A Food Safety Plan (FSP) consists of the primary documents in a preventive controls food safety system that provides a systematic approach to the identification of food safety hazards that must be controlled to prevent or minimize the likelihood of foodborne illness or injury.
It contains a collection of written documents that describes activities that ensure the safety of food during manufacturing, processing, packing, and holding (21 CFR 117.126).
The following written documents make up the FSP:
- Hazard analysis to identify whether there are hazards requiring a preventive control. This hazard analysis must be written, regardless of whether any hazards requiring a preventive control are identified. (Some facilities may not identify any hazards requiring a preventive control.)
- When the hazard analysis identifies hazards requiring a preventive control, the FSP also includes the following written documents:
Preventive controls including: * Process controls * Food allergen controls * Sanitation controls * Supply-chain controls * Recall plan * Other controls
Procedures for monitoring the implementation of the preventive controls, as appropriate to the nature of the preventive control and its role in the facility’s food safety system
Corrective action procedures, as appropriate to the nature of the hazard and the nature of the preventive control
Verification procedures, as appropriate to the nature of the preventive control and its role in the facility’s food safety system
A “preventive controls qualified individual” (PCQI) must develop (or oversee the development of) the FSP. A PCQI is a person with the education, training, or experience (or a combination of these) to develop and apply a food safety system. A PCQI can be qualified through job experience or by completing training equivalent to the standardized curriculum recognized as adequate by FDA (e.g., the Food Safety Preventive Controls Alliance (FSPCA) training). The PCQI does not need to be an employee of the facility. See 21 CFR 117.126(a) and the definition of PCQI in 21 CFR 117.3. The FSP must be signed and dated by the owner, operator or agent in charge of the facility when it is first completed and whenever the plan is modified (See 21 CFR 117.310.).
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