FDA Logo U.S. Food and Drug AdministrationCenter for Food Safety and Applied Nutrition
U.S. Department of Health and Human Services
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CFSAN/Retail Food Safety Team
DRAFT: February 28, 1998; DRAFT: April 24, 2001; DRAFT: June 28, 2001; DRAFT: April 2003; DRAFT: January 2005; DRAFT: December 2007

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Draft Voluntary National
Retail Food Regulatory Program Standards


standard 3
inspection program based on haccp principles

This standard applies to the utilization of HACCP principles to control risk factors in a retail food inspection program.

Requirement Summary

An inspection program that focuses on the status of risk factors, determines and documents compliance, and targets immediate- and long-term correction of out-of-control risk factors through active managerial control.

Description of Requirement

Program management:

  1. Implements the use of an inspection form that is designed for:
    1. The identification of risk factors and interventions.
    2. Documentation of the compliance status of each risk factor and intervention (i.e. a form with notations indicating IN compliance, OUT of compliance, Not Observed, or Not Applicable for risk factors)
    3. Documentation of all compliance and enforcement activities and
    4. Requires the selection of IN, OUT, NO, or NA for each risk factor.
  2. Develops and uses a process that groups food establishments into at least three categories based on potential and inherent food safety risks.
  3. Assigns the inspection frequency based on the risk categories to focus program resources on food operations with the greatest food safety risk.
  4. Develops and implements a program policy that requires:
    1. On-site corrective actions* as appropriate to the type of violation.
    2. Discussion of long-term control** of risk factor options, and
    3. Follow-up activities.
  5. Establishes and implements written polices addressing code variance requests related to risk factors and interventions.
  6. Establishes written polices regarding the verification and validation of HACCP plans when a plan is required by the code.

Outcome

The desired outcome of this standard is a regulatory inspection system that uses HACCP principles to identify risk factors and to obtain immediate- and long-term corrective action for recurring risk factors.

Documentation

The quality records needed for this standard include:

  1. Inspection form that requires the selection of IN, OUT, NO, or NA,
  2. Written process used for grouping establishments based on food safety risk and the inspection frequency assigned to each category,
  3. Policy for on-site correction and follow-up activities,
  4. Policy for addressing code variance requests related to risk factors and interventions,
  5. Policy for verification and validation of HACCP plans required by code, and
  6. Policy requiring the discussion of food safety control systems with management when out of control risk factors are recorded on subsequent inspections.
*Note: On-site corrective action as appropriate to the violation would include such things as:
  1. Destruction of foods that have experienced extreme temperature abuse,
  2. Embargo or destruction of foods from unapproved sources,
  3. Accelerated cooling of foods when cooling time limits can still be met,
  4. Reheating when small deviations from hot holding have occurred,
  5. Continued cooking when proper cooking temperatures have not been met.
  6. Initiated use of gloves, tongs, or utensils to prevent hand contact with ready-to-eat foods, or
  7. Required hand washing when potential contamination is observed.
**Note: Long-term control of risk factors requires a commitment by managers of food establishments to develop effective monitoring and control measures or system changes to address those risk factors most often responsible for foodborne illness. Risk control plans, standard operating procedures, buyer specifications, menu modification, HACCP plans and equipment or facility modification may be discussed as options to achieve the long-term control of risk factors.
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