Quality Safety Systems: Focusing on Prevention
By NIKKI WILLETT, Vice President of Product Marketing & Regulatory Affairs, Pilgrim Software Inc.
After a long wait, President Obama signed into law the Food Safety Modernization Act (FSMA) — the largest overhaul of our food system since 1938 — with a focus on prevention and traceability. With the recall of more than 550 million eggs and over 1,500 people sickened from salmonella, the 2006 E. coli spinach scare and the 2008 tomato recall all still fresh on our minds, this bill couldn’t be served up at a better time. These outbreaks exposed a big problem with our food safety system.
Many of the backers of this bill feel that it could have prevented or at least minimized these outbreaks, and are hopeful that it will “solve” all potential future outbreaks. However, the 483 violations found at the two egg plants were mostly facility-focused and clear violations of the Salmonella Prevention Plan. While the FDA has focused on the state of a food facility’s environment, where is the focus on the quality and safety systems that are supposed to be in place at the company to prevent a potential national crisis? A recall like the egg recall severely hurts consumer confidence. When consumer confidence in the nation’s food supply is weakened, it often causes a company irreparable damage in reputation and bottom line. The good news is that the biggest change is the focus on prevention.
Several key FDA initiatives and programs will result from FSMA, including more focus on:
FDA recalls — empowering the FDA to issue mandatory recalls on food products
Inspections — improved frequency of inspections especially for high-risk facilities
- Monitoring the Food Supply — companies will submit sales and food shipment records so that products can be tracked through the food supply chain.
- Identifying Risks — companies will submit detailed reports identifying risks within their facilities and systems, creating a plan for preventing contamination and a plan for handling problems when they occur
- Imported Foods — importers must verify the safety standards of foreign companies that supply their products and certify they meet the same standards required for production in the U.S.
With 60 percent of fresh fruits and vegetables and 80 percent of seafood coming from outside the U.S., imported food makes up a substantial and growing portion of our food supply. Also, we are increasingly eating foods that are consumed raw and that have often been associated with foodborne illness outbreaks, including leafy greens such as spinach. Yet outbreaks continue to happen.
It’s true that food processing companies are faced with the continuous challenge of maximizing food safety while adhering to the growing number of regulations, such as ISO 22000, FDA 21 CFR Part 110, FDA Bioterrorism Act of 2002, HACCP and upcoming regulations from FSMA. In addition to their concerns about their own internal operations, however, how are food companies managing their suppliers? Companies should start looking at their supply chain now and begin developing a verification program as it will be a challenge to get a system in place if you wait until the FDA issues the regulation. In addition, companies will need to stay abreast of changes with new regulations as they are developed to ensure they are continuously in the best position to be most responsive.
But while a lack of preparedness presents challenges, the real problem lies within the organization’s processes. In the majority of cases, they are fragmented and disconnected. Although food companies are currently required to track the products they purchase and then ship out, this information is usually on paper and not always easily available. Different departments in the corporation are often responsible for different aspects of production and may have their own methods of tracking the information. However, even Public Health officials rely on this information during a disease outbreak to determine the source of an outbreak and all the foods that might be affected. Lengthy paper trails complicate investigations and increase the chance that a non-contaminated food will be recalled, inadvertently exploding into a “brand reputation” crisis for a company.
Food processing companies need to take a look into the same principles of industrial automation and apply them to best practices in quality and safety management automation, and think of the system as a whole — a global program, trained employees, well-documented SOPs and properly utilized technology to put global practices and procedures in place. Right now the law does not require electronic records, but many companies are using or preparing to use tracking technology though not yet applying it to other areas now identified in the new Act.
By maintaining total automated quality and safety process control, food processing companies can look at achieving consistent yield and uniformity from product to product, and from batch to batch, with increased traceability and trust along your entire production process for complete sustainability.
For more information, please visit www.pilgrimsoftware.com.