A Human Reliability-Centered Approach to the Development of Job Aids for Reviewers of Medical Devices That Use Radiological Byproduct Materials (PSAM-0299)

Abstract

The U.S. Nuclear Regulatory Commission (NRC) is engaged in an initiative to risk-inform the regulation of byproduct materials. Operating experience indicates that human actions play a dominant role in most of the activities involving byproduct materials, which are radioactive materials other than those used in nuclear power plants or in weapons production, primarily for medical or industrial purposes. The overall risk of these activities is strongly influenced by human performance. Hence, an improved understanding of human error, its causes and contexts, and human reliability analysis (HRA) is important in risk-informing the regulation of these activities. The development of the human performance job aids was undertaken by stages, with frequent interaction with the prospective users. First, potentially risk significant human actions were identified based on reviews of available risk studies for byproduct material applications and of descriptions of events for byproduct materials applications that involved potentially significant human actions. Applications from the medical and the industrial domains were sampled. Next, the specific needs of the expected users of the human performance-related capabilities were determined. To do this, NRC headquarters and region staff were interviewed to identify the types of activities (e.g., license reviews, inspections, event assessments) that need HRA support and more » the form in which such support might best be offered. Because the range of byproduct uses regulated by NRC is so broad, it was decided that initial development of knowledge and tools would be undertaken in the context of a specific use of byproduct material, which was selected in consultation with NRC staff. Based on needs of NRC staff and the human performance related characteristics of the context chosen, knowledge resources were then compiled to support consideration of human performance issues related to the regulation of byproduct materials. Finally, with information sources and an application context identified, a set of strawman job aids was developed, which was then presented to prospective users for critique and comment. Work is currently under way to develop training materials and refine the job aids in preparation for a pilot evaluation. « less