Process Control in the Food Industry: The FDAs HACCP

Approach1
The 1993 outbreak of food borne illness caused by the E. coli O157:H7 pathogen focused
the attention of the public, the Congress, and USDA on the fact that the common system
of meat and poultry inspection based on visible detection did not address the major cause
of food borne illness, which is invisible pathogens. Traditionally, industry and regulators
have depended on spot-checks of manufacturing conditions and random sampling of final
products to ensure safe food. This approach, however, tends to be reactive, rather than
preventive. New challenges to the U.S. food supply have prompted FDA to consider
adopting a new approach, called HACCP (pronounced has-sip). HACCP stands for
Hazard Analysis and Critical Control Points. It is a system of process control that was
developed jointly between Pillsbury and the National Aeronautic and Space
Administration to reduce the risk of microbial contamination during space travel, and has
been adopted in many industries.

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. It is similar to failure mode and effect analysis in that it considers
how failures (hazards) may occur, where they are likely to occur, and how they might be
prevented or mitigated.

HACCP involves seven principles:

1. Analyze hazards. This usually begins by mapping the manufacturing process

using a process map or flowchart to clearly identify all possible control points.
Potential hazards associated with a food and measures to control those hazards are
identified. The hazard could be biological, such as a microbe; chemical, such as a
toxin; or physical, such as ground glass or metal fragments.

2. Identify critical control points (CCPs). These are points in a food's production--
from its raw state through processing and shipping to consumption by the
consumer--at which the potential hazard can be controlled or eliminated.
Examples are cooking, cooling, packaging, and metal detection.
 3. Establish preventive measures with critical limits for each control point.
Critical limits define the operating range of a CCP in which the process yields an
acceptable product. For a cooked food, for example, this might include setting the
minimum cooking temperature and time required to ensure the elimination of any
harmful microbes.

4. Establish procedures to monitor the critical control points. Such procedures

might include determining how and by whom cooking time and temperature
should be monitored. This information is carefully documented.

5. Establish corrective actions to be taken when monitoring shows that a

critical limit has not been met--for example, reprocessing or disposing of food if
the minimum cooking temperature is not met. Corrective actions define
predetermined responses to lack of control.

6. Establish procedures to verify that the system is working properly--for

example, testing time-and-temperature recording devices to verify that a cooking
unit is working properly. Such auditing is necessary to insure the effectiveness of
the procedures that have been implemented.

7. Establish effective record keeping to document the HACCP system. This

would include records of hazards and their control methods, the monitoring of
safety requirements and action taken to correct potential problems. Each of these
principles must be backed by sound scientific knowledge: for example, published
microbiological studies on time and temperature factors for controlling food borne
pathogens.

HACCP is designed for use in all segments of the food industry from growing,
harvesting, processing, manufacturing, distributing, and merchandising to preparing food
for consumption. Food safety systems based on the HACCP principles have been
successfully applied in food processing plants, retail food stores, and food service
operations. The HACCP principles have been universally accepted by government
agencies, trade associations and the food industry around the world. HACCP offers a
number of advantages over the traditional system. Most importantly, HACCP:

focuses on identifying and preventing hazards from contaminating food

 is based on sound science

permits more efficient and effective government oversight, primarily

because the record keeping allows investigators to see how well a firm is
complying with food safety laws over a period rather than how well it is
doing on any given day

places responsibility for ensuring food safety appropriately on the food

manufacturer or distributor

helps food companies compete more effectively in the world market

reduces barriers to international trade.

1
U. S. Food and Drug Administration, U. S. Department of Agriculture, National Advisory Committee on
Microbiological Criteria for Foods, HAZARD ANALYSIS AND CRITICAL CONTROL POINT PRINCIPLES
AND APPLICATION GUIDELINES, Adopted August 14, 1997; and Food Safety and Inspection Service, United
States Department of Agriculture, Washington, D.C. 20250, HACCP Questions And Answers/Hazard Analysis
And Critical Control Point (HACCP) Systems, January 1998