Generic HACCP Model for Thermally Processed Commercial

Now you are ready to develop your plant-specific HACCP plan(s) according to the
procedures shown in the generic process model(s).
Model Plan for Thermally Processed/Commercially Sterile
Hazard Analysis
Conducting an analysis of the physical, chemical, and biological hazards associated with
a process is a critical first step in the effective development and implementation of the plantspecific
HACCP plan. The information gathered should focus on addressing points of public
health significance associated with the manufacture of those products by a particular process used
in your plant. The hazard analysis must be conducted as a starting point in the development
of the plant-specific plan. Information for a hazard analysis can be obtained from a local
public library, community college or university library, the extension service, scientific
publications, FDA guidelines, USDA Guidebook for the Preparation of HACCP Plans and
Meat and Poultry Products Hazards and Control Guide, or other sources that are available
to the general public. It is important to include as much information as possible relevant
to the public health hazards associated with your process, including information on
suppliers performance at meeting public health related specifications, in-plant incidents
of contamination or adulteration, and product recalls. This will ensure that process hazards
are recognizable as you proceed through the remaining steps of creating the plant-specific
HACCP plan. An example of information needed for an analysis of the hazards associated with
a specific process follows on the next few pages. Included along with this information should be
your experience with, and knowledge of the process, and how it occurs in your plant.
There are a few important aspects to note when reviewing the information over the next
few pages. Every establishment should validate the HACCP plans adequacy in controlling the
food safety hazards identified during the hazard analysis, and should verify that the plan is being
effectively implemented. Each establishment should maintain records documenting the
establishment’s HACCP Plan, including references to all supporting documentation.
Epidemiological information is used to assess the public health significance of the known
hazards associated with the specific process. These include the types and severity of diseases and
injury caused by the occurrence of microbiological, physical, and chemical contamination. It also
will assist you when you are ready to use the decision tree to determine
the validity, existence, and appropriateness of a critical control point. This information can aid
in determining a significant hazard from an insignificant one based on the frequency, severity,
and other aspects of the risk.
The biological, chemical, or physical hazard information gathered will aid in determining
where a hazard may occur in the process, what could cause the hazard, how it can
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