You have a supply chain program. The supply chain program is a prerequisite programfor the safe manufacture of your product. For your ingredients, packaging and other materials, you are sourcing the best materials at the price you are willing to pay. For each ingredient, you have agreed upon specifications with your supplier. Some of those specs are sensory-related, like color, and affect quality. Some of those specs are chemical, like pH or moisture content. Some of those specs are microbiological, like Aerobic Plate Count or absence of Salmonella.
- Supply chain preventive controls are required for ingredients where YOUR suppliers control the hazards.
- A supply chain preventive control is required for imported packaging when a hazard is identified
The second requirement above is enforced under the Foreign Supplier Verification Program (FSVP) rule. Do you have imported ingredients? These must meet the same food safety standards as domestic ingredients, under the FSVP rule.
Only for those ingredients where you have identified a hazard requiring a preventive control AND the preventive control is a supply chain preventive control, are you REQUIRED to have a supply chain preventive control in your written food safety plan.
Most food manufacturers do not have a supply chain preventive control.
Why would you not have a supply chain preventive control?
- You have not identified a hazard in an ingredient or packaging.
- You identified a hazard and are controlling the hazard under your own roof.
- Your customer will control the hazard.
The good news is there is no validation of a supply chain preventive control! The Preventive Controls for Human Food rule only requires validation of process preventive controls. If you want to read the requirements for supply chain preventive controls in the FDA rule, follow the previous link and find Subpart G at the end of the rule. However, I recommend starting with the FDA At-a-glance document which provides a neat summary of the rule.
Paperwork! Paperwork! Yes, it is all about verification. Include verification of your supply chain preventive control in your food safety plan. Your FDA inspector will ask to see it. Supplier verification is discussed in a separate blog post.
Still not sure if you have a supply chain preventive control? The ConnectFood website has free resources, and the folks at ConnectFood are here to help! Contact us.
Kathy Knutson, Ph.D., Lead Instructor for Preventive Controls for Human Food (PCHF), Preventive Controls Qualified Individual (PCQI), and trained in prevention of Intentional Adulteration (IA). She has food safety expertise in microbiology, hazard analysis, and risk assessment. As a recovering academic, she resides in Green Bay home-of-the-Packers, Wisconsin with her brilliant husband and two handsome sons. Learn more about her consulting services at https://www.linkedin.com/in/kathyknutsonphd.