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What is the purpose of this Web page?
The validation page was developed to provide an information resource on validation to small and very
small meat and poultry establishments in order to help them obtain information to support the scientific
design of their HACCP systems.
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What is validation?
Validation is the process of demonstrating that the HACCP system as designed can adequately control
identified hazards to produce a safe product. There are two distinct elements to validation:
- The scientific or technical justification or documented basis for the system. This consists of having
scientific and technical documentation that demonstrate that the designed process can control the identified
hazard. In other words, will the HACCP work in theory?, and
- The initial practical demonstration proving the system can perform as expected. This consists
of having records which demonstrate the plan in operation, the HACCP plan achieves what is expected
to achieve. In other words, does the plan work in practice?
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What is the responsibility of the establishment?
The establishment is responsible for all aspects of developing and implementing the HACCP
plan including validation of the adequacy of the process that insures all food safety
hazards are under control. The following describes what validation is.
What is the HACCP regulatory requirement for validation?
Section 417.4 of the meat and poultry regulations requires that each establishment
validate the adequacy of its HACCP plans in controlling those food safety hazards
identified during the hazard analysis. The hazard analysis must have supporting
documentation for each step of a HACCP plan in order to show that the establishment
accounts for all hazards likely to occur. Specifically, the processing steps that reduce,
eliminate, or prevent food safety hazards - critical control points - and their
accompanying critical limits must be validated. Initial validation contains the recorded
documentation that shows that the HACCP plan functions as intended.
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What type of documentation does FSIS expect for validation?
The documentation assembled to validate a HACCP plan are usually of two types:
- HACCP design type of documentation: Theoretical principles, expert advice from processing
authorities, scientific data, or other information demonstrating that particular process control measures
can adequately address specified hazards, and
- HACCP execution type of documentation: In-plant observations, data, measurements, test results,
or other information demonstrating that the control measures, as written into a HACCP plan, can be
operated within a particular establishment to achieve the intended food safety objective.
Validation data for any HACCP plan must include some practical data or information reflecting an establishment's
actual experience in implementing the HACCP plan. This is because validation must demonstrate not only that the
HACCP plan is theoretically sound, but also that the establishment can implement it and make it work on a day
by day basis.
What are some examples of supporting documentation that may be used by the establishments to support the scientific
design or technical justification or documented basis for their HACCP system?
- Scientific journal articles or other published scientific literature;
- FSIS regulations, or regulatory performance standards;
- FSIS compliance guidelines;
- FSIS directives;
- Industry standards or surveys;
- Trade association guidelines;
- Pathogen modeling programs;
- Processing authority documents, instructions, or research;
- Written information from industry experts or consultants;
- University extension publications;
- In-plant studies, research or historical data;
- Written materials from equipment manufacturers.
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Validation by pathogen - Helpful scientific articles
The following is a listing of journal articles on various pathogens that provide
useful information to small and very establishments to validate the design of their HACCP
food safety system. These articles are representative, and are not intended to be all
inclusive.
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Validation by product and new technologies
Access this listing of journal articles on various products and new technologies. These articles are representative, and are
not intended to be all inclusive.
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Helpful Web Sites
Access a listing of Web sites that provide information useful to small and very establishments to
validate the design of their HACCP food safety system.
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Last Modified:
May 2, 2012 |
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