The FSMA Requirement: Facilities must have procedures to prevent two types of cross-contamination:
- Microbiological: Preventing pathogens from raw or soiled surfaces from contaminating Ready-to-Eat (RTE) products.
 - 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.
 
