Documentation is required only for hazards requiring what?

Documentation is required only for hazards requiring what?

• A. All hazards
• B. Verification
• C. No hazards
• D. Preventive control

Answer: (D)

When a hazard is identified in the hazard analysis as needing a control to prevent or significantly minimize it, you must document that control. The documentation for a preventive control includes what the control is, the critical limits, how you monitor it, what corrective actions you take if monitoring shows a problem, and how you verify that the control is effective. That’s why documentation is required only for hazards requiring a preventive control—the FSMA preventive controls framework targets these specific hazards with formal documented controls. Hazards that don’t require a preventive control are addressed through other elements (like GMPs/SSOPs) and don’t need the preventive-control documentation.

When a hazard is identified in the hazard analysis as needing a control to prevent or significantly minimize it, you must document that control. The documentation for a preventive control includes what the control is, the critical limits, how you monitor it, what corrective actions you take if monitoring shows a problem, and how you verify that the control is effective. That’s why documentation is required only for hazards requiring a preventive control—the FSMA preventive controls framework targets these specific hazards with formal documented controls. Hazards that don’t require a preventive control are addressed through other elements (like GMPs/SSOPs) and don’t need the preventive-control documentation.