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Preventive controls


Preventive controls are steps that you, a domestic or foreign food facility, must take to reduce or eliminate food safety hazards.

If the hazard analysis identifies a hazard that requires a preventive control, you are required to develop and implement a control to significantly minimize or prevent the hazard.

Through FSMA, the FDA has basically stated that Prerequisite Program (PRPs) are now considered of equal importance as Critical Control Points (CCPs), clumping them all together and calling them preventive controls.

The rule outlines preventive controls and associated requirements that could include:

  • process controls

  • food allergen controls

  • sanitation controls

  • other controls

Process controls: procedures, practices, and processes to control parameters during operations. Examples of process controls are cooking and refrigeration, and product formulation. Associated requirements for process controls include, as appropriate, parameters (and minimum or maximum values) associated with the control of the hazard, monitoring, corrective actions, verification including validation as necessary, records.

Process preventive controls play an important role in a facility’s food safety plan since they are considered very critical for food safety. Process preventive controls (e.g., thermal processing, irradiation) result in significant reduction in potential food safety hazards and hence are often deemed CCPs (CCPs require establishment of critical limits) to reinforce the importance of their role in a facility’s food safety plan.

OPRPs are defined as a PRP that has a control measure that controls a significant hazard. PRP Control measures secured exclusively by preventive actions/universal procedures used to control the production environment.

Food allergen controls: procedures, practices, and processes to control allergen cross-contact within a facility and procedures to ensure all food allergens are correctly labelled. Associated requirements for food allergen controls include, as appropriate, monitoring, corrective actions, verification, and records

Sanitation Controls: procedures, practices, and processes to make sure the facility is maintained in a sanitary manner to control hazards such as environmental pathogens. Environmental monitoring is required if contamination of a ready-to-eat food with an environmental pathogen such as Listeria monocytogenes is a hazard requiring a preventive control. Associated requirements for sanitation controls include, as appropriate, monitoring, corrective actions, verification (including environmental monitoring for an environmental pathogen or appropriate indicator organism as necessary), and records See Control of Listeria monocytogenes in Ready-to-Eat Foods (Draft Guidance for Industry) https://www.fda.gov/RegulatoryInformation/Guidances/ucm073110.htm

Other Controls: preventive control procedures that are not process, food allergen, or sanitation controls, but are necessary to ensure that a hazard requiring a preventive control will be significantly minimized or prevented. Associated requirements for other controls include, as appropriate, monitoring, corrective actions, verification, and records.

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