21 CFR 117.130 - Hazard Analysis

What it says

The facility must conduct and document a hazard analysis for each type of food it manufactures, identifying known or reasonably foreseeable biological, chemical and physical hazards, including those that occur naturally, are unintentionally introduced, or are intentionally introduced for economic gain, and evaluating them to determine which require a preventive control.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• The hazard analysis decides which hazards need controls, so a hazard missed here is a hazard no preventive control will address.
• Evaluating hazards considers the severity of the illness or injury and the probability it will occur absent a control, and the analysis considers factors such as ingredients, process, facility and employee practices.
• It must be revisited when something changes, so a new supplier, ingredient or process step should trigger a review.

What FDA inspectors look for

• Whether a written hazard analysis exists for each food type and covers biological, chemical (including allergens) and physical hazards.
• Whether the conclusions on which hazards require a preventive control are explained and reasonable.
• Whether the analysis was updated after changes in ingredients, processes or suppliers.

Related regulations