Handling Faults in Live Service

Abstract

It is only in live service that the claims of the safety case and hazard register can be truly tested. Observing the system in operation and responding to safety-related faults are key activities for the clinical risk management team. Faults needs to be assessed to determine whether new hazards have come to light or whether controls, once assumed to be effective, have proven less reliable in the real world. Manufacturers sometimes need to stay abreast of large numbers of concurrent faults and a sound clinical risk assessment will help to prioritise those which pose the greatest threat to patient safety. This chapter looks at how safety-related faults are handled and proposes a structure for conducting a concise safety assessment when they arise.