These regulations are subject to audit by federal regulators.  Let AMERICAN FOOD SAFETY SERVICES be your training and consulting center to help develop and implement practical steps to ensure you are compliant with the new federal regulation.

Upon completion of our course, you meet the requirements as an FSPCA Preventive Controls Qualified Individual (PCQI) with the Hazard-Analysis and Preventive Controls Rule of the US Food and Drug Administration (21 CFR 117)

Requirements of the new regulations include distinctive characteristics for Preventive Controls that differ from HACCP food safety plans in important ways. 




In August 2016, federal regulations required manufacturers, sellers, or distributors of food to implement food safety controls for products for human consumption. Nearly every company that handles or produces food must comply with the regulation unless your company is involved with seafood, juice products, low acid canned foods, meat, or poultry.

These new regulations are part of the Food Safety Modernization Act (FSMA) of 2011 that is now final. They requires certain activities involved with selling or distributing food to be completed by a “preventive controls qualified individual (s)”. These individuals are those that have “successfully 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 be otherwise qualified through experience to develop and apply a food safety system”.  Because of shift requirements, multiple manufacturing lines, and verification activities required under the new law, it is essential that there be more than one trained preventive controls qualified individual at each facility.

In addition, facilities impacted by FSMA are required to see that all other food handlers at the facility also meet the requirements of a “qualified individual”. This is a separate requirement from the preventive controls qualified individual, and applies to all employees engaged in handling and processing activities that can impact food safety. A “qualified individual” is a person who often reports directly or indirectly to a preventive controls individual. Such qualified individuals must have the education or experience to manufacture, process, pack or hold clean and safe food as appropriate to the individual assigned duties. 

Our trainer, Dr. Larry Hood, is accredited by FSPCA, AFDA & IFSH as a Lead Instructor for the required FSMA Preventive Controls for Qualified Individual Workshop. The preventive controls workshop is 2.5 days as necessitated by the recognized curriculum. We have scheduled public workshops and on-site preventive controls qualified individuals workshops.  The qualified individual workshop for general employees is generally 1.5 days in length if offered on-site at individual food companies.  

American Food Safety Services is a certified training center approved to offer the FDA recognized preventive controls and qualified individual curriculum. 

Please call Cathy at 908-295-1691 with questions

  • Ensure individual(s) have completed the FDA standardized training curriculum for risk-based controls to become their "Preventive Controls Qualified Individual". These individuals develop, monitor, & make changes to the Food Safety Plan.
  • Have a documented risk-based hazard analysis to support your Food Safety Plan
  • Have a written Food Safety System including: process flow, allergen hazards, supply chain approval, sanitation controls, verification & validation procedure & records, recall procedures, & record keeping
  • Have proof that all employees who handle food or raw materials have doucmented training as Qualified Individuals. This isn't the same as the 2 1/2 day class for PCQI. Usually Qualified Individual employee training is 1 1/2 day class.