The FSMA Requirement: Facilities must have procedures to prevent two types of cross-contamination:

  1. Microbiological: Preventing pathogens from raw or soiled surfaces from contaminating Ready-to-Eat (RTE) products.
  2. Allergen Cross-Contact: Preventing the unintentional incorporation of a food allergen. This is a separate Preventive Control but relies entirely on sanitation for its execution.

Recommended Solution & Expert-Level Pitfall:

  • The Solution: Implement strict physical or procedural separation. This includes:
    • Zoning: Physical separation of raw and RTE processing areas with separate tools, uniforms, and employee traffic patterns.
    • Scheduling: Running allergenic products last, followed by a full validated sanitation changeover.
    • Tool Management: Using color-coded tools (brushes, bins, utensils) for different zones or allergens.
  • The Pitfall to Avoid: Relying on “cleaning” for allergens. You must validate your allergen cleaning to ensure it removes the protein, not just the visible residue. A common failure is overlooking non-food-contact vectors like compressed air lines, employee traffic, and shared maintenance tools that move contamination from a raw or allergenic zone into a clean one.