What is a PCQI, and do you need one?

The Food Safety Modernization Act (FSMA) was signed into law in 2011 and requires FDA-regulated food and beverage facilities to employ at least one Preventive Controls Qualified Individual (PCQI).

What is a PCQI, and what do they do?

The PCQI is in charge of overseeing the development and implementation of a facility’s food safety plan.

The PCQI validates that a facility’s preventative controls successfully prevent and control hazards. It is their job to ensure that the equipment or process can fulfill its purpose without incident.

In addition, the PCQI reviews preventative control data every week to ensure hazards are addressed before they occur. Many facilities find it helpful to employ two PCQIs to ensure that this data is continuously being monitored. 

The PCQI also makes sure corrective actions are applied appropriately. For example, they will develop a preventative control enhancement to correct the problem if something fails.

Does your facility need PCQI training?

If your manufacturing business is registered under section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C) Act, then you must have a PCQI (unless specific exemptions apply.)

According to the FDA, other food safety certifications like HACCP or GFSI do not qualify as sufficient food safety knowledge.

While you could hire third-party PCQIs to develop and implement your facility’s food safety plan, you should have one in-house to safeguard your company’s compliance. Manufacturers may employ someone already PCQI certified or have an existing employee receive PCQI training.

A single PCQI can serve multiple locations according to FDA guidelines, provided that the PCQI develops site-specific food safety plans for each facility. The PCQI certification does not expire, but experts recommend that refresher training every one to two years.

How do you become a PCQI?

To become a PCQI, individuals must have successfully completed the FDA-recognized training developed by the Food Safety Preventive Controls Alliance (FSPCA). Alternatively, the individual may prove competency based on previous experience, training, or education equivalent to PCQI training.

To become a PCQI, the FDA states that an individual must 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 job experience to develop and apply a food safety system.”

iMpact Utah offers PCQI training that utilizes the FDA-recognized curriculum developed by the FSPCA. If you’re interested in any of your team members becoming PCQI certified, contact iMpact Utah or check our events page for upcoming PCQI training courses.