Last month 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.
Increasing incidents affecting the health and safety of hundreds of thousands of U.S. consumers has motivated the federal government to introduce new legislation and regulations aimed at improving the protection of consumers from defective food and beverage products being accidently shipped to U.S. retail outlets. The heightened concern lead to the introduction of the Food Safety Modernization Act (FSMA) in January 2011.
On August 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.
"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 FDA to determine if the manufacturer is in compliance with their 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 needs 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 pin-point 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 up-to-date 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 is 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 that the FDA will focus on. Generally, governments do not require anybody to keep electronic/digital records -- they just want the appropriate data to be available -- accurate data! What this can mean is that food and beverage manufacturers have to evaluate if 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 a closer look at the new landscape on safety issues and how it can affect their clients from potential legal actions and the "covered or not-covered" risks included in insurance policies.
In seeking ways to optimize the performance of their manufacturing facilities, manufacturers can take advantage of Manufacturing Execution Systems (MES), a software solution 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, enforce corporate quality and safety standards, reduce product variability, reduce energy and raw material costs, improve accuracy of preparation, improve packing line efficiencies and optimize production planning.
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. They are: a) Supply chains are growing longer and more complex b) consumers are demanding improved quality & safety and c) 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.
Steve Diggines is business leader - Europe and Peter Walker is business leader - North America for STICORP, an MES systems integrator and GE Intelligent Platforms partner.