President, HACCP Consulting Group, L.L.C.

One of the most important activities in developing a HACCP plan is conducting a hazard analysis and preparing a list of biological, chemical and physical hazards that are reasonably likely to cause injury or illness if not effectively controlled in your operation. This is HACCP Principle No. 1.

A thorough hazard analysis is the key to preparing an effective HACCP plan. If a hazard analysis is not done correctly and the hazards needing control are not identified, the plan will not be effective regardless how well it is followed.

The process of conducting a hazard analysis involves two steps. The first step, hazard identification can be accomplished by the HACCP team through a brain storming session. During this session, the HACCP team reviews the ingredients used in the product, the activities conducted at each step in the process (referring to the flow diagram), the final product and its method of storage and distribution, and the intended use and consumers of the product. Based on the brain storming session, the HACCP team develops a list of potential biological, chemical and physical hazards which may be introduced, increased or controlled at each step in the process.

After the list of potential hazards has been developed, step two -- the hazard evaluation -- is conducted by the HACCP team. In this step, the HACCP team decides which potential hazards must

be addressed in the HACCP plan. During this activity, each potential hazard is evaluated based on the severity of the potential hazard and its likely occurrence in your operation. To fully evaluate the severity of a potential hazard, the HACCP team may have to rely on the opinion of experts who assist in the development of HACCP plans.

The HACCP team must also assess how reasonably likely each potential hazard could occur in your operation. For example, due to differences in equipment and/or the effectiveness of maintenance programs, the probability of metal contamination may be significant in one plant but not another. Only those hazards that are determined to be of such severity and reasonably likely to occur in your operation must be dealt with in the HACCP plan. (Where the HACCP team relies on Prerequisite Programs or Good Manufacturing Practices (GMPs) to address the remaining potential hazards or to consider a hazard not significant in their process, the team must ensure that these programs are well written, implemented, monitored and records maintained to document their effectiveness.) A summary of the HACCP team=s deliberations and the rationale developed during the hazard analysis must be kept for future reference. This information will be useful during future reviews and updates of the hazard analysis and the HACCP plan.

Upon completion of the hazard analysis, the hazards associated with each step in the process must be listed along with any measures to control the hazard. The term Acontrol@ is now being used since not all hazards can be prevented. This list will then assist the HACCP team in identifying where in the process best control of the hazard can be maintained (critical control point).