Many food facilities assume they’re covered simply because they have a “certified” PCQI- someone who completed a PCQI training course. . But the FDA’s expectations go deeper than a certificate hanging on the wall. If your PCQI can’t demonstrate real-time, operational knowledge—or if their training is outdated—your audit risk skyrockets.

A Preventive Controls Qualified Individual is crucial for establishing and maintaining the credibility of your food safety plan and when that individual fails to meet the FDA’s expectations, your entire system can be compromised.

Here are five things FDA inspectors actually look for when evaluating a PCQI. If even one of these catches you off guard, your PCQI status may not be enough to protect you.

1. FDA Evaluates Your Operational Knowledge—Not Just Credentials

Having a certificate isn’t enough. A PCQI must be able to explain the rationale behind the food safety plan’s design and demonstrate how it addresses identified hazards.During inspections, FDA investigators often ask PCQIs to explain how preventive controls apply across your actual production floor. Can your PCQI speak to:

• How hazards were identified and evaluated at each step?
• What controls are in place, and why?
• How monitoring, corrective action  and verification are managed?

Too many facilities get caught off guard here. A certificate alone doesn’t prove the PCQI understands how the plan functions in real-world terms. The failure of a PCQI to effectively explain and justify the food safety plan, can raise concerns about the plan’s overall effectiveness and the facility’s ability to manage food safety hazards.

2. You’re Responsible for Implementation—Not Just the  Plan 

FDA doesn’t just review your written food safety plan. They look for evidence that the plan was properly implemented and that preventive controls are being applied correctly across your operation.

Your PCQI is accountable for:

• Overseeing day-to-day control execution
• Ensuring staff understand their roles
• Identifying breakdowns and revalidating the plan

When things go wrong, it’s the PCQI’s signature the FDA traces back as they are responsible for reviewing records related to preventive controls. In the agency’s eyes, the PCQI isn’t a figurehead—they are the foundation of compliance execution.

The FDA doesn’t just check paperwork—they evaluate the structure behind your PCQI role. Here’s how top facilities build systems that hold up under scrutiny.

3. Corrective Action Records Are a Direct Reflection of You

One of the clearest signs your PCQI is underperforming is a messy corrective action trail. FDA inspectors regularly review:

• Whether issues were identified quickly
• Whether the cause was investigated thoroughly
• Whether follow-up actions were documented and effective

If your logs are incomplete —or if there’s a disconnect between incidents and PCQI oversight—you’ll be held accountable.  Ineffective follow-up actions and delayed responses are common pitfalls in corrective action programs.

In the FDA’s eyes, unresolved issues signal systemic failure, not isolated error. Your documentation either supports your PCQI’s leadership—or exposes their absence.

4. Outdated Training Can Raise Concerns

If your PCQI completed training more than a few years ago, or if the program wasn’t specific to FSMA’s Preventive Controls Rule, FDA may identify it as a potential problem. 

They want proof that the PCQI:

• Knows current FDA expectations
• Is trained in risk-based controls
• Understands supply chain programs, recall plans, and verification procedures

“Experience” isn’t enough. Inspectors are increasingly reviewing PCQI training to ensure it incorporates the latest guidance from FDA. Outdated training doesn’t just signal noncompliance—it suggests complacency. Food safety regulations can evolve, staying updated ensures the food safety plan’s effectiveness and compliance with regulations. 

If your PCQI’s training can’t hold up to scrutiny, your entire system is exposed. These are the four questions that reveal whether your program is inspection-ready—or quietly noncompliant.

5. You Should Be Audit-Ready—At Any Time

FDA doesn’t always give advance notice of inspection. When they arrive, they expect your PCQI to:

• Be present or immediately reachable
• Answer technical questions about the plan
• Explain how monitoring, verification, and corrections are handled in real-time

If your PCQI is unable to provide a clear response —due to outdated training, unfamiliarity with the plan, or lack of documentation—it won’t just undermine the audit. It will raise questions about whether you’re truly in control of your food safety system.

That’s not a paperwork issue—it’s a systemic liability that could lead to facilities facing fines, recalls, and even shutdowns.

When audits determine your operational credibility, this is the PCQI training thousands of FDA-regulated facilities trust to stand up under pressure.

Final Word: Make Sure Your Title Isn’t Just for Show

The FDA doesn’t care what your certificate says. They care whether your PCQI can lead an inspection with confidence—and back up your plan with action.

Registrar Corp’s PCQI Training isn’t just about meeting the requirement. It’s about:

• Understanding FSMA’s Preventive Controls Rule inside and out
• Knowing what FDA auditors actually look for
• Preparing your PCQI to lead—not follow—your food safety system

Don’t wait for an audit to find out you’re not compliant. Get trained by the FDA compliance leaders.

You only get one chance to make a first impression with FDA. Make sure your PCQI is ready to speak for your system—before an inspector does it for you.