By Pamela Sweeten, Owner & Founder, P. Sweeten Consulting
Two cornerstones of FSMA’s final rule on Preventative Controls for Human Food are record keeping and sanitation. Food manufacturers and processors, along with companies importing goods into the U.S., are now being held to a much higher standard of sanitation, documentation, and compliance to better protect the health of the U.S. public.
Food Safety Records
It is not just that demand for record keeping has increased dramatically in scope, the FDA now has more legal authority to access and audit your records. This makes knowing and following the changes to Part 117 of the Current Good Manufacturing Practice (cGMP), Hazard Analysis and Risk-Based Preventive Controls (HARPC) for Human Food essential.
There are general requirements for all records that must be followed. All records must:
- Be kept as original or electronic records or true copies
- Contain factual observations and values
- Be legible, permanent, and accurate
- Must be done in real time
- Include the detail required to create a history of performed work
- Standard details including identifying the facility or plant, date/time of the activity being documented, signatures and initials of the person who performed the activity, and when applicable the identity and lot code of the product
Record Retention Requirements
- You must store and retain your records for a minimum of two years
- Any documentation relating to supporting the status of a facility as being a qualified facility should be kept as long as necessary to support the status of the facility
- Records that have been discontinued (records related to changes) must be kept for a minimum of two years
- Records, other than the Food Safety Plan, must be able to be present at the facility within 24 hours of being requested by an official for review.
- The Food Safety Plan may only be transferred to another accessible location only if the facility is closed for an extended period. The document still must be able to be obtained and given to an official at the facility within 24 hours of an official review request
Food Safety Plan
- Must be kept on-site at the plant or facility
- Upon completion of the food safety plan, the owner, operator, or agent in charge of the plant or facility is required to sign and date the plan. Any changes to the plan must also be signed and dated by this person of authority.
Three Categories Of Records To Keep
There are three categories of records you may need to keep, depending on your hazard evaluation. The records needing to be kept reflect the entire supply chain process and potential hazards from prior to receiving at the facility through to the customer carrying the product.
First are hazards controlled by the supplier (prior to delivery to the receiving facility). Once the hazard evaluation has been completed, if it is determined that a hazard will be controlled by the supplier, then a written supply chain program (or Foreign Supplier Verification Program for facilities that are importers) is required.
Documentation in this program includes but is not limited to:
- Approval of the supplier
- Supplier verification
- Sampling and testing
- Suppliers food and safety records
- Procedure for receiving ingredients and raw materials
- Reanalysis documentation
Next come hazards controlled at the receiving facility. If the receiving facility will control the hazards, then the receiving facility will be required to develop, implement, and document preventative controls.
Documentation requirements include, but are not limited to:
- Preventative control monitoring and verification of monitoring
- Any corrective measures that were taken and verification of actions taken
- Environmental monitoring
- Product testing
- Training documentation
- Reanalysis documentation
Finally, there are hazards controlled by the customer. If the receiving facility relies on a customer or another first receiver to control a hazard, then there are some records that must be developed and kept.
Documentation requirements include but are not limited to:
- Written disclosure (included in the food’s shipping documents) that an identified hazard was not controlled by the facility
- A written assurance (submitted annually) that contains the established procedures the customer must follow to prevent (or drastically reduce) the identified hazard
A large part of controlling hazards is creating sanitation regulations that will drastically reduce or prevent hazards before they can occur. The environment, equipment, and employees should all be part of the sanitation control solution. Sanitation controls should include:
- Food contact surfaces (including utensils, equipment, and food packaging)
- Food handling
- Cross contamination
- Food allergens
Sanitation can be costly, but you could lose so much more if your product quality or shelf life is affected by unsanitary facility conditions. The best sanitation departments audit their facility and then create a structure for consistency. When creating this structure, a facility should consider the type of soil that needs to be cleaned, what the chemical needs to do when used (dissolving, emulsification, wetting agents etc.), and the state of the plant’s water.
There are many products designed to properly manage each type of sanitation control. Depending on the type of food a facility is working with or the equipment utilized, the needs may be different. For example, facilities handling meat, poultry, or seafood should include in their sanitation controls antimicrobial treatments to maintain product quality and yield. And, depending on the type of conveyor a facility has, a wet or dry lubrication system is required to both lubricate and sanitize the conveyor.
Working with an experienced cleaning and sanitation company can ensure that a company’s unique needs are covered. Working with the sanitation department to identify the hazards, a sanitation company will implement a customized program and routinely test to ensure you are meeting food safety standards. These results should be kept in your records as evidence your facility has taken preventative measures and taken steps to control the environment.