Using the flow diagram and description of the product as a guide, the HACCP team must conduct a hazard analysis of the process as the first step in the formal HACCP plan design. By definition, a hazard is a biological, chemical, or physical agent in, or condition of, food with the potential to cause an adverse health effect . The purpose of hazard analysis is to develop a list of hazards at each step of the process that are of such significance that they are reasonably likely to cause illness or injury if not effectively controlled. For fruit and vegetable component operations to which HACCP may be applied, these hazards may be introduced as inputs during the crop production process, during the plant process, or as outputs from the process and the final product. Consideration of the myriad of conceivable hazards that might contaminate fresh and processed fruit and vegetable products is not within the scope of this chapter. However, extensive listings of hazards have been reviewed [19,20,29]. Based on epidemiological data and industry experience, the primary safety issue in fresh-cut processing is microbiological contamination.
Hazard analysis consists of a two-part process: hazard identification and hazard evaluation. During hazard identification, the HACCP team generates a list of all potential hazards associated with each step in the process, by following the flow diagram. Brainstorming and Pareto diagrams are two problem-solving tools that can aid in this process. Brainstorming stimulates creative, exhaustive thinking that can help team members by identifying every conceivable hazard so that none are missed. Pareto diagrams allow the team to prioritize identified hazards based on their relative importance to safety .
Step two of hazard analysis is hazard evaluation. Each identified hazard must be carefully considered based on its severity in the extent of exposure and likely occurrence (risk) in a product. For example, Listeria monocytogenes and Clostridium botulinum are both potential microbiological hazards in the fresh-cut produce industry. However, L. monocytogenes, due to its ubiquity, is a greater health risk to consumers of fresh-cut produce, even though C. botulinum would be considered a more severe hazard based on mortality rates . Potential listeria contamination within the processing and/or storage environment of fruit and vegetable facilities is a constant threat to products since there is a zero tolerance regulation for this hazard in ready-to-eat (RTE) foods.
Another problem-solving tool, the cause-and-effect diagram, can be utilized to find ways to minimize environmental hazards such as listeria. Constructing a cause-and-effect diagram of a process requires the HACCP team to itemize all possible locations where a problem or hazard could occur, to look for all causes of a problem, and to collect data to evaluate the possible risk. A cause-and-effect diagram highlighting the processing environment as the possible source of listeria contamination to fruit and vegetable products would show the effect or problem (e.g., listeria contamination in a fresh-cut plant) at the end of a horizontal arrow or spine. Primary causes (e.g., poor sanitation in the processing room, produce cooler) are represented by oblique arrows entering the spine. Secondary causes (e.g., condensate on overhead pipes, electrical conduits, floors, in drains, and on refrigeration units) are represented by perpendicular arrows off the primary cause arrow .
An important component of hazard evaluation is risk assessment, which is defined as a scientifically based process of four activities: (1) hazard identification, (2) exposure assessment, (3) dose-response assessment, and (4) risk characterization. A comprehensive discussion of risk assessment with relationship to HACCP cannot be covered in this chapter, but excellent resources to consult include Tapia et al.  and Forsythe .
Once all potential hazards have been identified and their risks to the final consumer of the product evaluated, the HACCP team must consider what preventive measures are to be used to control the hazard. Preventive measures are those actions or activities that are required to control hazards, eliminate hazards, or reduce their effect to an acceptable level. More than one control may be required for a specific hazard that occurs at different parts of the production process. For example, if the hazard is Listeria monocytogenes on raw fruit or vegetables, which are consistently heat-treated in the in the manufacture of a processed juice, then pasteurization could be the appropriate control measure for this hazard. If the same hazard arises from environmental contamination during ingredient assembly of a refrigerated product which is given no heat treatment, such as fresh-cut produce, other control measures (environmental sanitation, personnel sanitation, refrigeration management) would be required.
It cannot be overemphasized that a thorough hazard analysis is essential to the design of an effective HACCP plan. If this is not done correctly, and the significant hazards requiring control within the plan are not properly identified and evaluated, the HACCP program will not be effective, regardless of how well the plan is followed .
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