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FSMA Raises The Safety Bar

Two of the most important focuses are on preventative controls and the ability to track and trace defective products that have been accidentally shipped to retailers.

Increasing incidents affecting the health and safety of hundreds of thousands of U.S. consumers have motivated the U.S. government to introduce new legislation and regulations, including the Food Safety Modernization Act (FSMA), aimed at improving the protection of consumers from defective food and beverage products being accidently shipped to U.S. retail outlets.

On Aug. 17, 2011 the FDA released its “Strategic Plan for Regulatory Science,” calling for a sweeping modernization of the science used in developing and evaluating products critical to the nation’s health, economy and security.

According to the release, “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.”

The FDA expects manufacturers to maintain records of key manufacturing data that will allow the agency to determine if the manufacturer is in compliance with its directives and regulations. Two of the most important focuses are on preventative controls and the ability to track and trace defective products that have been accidentally shipped to retailers.

This means that up-to-date and accurate data need to be recorded, for example, on ingredients and the source of ingredients used, manufacturing processes and recipes used and other relevant data. This is extremely important for forward and backward tracking and tracing of products in order to pinpoint when and how a product batch was manufactured and where it was shipped.

The FDA now has “mandatory” recall powers, which when ordered can be more efficiently and effectively executed by having accurate and timely data that can be easily made available. Rapid recalling of defective products can help offset the negative financial impact on manufacturers in cases where the health and safety of consumers are affected. Even in non-critical situations, the negative impact of consumer opinion can be alleviated and managed more effectively, especially with the ever increasing popularity of social media that can positively or negatively impact a brand’s image and reputation within minutes.

Preventative controls and the ability to track and trace product batches are just two of the areas on which the FDA will focus. Generally, governments do not require anybody to keep electronic/digital records — they just want the appropriate, accurate data to be available. What this can mean is that food and beverage manufacturers have to evaluate whether paper records or electronic records will help them better comply with FDA regulations. Even the law profession and the insurance industry are starting to take closer look of the new landscapeon safety issues and how it can affect their clients from potential legal actions and the “covered or not- covered” risks included in insurance policies.

When a manufacturer does want to consider the benefits and proven ROI of an information technology solution to optimize the performance of its manufacturing facilities, it will discover there are solutions that will have a positive impact on its commercial operations as well as better prepare the company to comply with the new FDA regulations. Known as Manufacturing Execution Systems (MES), this software solution has been successfully deployed by numerous food and beverage manufacturers in the past. Today an additional reason has been introduced to take another look at MES.

What is a MES?

MES delivers a complete set of functionalities that allows a detailed “digital” view of operations at a glance on a computer screen, as well as 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 like an Enterprise Resource Planning system that will result in more efficient management of manufacturing, planning, accounting and product quality/safety related data.

MES manage key steps in a manufacturing process. Some examples are improving recipe management, enforcing corporate quality and safety standards, reducing product variability, reducing energy and raw material costs, improving accuracy of preparation, improving packing line efficiencies and optimizing production planning.

Reasons to deploy a MES

Manufacturers have always been extremely diligent with their operations to ensure the highest possible quality and safety of their products with the technology and methods available in the past. What’s new is the speed and ease of deployment of lower cost MES solutions that are available today, creating a rapid and effective path to improving the performance of present manufacturing facilities, as well as transitioning them to “factories of the future” to more efficiently comply with FDA regulations and improve commercial results.
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 are:

  • Supply chains are growing longer and more complex
  • Consumers are demanding improved quality & safety
  • Compliance to new government 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 with the desired results.

For more information on MES solutions based on scalable, safe and proven technologies, contact GE Intelligent Platforms or STICORP, a GEIP partner.