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PCQI Certification

What it means and why you need one

Since the enactment of the 2011 Food Safety Modernization Act (FSMA), the focus of federal regulators has shifted from a reactive response to the proactive prevention of food contamination. Included in FSMA’s requirements is the need for every covered facility to have and maintain a food safety plan and the introduction of a Preventive Controls Qualified Individual (PCQI) to manage the plan. A covered facility, with few exceptions, is any facility that manufactures, processes, packs, or holds food for human consumption in the United States and is therefore required to register with the FDA under section 415 of the Food, Drug & Cosmetic Act. 

Companies choosing not to utilize a PCQI face regulatory action including fines and the issuance of a 483 form detailing the FDA’s findings that constitute violations of FDA regulations. A food safety plan created by an individual who hasn’t taken the appropriate curriculum or otherwise fulfilled the PCQI knowledge requirements, will in most cases not comply with the Preventive Controls for Human Food rule.

What is a PCQI? How does it differ from a HACCP professional? Does your facility need them, and if so, where should you start? Let’s explore these important questions.

What is a PCQI?

A Preventive Controls Qualified Individual(PCQI) is one who has successfully completed an FDA-approved training program for Preventive Controls for Human Food focused on the development and application of risk-based preventive controls, or who is otherwise qualified through work experience.

The following activities must be performed by an individual with PCQI certification:

  • Creating and managing a FSMA-compliant food safety plan
  • Validation of preventive controls ensuring they are implemented and effective
  • Reviewing records and reanalysis of the food safety plan periodically to ensure its efficacy

During FSMA-based FDA inspections, the FDA ensures one or more individuals with PCQI certification are associated with each covered facility. A quick review of the company’s food safety plan, validation, and reanalysis will reveal this.

Does My Company Need a PCQI?

The vast majority of companies require the use of a PCQI and this individual may be a company employee or a third-party. Each facility required to register with the FDA that manufactures, processes, packs, or holds human food must use at least one PCQI for activities required under 21 CFR Part 117 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food. A food safety plan created by an individual lacking PCQI certification will not only open the company up to regulatory actions and fines, but will likely miss the critical food safety elements and mitigation techniques detailed in the curriculum.

Farms and retail food operations are exempt from the rule and do not require the use of a PCQI.  A few other exemptions exist for small facilities and certain food products such as juice and alcohol. Check out 21 CFR 117 Subpart A for further details on exemptions.

What’s the difference between HACCP, HARPC and PCHF?

HACCP (Hazard Analysis Critical Control Point) programs focus on the production process and are based on one or more CCPs. HACCP is accepted and endorsed by CODEX as the eminent risk mitigation tool across the globe and used in a variety of industries including food manufacturing. HARPC is a term coined by regulators when developing the Preventive Controls for Human Food Rule (PCHF) and stands for Hazard Analysis Risk-Based Preventive Controls. While HACCP plans typically focus on production and so encompass most elements required under Production Preventive Controls, the PCHF rule requires applying a HACCP approach to other preventive controls including allergen, sanitation, and supply chain, based on the operation’s hazard analysis.

Advance Your Career With PCQI Certification

In today’s demanding job market, differentiating yourself with PCQI certification gives you the advantage over your job seeking peers. Beyond legal compliance, many companies champion the ideals of supporting and empowering employees with programs for continued professional development.  Taking Avert’s Preventive Controls for Human Food course is a great step to achieve this while further insulating your company from food safety issues such as outbreaks and recalls.  Having a few PCQIs on staff positions a company to have the best food safety plan possible, where multiple individuals and backgrounds are less likely to miss something and the collaboration typically produces a stronger, more developed plan.

How Avert Can Help

Avert offers HACCP and PCQI training courses to meet your specific needs. Our International HACCP Alliance recognized HACCP Design and Implementation course focuses on providing easy to understand steps for designing and implementing HACCP systems, and features interactive activities to provide practical, actionable knowledge of the HACCP process. Likewise, our FSPCA-developed Preventive Controls For Human Food Course meets all requirements to become a PCQI upon completion. Our experienced instructors break down the program and regulations in a meaningful way, using real-world examples and discussion to give substance to an often dry topic.  In addition to training, we can assist with a myriad of FSMA food safety challenges including plan creation, validation, reanalysis, and FDA inspections. Contact us today for onsite PCQI certification by one of our FSPCA empowered lead instructors or check out our PCQI Course page to see course options and  to register early before classes fill up!


Matthew McClure provides sound strategies that instill cost-effective methods for building robust food safety, operational and quality assurance programs. Along with a Bachelor of Applied Science in Microbiology from The University of Akron and an MBA in Finance from Louisiana State University, Matthew brings over 20 years of experience in the food safety industry to AVERT Food Safety Advisors. His knowledge spans many areas including FDA food processing facilities, USDA meat and poultry plants, dietary supplement manufacturers, retail, cannabis manufacturing, and food service operations.

Contact us for more information: | Tel: +1 702.706.6574

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