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Preventive Controls Qualified Individual: The What, Who, Why and How

Denis Storey
June 16, 2021

On-Demand Webinar: Recipe for A Successful PCQI Team”

Watch the Recording

On-Demand Webinar: “Recipe For A Successful PCQI Team”

Learn the roles of a PCQI team and what your business needs to do to ensure you have a successful food safety plan.

Watch the Recording

The Food and Drug Administration’s (FDA) Hazard Analysis and Risk-based Preventive Control (HARPC) rule relies heavily upon tasks performed by a “Preventive Controls Qualified Individual” (PCQI). What is the purpose of a PCQI? Who are these individuals? Why are they so important? And how does an individual begin this journey? TraceGains examines all of these questions and more and provides the much-needed guidance to become PCQI Certified. 

What’s the Purpose of a PCQI?

A law exists within the FDA's Food Safety Modernization Act (FSMA) called the Preventative Controls for Human Food Regulation. The goal is to prevent foodborne illnesses through the safe preparation of food products for human consumption in the United States. This regulation requires food and beverage facilities to have at least one PCQI to lead the creation, application, and verification of risk-based preventative controls.

The FDA’s primary concern is that food facilities have one or more certified individuals on staff who hold the technical knowledge to make their food products and understand the processes to identify, evaluate, and control any associated risk.

A PCQI is critical to a company’s overall food safety program. The FDA will most likely want to hear from the PCQI if the agency ever has questions or concerns about its safety program or products’ adequacy. If a consumer ever claims harm by a company’s products, the PCQI will play a critical role in representing the organization, resolving the claim, and, if necessary, defending the company in a civil lawsuit.

What does it mean to become PCQI Certified?

Defined by the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation 117.3, a PCQI is a qualified individual who has 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.”

What are the Responsibilities of a PCQI?

Once an individual achieves PCQI certification, they’re responsible for performing or overseeing the following tasks:

  • Preparation of the food safety plan.

  • Validation of the preventive controls.

  • Review of records.

  • Reanalysis of the food safety plan.

How Does Someone Become PCQI Certified?  

The Food Safety Preventive Controls Alliance (FSPCA) is a collaboration among federal and state regulatory officials, academic food safety researchers from the Illinois Institute of Technology, educators, and U.S. food industry representatives. It develops the “standardized curriculum” that the FDA will require for PCQIs. 

Two components are required to obtain certification, an online course and an instructor-led course. Completion of the online course expires after six months, and the Instructor-led course must be completed six months from the completion date of the online course. Let’s examine both courses.

Part 1 – Online Training 

The online training consists of 16 modules:

  1. Introduction to the FSPCA Human Food Course 

  2. Food Safety Plan Overview 

  3. Good Manufacturing Practices & Other Prerequisite Programs 

  4. Biological Food Safety Hazards 

  5. Chemical, Physical, and Economically Motivated Food Safety Hazards 

  6. Preliminary Steps in Developing a Food Safety Plan 

  7. Resources for Preparing Food Safety Plans 

  8. Hazard Analysis & Preventive Controls Determination 

  9. Process Preventive Controls

  10. Food Allergen Preventive Controls

  11. Sanitation Preventive Controls 

  12. Supply-Chain Preventive Controls

  13. Verification & Validation Procedures 

  14. Record-Keeping Procedures

  15. Recall Plans

  16. Regulation Overview 

Part 2 – Instructor-Led Training  

The Instructor-led training course reviews materials from the online course and requires participation in real-world exercises that apply the knowledge collectively gained.  

Where Do I Sign Up?

Before you sign up for a certification course, take a moment to learn from Nancy Scharlach of Soterian Systems about building a successful PCQI team. Nancy’s invaluable real-world experience is on display in our on-demand webinar, “Recipe for a Successful PCQI Team – Building a Food Safety Plan.” Watch the recording here