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NC State Extension

FSMA: Training Requirements

Training requirements are new to the industry and are a significant part of complying with the FSMA rules.

Use this page to learn more about what training you may need to comply with the rules. This page will also help you find training courses.

What’s the difference between a Qualified Individual and a Preventive Controls Qualified Individual?

Two of the Preventive Controls for Animal Food (PCAF) rule training requirements can be quite confusing. The rule requires that anyone who can have an impact on the safety of animal food (managers, operators, maintenance, drivers, etc.) be trained in the principles of animal food safety and personal hygiene as it relates to their job duties/description. These people are called qualified individuals. Qualified individual training is discussed in 21 CFR 507.14 Personnel and is inspected during Current Good Manufacturing Practice (CGMP) audits.

The second training requirement is for the people involved in writing or signing off on the completion of the food safety plan (FSP). The FSP and the requirements for a Preventive Controls Qualified Individual (PCQI) are described in 21 CFR 507.31 Food safety plan. The FSP is inspected during hazard analysis and risk-based preventive controls inspections.

Qualified Individual

Anyone who takes part in the process of producing animal food is required to be a qualified individual (QI). The FDA has not mandated any specific training to fulfill this requirement. It’s up to each establishment to document the training offered to employees and decide (and be able to defend) if it is “adequate” according to the rule.

By definition, a Qualified Individual is “a person who has the education, training, or experience (or a combination thereof) necessary to manufacture, process, pack, or hold safe animal food as appropriate to the individual’s assigned duties.”

A qualified individual may be, but is not required to be, an employee of the establishment. A qualified individual must also receive training on animal food hygiene and safety, including the importance of employee health and personnel hygiene as appropriate.

NC State Feed Milling Extension has launched an online training course for animal food safety. The course is free and should be used to supplement facility-specific training.

The Qualified Individual Training for Animal Food Safety course is intended for anyone who must comply with CFR 507.4: Qualifications of individuals who manufacture, process, pack, or hold animal food.

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Preventive Controls Qualified Individuals (PCQI)

A Preventive Controls Qualified Individual (PCQI) is a qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA, or is otherwise qualified through job experience to develop and apply a food safety system.

It’s important to remember that a PCQI for a facility is not required to be an employee of that facility, but it is highly recommended to have someone at the facility during an inspection who is prepared to answer questions about the food safety plan. Learn more about the PCQI’s responsibilities.

PCQI Training at NC State

PCQI training is offered at NC State University on an as-needed basis. If you’re interested in completing the course, please contact Marissa Herchler for more information or to be placed on an interest list.

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More FSMA training opportunities

There are additional FSMA training requirements and opportunities available through NC State Extension and FDA.

Foreign Supplier Verification Programs (FSVP)

NC State Extension offers Food Safety Preventive Controls Alliance (FSPCA) FSVP training through the Food, Bioprocessing and Nutrition Services (FBNS) department.

For more information about FSVP training at NC State, visit the NC FSMA Training Course Descriptions page.

Sanitary Transportation of Human and Animal Food

The FDA provides a free training course for carriers to meet the training requirements of the Sanitary Transportation of Human and Animal Food rule.

Access Training for Carriers covered by the Sanitary Transportation of Human and Animal Food Rule.

Be sure to save or print the certificate generated at the end of the training course. These documents are not maintained by the FDA. If certificates are lost, the training course will need to be completed again.

For additional information contact

Marissa Herchler
NC State University
Cooperative Extension Service
Prestage Department of Poultry Science
236 Scott Hall
Raleigh, NC 27695-7608

E-mail: marissa_herchler@ncsu.edu
Phone: +1 919.515.5396