Employees working in a bread factory

Preventive Controls Qualified Individual

Denis Storey
March 17, 2017

On-Demand Webinar: “Recipe for a Successful PCQI Team”

Watch the Recording

On-Demand Webinar: “Recipe for a Successful PCQI Team”

Learn about the similarities and differences between HACCP and FSMA Preventive Controls and how to build a successful cross-functional PCQI team.

Watch the Recording

The FDA’s Preventive Controls for Human Food regulation applies to facilities required to register with FDA under section 415 of the Food, Drug, & Cosmetic Act. These facilities must comply if they manufacture, process, pack, or hold human food. For this particular FSMA regulation, food companies must have a food safety plan in place, and this plan needs to be developed by a Preventive Controls Qualified Individual (PCQI).

A PCQI is someone who’s “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 job experience to develop and apply a food safety system.” 

Although some activities are exempt from the Preventive Controls rule, most facilities will need to have a PCQI to complete certain activities. But a PCQI is not a one-size-fits-all position. The other tenets of food safety (ISO 22000, HACCP, all elements of BRC, SQF, and FSMA) are also common areas of expertise to be expected from PCQIs. 

By title, these PCQI individuals can be:

  • Quality Assurance/Quality Control Supervisors and Technicians.

  • Corporate Food Safety Managers, Directors, and Vice Presidents.

  • Production and Plant Management/Personnel.

  • HACCP Coordinators, Plant HACCP Team Members.

  • Regulatory Affairs Supervisors.

  • In-house Lab Personnel.

A careful examination of open PCQI positions starts to identify what food manufacturing employers and HR departments are looking for.

For example, one job description for a quality assurance manager for a manufacturing company in Omaha reads:

“In addition to being PCQI certified, the qualified candidate must have experience with HACCP Programs, GMPs, SSOPs, SOPs, USDA & FDA, and SQF experience.”

Another for a manager of food safety in New Jersey reads:

“Must be PCQI qualified with at least three years of experience in food safety related to manufacturing, or distribution, knowledge of Good Laboratory Practices and laboratory skills, possess a working knowledge of GFSI standards, and internal or lead auditor certification (SQF, FSSC22000, and BRC) are a plus.”

And another out of Florida reads:

“This candidate must be a PCQI and is responsible for supporting certifications of distribution centers and business units in the United States, as well as supporting the regulatory and food safety compliance for our businesses and products under license. The winning candidate will support the implementation and maintenance of GFSI, coordinate and schedule with certification bodies the annual BRC and Organic audits for the distribution centers, and maintain regulatory compliance regarding FSMA.”

Looking at these few job descriptions, it’s clear that companies are looking for excellent food safety and quality assurance candidates, and obtaining a PCQI certificate is something else to add to the list. With the wishy-washy definition of the “otherwise qualified” aspect to the PCQI requirement, it makes sense for candidates to take the courses offered by numerous companies.

Too often, technology decision-makers in the food sectors attempt to solve a particular pain point or challenge. Whether by job function or necessitated by regulatory compliance, there are competing interests. Only with a single version of the truth, real-time data, can these silos of functionality create a solution that allows all to access data quickly, accurately, and effectively.

Learn how to distinguish between HACCP and FSMA Preventive Controls and how to build a successful cross-functional PCQI team by checking out our on-demand webinar here.

FSMA FSVP PCQI