Food Safety Plan

What It Means

A food safety plan is a comprehensive written document required by the FDA's Preventive Controls for Human Food rule under FSMA. Every food facility registered with the FDA (with limited exemptions for very small businesses and certain low-risk activities) must develop and implement a food safety plan. The plan must be prepared or overseen by a Preventive Controls Qualified Individual (PCQI) — someone who has completed FDA-recognized training in food safety preventive controls. A food safety plan must include several key components: a hazard analysis that identifies known or reasonably foreseeable biological, chemical (including radiological), and physical hazards for each type of food manufactured, processed, packed, or held at the facility; preventive controls to significantly minimize or prevent the identified hazards, which may include process controls, food allergen controls, sanitation controls, supply-chain controls, and recall plans; monitoring procedures to ensure preventive controls are consistently performed; corrective action procedures to follow when preventive controls are not properly implemented; and verification activities to ensure the food safety plan is being followed and is effective. The food safety plan must be a living document that is reviewed and updated whenever there is a significant change in the facility's operations, products, or hazard analysis. The FDA reviews food safety plans during inspections and may issue warning letters or take other enforcement action if the plan is inadequate.