A Preventive controls qualified individual (PCQI) “means 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.”

In practice, a PCQI is essential in ensuring that a food processing facility’s preventive controls are effectively designed and implemented. They are responsible for preparing the Food Safety Plan, validating preventive controls, reviewing records, and reanalyzing the plan as necessary. Their expertise helps prevent food safety hazards and ensures compliance with FDA regulations, safeguarding public health.

Who needs the PCQI course?

While the list of FSMA’s new requirements is dense and varies greatly for some types of facility, one key change that applies to nearly all food companies is the introduction of a preventive controls qualified individual (PCQI). Not only does FSMA require facilities to have a food safety plan implemented by the deadline date of September 16, but the plan must be prepared and applied by a properly trained PCQI.

This means that food companies must ensure they have personnel who are either trained through an FDA-recognized standardized curriculum or have sufficient job experience to qualify as a PCQI.

The PCQI is responsible for developing and applying risk-based preventive controls, validating these controls, and overseeing their implementation and effectiveness within the food safety plan.

This requirement underscores the importance of proactive measures in food safety, shifting the focus from reactive responses to potential hazards to preventing them before they occur.

Ensuring that a qualified PCQI is part of the team is crucial for compliance and for maintaining high standards of food safety and public health protection.

FSMA and FSSC 22000

Many companies around the world have been motivated to implement a GFSI Certification Scheme as part of their preparation for FSMA. A common question is whether an FSSC 22000 certified company meets the FSMA requirements.
An initial comparison between FSMA and FSSC 22000 has been completed by the Acheson Group.

Preventive Controls for Human Food Training Course

This course, developed by FSPCA, is the “standardized curriculum” recognized by FDA; successfully completing this course is one way to meet the requirements for a PCQI. Your training certificate will be issued by the Association of Food and Drug Officials (AFDO).