Engineering risk and safety management methods, such as Failure Mode and Effects Analysis, Hazards and Operability Analysis and Fault Tree Analysis, are used to identify potential threats and opportunities within a system and to manage their likelihood and/or impact on people, property, progress or profit. The role of risk management is to identify, assess and control the level of known risk, accepting the inherent threat or opportunity that may be present within the system, in particular with complex medical interventions and in the distributed system of social care (Figure 18).

It is useful to consider the process of risk management to be made up of a series of iterative examine, assess and improve cycles that enable a team to progress from understanding what is known about the system through to developing interventions to manage the risk presented by the system. Active risk management is appropriate at all stages of a product or service lifecycle, from early conception, through use to disposal.

Risk can be referenced to a system’s ability to deliver high-quality, cost-effective care, where quality is defined as the combination of clinical and cost effectiveness, patient safety and patient experience. [1] Risk management is commonly used as a clinical tool for the prospective analysis of an individual patient’s risk, with or without a particular intervention.

However, it may also be used to evaluate the risk in sustaining or not achieving the desired outcomes for a population of patients, the efficiency of a care process or the finances of a care provider. [2]

Different stakeholders may have different risk priorities within the same system and risk tolerance levels will vary with time and be dependent upon the context of each specific care delivery system or process.

Risk may also be attributed to uncertainty in performance where mitigation will likely focus on the identification of the sources of such variation and their reduction.