The FDA’s Food Safety Modernization Act (FSMA) aims to ensure the safety of the U.S. food supply by shifting the FDA’s focus from responding to contamination to preventing it, and food and beverage manufacturers should have spent the past few years preparing to respond to an FDA inspection. Inspections can come with no notice, and FDA investigators expect you to be prepared with documentation demonstrating your use of good manufacturing processes (GMP) and overall food safety.
If you’re struggling to prepare (or just haven’t), you can ease the process by using a modern ERP system to adhere to FSMA guidelines and make FDA audits painless.
According to the FDA Inspection Checklist published by the Food Industry Counsel, the FDA’s number one enforcement priority is “to carefully critique each company’s written food safety programs and verification records to ensure they are compliant with the new FSMA requirements.”
The FDA has established three information requirements food and beverage companies must have to be compliant:
Here’s how to use ERP software to help with an FDA audit.
The FDA requires proof of written and finalized food safety systems. Moreover, they require you to have primary and secondary ‘designated individuals’ (DIs) who are familiar with all the elements therein.
These documents include a wide range of content, including:
To ensure the proper documentation exists in finalized form, you need the document version control and workflow approvals inherent in ERP. In addition, because your DIs must be knowledgeable about all aspects of the system, you need real-time updates regarding their training status; to ensure continuous learning, modern ERP enables you to model processes so that each time a new plan element is loaded to ERP, automated workflows require designated individuals to review and verify knowledge of the new information. You can even establish time-based parameters so automated alerts inform upper management when primary or secondary DIs have failed to keep up to date with training.
FDA investigators require fast and easy access to the supporting records for each of the programs and plans you have in place. They also expect the records to remain organized and maintained to allow for immediate retrieval in the event of an audit ─ including surprise audits – for a minimum of two years.
If your company responds to a deviation outside food safety parameters, you must document your corrective actions and be prepared to present them to FDA investigators – so your designated individuals need to:
Modern ERP allows you to model specific processes in the system to perform end-to-end corrective action management, so not only can you model the process necessary to react properly when a deviation occurs, you can model the process for documenting and sharing corrective actions.
Modern ERPs prove invaluable when preparing your company for an FDA audit, not only from an information management perspective but also from a process perspective. The ability to set strict parameters and processes for managing and reporting on your food safety measures virtually forces your company to be prepared to enforce food safety, its measurement, and its reporting.
To learn more about using an ERP to keep you compliant with the FDA's FSMA, contact us today.