Do small batch processors need a PCQI?
Are you a small batch operator? Do you need a Preventive Controls Qualified Individual (PCQI)?
If you are a small batch operator you may be under the impression that being small exempts your operation from some of the requirements of FSMA, like having a food safety plan developed by a PCQI. You may be right, but if you are wrong, it could cost you during an FDA inspection. Worse yet, a poorly designed food safety program developed without the proper expertise could lead to a recall or outbreak related to your product.
The regulation exempts very small businesses and qualified facilities from the requirement to have a PCQI-developed preventive controls food safety plan and a supply chain program as defined in the regulation. In 21 CFR 117.3, a very small business and a qualified facility are defined.
• A very small business is one that averages less than $1,000,000 in average annual sales plus product held without sale.
• A qualified facility is a facility that has less than $500,000 in average annual sales, and sells more than half of its product to qualified end-users (consumers, restaurants, or retail establishments in the same state or within 275 miles).
• Both of these definitions use values that are adjusted for inflation and averaged over 3 years.
• If this exemption is claimed, an attestation must be filed annually with the FDA on Form FDA 3942a.
Small batch bakeries may need a PCQI.
Small batch food manufacturers, despite their smaller scale of production, still need to comply with GMPs and training requirements in the regulation. They should also have robust food safety programs for other compelling reasons. Even small batches of food can pose significant risks if proper safety measures are not in place. Contamination, allergen cross-contact, and microbial growth can occur at any stage of production, from ingredient sourcing to packaging. In addition to satisfying the regulation, a PCQI-developed and implemented food safety plan ensures that these potential hazards are identified, mitigated, and monitored consistently, reducing the risk of foodborne illnesses and product recalls, and maintaining customer trust in your brand.
If you are a small batch operator who does not meet the definition of a qualified facility or very small business, consider the following steps to work towards compliance:
Verify your facility is properly registered and licensed with the FDA and with your state and local regulatory agencies.
Sign up for PCQI training, or consider hiring a food safety consultant to help you build your food safety plan.
Develop a preventive controls food safety plan that meets the requirements of 21 CFR 117 Subpart C.
Develop a supply chain program as defined 21 CFR 117 Subpart G.
Train your employees on good manufacturing practices and other relevant food safety topics.
Keep good records of all of the above activities!
Chocolate makers may need a PCQI.
