FDA's Risk-based Inspectional Decision Support System
Executive Summary
Each year, the U.S. Food and Drug Administration (FDA) conducts tens of thousands of inspections of products and manufacturing plants in order to help ensure the safety of our food supply and the products – like children’s toys – distributed throughout the country. The FDA’s Office of Regulatory Affairs (ORA) is the lead office overseeing the inspections of regulated products and manufacturers before they enter the United States. The FDA does not inspect all products and manufacturers, rather it must plan out which sites to inspect when. Field supervisors decide which products and manufacturers to inspect, when to inspect them, and who to assign to conduct the inspection.
The problem is that FDA Field supervisors do not have access to accurate and updated information about risk, facility operations, and investigators’ skills and availability. As a result, high risk firms may not be inspected in a timely manner, by the right investigator, or in the most cost-effective manner. The current planning process is cumbersome and sometimes produces inaccurate results, making risk-based targeting challenging.
The Innovation: This team has constructed a decision support tool that dynamically incorporates risk, capacity and inventory to inform field managers’ decisions to more effectively prioritize and assign inspectional resources. The tool is cloud-based, dynamic, and real-time to allow managers to effectively make decisions, and improve data quality without waiting for further iterations of an outdated decision tool.
A project supported by the: HHS Ignite Accelerator
Team Members
Chuck Hassenplug (Project Lead), FDA
Erica Pomeroy, FDA
Sarah Pichette, FDA
Mike Fesko, FDA
Stephen Manza, FDA
Leila Lackey, FDA
Michelle Bukowczyk, FDA
Damon Growl, FDA
Jamie Hughes, FDA
Milestones
May 2014: Project selected into the HHS Ignite Accelerator
June 2014: Time in the Accelerator began
September 2014: Time in the Accelerator ended
Project Sponsor
Katherine Bent, Assistant Commissioner for Compliance Policy, Office of Policy and Risk Management, Office of Regulatory Affairs (ORA), Food and Drug Administration (FDA)
