Under the federal Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration (FDA) has wide latitude to access records and inspect facilities to prevent or investigate safety issues. As mentioned in the recent post entitled “How FSMA impacts modern food and beverage manufacturers today”, for food and beverage manufacturers, these new guidelines around record-keeping require comprehensive procedures and technologies to ensure compliance and sound procedures required by the FSMA provisions.
Enterprise resource planning (ERP) software allows manufacturers to tie together the myriad operational and back-office functions within the organization to ensure prompt and accurate compliance. The need for accurate record-keeping with FSMA is one more reason for robust ERP.
Scope of FSMA record-keeping
The FSMA gives the FDA new tools to use for inspections and compliance. Among the new provisions are:
- Mandated facility inspections, the frequency of which is based on risk. For high-risk domestic sites, inspections must be completed within five years and then at least every three years thereafter. Non-high-risk facilities are to be inspected within seven years and at least every five years thereafter. In the first year, the FDA is directed to inspect 600 foreign facilities, with double the foreign inspections every year for the next five years.
- Access to records, including FSMA-mandated food safety plans and records that document how those plans are implemented.
- Testing carried out by accredited laboratories.
The final FSMA guidelines indicate the FDA will characterize high-risk sites based on:
- Known safety risks for the food made, processed, packed, or stored at a facility.
- The facility’s compliance history related to recalls, foodborne illness outbreaks, or violations of food safety standards.
- The strength (“rigor and effectiveness” according to the FDA) of a facility’s hazard analysis and risk-based preventive controls.
Record-keeping is an obvious essential element of FSMA compliance. The number of records required to be kept is significant and includes measurement of:
- Hazards and potential hazards
- Preventive controls
- Suppliers for each food ingredient
- Corrective actions taken
- Verification of the corrective actions
- Training of employees
Records need to be originals and must include measurements and observed values and be created concurrent with the activity measured or observed. Records must include the facility’s name and location, date and time, person doing the recording, and the product name and production code.
Preparing for records and inspections
The key for food manufacturers is to be prepared, with the proper procedures and recording systems in place. Compliance tracking software, used in tandem with manufacturing ERP software, helps ensure that companies remain in compliance, can track and retrieve required documents, and are following determined procedures fully.
At NexTec Group, we help identify the right compliance tracking and food processing software packages that ensure full FSMA compliance. Some available packages provide automated tracking functionality that helps not only with compliance but improves operational efficiency, too.
With NexTec as your trusted FSMA compliance partner, you will have access to expert advice about the vendors, products, and features that best meet your company’s needs. To learn more about how NexTec and Sage X3 can help with your compliance challenges, download the NexTec Food Brochure.