10 October 2011
Increasing incidents affecting the health and safety of US consumers motivated the US Government to introduce new legislation and regulations aimed at improving consumer protection from defective food and beverage products being accidently shipped to US retail outlets. The US Food Safety Modernization Act (FSMA) was introduced in January 2011, focused on food and beverage products manufactured in the US as well as on imported products. US regulators, such as the Food and Drug Administration (FDA) are working with their counterparts around the world to identify sources of contaminated foods. Regulators in the US plan to increase inspections of foreign facilities and to collect more import samples. The FDA’s summary of the FSMA Title III: Improving the Safety of Imported Food requires US importers to perform risk-based foreign supplier verification activities to verify that imported food is produced in compliance with applicable requirements related to hazard analysis and standards for product safety.On August 17th 2011 the FDA released its ‘Strategic Plan for Regulatory Science,’ calling for a sweeping modernisation of the science used in developing and evaluating products critical to the nation’s health, economy, and security. The strategic plan describes the agency’s intent to collaboratively enhance the process for developing and evaluating promising new products and novel materials from fields such as cell therapy, tissue engineering, genomics, personalized medicine, advanced computing, and information technology. It also underscores the agency’s emphasis on food safety.Information technology that improves the commercial results of a manufacturing facility has been available for some time. Manufacturing Execution Systems (MES) software solutions have been successfully deployed by many food and beverage manufacturers. However, with the new FDA regulations, MES could play an important role in helping European food and beverage manufacturers that export to the US comply with FDA requirements. MES delivers a complete set of functionalities that allow detailed visibility of operations, as well as giving the ability to record data on every step of the production process from quality assurance to equipment maintenance and beyond. These systems are usually integrated with other IT systems such as ERP systems. Keeping accurate and up to date records available for possible FDA audits and recalls will become critical. Having updated and accurate data easily and quickly available could reduce the time to take action and increase the confidence level of actions that need to be executed.Reasons to deploy MESThe speed and ease of deployment of lower-cost MES solutions available today can help create a rapid and effective path to improving the performance of manufacturing facilities and the safety of products manufactured. In addition, MES yields an attractive and proven ROI. A recent webinar on food safety and traceability highlighted the importance of modern MES solutions because of three trends that are placing additional pressures on manufacturers. These include: Supply chains growing longer and more complex; consumers demanding improved quality and safety; and compliance to new regulations is becoming more challenging. Certain MES solutions can directly and positively impact all three of these pressures by managing the manufacturing process more effectively. From raw material and recipe management to quality control and meeting customer order specifications MES systems improve agility, control, safety and the speed of product traceability –impacting the speed and efficiency of any product recalls ordered by the FDA. With the wide spread use of social media today, a brand’s image and reputation can be positively or negatively impacted within minutes. Running a more profitable and efficient facility that has the right MES solution to comply with product safety requirements is becoming essential – protecting the brand from adverse consumer opinions can be considered the ultimate benefit.
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