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Planning For FSMA Compliance

The postponement of many of the aspects of the Food Safety Modernization Act is good news for food manufacturers, as it allows additional time to implement changes to their processes in order to be in full compliance when the new regulations are fully in effect.

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Although the Food Safety Modernization Act (FSMA) was enacted by Congress and signed into law by President Obama on January 4, 2011, many aspects of this law have been postponed until after the November 2012 elections. This is good news for food manufacturers, as it allows additional time to implement changes to their processes in order to be in full compliance when the new regulations are fully in effect.

While planning for these new regulations is under way by now, there are ways to optimize preparation for FSMA and any regulations that may occur in the future. One of the most important factors is to focus onfood safety risk prevention and reporting. Producers must have in-depth visualization of the entire supply chain with the ability to quickly identify and mitigate problems before or just after they occur.

The following steps are a list of actions food and beverage manufacturers can take now to stay ahead of the curve on these pending new requirements and any other regulations that may come in the future.

Step One: Gain Clarity on the New Regulations

Food and beverage manufacturers need to identify who the specific regulations target and if they need to comply. The “who” is all producers of food and beverage except alcohol producers, fisheries, meat, poultry and eggs, and unprocessed produce from farm products. The “what”of the new regulations is broken into three main themes:

  • Recall products from the market faster. The emphasis is on speed and accuracy of the notification of the FDA of a recall, which means manufacturers need to be able to quickly diagnose and act upon problems anywhere in the supply chain. Producers must, at a minimum, understand the size of the recall, what happened, where the product was produced and what steps to take.
  • Prevent bad quality product from reaching the public. In line with the ability to recall products faster, food manufacturers are now required to follow current good manufacturing practices (cGMP) and use hazard analysis and critical control point processes (HACCP) when developing their food quality safety programs. These new requirements are an attempt to prevent bad quality products from reaching the public and must be readily available for FDA inspection and review at any time.
  • Keep key quality records longer. Key quality data is now required to be kept on record for two years, allowing the FDA to review more of the process issues and the producers’ reactions to them. Previously, these key quality records were only required to be on file for 90 days.

Step Two: Compliance

In order to comply with these new requirements, all food and beverage producers will register with the FDA, where they will be placed in risk assessment pools. Producers placed in the high risk pools will be inspected more frequently to gauge compliance with new FSMA and other regulations. 

Next, they  must develop a written HACCP plan for food safety that identifies all possible product risks and mitigates the most likely risks from reaching the public by engineering out the risk or inspecting the risk of occurrence. With a written plan in place, producers must keep records to prove their quality process is preventing bad product from reaching the public as well as the steps they would take to recall bad product, if this did occur, and what corrective actions would be taken to stop future outbreaks.

HACCP is a series of processes that identifies all the possible hazards associated with the manufacture of a product, evaluating the likelihood of that hazard occurring and ensuring that proper controls are in place to prevent or identify any hazards as they occur during the manufacturing process. The predictive analysis of the likelihood of potential hazards allows the areas of greatest concern to be addressed, with an understanding of which critical control points or processes need to be tracked or monitored to ensure proper notice is given should a hazard occur.

For example, when making products in a machine, it is possible for a piece of that machinery to flake off, placing metal into the product. The hazard, metal filings in the product, would then need to be reviewed in this HAACP plan for likelihood of occurrence, effect on the consumer and other factors giving the producer a risk factor. In this example, if the risk were deemed high, the producer would move to prevent the hazard from happening by engineering it out. However, if engineering cannot remove the likelihood of occurrence, then critical control points would be put in place, and processes would be developed to ensure metal filings are identified as soon as possible, notifying the operations people or even shutting down the process.

Step Three: Look beyond Regulations - The Opportunity for more Holistic Food Quality Planning

FSMA and other regulations should be viewed as an opportunity for food manufacturers to adopt a more holistic approach to solving food quality and safety concerns. One of the many benefits of FSMA compliance will be increased visualization and control over the manufacturing processes and supply chain. This ability reaches far beyond compliance and can benefit many different aspects of food manufacturing by increasing productivity, improving lean manufacturing processes and developing automated control systems.

Katie Beissel is the Global Industry Manager for Food and Beverage for GE Intelligent Platforms, a position that she assumed in 2012. Her responsibilities include leading the execution of global marketing strategies for the food and beverage vertical market and helping manufacturers create strategies to overcome their most challenging operational issues. You can contact Katie at [email protected].