Preparing for FSMA Compliance: Are You Ready?

Establish corrective action procedures to ensure that if the preventive are not properly implemented or are found to be ineffective:

• Appropriate action is taken to reduce the likelihood of recurrence of the failure;
• All affected food is evaluated for safety; and
• All affected food is prevented from entering into commerce if the owner, operator, or agent in charge of your facility cannot ensure that the affected food is not adulterated under section 402 or misbranded under section 403(w) of the Food Drug and Cosmetic Act.

Verify that:

• The preventive controls implemented are adequate to control the hazards identified;
• You are making appropriate decisions about corrective actions;
• The preventive controls implemented are effectively and significantly minimizing or preventing the occurrence of identified hazards, including through the use of environmental and product testing programs and other appropriate means; and
• There is documented, periodic reanalysis of the plan to ensure the plan is still relevant to the raw materials, conditions, and processes in the facility, and new and emerging threats.

Maintain records for not less than two years, documenting:

• The monitoring of the preventive controls implemented;
• Instances of nonconformance material to food safety;
• The results of testing and other appropriate means of verification instances when corrective actions were implemented; and
• The effectiveness of preventive controls and corrective actions.

Conduct a reanalysis of your preventive controls whenever a significant change is made in the activities conducted at your facility if the change creates a reasonable potential for a new hazard or a significant increase in a previously identified hazard, or not less frequently than once every three years, whichever is earlier. This reanalysis must be completed and additional preventive controls needed to address the hazard identified, if any, must be implemented before the change in activities at the facility is operative. You must revise the written plan if such a significant change is made or document the basis for the conclusion that no additional or revised preventive controls are needed.

Completing these steps will help companies prepare for FSMA and be ready once the final rules are passed.

Bail is the director of supply chain food safety technical services for NSF International. He can be reached at [email protected] or 734-827-6844.