FSMA compliance is vitally important to the success of any food company. There’s a good chance that you have already put steps into place to ensure such compliance, as well. Nonetheless, understanding how the FSMA could affect you – and ensuring that you are ready for inspections and audits – is one of the best ways to ensure your business continues to grow without a hitch.
Your Action Plan
An action plan is one of the best ways to ensure you’re prepared for FSMA audits and/or inspections. There are several things that go into this, as well.
- Create a written food safety plan. This plan is effectively a piece of written documentation that lines out exactly how your company complies with all the requirements of the FSMA. You must have this ready – along with documents to support it – when asked by an authorized representative of the FDA.
- Train and qualify the person to develop the food safety plan. This individual should have the knowledge and ability to create a plan that suits the requirements of the act.
- Carry out a hazard analysis. This is designed as a test to ensure that your company is protected from hazards that are already known or foreseeable within reason. Consider things like chemical, biological, and physical hazards that may make their way into your food, naturally and unnaturally introduced hazards, and hazards that may be introduced via acts of terrorism. Then, create a written analysis regarding these hazards.
- Create and implement various preventative measures. These should all verify things such as your limits, control points, and HACCP plan via scientific data. You should also ensure that you have taken measures to prevent, eliminate, and significantly minimize any of the risks laid out in your hazard analysis. Finally, ensure that the food your facility is responsible for meets all the guidelines found in sections 402 and 403(w) of the Food, Drug, and Cosmetic Act.
- Monitor your actions. Consider all the preventative controls you implemented during this time and actively monitor them.
Recordkeeping & Future Reanalysis
After completing the first series of steps, it is important to understand the ways in which the FSMA requires you to keep records and conduct reanalysis. You will need to maintain records for at least two years, and these should document the effectiveness of your preventative measures and the actions you’ve taken to prevent future issues, the results of testing following the implementation of corrective actions, instances when your company did not conform to food safety regulations, and monitoring records.
Reanalysis is required whenever the activities at your facility change in such a way that the potential for a new hazard that was not addressed in a previous action plan exists. If conditions and activities in your facility do not change, you will be required to conduct a reanalysis at least once every three years. If this analysis results in a significant change in your action plan, the action plan must also be updated.
Preparing for FSMA may sound difficult and tedious, but once you have established your action plan the first time, keeping it up-to-date is only a matter of conducting checks and analyses as lined out by the FDA. Doing so can protect not only your company, but also the consumers who buy and consume your products.