How do the rules recently proposed by the FDA under the Food Safety Modernization Act (FSMA) impact the way a company should prepare for contamination events?
Two years after President Obama signed the sweeping FSMA into law, the FDA has issued two proposed rules on produce safety standards and preventive controls for food processing facilities. The new rules, which will govern about 80 percent of the U.S. food supply, aim to usher in a new era of food safety by shifting the focus of federal regulators from reacting to contaminations to preventing them.
As a result, it is more important than ever to have reliable and efficient lean manufacturing practices in place as part of your overall contamination prevention and recovery plan. Under the proposed rules, facilities will be required to keep a written food safety plan, including hazard analysis. An effective strategy will protect your company’s brand and get your production line back on track as quickly as possible.
One important component should be a record-keeping system that helps you easily retrieve the specific records that will be requested by the FDA if your company is involved in a contamination event. Implementing a computer-based rapid detection system will provide you with the tools to comply with the FSMA and provide security and peace of mind as you institute a positive release method.
When does the FDA request information from a manufacturer, and what do they want to know?
As part of its Reportable Food Registry (RFR), the FDA requires manufacturers to report any products that have left your plant that could potentially cause illness to consumers. Reports must be submitted to the FDA within 24 hours of realizing that a contaminated product has left your facility. These reports may be primary, meaning you notify the FDA that your product has been contaminated; or subsequent, meaning you are reporting contaminated products you received from a supplier. Likewise, your customers could report that products received from you are contaminated in some way. Because of this requirement, even if you are confident that all products leaving your facility are clean and contamination-free, you may need to produce detailed records of your quality testing for the FDA.
How can companies be proactive in avoiding contamination events and ensuring they comply with the FDA’s new requirements?
- Do everything possible to ensure product safety before goods leave your facility. Manufacturers feel pressure to get products out to market as quickly as possible. This may entice them to release lots before all quality testing is complete: the “ship and pray” method. Because manufacturers are confident that their products are clean 99 percent of the time, they will take a potentially costly risk by shipping lots before samples from those batches are tested. Although their products are clean most of the time, if there is a contamination event and hazardous products have left the facility, they must be reported to the FDA and recalled — whether they are on trucks moving around the country or, even worse, on shelves and in the homes of consumers. Just the notion of a recall can cause brand damage, even when there is no contamination. And major retailers will not spend time searching for particular lot numbers: they simply will remove all relevant product inventory from their shelves, causing lost sales.
While the FDA requires reporting on all contaminated products that leave a facility, it does not require contaminated products to be reported if they have not yet left the plant, as they do not pose a risk to consumers if they never leave the facility. This makes it all the more important to test your products before releasing them.
- Employ rapid microbial testing methods. While traditional microbial testing methods add 4–14 days to the production cycle, a rapid detection system provides reliable microbiological results in just 2–3 days. By removing days from the product quality testing process, manufacturers find it more affordable to hold each lot until negative results for contamination are confirmed. This eliminates the need to notify the FDA of a potential contamination event or a possible recall of products that shipped before test results were available.
- Implement a testing system with robust record-keeping technology. The proposed rules require facilities to keep records of preventive controls, monitoring, corrective actions and verification. They also expand the FDA’s access to records beyond those related to the specific suspect product. And companies may still be required to produce records to the FDA even if their products were tested and confirmed to be contamination-free when they left the plant. In addition to the Reportable Food Registry (RFR), the FDA enforces specific regulations in its guidelines on the Establishment and Maintenance of Records (EMR), which includes the source of your ingredients as well as what happens to your products once they leave your facility.
The FDA’s regulations on the EMR require a detailed list of information, including, but not limited to, the name and contact information for the source of each ingredient, dates ingredients were received, quantity and type of packaging of these ingredients, details about the transportation companies that delivered ingredients to you and transported products to your recipients, dates your products are released and more. These records must be created for all lots, held for as long as two years, and kept well-organized so they are easily accessible for the FDA in the event of a contamination at any point in the supply chain.
These regulations can be quite overwhelming, but help is available. Although the primary benefit of a rapid screening is to release products faster, they can also provide valuable assistance in complying with FDA record-keeping requirements.
For example, the Celsis Rapid Detection system includes a fully customizable database that allows for storage of records related to quality department microbiological testing, and provides querying and reporting capabilities that can make accessing specific data quick and easy. The database allows results to be exported as Excel files to facilitate simple data sharing, and can be configured for remote access. Results are secure and protected, as the database can be installed on a networked server with firewall protection and scheduled backups.
When selecting a system, make sure the software is compatible with LIMS and ERP systems like SAP. The Innovate.im software that supports the Celsis Innovate™ system can be configured to share data in real time with these and other software platforms. It also supports compliance with 21CFR through features like password security, protected data, easy search capabilities, report exporting, record logging and more.
How can a Rapid Detection system help companies comply with the FSMA?
In addition to reducing the production cycle by several days, rapid detection systems also simplify and streamline the record-keeping process, thus making it easier to comply with the FSMA. These significant benefits also contribute to lean manufacturing practices, including reduced working capital requirements due to shortened cycle times, improved return on invested capital, and optimized inventories and warehouse utilization.
If a company is involved in a contamination event, a rapid detection system can help not only report the incident to the FDA quickly and accurately, but also physically recover from the event faster. The rapid results provided by systems such as Celsis detect contamination earlier in the process, while products are still being held in the warehouse. This allows the manufacturer to quickly identify the contamination, find the source, take corrective action, pull the affected products before they are released into distribution, prevent having to notify the FDA or customers, and get the production cycle back up and running fast.
Scott Scdoris serves as Director, Food & Beverage for Celsis Rapid Detection. Experienced in microbiological testing procedures for the dairy and beverage industry, Mr. Scdoris has been with Celsis for more than 10 years and works closely with Celsis’ customers, product management and technical support teams to develop customer-focused innovations. He helps prospective customers quantify the value of adopting Celsis Rapid Detection systems, and successfully implement and validate their systems. Prior to joining Celsis, he spent 15 years in quality control for the dairy industry, most recently as Quality Manager for Morningstar Foods, a division of Dean Foods in Gustine, CA. Mr. Scdoris graduated from Portland State University with a degree in biology. He can be contacted at firstname.lastname@example.org.
Celsis Rapid Detection is the world leader in rapid microbial methods for industry. Utilizing patented enzyme technology, it develops and supplies screening systems (instruments, software, reagents and services) for the rapid detection of microbial contamination in food and beverage, home and beauty and pharmaceutical products. Its rapid screening systems provide significant economic value by reducing the time it takes companies to test and release their raw materials, in-process goods and finished products to market. Celsis’ extensive client base includes hundreds of customers in more than 50 countries worldwide.