Quantitative risk analysis

Abstract

Problem. Each year, unsafe consumer products are involved in millions of injuries and thousands of fatalities around the world. There is a need to quantitatively assess the risks to consumers posed by all types of consumer products. Objective. Quantitative Risk Analysis (QRA) is a scientific methodology that was developed to quantitatively demonstrate the potential risk associated with any given consumer product. QRA is based on the Risk Equation which is Risk = Hazard X Exposure. Methods. Key factors affecting Risk were studied. Factors impacting Hazard include Design Defects, Manufacturing Defects, and Foreseeable Use. Factors impacting Exposure include Product Quantity in distribution, Product Durability, Caregiver Vigilance, and Product Accessibility. Monte Carlo Simulation methods were utilized to generate estimates of product-related risk. Results. The Kinder Egg is used as an example and the QRA results for this product in the North American market are presented. Conclusion. QRA results can do the following: 1.) Determine if a design meets desired or necessary safety expectations 2.) Allow one to understand which components of a given design can be modified to ensure the greatest improvements in the safety of a given product 3.) Guide the development of product safety specifications and requirements and 4.) Determine if a recall is warranted. QRA can benefit risk managers and others by allowing them to identify the critical factors influencing the risks posed by consumer products in the global marketplace.