In the "Food Safety Modernization Act" blog series, Mohan Ponnudurai has been examining the key elements and effects of FSMA as well how best to prepare for FSMA compliance. This is part three of three. What Should You do to Prepare for FSMA Compliance?
During the past two installments, we discussed the elements and focus of FSMA and how FSMA oversight affects various participants in the food and beverage industry. We will continue with what best-in-class companies should be doing to prepare for the FSMA compliance.
The implications of the FSMA are hard to decipher and different based on who you are since many details of the legislation have yet to be worked out, and there is no specific timeline for promulgating regulations. Despite this, it is believed that substantial portions of the FSMA will be implemented over the next three years. This is evidenced by the fact that some of the FSMA are effective immediately, and some in the next 24 months.
Glaringly obvious are aspects centered around electronic records. This would require food companies to make investments to capture, record and manage information electronically so it would be easy and efficient to quickly produce required records upon request by FDA. Many of the required traceability elements can be covered under an enterprise resource planning (ERP) system and the rest of the compliance elements under an enterprise quality management system (EQMS). Typical EQMS used currently by FDA regulated companies under 21 CFR 11 or 21 CFR 820 compliance can easily be adopted for FSMA compliance by the food industry. Such a system with FDA accepted best practices could help these companies in the following critical areas:
- Hazards analysis, control plans and mitigation
- Corrective and preventive action (CAPA) and remediation management
- Employee safety and competency training
- Audit management (internal and external)
- SOP management
Based on how FDA has managed regulations in the life science sector, we can make educated guesses as to how FDA might tackle FSMA. FDA would first address the major food producers who ‘touch’ the biggest population segments and work their way down the chain. Since these major producers will be responsible for their suppliers, this approach makes sense as those large producers would cover a swath of smaller suppliers as part of the safety tracking and food safety/quality.
This does not mean, however, that you should take a wait-and-see approach until the enforcement gavel is dropped against you. You can start to prepare by looking into getting an electronic quality and compliance management system that would help you with electronic record keeping to stay abreast with the FSMA requirements.
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