IAEA E-learning Program

IAEA E-learning Program
Safety and Quality in Radiotherapy

Safety and Quality in Radiotherapy
MODULE 8: failure modes and effects analysis Safety and Quality in Radiotherapy Sections: 8.1 Purpose and principles 8.2 Treatment planning 8.3 Information transfer 8.4 Calibration In Module 8 we’ll be discussing Failure Modes and Effects Analysis. We’ll start by describing the purpose of Failure Modes and Effects Analysis and the main principles for its application. As we’ll see shortly, it is mainly a prospective quality management technique. That means it is generally employed before a new technology or process is introduced. However, it can also be used on an existing process or equipment. It is worth noting that whether it is incident learning, failure modes and effects analysis or any other safety/quality initiative that encompasses the whole clinical program, a multidisciplinary radiotherapy team is recommended to ensure that all perspectives are taken into account.

MODULE 8: failure modes and effects analysis Safety and Quality in Radiotherapy Module objectives To introduce and demonstrate failure modes and effects analysis as a safety/quality tool. To perform partial analyses for situations that resemble the three actual incidents that we have discussed during this e-learning program. Here is what we will do in this module. In this, the first, section we will introduce and demonstrate failure modes and effects analysis as a safety/quality tool. In the following three sections we will provide examples of the use of Failure Modes and Effects Analysis in situations that are loosely based on the three incidents we have been discussing throughout this e-learning program. Apart from reinforcing the key concepts of Failure Modes and Effects Analysis, examining these three types of incidents in more detail will lead us into the discussion of some of the more common safety and quality measures.

MODULE 8: failure modes and effects analysis Safety and Quality in Radiotherapy Sections: 8.1 Purpose and principles 8.2 Treatment planning 8.3 Information transfer 8.4 Calibration We will start the module by looking at the purpose and principles of Failure Modes and Effects Analysis.

MODULE 8: failure modes and effects analysis Safety and Quality in Radiotherapy Section 1: purpose and principles OBJECTIVES To understand the purpose and the key steps of failure modes and effects analysis. To work through failure modes and failure pathways using an everyday example of a process. To learn how this prospective risk management approach can help us prioritize safety/quality improvement initiatives. Here are our objectives for this section. To understand the purpose and the key steps of failure modes and effects analysis To work through failure modes and failure pathways using an everyday example of a process To learn how this prospective risk management approach can help us prioritize safety/quality improvement initiatives.

MODULE 8: failure modes and effects analysis Safety and Quality in Radiotherapy Section 1: purpose and principles OBJECTIVES To understand the purpose and the key steps of failure modes and effects analysis. To work through failure modes and failure pathways using an everyday example of a process. To learn how this prospective risk management approach can help us prioritize safety/quality improvement initiatives. First, we will understand the purpose and the key steps of failure modes and effects analysis.

MODULE 8: failure modes and effects analysis Safety and Quality in Radiotherapy Section 1: purpose and principles Approaches to Quality Management Incident learning systems are used retroactively to analyze incidents that have occurred or proactively to analyze potential incidents (near misses). Failure modes and effects analyses (FMEA) and fault tree analyses (FTA) are (typically) used prospectively to analyze systems for weaknesses. There are 2 major classes of approach to quality and error management. incident learning systems are used reactively to analyze incidents that have occurred or proactively to analyze potential incidents (near misses). Failure modes and effects analysis and fault tree analysis are (typically) used prospectively to analyze systems for weaknesses. We discussed incident learning systems in Module 3. We will discuss fault tree analysis in the next module.

MODULE 8: failure modes and effects analysis Safety and Quality in Radiotherapy Section 1: purpose and principles What’s the purpose of a failure modes and effect analysis in radiotherapy? Failure modes and effects analysis helps us, through a structured and logical analysis of a clinical process, to identify the steps in the process which are associated with the highest risk and hence to prioritize interventions and actions which will enhance the safety and quality of the care that radiotherapy patients receive. What’s the purpose of a failure modes and effects analysis in radiotherapy? Failure modes and effects analysis helps us, through a structured and logical analysis of a clinical process, to identify the steps in the process which are associated with the highest risk and hence to prioritize interventions and actions which will enhance the safety and quality of the care that radiotherapy patients receive. Prioritizing interventions is important because we don’t have unlimited resources so we have to direct those resources that we do have to where they will be most effective.

MODULE 8: failure modes and effects analysis Safety and Quality in Radiotherapy Section 1: purpose and principles Where does failure modes and effects analysis fit into a clinical quality management and patient safety program? Failure modes and effects analysis (FMEA), being a prospective approach to quality and safety, complements retrospective approaches such as incident learning. A well developed safety culture will include performing both retrospective (root cause analysis) and prospective (FMEA) analyses. Where does failure modes and effects analysis fit into a clinical quality management and patient safety program? Failure Modes and Effects Analysis, FMEA, being a prospective approach to quality and safety, complements retrospective approaches such as incident learning. A well developed safety culture will include performing both retrospective and prospective analyses. It’s important to realise that failure modes and effects analysis does not and cannot replace learning from incidents. It’s a complementary approach.

MODULE 8: failure modes and effects analysis Safety and Quality in Radiotherapy Section 1: purpose and principles Failure Modes and Effects Analysis: The key steps Several national organizations have developed methodologies for performing FMEAs. For the most part the different published approaches follow a common path although details and emphasis vary. We will adopt a simplified but generic approach in our discussion. Several national organizations have developed methodologies for performing failure modes and effects analyses. Two sources are provided in the references for this section and more can be easily found with an internet search. For the most part the different published approaches follow a common path although details and emphasis vary. We will adopt a simplified but generic approach in our discussion as we did in the context of Root Cause Analysis. Be easily find

MODULE 8: failure modes and effects analysis Safety and Quality in Radiotherapy Section 1: purpose and principles TG 100’s Failure Modes and Effects Analysis1 Step # Major Processes Step Potential Failure Modes Potential Causes of Failure Potential Effects of Failure O S D RPN Examples of Causes and Failures 178 11 - Day 1 Treatment Treatment delivered LINAC hardware failures/wrong dose per MU; MLC leaf motions inaccurate, flatness/symmetry, energy, etc Poor hardware design Poor hardware maintenance. Inadequate physics QA process Wrong dose Wrong dose distribution Wrong location Wrong volume 5.4 8.2 7.2 354 Wrong to very wrong dose affecting all patients treated on machine (or with affected beams) until problem is found and corrected. 195 7 - RTP Anatomy Delineate GTV/CTV (MD) and other structures for planning Contouring errors: wrong organ, wrong site, wrong expansions User error Inattention, lack of time, failure to review own work Very wrong dose distributions Very wrong volumes. 5.3 8.4 7.9 366 Wrong target volume contour leads directly to very wrong dose distributions and volumes. Low detectability assumes only review is by physicist and MD 31 4 - Other pretreatment imaging for CTV localization Images correctly interpreted Incorrect interpretation of tumor or normal tissue. User not familiar with modality or inadequately trained. Poor inter-disciplinary communication Wrong volume 6.5 7.4 8.0 387 Here’s a very recent example of a Failure Modes and Effects Analysis. It was developed by the American Association of Physicists in Medicine’s Task Group 100. The approach presented in this e-learning program is similar but not identical.

MODULE 8: failure modes and effects analysis Safety and Quality in Radiotherapy Section 1: purpose and principles OBJECTIVES To understand the purpose and the key steps of failure modes and effects analysis. To work through failure modes and failure pathways using an everyday example of a process. To learn how this prospective risk management approach can help us prioritize safety/quality improvement initiatives. Next, we will work through failure modes and failure pathways using an everyday example of a process.

MODULE 8: failure modes and effects analysis Safety and Quality in Radiotherapy Section 1: purpose and principles Let’s take as an everyday example our morning routine. We can apply failure modes and effects analysis to any process whether in the clinic, at home or in any other situation. Here is what we will do in this section. We will work through failure modes and failure pathways using an everyday example. Let’s take as an everyday example our morning routine.

MODULE 8: failure modes and effects analysis Safety and Quality in Radiotherapy Section 1: purpose and principles We will use this simple worksheet for our FMEA. All the terms will be explained as we go along. We will use this simple worksheet for our FMEA. All the terms will be explained as we go along. This is similar to TG 100’s Worksheet presented earlier but not identical.

MODULE 8: failure modes and effects analysis Safety and Quality in Radiotherapy Section 1: purpose and principles FMEA: Process Map A failure modes and effects analysis starts with a process map. These might be the steps in our morning routine. Get up Shower Breakfast Dress Drive to work Attend meeting A failure modes and effects analysis starts with a process map. These might be the steps in our morning routine.

MODULE 8: failure modes and effects analysis Safety and Quality in Radiotherapy Section 1: purpose and principles FMEA: Process Map We can enter the process map into our worksheet. We can enter the process map into our worksheet.

MODULE 8: failure modes and effects analysis Safety and Quality in Radiotherapy Section 1: purpose and principles FMEA: Process Map We pick one step in the process for our first analysis. Get up Shower Breakfast Dress Drive to work Attend meeting We pick one step in the process for our first analysis.

MODULE 8: failure modes and effects analysis Safety and Quality in Radiotherapy Section 1: purpose and principles FMEA: Process Map We pick one step in the process for our first analysis. Get up Shower Breakfast Dress Drive to work Attend meeting Let’s pick “drive to work”.

MODULE 8: failure modes and effects analysis Safety and Quality in Radiotherapy Section 1: purpose and principles FMEA: Process Map We can identify the selected step on our worksheet. So here’s “drive to work” identified on our worksheet.

MODULE 8: failure modes and effects analysis Safety and Quality in Radiotherapy Section 1: purpose and principles FMEA: Potential Failure Modes Now we ask “what could go wrong on our drive to work?” Get up Shower Breakfast Dress Drive to work Attend meeting Now we ask “what could go wrong on our drive to work?”

MODULE 8: failure modes and effects analysis Safety and Quality in Radiotherapy Section 1: purpose and principles FMEA: Potential Failure Modes Now we ask “what could go wrong on our drive to work?” The car could break down. We might get lost. We might have a crash. Here are 3 things that could go wrong. The car could break down. We might get lost. We might have a crash. These are our potential failure modes. There are, of course, other things that could go wrong but let’s focus on these to illustrate failure modes and effects analysis. These are our potential failure modes.

MODULE 8: failure modes and effects analysis Safety and Quality in Radiotherapy Section 1: purpose and principles FMEA: Potential Failure Modes We enter our potential failure modes into our worksheet. We enter our potential failure modes into our worksheet. We note here that each main step in the left most column could be divided into sub-steps. We can omit sub-steps for the moment without compromising the value of this illustration.

MODULE 8: failure modes and effects analysis Safety and Quality in Radiotherapy Section 1: purpose and principles FMEA: Severity Now we ask “how bad would it be if these things happen?” Miss the meeting, expensive. Miss the meeting. Miss the meeting, possible injury. The car could break down. We might get lost. We might have a crash. Now we ask “how bad would it be if these things happen?” The car could break down and we miss the meeting. It could be expensive too. We might get lost and miss the meeting. Or we might have a crash, and then we miss the meeting and possibly get injured.

MODULE 8: failure modes and effects analysis Safety and Quality in Radiotherapy Section 1: purpose and principles FMEA: Severity Next we assign a number between 1 and 10 to describe the severity of the failure mode. Miss the meeting, expensive. Miss the meeting. Miss the meeting, possible injury. The car could break down. We might get lost. We might have a crash. 6 2 9 Next we assign a number between 1 and 10 to describe the Severity of the Failure Mode. 10 is the highest severity and 1 the lowest. Assigning the numbers that we need to perform a failure modes and effects analysis is a subjective activity. In other words, it depends on our judgement. That being the case, a failure modes and effects analysis is best carried out by a multidisciplinary team and consensus used to arrive at these metrics. As we will later see, the numerical value we associate with the severity of the potential failure mode is used, with or without other metrics, to rank risks. The absolute numbers are not important. Our aim is to identify where the greatest risks are so that we can prioritize preventive actions. If we choose to make the table a bit bigger we could add a column listing these consequences of the failure and not just the severity numbers. Will later see

MODULE 8: failure modes and effects analysis Safety and Quality in Radiotherapy Section 1: purpose and principles FMEA: Severity We enter our severity scores into our worksheet. We enter our severity scores into our Worksheet.

MODULE 8: failure modes and effects analysis Safety and Quality in Radiotherapy Section 1: purpose and principles FMEA: Failure Pathways Now we ask “how could these things happen?” We might get lost. We forget to bring a map. There is a detour around road works. We think the meeting was in a different institution. Now we ask “how could these things happen?” In general there would be several ways in which a failure could happen. For the purposes of illustration, we’ll just look at the failure pathways that could result in our getting lost on the way to work. We might forget to bring a map. Perhaps there was an unexpected detour or perhaps we were heading to the wrong place. These are just a few possibilities. We will use these as examples of failure pathways. These are our failure pathways.

MODULE 8: failure modes and effects analysis Safety and Quality in Radiotherapy Section 1: purpose and principles FMEA: Failure Pathways We enter these into our worksheet. And now we enter these into our worksheet as shown.

MODULE 8: failure modes and effects analysis Safety and Quality in Radiotherapy Section 1: purpose and principles FMEA: Occurrence We then ask “how likely are these things to happen on a scale of 1 to 10?” We forget to bring a map. There is a detour around road works. We think the meeting was in a different institution. 6 8 2 We then ask “how likely are these things to happen on a scale of 1 to 10?” Of course, this is subjective too and the numbers we come up with will depend on our own personal way of doing things. For example, if we tend to get things muddled up, the likelihood of heading for the wrong meeting room might be higher than the proposed value of occurrence suggests. However, the numbers shown here seem reasonable for the failure pathways we are considering. These numbers are our occurrence values. The numbers are occurrence, O, values.

MODULE 8: failure modes and effects analysis Safety and Quality in Radiotherapy Section 1: purpose and principles FMEA: Occurrence We enter these occurrence values into our table. We can enter these occurrence values into our table.

MODULE 8: failure modes and effects analysis Safety and Quality in Radiotherapy Section 1: purpose and principles FMEA: Detectability We then ask “how likely is it that these pathways will not be interrupted on a scale of 1 to 10?” We forget to bring a map. There is a detour around road works. We think the meeting was in a different institution. 7 8 3 We then ask “how likely is it that these pathways will not be interrupted on a scale of 1 to 10?” If the failure pathway, once initiated, is not interrupted, the potential failure mode will become an actual failure. We use various quality assurance and control strategies in an attempt to eliminate the propagation of errors. Detectability is a measure of how effective we believe these strategies to be. The higher the number, the less effective the strategy. As with occurrence we have to make our best judgement as to what numbers for detectability to choose. To bring the example on this slide to life: if we routinely check for a map when we get into our car the detectability number would be much lower than the 7 we have used here. In that case the number would reflect the chance that, for some reason such as being in a hurry, occasionally we forget to check for the map. For the purposes of this illustration it is reasonable to assume that we are much less likely to be aware of a detour somewhere on our way to work than realising where the meeting is taking place having just read the agenda before leaving home. The assignment of D or detectability values can cause confusion. A high detectability value signifies that the pathway is unlikely to be interrupted. A high Occurrence value means the failure pathway is likely to be initiated but, in contrast, a high Detectability value means that the pathway is NOT likely to be interrupted. The numbers are detectability, D, values.

MODULE 8: failure modes and effects analysis Safety and Quality in Radiotherapy Section 1: purpose and principles FMEA: Detectability We enter these detectability values into our worksheet. Now we can enter our detectability values too.

MODULE 8: failure modes and effects analysis Safety and Quality in Radiotherapy Section 1: purpose and principles FMEA: Risk Priority Numbers Now we multiply the severity (S) by the occurrence (O) and the detectability (D) numbers to give us the risk priority number. Risk Priority Number = S x O x D Now we multiply the severity by the occurrence and the detectability numbers to give us the Risk Priority Number for the particular potential failure mode and failure pathway we are considering. Thus we have a risk priority number for each failure mode/failure pathway combination.

MODULE 8: failure modes and effects analysis Safety and Quality in Radiotherapy Section 1: purpose and principles FMEA: Risk Priority Numbers Finally we enter the risk priority numbers into our worksheet. So finally we can enter the risk priority numbers into our worksheet.

MODULE 8: failure modes and effects analysis Safety and Quality in Radiotherapy Section 1: purpose and principles FMEA: Risk Priority Numbers Now we can prioritize process and quality management changes starting with the highest risk priority number and working down. Failure Pathway There was a detour around road works. We forgot to bring a map. We thought the meeting was in a different institution. Risk Priority Number 128 84 12 Now we can prioritize process and quality management changes starting with the highest risk priority number and working down. Thus, we have achieved our objective which is to identify the weakest points in our process. These are the steps in our process map with the highest risk priority numbers.

MODULE 8: failure modes and effects analysis Safety and Quality in Radiotherapy Section 1: purpose and principles OBJECTIVES To understand the purpose and the key steps of failure modes and effects analysis. To work through failure modes and failure pathways using an everyday example of a process. To learn how this prospective risk management approach can help us prioritize safety/quality improvement initiatives. Lastly, we learn how this prospective risk management approach can help us prioritize safety/quality improvement initiatives.

MODULE 8: failure modes and effects analysis Safety and Quality in Radiotherapy Section 1: purpose and principles FMEA and Quality Management In developing a quality management program, on the basis of this analysis, we would start with the failure pathway associated with a detour around road works, then move on to the lack of a map and finally, if considered necessary, the issue of heading for the wrong meeting place. In general, if a failure pathway is associated with a high occurrence, O, value we would look to refining the process to make it intrinsically safer. A high (un)detectability, D, value would guide us towards improving our quality control and checking procedures. In developing a quality management program, for this particular potential failure mode and on the basis of this analysis, we would start with the failure pathway associated with a detour around road works, then move on to the lack of a map and finally, if considered necessary, the issue of heading for the wrong meeting place. In general, if a failure pathway is associated with a high Occurrence, O, value we would look to refining the process to make it intrinsically safer. A high (un)Detectability, D, value would guide us towards improving our quality control and checking procedures. So apart from helping us to allocate our quality management resources according to the priority list resulting from the failure modes and effects analysis we also have suggestions as to whether it’s the process or the quality control or both that most urgently needs attention.

MODULE 8: failure modes and effects analysis Safety and Quality in Radiotherapy Section 1: purpose and principles FMEA and Quality Management The process described in this module is repeated for all process steps, failure modes and failure pathways. Clearly, this is a lot of work so it’s best to start small and work up to the full analysis. The process described in this module is repeated for all Process Steps, Failure Modes and Failure Pathways. Clearly, this is a lot of work so it’s best to start small and work up to the full analysis. Generally, it is recommended that your multidisciplinary team starts with just a part of a full clinical process to gain experience with this technique. When the team is comfortable it can move on to tackle more complex processes. Earlier, we recommended prioritizing quality management initiatives on the basis of risk priority number. However, at that time we were focusing on one failure mode only. Once the table is more complete, with several potential failure modes, all with their own severity values, an alternative method of prioritizing interventions might be considered. The Severity, or S value, presents an option for ranking risky situations. A decision could be made to deal with those potential modes with the highest S values first, irrespective of their risk priority numbers. As in much of this approach to error management and quality improvement, judgment will be exercised in the decision to prioritize according to severity or risk priority number or some combination of both.

MODULE 8: failure modes and effects analysis Safety and Quality in Radiotherapy Section 1: purpose and principles summary We have: Understood the purpose and the key steps of failure modes and effects analysis. Worked through failure modes and failure pathways using an everyday example of a process. Learnt how this prospective risk management approach can help us prioritize safety/quality improvement initiatives. Here is what we’ve done in this section. Understood the purpose and the key steps of failure modes and effects analysis Worked through failure modes and failure pathways using an everyday example of a process Learnt how this prospective risk management approach can help us prioritize safety/quality improvement initiatives.

MODULE 8: failure modes and effects analysis Safety and Quality in Radiotherapy Section 1: purpose and principles References and additional resources Huq MS, Fraass BA, Dunscombe PB, et al. A method for evaluating quality assurance needs in radiation therapy. International Journal of Radiation Oncology, Biology, Physics, 71, S2-S

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