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What is PCQI?

A Preventive controls qualified individual “means a qualified individual who has 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 is otherwise qualified through job experience to develop and apply a food safety system.

The Current Good Manufacturing Practice, Hazard Analysis, and Risk‐based Preventive Controls for Food regulation was published on September 17, 2015 and is intended to ensure safe manufacturing/processing, packing and holding of food products for consumption in the United States. The regulation requires that certain activities must be completed by a “preventive controls qualified individual” who has “successfully completed training in the development and application of risk-based preventive controls”. This course developed by the FSPCA is the “standardized curriculum” recognized by FDA; successfully completing this course is one way to meet the requirements for a “preventive controls qualified individual.”

Why ‘PCQI’ is required?

The Food Safety Modernization Act (FSMA) Preventive Control for Human Foods (PCHF) regulation signed into law in 2011 offers a wealth of opportunity for companies to improve their food safety procedures and protocols through the implementation of a preventive strategy against food-born risks. As part of this regulation, food manufacturers must require that employees are qualified to perform their assigned tasks in a manner that protects food safety and prevents against adulteration. In addition, each company must have at least one employee, preferably located at the food manufacturing facility, who functions as a Preventive Controls Qualified Individual (PCQI). The PCQI functions as the responsible party overseeing the development and execution of all food safety programs and must have the knowledge, skills and abilities to perform these tasks based on their education, on the job experience or a combination.

Responsibilities of a PCQI

Under the Preventive Controls for Human Food rule, the responsibilities of a “preventive controls qualified individual” include to oversee or perform

  1. preparation of the Food Safety Plan
  2. validation of the preventive controls
  3. records review
  4. reanalysis of the Food Safety Plan, and other activities as appropriate to the food

Who can become a ‘PCQI’?

  • Organizations exporting to the USA
  • People seeking a way to demonstrate regulatory compliance, having a PCQI within their organization
  • Quality Managers or other Managers involved in the Food Safety team
  • Food Safety Team Leaders
  • Personnel responsible for Regulatory affairs
  • Importers
  • Consultants

Prerequisite/Prior knowledge

Prior knowledge in GMPs, HACCP and experience in Food Safety Management systems is highly recommended.

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