PCQI Training – What You Need to Know

Food Safety and Quality Services provides a comprehensive, FDA-recognized PCQI training program. The goal is to prepare attendees to take on the role of a preventive controls qualified individual (PCQI). The curriculum for this program was developed by the Food Safety Preventive Controls Alliance (FSPCA) with input from regulatory professionals, academics and industry leaders.

Successful completion of an FDA-approved PCQI training course prepares attendees to be qualified individuals. The FDA expects qualified individuals to develop and apply risk-based prevention protocols in order to process and hold food in a safe and clean manner. They may also be qualified through job experiences to oversee food safety programs. PCQIs must supervise or personally prepare a food facility’s comprehensive written food safety plan. They are also responsible for records reviews, and for ensuring that preventive efforts are sufficient to control any identified significant hazards.

The FDA’s Final Rule for Preventive Controls for Human Food created food-safety plan requirements for domestic and overseas facilities involved with processing, manufacturing, holding or packing food for consumption. A PCQI is expected to perform the following functions:

Improper documentation or oversight of the above requirements could result in a notice of violation from the FDA. So if your company must register under Section 415 of the Federal Food, Drug and Cosmetic Act, you are required to have an individual with PCQI training available to create and implement a food-safety program unique to your particular needs. There are some exceptions, as well as the possibility of modified standards, depending on the facility.

Taking an FDA-recognized training course provides prospective PCQIs with a certificate demonstrating that they have met federal training requirements, providing a straightforward pathway to qualification. In certain other instances, however, an employee may have equivalent experience that applies.  For instance, someone who has received Hazard Analysis Critical Control Point training and implemented a previous HACCP plan may be qualified through experience if they can develop and manage a comprehensive preventive controls program in compliance with the new rule.

The Preventive Controls for Human Food rule doesn’t prohibit companies from using a single PCQI at more than one location. There are also no restrictions on how far apart facilities must be under the direction of any individual PCQI. The regulations do mandate separate food-safety plans specific to each individual facility, and all of them must be prepared and overseen by a "qualified individual".

Signed into law in 2011, the Food Safety Modernization Act (FSMA) is designed to keep the food supply safe by shifting the focus of federal enforcement from responding to contamination toward prevention.

The Preventive Controls for Human Food rule is one of seven rules enacted as part of the FSMA. The rule expands upon previous HACCP principles by specifying that preventive controls be developed for all significant hazards, whether they are process-related hazards or those that were historically controlled by pre-requisite programs in HACCP plans.

Now, all identified significant hazards must be prevented by documented monitoring programs such as those used to document CCP’s in HACCP plans. Facilities are required to have PCQI’s who prepare and maintain food safety plans, and their PCQI training and/or experience must now exceed all existing Hazard Analysis Critical Control Point-based systems.

Experience on the job may qualify someone to perform the functions of a preventive controls qualified individual. Otherwise, the FDA mandates that a PCQI successfully complete training in the developing and applying of specific risk-based controls through a curriculum that is accepted by federal regulators.

Make sure your company has someone with proper PCQI training by scheduling one of our convenient face-to-face classes or in a blended online/in-person setting. View our list of upcoming FSMA Preventive Controls for Human Food classes or contact us today to request private training at your facility.