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  • Improper Holding Temperatures

  • Contaminated Equipment

  • Poor Personal Hygiene.

The FDA manual, Managing Food Safety: A Regulator’s Manual for Applying HACCP Principles to Risk-based Retail and Food Service Inspections and Evaluating Voluntary Food Safety Management Systems (FDA’s Regulator’s Manual) (http://www.cfsan.fda.gov/~dms/hret3toc.html), provides additional information on conducting risk-based inspections. Annex 4 of the Food Code provides additional information on Hazard Analysis and Critical Control Point (HACCP) principles and the process approach to HACCP. It should be reviewed in conjunction with the material found in this Annex to better prepare for performing risk-based inspections.

The "Retail Food Program Resource Guide," a CD-ROM containing pertinent FDA documents referenced in this Annex, is available for use by federal, state, local, and tribal regulatory agencies. It is produced by and available through FDA Regional Retail Food Specialists or the FDA Division of Federal-State Relations (HFC-150); U.S. Food and Drug Administration; 5600 Fishers Lane, Room 12-07; Rockville, Maryland 20857; PHONE (301) 827-6906; (FAX) (301) 443-2143.



Inspections have been a part of food safety regulatory activities since the earliest days of public health. The term "routine inspection” has been used to describe periodic inspections conducted as part of an on-going regulatory scheme.

Program managers should strive to have adequate staffing and resources to allow all inspectors ample time to thoroughly evaluate establishments and ask as many questions as needed to fully understand establishments’ operations. For most jurisdictions, however, inspectors continue to have limited time in which to complete inspections. This does not negate the need to thoroughly identify and assess the control of foodborne illness risk factors during each inspection.

It is a false assumption that inspectors cannot conduct risk-based inspections in a limited timeframe. Even with limited time, inspectors can focus their inspections on assessing the degree of active managerial control an operator has over the foodborne illness risk factors. By focusing inspections on the control of foodborne illness risk factors, inspectors can be assured that they are making a great impact on reducing foodborne illness.

As described in Annex 4, active managerial control means the purposeful incorporation of specific actions or procedures by industry management into the operation of their businesses to attain control over foodborne illness risk factors. It embodies a preventive rather than reactive approach to food safety through a continuous system of monitoring and verification.

Annex 5 – Conducting Risk-based Inspections 510

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