Risk Management Analysis
Risk Management is defined by ISO 14971 as “the systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating and controlling risk” (Schmidt). The purpose of risk management is to identify risks, take steps to mitigate them, and evaluate whether the actions had the intended outcome. ISO 14971 (Schmidt) lists three steps to the risk management process:
- Risk analysis – identifying hazards associated with a device, a procedure, or activity.
- Risk evaluation – assess the probability of the hazard occurring and the severity or impact of the consequence. Probability and severity can be scored using a lowmedium-high determination. A sample matrix can be found in the NFPA 99 Handbook (2015, p.74).
- Risk control – methods for mitigating the risk which can include redesigning a system or process, staff training or protective measures
Redesigning a process or system (inherent safety) is considered the most effective for controlling risk, while a focus on training is considered the least. Some risks can be eliminated (adding an item to the No Go list prevents risks associated with that item); however, often risks cannot be completely eliminated. As stated by Schmidt, “safety means the freedom from unacceptable risk.”
There are two risk analysis methods, retrospective and prospective, based on whether the process is being completed proactively or reactively. If an incident has already occurred a retrospective risk analysis is used to evaluate the cause or causes of the error and try to prevent reoccurrence. A prospective risk analysis attempts to identify possible risks and tries to reduce or eliminate them before an occurrence. In a perfect world all risk analysis would be proactive: In reality both techniques are subject to biases that can affect quality or accuracy. Bias constitutes a “pre-conceived preference or inclination that has the potential to affect the impartiality of evaluations or decisions” and can result in risks being overlooked or prematurely dismissed (Peacos). Different forms of bias that can affect risk management include: 1) team assembly (individuals with a similar mindset or not including someone who is not affected by the outcome); 2) not considering risks from supporting systems; 3) resistance to change. A hospital system’s internal resources (risk management, environment of care, safety, and infection control) can qualify as team members not affected by the outcome and of a different mindset. Risk analysis expert Paul Baybutt recommends having a devil’s advocate on the assessment team to combat the effects of cognitive biases, someone willing to challenge your views to help determine their validity.
Prospective risk management techniques are often used when evaluating or modifying equipment for the hyperbaric environment; however, this process can be applied throughout the hyperbaric department. It is important to have a systematic method for completing any risk assessment so none of the items or steps that may be required are missed or forgotten. These items/steps may include: identifying the hazard, the probability and severity matrix used, infection control, fire risk, consulting external or internal resources, relevant information/literature review, training and documentation of the process.
Before I lose anyone, the key word is may; not all of these items will be necessary, depending on what is being considered or assessed, and the time commitment depends on the project and the key players (or resources) that need to be involved. An expertise in risk analysis is not necessary; literature reviews, consulting resources, and assembling a diverse team can help ensure everything addressed. Documentation may not need to be extensive but having a record trail is important, as it can serve as a template for future assessments and provide justification for the end result.
To illustrate how quickly and easily some risk assessments can be completed and documented, following are two examples of completed prospective risk analyses that resulted in a change in practice and/or policy.
Special thanks to devil’s advocate Jane Ahlstrom, CHT.
Baybutt P. Cognitive biases in process hazard analysis. J Loss Prev Proc Ind. 2016; 43: 372-377.
Peacos P. Bias: The hidden danger to your risk assessment. 2016. Am Pharm Rev. Retrieved from: https://www.americanpharmaceuticalreview.com/Featured-Articles/184365-Bias-The-Hidden-Danger-to-Your-Risk-Assessment/
Schmidt B. (201). Prospective risk management. Patient Safety and Quality Healthcare. 2010. Retrieved from: https://www.psqh.com/analysis/prospective-risk-management/