Why FSMA and HACCP Must Work Together

For many food facilities, FSMA’s Preventive Controls for Human Food rule didn’t replace HACCP—it added to it. As a result, facilities now face dual expectations: comply with FSMA while maintaining HACCP-based food safety systems for certifications like GFSI, SQF, or international regulatory requirements.

The Preventive Controls Qualified Individual (PCQI) becomes the translator and bridge between these systems. They must understand how to integrate the prescriptive, science-based methodology of HACCP with FSMA’s broader preventive framework—without duplicating effort or creating gaps in coverage.

This article explores how the PCQI navigates the relationship between Preventive Controls and HACCP to build unified, inspection-ready food safety plans.

1. Understanding the Differences—and the Overlap

While FSMA and HACCP share common DNA, they’re not identical.

HACCP focuses on:

• Identifying Critical Control Points (CCPs)
• Monitoring specific hazards at precise steps in the process
• Controlling microbiological, chemical, or physical risks

FSMA’s Preventive Controls focus on:

• A broader spectrum of hazards, including supply chain and sanitation-based risks
• Preventive Controls that may or may not be CCPs
• Management components such as monitoring, verification, and corrective action

The overlap:

• Both require documented hazard analysis
• Both require control measures and verification
• Both demand a trained individual (PCQI for FSMA; HACCP-trained individual for HACCP)

Key Insight: The PCQI must determine which hazards require CCPs and which must be managed through other types of preventive controls—then structure the plan accordingly.

2. Harmonizing Hazard Analysis Across Systems

One of the most critical functions of the PCQI is to ensure the hazard analysis serves both systems without redundancies or omissions.

A robust hazard analysis under FSMA must:

• Identify known or reasonably foreseeable hazards
• Assess severity and likelihood
• Determine which require preventive controls and what type (Process, Allergen, Sanitation, Supply Chain)

This dovetails naturally into HACCP’s process-based hazard analysis—allowing PCQIs to:

• Create a unified hazard analysis that maps each risk to both HACCP and FSMA outcomes
• Use flow diagrams and risk matrices that satisfy both regulatory and certifying bodies

Actionable Tip: Build a hazard analysis table that clearly denotes whether each hazard is managed as a CCP, a preventive control, or both.

3. Integrating CCPs Into a FSMA-Compliant Food Safety Plan

FSMA does not eliminate the need for CCPs—it simply places them within a wider risk management framework.

PCQIs should:

• Retain validated CCPs where appropriate (e.g., thermal processing, metal detection)
• Ensure management components—monitoring, corrective action, verification—are defined per FSMA standards

By embedding CCPs into a broader food safety plan, PCQIs provide full coverage for both auditors and FDA inspectors.

Pro Tip: If your HACCP plan includes validated CCPs, you can elevate them within your FSMA plan as “Process Controls”—ensuring continuity without rewriting from scratch.

4. Documentation and Terminology: Avoiding Confusion During Audits

One common issue during audits is the inconsistent use of terminology. For example, referring to a “HACCP Plan” when FSMA requires a “Food Safety Plan” can raise red flags.

The PCQI must:

• Use FSMA-compliant terminology in documentation: “Preventive Controls,” not “Control Points”
• Maintain a glossary or legend that shows alignment between the two systems

Actionable Tip: During internal audits, use mock inspections to test how well your documents and team members distinguish FSMA versus HACCP terms.

5. The Role of Training in Bridging the Systems

A PCQI that’s only trained in FSMA may not understand the logic of HACCP. Likewise, a HACCP-trained individual may miss the broader scope of FSMA’s requirements.

That’s why cross-training matters. Facilities benefit from:

• PCQIs with formal HACCP certification
• Refresher training that highlights the interaction between the systems
• Internal workshops that review how Preventive Controls and CCPs align in daily operations

Registrar Corp offers PCQI and HACCP training to help individuals understand and align these frameworks with confidence.

Stronger Together: Building Unified Plans that Work in Practice

HACCP and FSMA aren’t competing philosophies—they’re complementary strategies. When the PCQI understands how to bridge them, facilities benefit from food safety plans that are more resilient, more streamlined, and more aligned with global expectations.

The result is a system that works in practice and stands up under inspection, no matter who’s at the door.