In the "Food Safety Modernization Act" blog series, Mohan Ponnudurai will be examining the key elements and effects of FSMA as well how best to prepare for FSMA compliance. This is part two of three. How does the FSMA Focus Affect the Various Industry Participants?
During the first of three installments, we discussed the elements and focus of FSMA. We will now continue with how the FSMA affects various participants in the food and beverage industry.
The FSMA is vast and involves various levels of participants of the food supply, in the farm-to-table spectrum. As with other legislations, FDA eventually will define more prescriptive methods for the participants’ compliance. Let’s take a look at the specific areas of change and the kind of effects these requirements might place you under.
With the enhanced authority to issue immediate recall, companies have a need to provide appropriate data on traceability so FDA can trace the source of contamination standpoint. This substantially increases food safety from a contamination, and lowers impact on food supply and business. The companies subject to re-inspection or recall will incur FDA designated fees as well. This means they need to make sure to have a system of food traceability or adhere to FDA’s traceability needs in a farm-to-table spectrum, such as electronic record keeping to track each batch of produce with latitude/longitude of the production/farm location and where the location of the food is in the supply chain..
Another component of effective record keeping is to monitor against intentional adulteration; FDA will issue regulations that prevent food companies from knowingly including illegal additives, chemicals or other substances in their food products.
SOLUTION: Component History Records > Trace data such as ingredient/produce production location (lat/long) together with the incoming lot information. This can be part of the existing ERP system or a stand-alone system.
Third Party Accreditation:
FDA is mandated to monitor any foreign companies that bring food items into the US, and FDA will have the authority to inspect and to validate third party accreditation. If your company deals with a foreign supplier, or if you are the foreign supplier, make sure you are dealing with an accreditation entity that certifies you as a FDA certified supplier/producer.
SOLUTION: Audit Management > Supplier audit records to maintain the supplier accreditation status, audit report, findings/observations and status of resolutions.
FDA is required to identify the most significant food threats, such as food borne contaminants and diseases, and prescribe science based regulations every two years. This will include hazards identification and mitigation plans and controls by the food companies. That means every two years these tasks need to be revised, proper personnel trained and suppliers audited to make sure they meet these preventive measures. Under this measure, FDA will require a new registration process every two years and the companies must meet the updated requirements or risk suspension of that food production facility.
Food production facilities also must advise FDA of the hazardous practices currently in place and their plans to implement preventive measures going forward. These are subject to FDA audit, therefore, you should plan on maintaining records of the identified hazards, how to prevent those hazards, sanitation procedures, employee hygiene training, environmental monitoring program, food allergen control program, mitigation plans and corrective actions. This will help you with internal operational and compliance audits as well as FDA registration audits.
FDA will have power to set nationwide standards on production, harvest, and transportation of fresh produce. FDA will also identify and publish safety guidelines for specific high risk fruits, vegetables, and produce. How specifically this will operationally affect you is not known yet.
SOLUTION: Audit Management > Audit Records for internal processes, facilities, practices; audit report of findings/observations and status of resolution.
SOLUTION: Corrective and Preventive Action Management > A single / central CAPA system to manage actions and remediation resulted from audit and other sources.
SOLUTION: Training Management > Employee training tracking and management to ascertain employees are trained on up-to-date SOPs.
FDA also will have wider authority to gain access to records of food production facilities. If there is any suspected potential public health risk, FDA will have the authority to access those records. You as a food company should have a system (automated web based quality and compliance management) to record and maintain food safety related information, as well as rule and workflow based business processes to manage these compliance and business critical processes. This will aid in providing appropriate records to FDA upon request in a timely fashion as well as trending and dashboard visibility to your management before any serious violations are discovered.
Look for part three of this article coming soon - What you should be doing to prepare for the FSMA compliance when it becomes effective in July 2012?
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