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 (This document is also available in PDF (683 KB))

Additional copies are available from:
Office of Compliance
Division of Cooperative Programs (HFS-625)
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
(Tel) 301-436-2350

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
[April 2006]

Table of Contents

• Chapter 1 - Introduction
  • Purpose and Scope
  • Background
    • What are Foodborne Illness Risk Factors?
    • What is Meant by Active Managerial Control?
    • How are HACCP Principles Being Used in Retail and Food Service?
  • Summary
• Chapter 2 - Conducting Risk-Based Inspections
  • The Focus of Risk-Based Inspections
  • Setting the Example
  • Establishing Inspection Priorities
    • Establishing an Open Dialogue with the Person In Charge
    • Reviewing Previous Inspection Reports
    • Conducting a Menu/Food List Review
    • Conducting a Quick Walk-Through
  • Evaluating Existing Food Safety Management Systems
  • Determining Process Flows
  • The Hazard Analysis
  • Determining Risk Factors in Process Flows
    • Facility-wide Considerations
    • Food Preparation Process 1
    • Food Preparation Process 2
    • Food Preparation Process 3
  • Assessing Active Managerial Control of Risk Factors
  • Evaluating Basic Sanitation and Facilities
  • Summary
• Chapter 3 - Intervention Strategies
  • The Role of Intervention Strategies in Compliance and Enforcement
  • On-Site Correction
  • Determining the Appropriate On-Site Correction
    • Limitations of Reheating as an On-Site Correction
  • Long-Term Compliance
    • Equipment and Layout
    • Buyer Specifications
    • Recipe/Process Instructions
    • First-In-First-Out (FIFO)
    • Standard Operating Procedures (SOPs)
    • Risk Control Plans (RCPs)
    • Voluntary Food Safety Management Systems Based on HACCP Principles
  • Summary
• Chapter 4 - Reviewing Voluntary Food Safety Management Systems
  • Voluntary Food Safety Management System Based on HACCP Principles
  • Validation
  • Field Verification
  • The Verification Process
    • Step 1 - Document Review
    • Step 2 - Record Review
    • Special Considerations Regarding Records
    • Step 3 - On-Site Verification
    • Verification Report
  • Summary
• Glossary
• Annex 1 - References
• Annex 2 - Sample HACCP Tables
• Annex 3 - Hazard Analysis
• Annex 4 - Food Safety Questions
• Annex 5 - Sample Risk Control Plan
• Annex 6 - Suggested Intervention Strategies For Out-Of-Control Procedures
• Annex 7 - Verification Inspection Checklist
• Annex 8 - Paperwork Reduction Act of 1995