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Are You a “Qualified Individual” According to FSMA?

Denis Storey
December 17, 2019

On-Demand Webinar: “Recipe for a Successful PCQI Team”

Watch the Recording

On-Demand Webinar: “Recipe for a Successful PCQI Team”

Learn about the similarities and differences between HACCP and FSMA Preventive Controls and how to build a successful cross-functional team.

Watch the Recording

If you are a Food Safety and Quality Assurance (FSQA) professional, how do you know if you are "qualified" under the Food Safety Modernization Act (FSMA) to be involved in the development and oversight a food safety plan?

The Preventive Controls for Human and Animal Food rules, posted by the U.S. Food and Drug Administration (FDA) regulates compliance for the food supply chain. 

According to the FDA, qualified individuals must "successfully complete training in the development and application of risk‐based preventive controls at least equivalent to what is achieved through the standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety system."

The FDA, in association with the Food Safety Preventive Controls Alliance (FSPCA), coordinates with the Illinois Institute of Technology's Institute for Food Safety and Health, to offer standardized food industry training and education programs for Preventive Controls rules for human and animal food and Foreign Supplier Verification Programs (FSVP) compliance.

Though the FDA states, jobs or educational experience must be equivalent to PCQI curriculum developed by FSPCA. It is up to the individual to prove to an FDA Auditor/Inspector that the education and experience are equivalent to the FDA curriculum. The FDA recommends PCQI certification as the best method of determining compliance, as trying to prove one's qualifications without a certification can be subjective to the Inspector and might result in a non-conformance.

For many companies, this is simply too much risk. Course fees range from $800 to $1200 per student, a sound investment to obtain the certification to develop and implement a FSMA-compliant food safety plan. If your facility does not have a PCQI certificate (or several) hanging on the wall, you could be inviting additional scrutiny from the FDA.

What to Expect From Training?

PCQI training curriculum addresses the following:

PART 1: The Online Training course consists of 16 modules:

  1. Introduction to the FSPCA Human Food Course 

  2. Food Safety Plan Overview 

  3. Good Manufacturing Practices and 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 and Preventive Controls Determination 

  9. Process Preventive Controls

  10. Food Allergen Preventive Controls 

  11. Sanitation Preventive Controls 

  12. Supply-Chain Preventive Controls

  13. Verification and Validation Procedures 

  14. Record-Keeping Procedures 

  15. Recall Plans

  16. Regulation Overview 

PART 2: 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?

TraceGains regularly holds two-day PCQI workshops for employees to gain expertise and build its internal FSMA knowledge base. Our company's commitment to the food supply chain includes FSMA compliance for more than fifteen staff members, including our CEO, who all learned by walking a mile in our customers' shoes.

During the course, TraceGains' employees participate in exercises to craft food safety plans and conduct hazard analysis. Even employees with scientific backgrounds and years of experience working on a plant floor described the course as "essential" to understanding FSMA's regulations.

The instructor for the PCQI course was Lead FSMA Trainer, Nancy Scharlach of Soterian Systems. Nancy is the author of the hands-on workshop and uses the FDA-approved curriculum developed by FSPCA. The Soterian Systems course mixes textbook material, classroom discussion, and small group exercises to reinforce learning objectives. Scharlach leads students through real-life scenarios and problem-solving activities to boost their FSMA readiness. While the material presented in the course is highly technical, the way Scharlach delivers the training is enjoyable.

Where To Turn for PCQI Training?

TraceGains has experience working with food safety subject-matter experts who are conducting PCQI training in the U.S. and Canada and recommends Soterian Systems based in Denver as the training provider.

As a bonus, Soterian Systems is offering a special discount to friends of TraceGains. Use the coupon code "TRACEGAINS" when registering for a course on their website to receive $50 (USD) off. For more information, please contact Alicia Turner at Soterian Systems: at +1-303-593-2757 or

Want to get a sneak peek at Nancy's expertise? Hear 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." Watch the recording here.