By far, I think the biggest challenge in setting up a HACCP plan is the hazard analysis. It takes a lot of time and team collaboration to really put a good one together. You want to do a good job here because the hazard analysis will be the basis for identifying and managing your critical control points (CCPs).

The purpose of hazard analysis is to identify all the potential hazards that may be introduced or increased in the process, resulting in significant health risk to the consumer. The process also gives the HACCP team an opportunity to identify flaws in the process flow that needs to be addressed in order to adequately keep all significant hazards in check.

That said, a thorough knowledge of the entire process and ingredients is needed. As the team reviews each hazard, they have to consider a number of questions. For example, the type of ingredients used, characteristics of the ingredients (physical, chemical and microbial), each processing step, equipment and facility design, packaging type, sanitation procedures, employee health and hygiene, storage conditions, the intended use, and the intended consumer. The FDA’s HACCP Principles and Applications Guidelines provide an excellent outline of questions to consider when conducting a hazard analysis.

The hazard analysis consists essentially of two phases. There is the hazard identification phase and the hazard evaluation phase. In hazard identification, the hazards are simply listed for each ingredient and process step. In hazard evaluation, the identified hazards are assessed to determine their significance and control.

Hazard Identification

Hazard identification is a brainstorming process to identify the hazards that are associated with each step of the process, whether they are introduced or increased at the process step. A common practice in listing hazards during this phase of the hazard analysis is to simply note “physical hazard”, or “pathogens” as a descriptor for hazard type. Don’t be surprised if you see many hazard analysis documents filled out like this. However, it is better to be more specific as to the particular hazard that is being identified. Is the “physical hazard” glass, metal, plastic or stone etc? Depending on the hazard type, a different control measure may be required. For example, a metal detector will be effective in removing metal but will not remove glass, plastic or stone. Other control measures would be required for these. Likewise, different pathogens will need different control strategies depending on their unique characteristics such as susceptibility to heat/time treatment, pH, vacuum, preservatives etc. This is where a fair knowledge of basic food chemistry, food composition and food microbiology are essential for the team.

Luckily there are many resources available to get you up-to-speed with the basic knowledge if you are willing to learn. For example, the Bad Bug Book published by the FDA is an excellent resource to start becoming familiar with pathogenic microorganisms and toxins..

Hazard Evaluation

Listing all your hazards can be a tedious process but essential before moving forward. If you overlook significant hazards you are less likely to implement the controls that will be required to eliminate or reduce them to a safe level. Hazard evaluation is where you will determine if the hazards you have identified are significant. This is important because you don’t want to spend time trying to figure out how to control hazards that will pose little or no risk.

You want to use your time focusing on the ones that are more important. So how do you know if a hazard is significant? A hazard is significant if it meets two criteria. First, it must be reasonable likely to occur and pose serious threat of injury, illness or death. If the hazard is a serious threat but not likely to occur, you shouldn’t worry about it. Simply noting that the hazard is not significant, with an acceptable justification is adequate. If the hazard is likely to occur but will not cause any serious injury, don’t worry about it either. However once both criteria are met, i.e. the hazard poses a serious threat, and is likely to occur, you cannot ignore it. You must deal with the hazard by identifying how it will be controlled and indicate if the measure is a CCP. Determining CCP status can be done using a CCP Decision Tree.

Be aware though, that whether you decide the hazard is significant or not, you must provide a justification to support your decision. The decision is not always clear cut, so the following is a guide to help you out.

A hazard may be deemed LIKELY to occur if:

  1. There are no prerequisite programs to adequately control the hazard
  2. Even in the presence of prerequisite programs, this hazard would still not be adequately controlled
  3. Validated scientific studies have shown a strong association with the raw material and the hazard e.g. salmonella on chicken
  4. Historical plant records show frequent occurrence of the hazard
  5. There have been recent food safety outbreaks associated with the hazard
  6. The process step will not adequately remove the hazard or will cause it to increase

A hazard may be deemed NOT LIKELY to occur if:

  1. Prerequisite programs have been found to adequately control the hazard
  2. Historically, even without controls the food establishment has not found the hazard
  3. The hazard is present in insignificant amounts that is not likely to cause injury
  4. Equipment are in place to control the hazard e.g. screens or filters

Just a note on prerequisite programs before I go. Make sure that if you use “prerequisite programs” as your justification for not considering a hazard to be significant, that the prerequisite program is adequate to control the hazard. For example, a mistake would be to assume that because you have an equipment preventative maintenance program, that you don’t need to consider metal as a significant physical hazard in your meat grinding operation. That would be an error because even in the place of preventative maintenance, you are still likely to have metal as a significant hazard due to metal-to-metal contact and moving parts. I am saying this to say, just be careful not to use “prerequisite programs” as an exit strategy to dodge having to establish hazard controls.

Courtney Simons
Courtney Simons is a food science professor. He holds a BS degree in food science and a Ph.D. in cereal science from North Dakota State University.
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