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?
Advance Your Career With PCQI Certification
How Avert Can Help
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.
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