For Campylobacter, Category 2 is defined as?

• A. Variable process control
• B. Highly variable process control
• C. Consistent process control
• D. Inconsistent data

Answer: (A)

Understanding how process controls are described helps interpret risk categories. When a pathogen has a category describing variable process control, it means the preventive measures in place do not perform consistently across batches or time. Some lots meet the controls and keep risk low, while others fall short, leading to fluctuating levels of risk overall. This shows that the system isn’t reliably stable and requires improvements in standard operating procedures, more rigorous monitoring, and stronger corrective actions to reduce variability.

If control were described as highly variable, that would imply even less reliability; consistent process control would indicate a stable, well-functioning system; and inconsistent data would point to data quality issues rather than how the process itself controls the hazard.