Food Safety Plans
The Preventive Controls Rule requires food manufacturers to identify and minimize food safety hazards, implement and monitor control measures, conduct verification activities, and take corrective actions when deviations or issues occur. A Food Safety plan must include a Recall plan when significant hazards are identified.
- The U.S. Food and Drug Administration (FDA) requires most registered food facilities to create and implement Food Safety plans
- These plans must follow FDA’s Preventive Controls regulatory requirements:
- Other food safety systems, such as Hazard Analysis and Critical Control Points (HACCP) plans may not satisfy Preventative Controls requirements
- Food Safety plans must be written, implemented, and overseen by a Preventive Controls Qualified Individual (PCQI)
- Certain foods processed for U.S. consumption without a Food Safety plan may be considered noncompliant
Food Safety Plan Components
Hazard Analysis
- Process of collecting and evaluating information on hazards and their conditions to decide how they can be addressed through preventive controls.
- Facilities must also consider hazards that may be intentionally introduced for economic gain.
Preventive Controls
- Risk-based procedures, practices, and processes that any person qualified to manufacture, process, pack, or hold food products safely would employ to minimize or prevent potential identified hazards based on an up-to-date hazard analysis.
Supply Chain Program
- Procedures for evaluating suppliers, using approved suppliers, and determining and conducting supplier verification. Supply Chain Programs are required when there are significant hazards controlled by suppliers before products arrive at a manufacturer’s or processor’s facility.
- Manufacturers do not need a supply chain program for hazards they control at the facility, even if the supplier has applied a control.
Recall Plan
- Plan establishing procedures to notify appropriate parties of a recall, conduct effectiveness checks to verify recall implementation, and dispose of recalled products.
- A facility must develop a recall plan if it identifies a hazard requiring a preventive control.
Monitoring
- Written procedures for conducting checks at each preventive control step to assure the parameters or limits established for reducing, minimizing, or eliminating a significant hazard have been achieved.
Corrective Action
- Written procedures for steps that responsible individuals must take when a preventive control parameter or limit has not been achieved or a food safety issue is discovered.
Verification
- Written procedures and activities for checking that the control measures applied effectively controlled the hazards in the food.
- The most common verification is sampling and testing of the food.
Validation
- Obtaining and evaluating evidence that control measure(s) or the entire Food Safety plan can effectively control the identified hazards.
- Validation is not required for all preventive controls (e.g., sanitation controls).
Record Keeping
- The owner, operator, or agent in charge must approve (sign and date) the Food Safety plan once completed or when there is any modification.
- Documentation and any records associated with the components of the Food Safety plan must be maintained.
- FDA requires all related records to be kept for a minimum of two years.
Complying with FDA’s food safety standards can be challenging, but Registrar Corp is here to help. Our team of food safety PCQIs works with you to develop comprehensive Food Safety plans that meet current U.S. FDA regulations and help you achieve compliance.
Get Started
We Make Food Safety Compliance Easy.
Our Food Safety plan services include :
- A review of your current Food Safety plan(s) or HACCP plan(s)
- A Food Safety plan for the established product(s)
- One-on-one expert assistance from the qualified food safety specialist assigned to you
- A 2nd revision period of 30 days to ask questions and conduct one additional review of the drafted plan to incorporate corrections or changes
Registrar Corp assists food safety professionals quickly and efficiently with FDA compliance.
Frequently Asked Questions
In addition to the biological, chemical, and physical hazards often identified in HACCP plans, Food Safety plans must also consider :
- Radiological hazards
- Allergens
- Hazards requiring supply chain controls
- Hazards introduced for economic gain
While HACCP plans may apply process controls at critical control points, a Food Safety plan may also apply :
- Allergen controls
- Sanitation controls
- Supply chain controls
- Other preventive controls
A Food Safety plan as required by the Preventive Controls Rule also introduces components not addressed by HACCP. In their Food Safety plans, most facilities are required to establish :
- A Recall Plan
- A Supply Chain Program
