This chapter explores the four elements of risk assessment: hazard identification, exposure assessment, hazard characterization and risk characterization. Hazard identification is the first stage of a risk assessment in which the evidence that the hazard presents a risk to consumers for the specific situation is documented. Exposure assessment (EA) is the qualitative and/or quantitative evaluation of the likely intake of pathogens or their toxins via food. Hazard characterization ideally quantifies the probability of illness or infection associated with microbial hazards that may be present in food. Risk characterization (RC) synthesizes the exposure assessment with the dose–response relationship to generate an estimate of human health risk. A reality check provides confidence that the estimate is at least of the right order of magnitude. The chapter concludes with case studies on how risk managers in various countries used estimates generated in risk assessments to determine risk management strategies.