Safety in medicine is a rapidly developing field. However, until recently it had been unclear how the skills and tools developed by human factors practitioners in other industries could be applied to medicine. This paper initially outlines the quality and safety programmes healthcare systems have traditionally used to improve quality of care, before turning our attention to the epidemiology of medical adverse events. The development of clinical risk management is explained, with a focus on how human factors methods could be used to assist safety management in healthcare. A formal and systematic method to investigate and analyse clinical adverse events and near misses is described, which is based on traditional human factors methodologies. The investigation of clinical adverse events utilises a semi-structured interview and performance influencing factor questionnaire, whilst Reason's organisational accident causation model is used to analyse adverse events (Reason, J.T., 1993. The human factor in medical accidents. In: Vincent, C. (Ed.), Medical Accidents. Oxford Medical Publications, Oxford). An obstetrics case, concerning a post-partum haemorrhage is used to show how the investigative methods can be used by a clinical risk manager to build up an accurate and detailed description of what happened and the organisational accident causation model can be used to systematically identify why errors occurred. Finally, the applicability and necessary modifications of human factors methods for use in medicine are discussed. (C) 1999 Elsevier Science Ltd. All rights reserved.