Why a Recall Plan Matters for FSMA Compliance

Even with the most robust preventive controls in place, food safety risks can still occur. That’s why the Food Safety Modernization Act (FSMA) requires facilities to have a documented Recall Plan when a hazard requiring a preventive control is identified. Under 21 CFR §117.139, the facility is tasked with developing and implementing this plan to protect public health and ensure regulatory readiness. The PCQI can play a key part in developing the plan.

A well-crafted recall plan isn’t just a box to check—it’s a critical safeguard that limits liability, accelerates crisis response, and protects consumer trust. The PCQI will pull together a multi-functional team to develop the plan and to implement it if a hazardous situation arises.

Key Elements of a FSMA-Compliant Recall Plan

A recall plan must be written, facility-specific, and actionable under pressure. The PCQI should ensure the plan includes:

1. Recall Team Assignments

• Define roles and responsibilities for managing recalls.
• Include representatives from legal, regulatory affairs, quality assurance, operations, and communications.
• Designate a recall coordinator as the lead to oversee the process and serve as the point of contact.

Actionable Tip: Ensure all recall team members undergo annual recall training and maintain documentation of participation.

2. Product Identification and Tracking

• Outline how affected products are traced through lot codes, batch numbers, and distribution records.
• Integrate systems with inventory software for real-time product status.
• Ensure systems are capable of tracking both upstream (ingredients) and downstream (distribution).

Actionable Tip: Perform random traceability drills to assess system speed and accuracy.

3. Notification Protocols

• Include step-by-step procedures for notifying:
  • FDA or appropriate regulatory agency within 24 hours of initiating a recall.
  • Distributors and retail partners with clear instructions.
  • Consumers, where applicable, through press releases, websites, or customer service.
• Define internal communication procedures to inform leadership and employees.

Actionable Tip: Develop pre-approved communication templates to save time during high-pressure scenarios.

4. Product Disposition Procedures

• Detail protocols for isolating, destroying, reprocessing, or returning recalled product.
• Include sanitation and environmental controls for affected storage and handling areas.
• Require reconciliation of quantities to verify all affected products are accounted for.

5. Recordkeeping Requirements

• Keep logs of every action taken, including:
  • Emails, phone logs, and press releases
  • Product retrieval forms
  • Corrective actions taken post-recall

Actionable Tip: Maintain a recall binder (physical or digital) that consolidates all documentation in a single, audit-ready location.

Testing and Validating the Recall Plan

An unused recall plan is a vulnerable one. PCQIs and recall teams must actively test and refine recall preparedness to ensure performance under pressure.

1. Conduct Mock Recalls

• Use real product SKUs, batches, and lot codes to simulate an actual event.
• Track key performance indicators:
  • Time to identify affected product
  • Time to notify regulatory agencies
  • Response times from recall team members

Actionable Tip: Treat mock recalls as formal drills—document outcomes, rate performance, and assign follow-ups.

2. Evaluate and Update the Plan

• After each test or actual recall, hold a structured after-action review with the recall team.
• Revise protocols, update contact lists, improve documentation tools.
• Cross-check that any changes are reflected in associated SOPs and training materials.

3. Integrate with Broader Emergency Response Plans

• Ensure the recall plan aligns with other crisis protocols, including:
  • Food defense
  • Cybersecurity incidents
  • Facility shutdowns or contamination events
• Collaborate with risk management, operations, and HR to ensure messaging consistency.

Actionable Tip: Conduct an annual “emergency readiness week” combining recall and crisis simulations to reinforce response preparedness across departments.

Common Pitfalls in Recall Planning and How to Avoid Them

Even the best plans fall short if not properly maintained. PCQIs should regularly assess their recall preparedness to avoid:

• Outdated contacts or unassigned roles → Maintain an annually updated recall roster.
• Generic plans → Customize based on product types, facility size, and distribution complexity.
• Untrained staff → Conduct role-specific training, not just general awareness.
• No system for measuring recall effectiveness → Track recall speed, recovery percentage, and follow-up compliance.

Actionable Tip: Include recall readiness in quarterly internal audits and document improvements.

Building Recall Readiness into Your Food Safety Culture

A recall may never happen—but readiness is non-negotiable. A tested, well-maintained recall plan reflects the maturity of your food safety system. PCQIs serve as the strategic lead, ensuring every part of the organization knows its role, reacts swiftly, and follows through.

When recall preparedness is baked into culture—not just policy—facilities are more agile, more compliant, and better positioned to protect public health.

Registrar Corp offers PCQI training and compliance support to help food facilities build FSMA-compliant recall procedures, test their plans, and stay inspection-ready.

In future articles, we’ll explore how PCQIs oversee corrective actions and continuous improvement to reinforce preventive control systems and maintain long-term compliance.