Tip of the Week - Preventive Controls Sequel

Last week’s FSMA tip was about the definition of preventive controls. A part of the definition that created a lot of interest was the one that links the definition of preventive controls to the definition of a hazard requiring a preventive control. We thought it would be of interest to revisit the link between these two definitions and reflect on some practical applications.

Remember, the PC rule defines a hazard requiring a preventive control as: 

"a known or reasonably foreseeable hazard for which a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would, based on the outcome of a hazard analysis (which includes an assessment of the severity of the illness or injury if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls), establish one or more preventive controls to significantly minimize or prevent the hazard in a food and components to manage those controls (such as monitoring, corrections or corrective actions, verification, and records) as appropriate to the food, the facility, and the nature of the preventive control and its role in the facility's food safety system”.

In last week’s tip, we provided theoretical examples of what might become Preventive Controls, as related to the bolded part of the definition. Today we want to explore some specific ones, and what that would imply.

Defining a Preventive Control

We can start by asking, “is there a procedure/activity in the supply chain, allergen, or sanitation programs that if it were absent would lead to a recall?” Alternatively, is such procedure/activity “essential” for food safety? If the answers were YES then it would be wise to identify such procedures/activities as Preventive Controls.

For example, what activities in the allergen control program would lead to a recall if they were absent? I can think of at least two, namely allergen changeover cleaning and allergen label control at packaging. If either one of them was absent or if you have it, but not effectively implemented the probability of a failure would be “higher”, quite possibly resulting in a misbranded product subject to recall.

Sanitation Programs

In a similar manner, we could ask the same question about the sanitation program. Are there certain cleaning/sanitation activities/procedures that if not present or not effectively implemented, if present, would result in an adulterated product, say with a pathogen, and therefore subject to recall? Think about RTE foods as defined in the PC rule, which is defined as a food product, which is exposed to the manufacturing environment after a kill step before packaging, and does not have a product formulation lethal to pathogens. Do you have cleaning/sanitation SSOPs in that area of the food plant, which in their absence or ineffective implementation could lead to a recontamination of the product? If so, it would be wise to elevate such SSOPs to the level of Preventive Controls.

Supplier Control Program 

Similar questions can be asked about your current supplier control program, if the hazard analysis identifies a hazard requiring a preventive control and such control is applied before the product is received by your facility, i.e., the Preventive Control is applied by your supplier.

SSOPs and Preventive Controls

If such SSOPs are elevated to the level of a PC, the management elements will have to be reviewed to assure effectiveness and compliance. Personnel in charge of these new PCs will have to be trained accordingly to “demonstrate capacity to manufacture, process, pack and hold clean and safe food as appropriate to the individual’s assigned duties”. Similar, supervisors will have to be trained to be “qualified individuals” at that level to assure proper implementation of the management elements. Such training must be documented.


Finally, the PC rule states that allergen, sanitation and the supply-chain programs need not be validated. We should read such statement with reservation and reflection. Would it not be wise to validate the effectiveness of a cleaning/sanitation procedure, and allergen cleaning procedure, if elevated to the PC level?

Next week we will review the additional hazards considered under HARPC, discuss why they were included and how to approach their analysis.

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