Are You Playing Catch-up with Preventive Controls? 

 January 26, 2022

By  Rachel Montgomery

Three quick actions a company can take to become FSMA PC Compliant as fast as possible

1. Schedule PCQI training for yourself and key cross-functional personnel

PCQI stands for “Preventive Controls Qualified Individual” – a person required to conduct or oversee compliance with the Hazard Analysis and Risk-Based Preventive Controls Rules under FDA’s FSMA, either for Human Food (21CFR 117) or for Food for Animals (21CFR 507).  This individual is needed in every facility, domestic and foreign, that supplies food for consumption in the United States and is subject to the rule.

A facility’s PCQI is responsible for preparing a food safety plan using a systematic and risk-based approach to identify and consider the hazards related to a food or facility – biological, chemical, or physical, and existing in the process, related to food allergens (human food), requiring increased attention to sanitation, and/or controlled by a supplier – and determine which of those hazards require preventive controls to prevent food-borne illness or injury.  

Additionally, the PCQI is the individual who must perform or oversee validation of the preventive controls, the records review, and reanalysis of the Food Safety Plan and other activities as appropriate to the food and the facility.  Be sure you find an official course led by a Lead Instructor delivering the “Standardized Curriculum” developed by FSPCA and recognized by FDA.  

2. Enlist your entire Food Safety Team to move forward:    

An “all-hands-on-deck” approach is useful for many compliance activities and the Preventive Controls Rule is no exception.  Having those multiple cross-functional individuals trained as PCQI’s ensures the understanding needed to conduct a thorough hazard analysis, determining which hazards need a preventive control, and developing what are the most practical preventive controls.  Involving those individuals from different functional areas of the facility also brings about their buy-in, critical to implementation, as they will be training and leading their teams day-to-day in carrying out the GMPs, the Prerequisite Programs, and the Preventive Controls.  Day-to-day leadership and communication by those with knowledge and who have bought in to the Food Safety Plan transfer that feeling of ownership to all employees, creating a culture essential to food safety.

3. Use what you already have in place where possible:

Recognize and make use of your existing food safety program where it is already successful.  It’s not necessary to re-invent the wheel in coming into compliance with preventive controls.  For example, an existing HACCP plan can be included and transformed into a Hazard Analysis and Risk Based Preventive Controls plan, by considering the additional hazards called out by the FSMA rule and the additional types of controls beyond process CCPs.   

In summary: 

An effective approach results from involving those closest to the process and most knowledgeable about the process, the sanitation, the allergens which are used or may present cross contact concerns, the supply chain, and your customer’s use of the product.    With all of your key players trained as PCQIs, they can apply their existing knowledge and develop a practical approach.   After all, only a practical approach is going to be truly effective not only initially but long term, and that effectiveness will be obvious whenever FDA or a third-party auditor surprises you with an inspection.  It’s a comfort to know you are always ready for an audit, all the time and even more comforting to know that you are protecting your customers, consumers, and your business by preventing food safety problems.

About the author

Mrs. Montgomery is an FSPCA Lead Instructor for PCQI Human Food, PCQI Animal Food and Foreign Supplier Verification Programs (FSVP) courses with over 30 years experience as a food safety executive in large-scale manufacturing. Montgomery offers virtual training spread over multiple shorter days to fulfill the hours required yet allow team members more time to absorb the training and also stay in touch with their work teams. Montgomery is the Principal of Simple Compliance Solutions, LLC and a Registered Microbiologist (National Registry of Certified Microbiologists).

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