Under the new regulations, all affected firms would have to make food safety records available to FDA inspectors. Your company must identify not only the records that are maintained, but also their storage duration, their storage location, and how the records are protected (hard copy and electronic). Keep in mind that the bill would grant the FDA authority to compel the production of documents.
Specifications and requirements must be developed with some scientific rationale. The FDA websites and trade journals can provide valuable scientific data relating to contamination controls. If no scientific data is available, consider creating your own studies based on accepted practices.
Each company should detail the basic steps employed to prevent food hazards and should put those requirements into an auditable format so that compliance can be verified internally.
Supply Control
Your system needs to address the initial and ongoing evaluation of your supply chain. This will be particularly important for those companies importing product from foreign countries. Try to address any certification programs or quality expectations a new supplier must meet before purchase. In addition, identify how any raw materials or processes will be verified. Every company that intends to stay in business has a system for dealing with upset customers. A necessary component of any effective food safety plan covers the proactive steps taken to prevent food contamination. Many of these steps can be addressed in the HACCP plan.
My guess is you wouldn’t be in business if you didn’t already employ basic good manufacturing practices, which can range from pest control to facility security. The difficulty for some companies is providing a written plan that defines these processes. Each company should detail the basic steps employed to prevent food hazards and put those requirements into an auditable format so that compliance can be verified internally.
There’s no question about it; the new food safety bill is going to include more FDA on-site review. Good food safety plans can take time to develop, document, and implement, so it is probably not in your best interest to wait until you get that “we can’t wait to visit your facility” notice in the mail.
Pecoraro has been a food safety consultant and trainer for 15 years. He is also the food safety director for an international produce distribution firm. He can be reached at www.bmstraining.com.
References
- Food Safety Enhancement Act of 2009. H.R. 2749, section 743˚Facility registration fee. Available at: www.gpo.gov/fdsys/pkg/BILLS-111hr2749rfs/pdf/BILLS-111hr2749rfs.pdf. Accessed January 23, 2011.
- Food Safety Modernization Act. S. 510, section 101—Inspections of records. Available at: www.gpo.gov/fdsys/pkg/BILLS-111s510es/pdf/BILLS-111s510es.pdf. Accessed January 23, 2011.
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