FDA-iRISK® 5.0 and Quantitative Risk Assessment

Course Description

This five-day course provides a practical introduction to quantitative risk assessment and FDA-iRISK® 5.0, the U.S. Food and Drug Administration's enhanced web-based food safety risk assessment and modeling tool.

Designed for professionals in government, industry, academia, and public health, the course helps participants move beyond qualitative discussions of risk and begin applying quantitative approaches to real-world food safety challenges. Through a combination of instructor-led presentations, guided exercises, and hands-on modeling activities, participants will learn how quantitative risk assessment can be used to evaluate hazards, compare risks, assess intervention strategies, and support risk-based decision-making.

Participants will gain experience using FDA-iRISK® 5.0, Microsoft Excel, and @RISK® to build and analyze probabilistic models. Along the way, they will explore key concepts such as probability, uncertainty, variability, stochastic processes, and Monte Carlo simulation in a practical, approachable learning environment.

Using real-world food safety examples and case studies, participants will develop a deeper understanding of how quantitative risk assessments are created, interpreted, and communicated. By the end of the course, they will have the confidence and practical skills needed to apply quantitative risk assessment tools and methods within their own organizations.

Whether you are involved in food safety, regulatory decision-making, public health, research, or industry compliance, this course provides valuable hands-on experience with modern risk assessment tools used to support science-based food safety decisions.

Prerequisite:
Basic knowledge of probability and statistics and intermediate-level Microsoft Excel skills are recommended. Completion of Risk Management Essentials and Risk Assessment Fundamentals is encouraged but not required.

Additional Resources

FDA-iRISK® 5.0 Overview and Resources
Excel: There are web-based resources that provide introductory Excel such as  www.videoprofessor.com.
Basic Statistics: The quantitative methods course does not require in-depth knowledge of statistics, but an understanding of basic terminology is necessary. There are web-based resources that provide information about basic theory in probability and statistics. Some examples include http://www.robertniles.com/stats and http://www.statsoft.com/textbook.

Overview of Topics

Introduction to FDA-iRISK®, Building scenarios in FDA-iRISK®, Guided walk through of working in FDA-iRISK®
Going beyond terminology, Introduction to modeling, Deterministic modeling, Probability, Monte Carlo simulations, Triangular, Pert and Beta distribution and Bayes’ Theorem

Learning Objectives

  • Understand usefulness of models and the important tradeoffs in the design of models
  • Understand the differences between deterministic and stochastic models
  • Gain a strong foundation in basic probability theory and probability distributions
  • Be able to build basic probabilistic models using Excel and @RISK
  • Case studies: Microbial hazard and Chronic chemical hazard
  • Simulation principles and techniques
  • Scenario and Sensitivity analysis
  • Understand why models are useful
  • Understand important tradeoffs in the design of models
  • Understand the differences between deterministic and stochastic models
  • Gain a strong foundation in basic probability theory and probability distributions
  • Be able to build basic probabilistic models using Excel and @RISK
  • Simulation principles and techniques
  • Stochastic processes
  • Scenario and Sensitivity analysis