A start-up facility must have a basic food safety plan based on HACCP (Hazard Analysis and Critical Control Points) in place to meet current regulatory requirements. Any food processing facility must first register with the Food and Drug Administration (FDA) and assigned a site-specific FDA Registration Number.
The next requirement for implementing a food safety plan is to designate a HACCP Team Leader to develop a HACCP Plan based on 5 Codex methodology steps and 7 HACCP steps. The HACCP plan is required to be supported by developing PRP’s (Pre-requisite programs) such as GMPs (Good manufacturing practices) Preventive maintenance, Cleaning and sanitation, Allergen management, Training regarding the food safety plan – role based (new hire,, Environmental monitoring program, pest control, Control of Foreign Matter, Chemical Control, and Equipment Calibration, etc.
The food safety plan (or HACCP plan) must include a written hazard analysis that identifies and evaluates known or reasonably likely to occur hazards for each type of food manufactured, processed, packaged, or held at the facility. The hazard identification must consider biological, chemical, physical, and radiological hazards that may occur naturally or be unintentionally introduced.
The requirements for the implementation of the HACCP plan and food safety plan for the FSMA preventive controls are more or less similar. Hence, as an example, the FSMA PC food safety plan implemtation requirements are described below.
All food manufacturing facilities are required to comply with FSMA preventive control for human food by September 2019 (depending upon the FDA criteria set for timeline to meet compliance upon facility size, revenue, employee, etc.). The site is required to have a trained PCQI (Preventive Controls Qualified Individual) responsible for FSMA Preventive Controls Compliance. It is highly recommended that the individual receives formal training recognized by the FDA. The Preventive Control Qualified Individual (PCQI) will then plan, implement and manage a food safety plan, consisting of a hazard analysis and risk-based preventive control (HARPC).
Preventative controls such as Process preventive controls (similar to CCPs- Critical Control Points ) allergen preventive control, sanitation preventive control, supply chain preventive controls and a robust recall plan are required for a strong food safety plan. This will ensure all identified hazards are either eliminated, prevented or reduced to acceptable levels.
Among the Preventive controls required under the FSMA preventive control, an example of what each preventive control entails is provided. For example, the Allergen Preventive Controls are required to prevent allergen cross-contamination and accurate allergen labeling. Employee training on allergen control programs or allergen awareness is the key to a successful program. Allergen cleaning verification must also be conducted and monitored to ensure allergenic proteins are completely removed on shared equipment prior to processing non-allergenic products during a change-over.
A written traceability and recall plan is essential when food products are required to be recalled in the event of a food safety issue. An effective recall plan will help to quickly identify, contain and resolve the affected product during a recall; which in turn, reduces cost and protects the pubic health and safety. Recall plans must be tested annually to ensure that the plan is still valid and effective in the event of an actual recall.
Record keeping procedures are required for the food safety plan. Records for preventive controls, employee training, recalls, etc. must be maintained in order to prove food safety program is effectively implemented and maintained. The period for which records must be maintained depends on the perish ability of the food.