Young male manager in sterile clothes standing in food factory and looking at tablet

PCQI: What Type of Investment Do I Need to Make?

Denis Storey
December 20, 2019

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 role of the Preventive Controls Qualified Individual (PCQI) takes center-stage when determining corporate compliance within the U.S. Food and Drug Administration’s (FDA) Hazard Analysis and Risk-based Preventive Control (HARPC) rule. PCQI compliance is an important role shouldering a lot of responsibility, so it is essential to understand the details. 

Preventing foodborne illnesses through the safe preparation of food products for human consumption requires food and beverage facilities to “have at least one PCQI to perform or oversee the preparation of a food safety plan, validate the preventive controls, review records and perform reanalysis of the food safety plan.”

The terms “perform or oversee” could be interpreted as inclusive of one or more individuals. However, a Preventative Controls Qualified Individual is the requirement, not a Preventative Controls Qualified Team. Given the name within the rule, all responsibility falls onto an individual, and there’s no aggregation of abilities within the rule. If a company relies on a QA team where one party is handling food science activities, and another party is handling HACCP-style drafting, combining both efforts will not be considered “qualified” in the eyes of the regulation. In this case, companies need to denote one team lead and make sure every person on the “team” is PCQI. They must also understand that this approach may change some operations for select facilities.

What about PCQI Consultants?

Though consultants or third-party Preventive Controls Qualified Individuals are available to all organizations, they should never hire someone as a replacement for a full-time PCQI within an organization. In the case of Jensen Farms, they learned this lesson the hard way.  

In response to consumer demands, Jensen Farms, growers of cantaloupes, decided to make operational changes to their farming enterprise and pursue organic certification. Not having a PCQI on staff and at the recommendation of a third party consultant, they discontinue synthetic chemicals to wash their produce before shipment.

Their following harvest of cantaloupes then caused the deadliest food poisoning outbreak in the United States in over 100 years. Thirty-three people died from consuming their cantaloupes, as they have carried Listeria monocytogenes on the rinds.

The culprit? A potato washing system replaced a chlorine rinse using a potable municipal water rinse and allowed the listeria to flourish.  

If a company-based PCQI were in the facility to receive the recommendation to use the potato washing system in this fashion, they likely would have identified the risk as part of their food safety plan. A person with a scientific background required for PCQI certification would have identified the risk and assessed potential ways of controlling it; either focusing on the source of the water, the washing system itself, or making sure the appropriate temperatures were in place and identifying the potentially mitigating kill step. These are all components of the failure a PCQI would be qualified to identify and remediate.

Where can I learn more about PCQI?

TraceGains is a proud strategic partner of the United Natural Products Alliance (UNPA), an international trade group representing more than 100 natural product companies, all of which share a commitment to providing consumers with better natural health products.

“We have an increasingly complex supply chain and regulatory landscape,” UNPA president Loren Israelsen said. “Both domestic and foreign suppliers are often not equipped to meet the new Food Safety Modernization Act (FSMA) record-keeping requirements, and the industry as a whole is suffering from certifier audit fatigue. UNPA chose to partner with TraceGains because the supply chain transparency its software provides is in alignment with UNPA’s long-standing mission to help industry provide end-user consumers with natural health products of superior quality, benefit, reliability, and sustainability.”

TraceGains and UNPA jointly conduct educational programs to address industry pain points, such as FSMA, new product development, and audit readiness. Additionally, the UNPA-TraceGains alliance will work collaboratively to develop and promote industry best practices around raw ingredient sourcing to boost supply chain trust and transparency.

To understand more about the specific rules and responsibilities of a PCQI team, watch the “Recipe for a Successful PCQI Team” webinar hosted by Nancy Scharlach here.

FSMA UNPA PCQI