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Annex

5

Conducting Risk- based Inspections

  • 1.

    PURPOSE AND SCOPE

  • 2.

    RISK-BASED ROUTINE INSPECTIONS

  • 3.

    WHAT IS NEEDED TO PROPERLY CONDUCT A RISK-BASED

INSPECTION?

  • 4.

    RISK-BASED INSPECTION METHODOLOGY

  • 5.

    ACHIEVING ON-SITE AND LONG-TERM COMPLIANCE

  • 6.

    INSPECTION FORM AND SCORING

  • 7.

    CLOSING CONFERENCE

  • 8.

    SUMMARY

  • 1.

    PURPOSE AND SCOPE

This Annex provides regulatory program managers and front-line inspection staff with guidance on planning, scheduling, conducting, and evaluating risk-based inspections. The draft FDA’s Recommended National Retail Food Regulatory Program Standards (Program Standards) (revised April 2003) (http://www.cfsan.fda.gov/~dms/ret-toc.html) provide additional recommendations to assist regulatory program managers in the planning and development of a risk-based inspection program.

The primary focus of this Annex is to provide inspectors with methods for conducting risk-based inspections. Various strategies that can be used by regulatory professionals to assist operators in achieving active managerial control of foodborne illness risk factors are also included in this Annex.

As presented in Annex 4, the Centers for Disease Control and Prevention (CDC) Surveillance Report for 1993-1997, “Surveillance for Foodborne Disease Outbreaks – United States” (http://www.cdc.gov/mmwr/preview/mmwrhtml/ss4901a1.htm) identifies the most frequently reported contributing factors to foodborne illness. Five of these broad categories of contributing factors directly relate to food safety concerns within retail and food service establishments and are collectively termed by the FDA as “foodborne illness risk factors.” These five broad categories are:

  • Food from Unsafe Sources

  • Inadequate Cooking Annex 5 – Conducting Risk-based Inspections 509

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