Introduction: Three-dimensional radiotherapy (3D) is an important modality in management of cancer. This complex process is liable to many types of errors. Risk management approaches are mandatory to decrease the risk of these errors. Failure mode & effect analysis(FMEA) is a proactive risk assessment strategy used to in identify and anticipate potential errors and to take action before a radiation incident occurs. Aim: The aim of this study is to apply a proactive risk analysis of the 3D radiotherapy process,to quantify the most significant sources of failures using FMEA & to recommend risk reduction measures. Methods: A FMEA was conducted over 12-months period at Clinical Oncology and Nuclear Medicine Department at Ain-Shams University Hospital. A detailed process map for 3-D radiotherapy technique was created starting from the decision taken for radiotherapy till the end of radiotherapy sessions. The Delphi method was used in this study to achieve consensus among participants about the level of risk associated with failure modes.Semi-structured interviews wereconducted with twenty radiation personnel to identify potential failure modes in each step of 3-D radiotherapy
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