If your facility has a food safety plan in place—maybe even one that helped you pass a previous inspection—you might think you’ve already satisfied FDA expectations under FSMA. But here’s the critical oversight many facilities make: having a food safety plan doesn’t automatically mean it was developed, overseen, or validated by a certified PCQI.

And under FSMA, that distinction isn’t optional—it’s federally required.

Understanding the difference between a documented plan and a compliant plan can be the difference between passing your next FDA inspection or facing a serious violation. This article breaks down what FSMA really requires, why even strong food safety systems fall short without PCQI oversight, and how training protects both your operation and your credibility.

What FSMA Actually Requires

The Food Safety Modernization Act (FSMA) redefined food compliance in the U.S. Its goal wasn’t simply to make plans more robust—it was to make the individuals managing those plans verifiably qualified. That’s why the Preventive Controls for Human Food rule (21 CFR 117) includes a personnel-based requirement: the PCQI.

To comply, your facility must have:

• A written, hazard-based food safety plan
• Documented preventive controls based on risk assessment
• Ongoing oversight by a Preventive Controls Qualified Individual (PCQI)

This individual must have completed FDA-recognized training or acquired equivalent job experience. But during audits, it’s formal training that gives you defensible proof.

Even if your plan has served you well in the past, it may not satisfy FDA inspectors if you cannot show that it was created or reviewed by a PCQI. That’s not speculation—it’s codified in FSMA regulations.

To see how FSMA’s requirements compare to traditional food safety frameworks, review the core credentials modern food facilities can’t afford to miss.

Why a Food Safety Plan Alone Isn’t Enough

It’s common for facilities to assume their documented plans are sufficient—especially if they’ve passed previous audits. But unless your plan explicitly names a PCQI as the author or overseer, and unless that person holds formal training credentials, your plan is vulnerable.

Here’s why:

• PCQI training validates that the person in charge understands hazard analysis, monitoring, verification, and corrective action principles
• FDA inspectors don’t just ask about what’s written in your plan—they ask about who wrote it, and why they’re qualified to do so
• HACCP-based plans and internal SOPs, while valuable, do not substitute for FSMA’s preventive controls framework

In short, a food safety plan without PCQI oversight may look thorough—but it’s still noncompliant. The foundation is in place, but the credentialed authority behind it is missing.

This risk is especially high for facilities that rely on legacy documentation or internal knowledge transfer. A plan is only as strong as the credentials supporting it.

Unsure if your current plan meets FDA scrutiny? If you’re unsure whether your current food safety plan truly aligns with FSMA expectations, this 4-question check can help you identify any critical gaps before your next inspection.

Registrar Corp’s FDA-Recognized PCQI Course

Registrar Corp’s PCQI training course is tailored for facilities that already have a food safety plan and want to bring it into full alignment with FSMA expectations—without scrapping what already works.

The course is:

• Online, self-paced, and structured around FDA-recognized FSPCA curriculum
• Compatible with existing plans—designed to strengthen, not replace
• Built with real-world food operations in mind, from processors to packers to distributors

You’ll walk away with:

• A verifiable certificate showing you’ve met PCQI training standards
• Clarity on how to assess and improve your current plan
• Templates, procedures, and audit strategies to help you lead with confidence

Our training has been trusted by over 30,000 professionals in every sector of the food supply chain. Whether you’re preparing for your first FSMA inspection or need to prove ongoing compliance, this course connects knowledge to legitimacy.

If you also manage imports, Facilities managing both domestic and imported food often overlook the fact that FSMA applies differently across the supply chain.

Final Word: Training Isn’t Optional—It’s What Makes the Plan Valid

FDA doesn’t just want documentation. It wants verified accountability.

If you can’t demonstrate that your food safety plan was authored or managed by a certified PCQI, your facility could be flagged for noncompliance—regardless of how detailed your plan may be.

PCQI training gives your plan legitimacy. It affirms that your preventive controls were developed by someone trained to understand risk, identify hazards, and execute controls that hold up under regulatory scrutiny.

Training isn’t just a technicality—it’s the credential that makes your plan legally viable.

To bring your existing food safety plan into full FSMA compliance, train your PCQI through Registrar Corp’s FDA-recognized training program.