Process Control in the Food Industry: The FDA’s 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
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
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 CPP 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
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
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