How will the existing GFSI certifications of companies be affected by preventive controls?

Firms that have received GFSI recognized certifications will need to comply with FDA’s Preventive Controls regulation (unless they are subject to one of the exemptions) regardless of their certification. Third party audits and certifications will not be accepted in lieu of an FDA inspection; however, private audit certifications may be considered by FDA as they assess a firm’s performance history for work planning purposes. GFSI audits may also be useful with respect to supplier verification.

Can I use my existing HACCP plan and just add the things required for Preventive Controls?

Yes, your HACCP plan includes controls such as process controls applied at CCPs. Other controls such as sanitation controls may apply to your products, but you do not need to rewrite your HACCP plan to include these. In fact, you may already have programs in place in addition to your HACCP plan that address the Preventive Controls rule requirements. As long as these programs meet the requirements of the rule, you can use them and the existing records. You can also supplement your HACCP plan with other things required by the rule, such as a recall plan.

Why is it a good idea to include a product description and flow chart in my Food Safety Plan even though not required?

A product description and flow chart provide basic information and an organizational structure for conducting a hazard analysis. Documenting the information makes it easier to proceed through the hazard analysis without forgetting something. This information is also useful for explaining the decisions made during hazard analysis to others who may be reviewing your Food Safety Plan.

Do I need to validate my Recall Plan?

No, recall plans are not subject to the requirements for validation.

Do I have to use a certain format for the Hazard Analysis? What HACCP formats are accepted?

No, there is no required format. The company can choose the format that they wish as long as the format addresses the requirements of the regulation.

Do I have to split every variation of a product I make into separate Food Safety Plans or can I combine them?

A Food Safety Plan may cover multiple products when the hazards and controls are the same for the foods or any differences are clearly identified in the Food Safety Plan.