otherwise unable to meet the customer's needs. For a process fmea, the function column on the far left of the worksheet will list process steps that create these part characteristics or meet the customer's service requirements. For a design fmea, the function column on the far left of the worksheet will list features that customers want from our product or service. A second difference is in how we set the scope for an FMEA activity. Scoping a process FMEA project is generally simpler than for products. It can be done with a block diagram supplemented by an interface matrix. When needed for design FMEA's, it's necessary to consider complex interactions between components and subsystems and how these affect risk. This often requires looking across multiple levels such as product system, sub assembly components and piece parts. Scoping for DFMEA requires additional visualization tools such as boundary diagrams, the P diagram, or interface matrix when setting the scope for a design fmea. Third, the ranking scales for severity, occurrence and detection will follow the same principles but cover different content and will have different definitions. And fourth, the outputs between the two are different. For a design fmea, these are typically a design verification plan, a robustness checklist, and a design sign off report. The output of a process FMEA includes a revised or enhanced control plan or alternatively a dynamic control plan part drawings showing the special characteristics and actions to improve methods, materials, equipment, training, or the operating environment. In addition to validating product or process specifications to meet regulatory or customer requirements, FMEAs are widely used in continuous improvement circles within the Six Sigma DMAIC process. FMEA plays a key role in the analyze phase to find the critical x. In addition, we can use the FMEA to identify potential variables to consider when planning multivariate analysis and design of experiments or DOE studies. Failure modes and effects analysis is particularly helpful in tpm. FMEA is used to analyze sources of equipment failures and breakdowns and to set up periodic and preventive maintenance activities to prevent them. The FMEA can also be employed at the very beginning of a large project or launch of a transformation effort to evaluate and plan for possible risks. Likewise, many use fmea, the conclusion of a cycle improvement activity, to identify remaining risks or reasons that we may fail to sustain our gains. By periodically reviewing and taking action on sources of risk, the FMEA enables us to make our processes, products, projects, services, or other systems safer, better, and more reliable. That wraps up our review of FMEA or failure modes and effects analysis.

And finally, we have our course focused on fault tree analysis. A fault tree analysis is a top down deductive approach to understanding how a series of lower level events can result in an undesired event or accident or equipment failure. This diagram uses a set of symbols to represent formal logic and to assign probabilities. Performing fault tree analysis helps us to understand how specific systems can fail, assign risk rates, and identify the best ways to reduce these risks. Okay, let's listen.

Hi there. Fault tree analysis is a top down deductive approach to understanding how a series of lower level events can combine to result in an undesired event such as as an accident or equipment failure. By creating a diagram using A set of symbols quantifying risk and following formal logic. A fault tree analysis helps us to understand how specific systems can fail, identify the best ways to reduce risk, and assign a risk rate or probability to a failure. The fault tree is a visual model of the logical relationship of the unwanted event to the more basic events that contribute to it. We use the fault tree analysis to methodically investigate what happens to a system when there is a change to the status of one or more elements of that system. We want to know how likely it is for specific combinations of these changes to result in an accident, defect or breakdown. Fault trees are structured with symbols for events, gates and transfers. The unwanted event is located at the top of the fault tree. Now, examples of unwanted events include accidents, defects in product or process, an equipment failure, or it may be a risk or potential hazard events. In the middle of the tree are intermediate events. These are caused by other events. At the bottom of the tree are the basic events, the most elemental factors causing the fault. The logical relationship between events is shown by symbols for various types of gates. Transfer symbols may be used to connect the inputs and outputs of related fault trees, such as when a system has several subsystems. Whenever possible, we assign values for a probability of occurrence to the lowest level events in the tree. The quantitative data may be for reliability, safety or quality. This data is used to evaluate the probability of the top event occurring. As we can see, the fault tree analysis is a top down deductive approach that begins with a general conclusion, then works out its specific causes by constructing a logic diagram. The most common purpose of a fault tree analysis is to identify potential causes of failures before they occur. The fault tree analysis is used widely in the fields of aerospace safety engineering and reliability engineering. Additionally, they're used to evaluate the statistical probability that the top level event will occur and provide more in depth analysis to other tools and problem prevention practices. The added degree of detail that fault tree analysis provides allows us to focus efforts on improving elements critical to reliability or safety. For example, during an FMEA or failure modes and effects analysis, we take a bottom up approach to examine potential failure component by component rather than at a system level. This may identify certain failure modes as being high severity, frequent or hard to detect. In such situations, the fault tree analysis is useful to evaluate these failures in more depth and with specific metrics. Fault tree analysis is used widely during TPM efforts. It serves as a foundational tool used extensively during focused improvement activities. Understanding the causes and risks of various types of equipment failures is also a key step in establishing a planned maintenance system in the mature stage of autonomous maintenance, equipment operators often learn the fault tree analysis technique as a part of their ongoing daily improvement and skill development activity. Other pillars of tpm, such as early equipment management, safety and environmental management, and quality maintenance, all rely on insights from using the fault tree analysis method. A completed fault tree analysis helps us to visualize our understanding of complex systems, quantify the factors that lead to failures, and prioritize our efforts to improve safety and reliability. That wraps up a review of the fault tree analysis method.

Again, if you'd like to watch the actual videos in that last one, the Fault Fault Tree Analysis, that would be a good one to go watch because there are some unique symbols when we're doing fault tree analysis, but all of these videos you can just scroll down there on your podcast player and you'll find the links. Or you can go over to our show notes page@gembapodcast.com and just look for episode 458. Okay, well, thanks for listening and we'll be back next week with another interview. Take care of thanks for listening. Whether you've been on the continuous improvement journey for many years or perhaps you're just getting started, GEMBA Academy is here to support you. And while we're best known for our more than 1500 Lean and Six Sigma teaching and virtual tour videos, we also have a team of experienced Lean and Six Sigma practitioners available for one on one coaching as well as a variety of of Lean and Six Sigma certification options. To learn more and to schedule a demo, head on over to gembaacademy.com.