Getting Started with Risk in ISO 9001:2015

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1 Getting Started with Risk in ISO 9001:2015

2 Executive Summary The ISO 9001:2015 standard places a great deal of emphasis on using risk to drive processes and make decisions. The old mindset of using corrective and preventive actions to deal with adverse events has been replaced with the risk-driven approach, aiming to prevent it from happening rather than recovering once it happens. For those that are new to Risk Management, however, this can be a challenging shift. Not only do business leaders need to understand the latest standard, they need to understand the role of risk and the tools available to them to help manage risk. This white paper will overview the major shifts that ISO 9001:2015 presents within the context of risk, mainly focusing on building your quality management system around risk. Next, it will outline the key features of risk and the process of Risk Management, while applying that to the new standards. Finally, it will give examples of common tools for leveraging Risk Management in your organization: The Decision Tree, Risk Matrix, Failure Modes and Effects Analysis, Bowtie Matrix and Risk Register. ISO 9001:2015 A Change in Mindset A shift to risk-based thinking. The ISO 9001:2015 standard is not just a new set of requirements. They present a shift in mindset towards quality as an underlying concept throughout your entire organization. Now, leaders are urged to make quality a top priority for everyone, not just those directly involved in quality management. Quality management shouldn t be treated as a separate part of business, but something that is embedded within all aspects. With that shift comes an emphasis on risk-based thinking as a catalyst for all business decisions, especially those that directly affect the quality of your products. Finding risks and opportunities in all areas of your business can help you improve all processes and lead to overall success. Your team can achieve a higher level of quality by adopting a holistic approach to Risk Management, where you understand that risk assessment and management is interdependent within all areas of your business rather than a separate entity. Building a risk-focused quality management system. Building a risk-focused method of quality management system allows you to streamline compliance by creating an entire system around a central focus. This is a much more practical approach to risk-based quality management planning. Rather than planning separate aspects of your quality system and hoping that they work together, you can centralize them by having the same focus. That way, all actions will be prioritized similarly and carried out with the same goals in mind. Rising to meet new business challenges. A risk-focused quality management system helps you respond to new business challenges that companies are currently facing. With an increase in rapidly growing businesses, there is a higher rate of change in products, processes and regulations. Businesses are more complex as there is more competition and more compliance regulations to keep up with. Keeping up with the pace of business is challenging enough, but adding the pressure of compliance is even more difficult. The cost of compliance is also increasing as it becomes more of a priority in more areas within organizations. Leveraging Risk Management and Risk Assessment tools can help you stay on top of these rapid changes by integrating quality management into new business techniques. It also helps you avoid the costly mistakes that result from poor quality management. Overall, incorporating risk into your quality standards leads to improved business operations. Understanding Operational Risk Management The first step in applying these new risk standards to your organization is understanding risk in terms of your organization. Then, you can learn the steps for properly managing it. What is risk? Before we can discuss methods for managing risk, you should understand exactly what that term means. A common misconception is that risks and hazards are the same thing, but that leads to confusion and often a mishandling of potential adverse events. A hazard is a condition or situation that creates the opportunity for a problem. A risk is the likelihood that the hazard will lead to a negative consequence. This distinction is important because although identifying hazards is important to risk identification and management, the two are not the same thing and should be treated differently. Understanding the Risk Management process. Risk Management is a process by which we use risk to improve our processes and reduce the likelihood of an adverse event. In doing so, we take our operational data and use it to make decisions focused around reducing risk and increasing quality. The result is a repeatable and objective decision-making approach that is free from opinions or assumptions.

3 Although details of the risk management process will vary from business to business, there are a few common steps that should underlie all processes: 1. Identify all relevant risks. Use internal audits, surveys and documents to catalog the hazards in each area of your business and which ones present a possible risk. This may take a lot of time and effort, but it s an important first step in identifying risks that otherwise would go unnoticed. 2. Quantify the risk. Use a few variables such as severity (how impactful the event would be) and frequency (the probability that the event could occur) to quantify the risk. Using a Risk Assessment tool, give the event a numerical value and prioritize which potential event needs controls put in place first. Events with the highest potential risk should be dealt with first, even if they are discovered after other possible events. 3. Treat the risk. Once you know a certain risk exists, the next step is determining whether the risk needs to be dealt with, or if it can stay as is. This decision should be based on the severity and frequency of the event as well as your organization s available resources for handling it. Depending on the circumstances, your organization may choose one of the following ways to treat risk: Acceptance: If the event isn t high enough risk to warrant the implementation of controls, you can choose to simply ignore it, since the time and effort it would take to put those controls in place are greater than that of dealing with the event happening. This most often happens with events that have a very low severity, frequency or both. In some cases, implementing controls would take too much time and effort as compared to the level of risk, so they are accepted. Reduction: When risks are slightly above the acceptable threshold, the risk needs mitigation, or reduction. These types of events may not be the highest priority event requiring immediate attention. They are, however, potentially impactful enough where controls should be implemented to prevent them. Compensation: When risks are moderately severe or frequent, there should be a deliberate effort to make sure the event does not happen. Compensation is the implementation of an insurance policy, something designed specifically to make sure that event doesn t happen. It requires putting a decent amount of time and effort into certain areas of your processes to make counteract the likelihood of that event happening. Transference: Sometimes mitigating risk is not enough, or not possible given your organization s setup and circumstances. In those cases, it may be more effective to instead (or additionally) change or move processes to lessen the risk. This could be a physical aspect like changing where something takes place, or changing the order or steps in which a task is completed. It could also be changing the personnel, training or safety measures associated with a task whatever will result in reduced risk. Avoidance: When a risk is very severe or very likely to happen, it must be a priority to avoid them. These cases usually lead to potentially catastrophic consequences if they happen, or are events that are likely to happen again and again. These may require the most work to prevent, but it is really important to your organization s well-being to do so. 4. Implement a control. Controls are the actions taken to increase quality and decrease the likelihood of the possible adverse event from happening. It might be a safety precaution, employee training or even a change in processes. These controls should be planned, implemented and monitored with risk mitigation in mind, and documented thoroughly so they can be monitored. 5. Manage Change. When something is done to reduce a risk, there are residual changes in processes. At this point, your organization needs to take the final step in Risk Management, which is adapting to whatever changes are taking place. This happens in two stages: first introducing the change, and then monitoring the new processes while making improvements where necessary. The result is a documented and monitored system for promoting improvement within your processes. Risk Management and ISO 9001:2015 The unifying principles of the new standard. The changes in ISO 9001:2015 affect how organizations plan their quality systems and make quality-related decisions. Risk-based thinking replaced the old way of using corrective and preventive actions to drive change. This is done with an aim of unifying the organizations quality systems with one underlying principle: risk. Although risk-based thinking is found in many sections of the revision, two main sections focus on risk as a unifying principle of quality. Section 5 prescribes the roles of leaders and how risk

4 should play into their leadership styles. Leaders should now focus on creating a culture of risk-driven decisions throughout all operations. That way, quality is a priority for all team members, and they are all acting under the unifying principle of risk. Section 6 focuses on the planning of your quality management system. Throughout all steps of planning your quality management system, you should consider risks and opportunities and how they will affect your operations. you should plan systems to identify the risks and opportunities as well as manage them over time. Part of this planning includes the aforementioned steps: identifying hazards, categorizing those that pose risks, quantifying risks and treating them accordingly. Take action. Although there are no specific regulations for which procedures and tools you should use for planning your quality management strategy, it is stated that you have a set procedure. The most effective way to build a reliable procedure is to utilize objective tools that produce repeatable results. A process that is backed by real-world data is efficient and yields accurate and useful results. It provides visibility into your processes and allows greater control over risks and opportunities. By leveraging quality management tools such as Corrective and Preventive Actions (CAPAs), action plans, reporting and trend analysis, you can accurately document all activities and use that information to make risk-driven decisions. Documentation is important on two levels: first, it helps you identify trends, opportunities and further risks within your organization. Second, the latest round of ISO revisions mandates documentation for all processes throughout all stages of production, not just during planning. Common Tools for Leveraging Risk Management There are multiple tools that help you approach Risk Management from different angles. You can use different combinations and variations of these tools to best analyze the specific types of risks you encounter, depending on the needs of your organization. Although they vary greatly in presentation and function, they all provide systematic, objective and repeatable risk assessment and analysis. Although there are many ways to assess risk, there are a few common methods that provide reliable results: 1. Decision Tree. This tool is extremely simple and easy to integrate into your already-existing systems. It is a simple map containing lines that connect possible decision points in a logical order of occurrence. The decision points are based on a series of (usually) yes or no questions that represent the different deciding factors of a situation. You can trace a given event through various possible paths from start to finish to see what the possible outcomes would be. That way, you can see which paths lead to the highest risk. This is an effective method for seeing the effects that a single decision point can have on the outcome of a series of events. That lets you pinpoint exactly which decision has the biggest effect on overall risk. That way, your team can carefully craft a course of action that avoids the choices that increase risk. Decision trees are also well-organized visual representations of many possible outcomes, which can otherwise be difficult to keep track of. Now, you can be prepared for any scenario yet remain organized. 2. Risk Matrix. The risk matrix is one of the most commonly used Risk Management tools. It is another simple tool that is an excellent visual representation, making it a good choice for those that prefer visual information or are not as comfortable with large amounts of quality data. It is a colorful and bold chart, so it is very easy to interpret. The risk matrix is a good choice for organizations who are transitioning into risk-based thinking for the first time. The risk matrix quantifies risk level using tested assumptions about an event most commonly severity and frequency (probability). Those levels are put on a numerical scale and the given event is plotted in the matrix accordingly. Colors are assigned to different numerical ranges based on personalized algorithms to determine if a risk is acceptable, needs mitigation or needs to be avoided. Risk matrices commonly use bold and symbolic colors like green, yellow and red to prevent confusion, although they can be personalized in whatever way works best for your organization. Although this tool is simple and widely used, you should exercise caution when using the risk matrix to make decisions. A common mistake especially for people who are new to risk-based thinking is to completely rely on this tool and make decisions solely based on its given outcome. There may be events that fall on the borderline between acceptable and unacceptable, or have contingent circumstances that could determine whether it is acceptable or not. You have to evaluate the results within the context of your organization and adjust the parameters realistically. 3. Failure Modes and Effects Analysis (FMEA). This is a more advanced and complex tool for risk management, but it can be very effective if leveraged properly. It takes more time

5 and effort to formulate and analyze results with an FMEA, but that investment may be worth it. This tool can help you prevent serious quality issues that would have catastrophic quality issues. The FMEA is designed to identify possible failures during the design phase of a product. That way, you are aware of potential issues before the product is even produced. At each step in the design process, the FMEA asks questions like, What could break during this step? and How could this component affect other parts? and so on for every possible error. The different components of the design are broken down and assessed for risk at that level. Although this is a complicated and intricate process, it is favored because it tends to eliminate quality issues before they even happen. Identifying potential risks and failure points in the design process is more cost-effective than discovering them during the production or post-market phases. It is more efficient to correct potential problems before they exist than to fix them after they occur. Although that is not always a realistic approach, it can be very beneficial when planning products that will be sold to a large market or would have potentially catastrophic effects on customers. 4. Bowtie Matrix. This matrix is similar to the decision tree in that it shows potential outcomes for certain events, but it is different because it includes preventive measures and is used for different purposes. This tool is used for events that have low occurrence, but are potentially catastrophic. It aims to highlight the proactive and preventive measures that you can use to mitigate the risk and prevent the event, since it is so potentially catastrophic. Some organizations find the bowtie matrix challenging to work with. Since this tool is used for low-occurrence events, there is usually little data or information about the event. Therefore, it may be difficult to fully plot preventive actions or recovery controls since there may be little knowledge of them. However, the events that warrant a bowtie matrix could be so impactful that they must be thoroughly assessed as a risk. To craft the bowtie matrix, you start by plotting the undesired event in the middle. This could be a recall, an employee injury, a death or any other serious outcome. From there, you build out preventive barriers on the left side, and recovery controls to minimize the consequences on the right side. In one single view you see the ways to prevent the bad event as well as ways to respond to it if it were to happen despite the preventive controls. This gives good insight into what to use to prevent the occurrence as well as what systems to have in place as a precaution. 5. Risk Register. Having a risk register is an important part of Risk Management, although it is not necessarily a tool for assessment or analysis. It is a way to plan your Risk Management efforts and manage them over time. A Risk Register has two main components. The first is a library of hazards, which is a reference for containing all of the known hazards in different areas of your business. This is a useful collection of information for using hazards to identify risks. The second component is a collection of risk data for all of your processes. All of the data related to risk is in one central place. This provides visibility into critical events since you will have as strong reference point backed by data. That data can then be used for trend reporting, so you know how your organization is responding to your Risk Management efforts over time. The risk register is a good way to check the effectiveness of your other Risk Management procedures and the controls you implemented. Closing Thoughts Risk Assessment and Management are key factors in transitioning to the ISO 9001:2015 standard. Risk-based thinking is the focus of planning, executing and maintaining a successful quality management system under this standard. Understanding the process of operational Risk Management and Assessment is crucial to the successful implementation of a compliant quality system. To best meet the standard, you should develop a quality system focused around one or more Risk Management tools. Leveraging these tools as part of an automated quality management system can help you maximize the impact of risk data while minimizing the time and effort necessary to collect and analyze that data. Adopting the technological and ideological advances of quality management will help your organization gain and maintain compliance under the new standard. EtQ Reliance is a trademark of EtQ, Inc. All other product names and company names are trademarks or registered trademarks of their respective owners. No endorsement of EtQ by such companies is intended or implied. Copyright 2017, EtQ, Inc.

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