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U.S. Department of Health and Human Services

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Risk Informed Algorithm

Description: Develop a risk informed algorithm based on FDA and State agreed upon risk criteria that will be utilized to prioritize high risk food inspections in FY 2011. By using a risk informed system, the FDA hopes to better target the use of the limited pool of inspection resources. The algorithm seeks to more systematically identify the firms of highest risk to public health and make them a high priority for inspection.

Accomplishment: The increasing complexities of the food supply, combined with resource constraints, require FDA to better utilize available information to improve its operational efficiency. Thus, FDA has taken steps to focus its activities to direct resources towards firms that present potential risk. The general framework is a risk scoring approach based upon inherent risk and compliance history. Inherent risk factors at the industry level include date from Class 1 recalls, national foodborne outbreaks, and adverse events. Weighted values were also assigned based on the firm's inspection history and whether FDA had not visited the establishment in some time. The project outcome is a public health decision-making tool from a qualitative and semi-quantitative approach to strengthen surveillance of food processing facilities. Although this project is completed, the risk-based algorithm will continue each year and be refined based on evaluations, feedback from stakeholders, and emerging public health issues. OC issues a brief description of the model on FDA's website, "FDA's Risk-Based Model for Prioritizing Inspections of Domestic Food Establishments At-a-Glance" - http://www.fda.gov/downloads/Food/GuidanceComplianceRegulatoryInformation/Compliance%20Enforcement/UCM227828.pdf

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date
A. Review FY09 Evaluation Results 3/1/2010
Completed 2/22/2010
B. Compile state input related to risk informed modeling 5/1/2010
Completed 4/19/2010
C. Select key factors and risk criteria to be used for defining factors, consider both State and FDA input 5/1/2010
Completed 4/28/2010
D. Weigh factors/criteria 6/1/2010
Completed 5/28/2010
E. Create a functional model and run relative risk ranking of OEI 8/1/2010
Completed 6/14/2010
F. Based on federal, state and other stakeholder input, catalog potential factors and risk criteria for future risk model iterations 9/12010
Completed 7/15/2010
G. Finalize and implement for the field 10/1/2010
Completed 8/6/2010

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.


Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.