Fee: $1,500 USD Each Plan
Food Safety Plan (FSP) Development Services
A Food Safety Plan (FSP) is the core component of a preventive controls food safety system and provides a structured, systematic approach to identifying and controlling food safety hazards. The purpose of an FSP is to prevent or significantly minimize the risk of foodborne illness or injury.
An FSP consists of a collection of written procedures and records that describe how food safety is ensured during the manufacturing, processing, packing, and holding of food products.
What Is Included in a Food Safety Plan?
A compliant Food Safety Plan typically includes:
Hazard analysis
Preventive controls
Monitoring procedures
Corrective actions
Verification activities
Recordkeeping requirements
Recall plan (when applicable)
These elements work together to demonstrate compliance with FDA preventive controls regulations under the Food Safety Modernization Act (FSMA).
Preventive Controls Qualified Individual (PCQI)
A Preventive Controls Qualified Individual (PCQI) must develop or oversee the development of the Food Safety Plan.
A PCQI is a person who has the education, training, experience, or a combination of these necessary to develop and implement a food safety system. PCQI qualification can be obtained through:
Relevant job experience, or
Completion of training equivalent to the FDA-recognized standardized curriculum
The PCQI does not need to be an employee of the facility and may be an external consultant.
Food Safety Plan Development Services
FDA Registration Assistance provides professional support for the development of FDA-compliant Food Safety Plans.
Our services help ensure:
Proper hazard identification and analysis
Preventive controls aligned with FDA requirements
Clear documentation for FDA inspections
Practical, facility-specific food safety systems
We work closely with your team or act as the external PCQI to guide the process efficiently and accurately.
To have FDA Registration Assistance assist you with the creation of a Food Safety Plan, please contact us today.
Frequently Asked Questions (FAQ)
What is a Food Safety Plan?
A Food Safety Plan is a written program required by FDA regulations that identifies food safety hazards and documents preventive controls to manage those hazards.
Who is required to have a Food Safety Plan?
Most food facilities subject to FDA preventive controls regulations must have a Food Safety Plan, unless an exemption applies.
What is a PCQI?
A PCQI is a Preventive Controls Qualified Individual responsible for developing or overseeing the Food Safety Plan.
Does the PCQI need to be an employee?
No. The PCQI may be an external consultant and does not need to be employed by the facility.
Is PCQI training required?
PCQI qualification may be achieved through job experience or by completing FDA-recognized training equivalent to the standardized curriculum.
Can FDA Registration Assistance act as the PCQI?
Yes. FDA Registration Assistance can serve as your external PCQI and assist with Food Safety Plan development and maintenance.
Does a Food Safety Plan need to be updated?
Yes. Food Safety Plans must be reviewed and updated when processes, products, ingredients, or hazards change.
Contact FDA Registration Assistance
Ensure your Food Safety Plan meets FDA preventive controls requirements.
