The FDA’s Reportable Food Registry electronic portal became operational in early September 2009, requiring food manufacturers, processors, packers and distributors to report potential issues and adverse events electronically within 24 hours. Prior to this, mandated adverse event reporting was largely limited to the life sciences industry for product issues, but with recent and ongoing incidents involving produce, meat and pet food, food safety issues have once again raised public consciousness of the issue.
With the launch of the new portal, constituents across the food industry—from food industry insiders, government agencies and the general public—are now armed with a system and mandate that elevates the importance of food safety to a new level. More rapid notification of the FDA and, as warranted, subsequent warnings to the public will result in fewer foodborne illnesses. This is a major concern, since the CDC estimates that one in four Americans is affected each year and 5,000 people reportedly die annually.
Many food companies are still trying to figure out how to handle this new requirement. Some are planning to address it only when it becomes necessary. This “wait and see” approach and the resulting lack of advance preparation will hinder their ability to meet the stringent new 24-hour deadline. Negative repercussions could move beyond regulators’ sanctions and fines and inflict irreparable harm to these companies’ reputations. Leading food companies are addressing the new requirements proactively to ensure they are positioned to handle any emerging issues that occur.
Adverse events are unavoidable in the food manufacturing process. Over the past several decades the process has grown exponentially more complex with countless global ingredients, suppliers and expanding supply chains, each with differing quality and safety standards. With many stakeholders, food companies struggle to manage the information they need to understand and address issues that can and do arise. These mountains of data generated by extended supply chains and multiple facilities make identifying issues and addressing them quickly all the more challenging.
However, the food industry is not the only industry facing challenges to maintain quality, safety and compliance with global manufacturing operations and changing standards. These challenges mirror those faced by other highly regulated industries such as life sciences—drug, medical device, blood and tissue and more. Like those industries, it is absolutely imperative that food and beverage manufacturers automate the collection and reporting of data to manage adverse events and react to incidents quickly. With more aggressive regulatory oversight, life sciences companies have needed to implement standards and systems for ensuring quality, mitigating risk and maintaining regulatory compliance. Like these companies, food and beverage companies need to implement more stringent practices—whether mandated by the FDA or other regulatory authorities or not—to protect their business, consumers and the industry at large.
To do this, companies need to maintain an electronic, centralized repository of all quality-related information to make this information available to those responsible for reporting it and expediting the response. For organizations to address food safety and reporting concerns, they must proactively collect and manage regulatory submission data, ensuring that the information will be available within minutes of adverse events to stave off warning letters and other FDA reprimands.
With such an approach, organizations may be able automate the reporting process and submit files electronically to the FDA in the form they require, enabling companies to prepare themselves to report adverse events before these events occur, ensuring that business continues as usual in the case of an incident and daily operations are unaffected.
In response to the new requirements, food companies will require adequate quality and compliance processes and systems to ensure that all data is collected and submitted to the FDA in the correct electronic format. With the Reportable Food Registry, this includes the following data:
- Responsible party information including the food facility registration number
- Location of reportable food—meaning the current manufacturer, processor, packer and holder of the food to the best of the company’s knowledge
- Problem origination site (or sites)—location where the problem was identified
- Product problem—a summary of the problem, including time and reason of discovery, and information about the suspect products
- Distribution information
- Supplier information
As the FDA continues to take a sharper look at food safety standards, stakeholders from across the food industry spectrum also need to examine its practices to maintain product and supplier quality to mitigate risks and incidents. What’s clear is that the future of quality and safety in the food manufacturing process is dependent on the ability of organizations to respond swiftly to external pressures like legislation and internal quality management requirements. Adverse events, critical incidents and food safety issues are not going away, but companies can improve their quality practices to reduce the impact they have starting now.
Sparta Systems, Inc. is the leading provider of enterprise quality management software.