21 CFR 117.170 - Reanalysis

What it says

The food safety plan must be reanalyzed at least once every three years, and sooner whenever a significant change is made in the activities conducted at the facility that creates a reasonable potential for a new or increased hazard, whenever the facility becomes aware of new information about potential hazards, when a preventive control is found to be ineffective, and when a similar problem occurs.

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

What it means in practice

• Change control for the food plant should include a question about whether the plan needs to be reanalyzed.
• New supplier problems, outbreaks or scientific information can each trigger a review.
• The reanalysis should be documented, even where the conclusion is that no change is needed.

What FDA inspectors look for

• Whether the plan was reanalyzed on schedule and after significant changes.
• Whether the reanalysis is documented and signed.
• Whether the result of a reanalysis led to changes in the plan.

Related regulations