Tip of the Week - What does hazard documentation mean and how does one go about doing it?

Continuing to build on our FSMA tip of the week series, this week’s tip will be focusing on plant-specific hazard analysis. Next week we will cover additional documentation such as illness and recall data, FDA guidance documents, and other sources of information to support your hazard analysis conclusions.

We have identified and explained in previous Tips that a hazard means “any biological, chemical (including radiological), or physical agent that has the potential to cause illness or injury”, economically motivated adulteration (EMA) is included in this definition.
A written hazard analysis must document the severity of the illness or injury if the hazard were to occur, as well as the probability that the hazard will occur in the absence of an effective preventive control. Let’s evaluate your options for existing hazard documentation derived from your HACCP Plan, prerequisite programs, and plant history to help determine what preventive controls need to be considered.

Formulation of the food

Your raw material hazard analysis should already identify biological, chemical, and physical hazards. Who is controlling the identified hazards? If controlled with a process step, then that step will likely be a preventive control. If your supplier is controlling the hazard, you will use Subpart G – Supply Chain Program to document your evaluation and verification activities for that supplier. If you make a ready-to-eat (RTE) product where pathogens are a concern, then an evaluation for pH, water activity, antimicrobials, etc. should already be provided in your HACCP documentation.

Condition, function, and design of the facility and equipment

Knowing your food safety history of “what could or could not go wrong”, it is expected that your existing preventive controls would be evaluated to determine if specific operational activities and equipment/facility conditions impact the severity of that hazard in the absence of a documented preventive control. If you make RTE product, you will need a hazard analysis for environmental monitoring if your product is not protected or otherwise formulated to significantly reduce pathogens of concern associated with your product type. Your process hazard analysis is another way to identify known hazards.

Raw materials and other ingredients

This hazard evaluation should be readily available in your HACCP raw material hazard analysis, but there will be additional scrutiny on chemical hazards such as allergens, pesticides, drug residues, natural toxins, decomposition, and unapproved food colors/additives. If your supplier controls these hazards, there will be additional documentation per Subpart G – Supply Chain Program.

Storage/distribution and transportation practices

This hazard evaluation should already exist in your food safety specifications, HACCP plan and contracts for storage, distribution, and transportation. If yourproduct needs refrigeration to prevent pathogen or toxin growth, then those requirements would likely be a documented preventive controls that are already in effect.

Manufacturing/processing procedures

Processes that have a kill step may not have performed a formal validation study but facilities would likely have processing procedures and equipment capability history that confirms through finished product testing and/or equipment capability studies that the process is stable. Facilities using foreign material control devices (e.g., glass detection) would have similar hazard analysis capability. Historical data would not preclude a company from conducting a formal validation study where necessary due to the severity of the hazard.

Packaging activities and labeling activities

Companies would review internal controls in place for creating, approving, and modifying labels and label usage. Historical evidence for having an effective process in place and using the right label consistently will help identify preventive controls. If you purchase labels, particularly labels containing different allergens this would likely require a preventive control due to the severity of an undeclared allergen.

Intended or reasonably foreseeable use

The systems in place to ensure that all known uses of your product should be readily available in the facility’s HACCP plan. If your product could be used in a RTE application or consumed in a raw state, not be cooked, or prepared properly your hazard analysis must take this into account.

Sanitation, including employee hygiene

Most facilities have already determined which cleaning and employee hygiene requirements are critical for food safety such as allergen and pathogen controls. Your analysis of your capability to achieve these controls consistently will help you determine and prioritize your preventive controls.

Other relevant factors, such as the temporal (e.g. weather related) nature of some hazards

The facility would review historical evidence of having a higher incident of known hazards due to different weather conditions such as high humidity, hot weather, or other factors that could increase hazards due to plant environment conditions.

Next week, we’ll review additional external documentation that will help support your conclusions on what preventive controls you have chosen to put in place.

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