HACCP Principles & Application Guidelines FDA
HACCP Principles & Application Guidelines FDA
HACCP Principles & Application Guidelines FDA
TABLE OF CONTENTS
EXECUTIVE SUMMARY
DEFINITIONS
HACCP PRINCIPLES
Introduction
Prerequisite Programs
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APPENDIX B - Example of a flow diagram for the production of frozen cooked beef patties.
APPENDIX D - Examples of how the stages of hazard analysis are used to identify and
evaluate hazards
EXECUTIVE SUMMARY
The National Advisory Committee on Microbiological Criteria for Foods (Committee)
reconvened a Hazard Analysis and Critical Control Point (HACCP) Working Group in 1995.
The primary goal was to review the Committee's November 1992 HACCP document,
comparing it to current HACCP guidance prepared by the Codex Committee on Food
Hygiene. Based upon its review, the Committee made the HACCP principles more concise;
revised and added definitions; included sections on prerequisite programs, education and
training, and implementation and maintenance of the HACCP plan; revised and provided a
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The Committee again endorses HACCP as an effective and rational means of assuring food
safety from harvest to consumption. Preventing problems from occurring is the paramount
goal underlying any HACCP system. Seven basic principles are employed in the development
of HACCP plans that meet the stated goal. These principles include hazard analysis, CCP
identification, establishing critical limits, monitoring procedures, corrective actions,
verification procedures, and record-keeping and documentation. Under such systems, if a
deviation occurs indicating that control has been lost, the deviation is detected and
appropriate steps are taken to reestablish control in a timely manner to assure that
potentially hazardous products do not reach the consumer.
In the application of HACCP, the use of microbiological testing is seldom an effective means
of monitoring CCPs because of the time required to obtain results. In most instances,
monitoring of CCPs can best be accomplished through the use of physical and chemical tests,
and through visual observations. Microbiological criteria do, however, play a role in verifying
that the overall HACCP system is working.
The Committee believes that the HACCP principles should be standardized to provide
uniformity in training and applying the HACCP system by industry and government. In
accordance with the National Academy of Sciences recommendation, the HACCP system
must be developed by each food establishment and tailored to its individual product,
processing and distribution conditions.
The Committee designed this document to guide the food industry and advise its sponsoring
agencies in the implementation of HACCP systems.
DEFINITIONS
CCP Decision Tree: A sequence of questions to assist in determining whether a control point
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is a CCP.
Control Measure: Any action or activity that can be used to prevent, eliminate or reduce a
significant hazard.
Control Point: Any step at which biological, chemical, or physical factors can be controlled.
Critical Control Point: A step at which control can be applied and is essential to prevent or
eliminate a food safety hazard or reduce it to an acceptable level.
Critical Limit: A maximum and/or minimum value to which a biological, chemical or physical
parameter must be controlled at a CCP to prevent, eliminate or reduce to an acceptable level
the occurrence of a food safety hazard.
HACCP: A systematic approach to the identification, evaluation, and control of food safety
hazards.
HACCP Plan: The written document which is based upon the principles of HACCP and which
delineates the procedures to be followed.
HACCP Team: The group of people who are responsible for developing, implementing and
maintaining the HACCP system.
Hazard: A biological, chemical, or physical agent that is reasonably likely to cause illness or
injury in the absence of its control.
Hazard Analysis: The process of collecting and evaluating information on hazards associated
with the food under consideration to decide which are significant and must be addressed in
the HACCP plan.
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Step: A point, procedure, operation or stage in the food system from primary production to
final consumption.
Validation: That element of verification focused on collecting and evaluating scientific and
technical information to determine if the HACCP plan, when properly implemented, will
effectively control the hazards.Verification: Those activities, other than monitoring, that
determine the validity of the HACCP plan and that the system is operating according to the
plan.
HACCP PRINCIPLES
HACCP is a systematic approach to the identification, evaluation, and control of food safety
hazards based on the following seven principles:
HACCP is a management system in which food safety is addressed through the analysis and
control of biological, chemical, and physical hazards from raw material production,
procurement and handling, to manufacturing, distribution and consumption of the finished
product. For successful implementation of a HACCP plan, management must be strongly
committed to the HACCP concept. A firm commitment to HACCP by top management
provides company employees with a sense of the importance of producing safe food.
HACCP is designed for use in all segments of the food industry from growing, harvesting,
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