The investigation of an unintended occurrence has resulted in a risk of harm essentially comprises a ‘root cause analysis’ (RCA) process. RCA is a structured approach to identify the factors that resulted in the nature, the magnitude, the location, and the timing of a harmful, or potentially harmful, occurrence. RCAs should be conducted in a structured and objective way, to reveal all the influencing and causal factors that have led to an adverse event. The aim is to learn how to prevent similar incidents happening again.

The approach should shift the focus from individuals to the system.
There will usually be a coordinator and a team that carries out the investigation. Normally, the following steps should be included in the process:
1. Gathering Data - to include full details of what happened, as well as relevant policies and procedures.
2. Mapping the Information - possibly in timelines, flowcharts or a chronological narrative of the chain of events allowing the identification of any information gaps and showing contributing factors.
3. Identification of the problem(s) that contributed to the occurrence - this could require a review meeting with relevant personnel involved.
5. Identification and agreement on the root causes - the fundamental contributory factors which, if resolved, will eradicate or have the most significant effect on reducing likelihood of recurrence
6. Reporting.
The implementation of corrective and preventive actions should be managed and monitored within the Quality Management System, including an action plan and audit, with any relevant findings being fed back into the original investigation report.
It is easy to conclude that mistakes are caused by ‘human error’ but this error often has an underlying cause that must be identified and addressed if repetition of the error is to be avoided. The underlying causes might be understaffing, unduly long working hours, procedures that are not clear to staff, inadequate training or, indeed, true human error. It is recommended that a structured approach be adopted to arrive at the ‘root’ cause. Relevant personnel should be trained in effective methods for conducting RCAs.