FSMA Fridays: Traceability Requirements And Best Practices (Part Two Of Four)

On the last Friday of every month, Barbara Levin of SafetyChain, a leading provider of food safety and quality assurance automation and compliance solutions, hosts FSMA Fridays™, the leading online forum for the food and beverage community to learn the latest information about the FDA’s Food Safety Modernization Act (FSMA). Featuring Dr. David Acheson, the popular monthly interactive pod/webcast is sponsored by SafetyChain Software and The Acheson Group.

In the first portion of FSMA Fridays: Traceability Requirements And Best Practices, Safety Chain’s Barbara Levin discussed the difference between mock recalls, recall plans, and preventative controls, why traceability is a part of FSMA, and what would be consider adequate record keeping under upcoming FSMA guidelines with the Acheson Group’s David Acheson and Jennifer McEntire. Here, in part two of the segment on traceability requirements and best practices, the panel address questions regarding what FSMA requires the FDA to do in terms of traceability, recommended actions for traceability pilot programs, and how to initiate those actions in pilot programs.

Barbara: Let's go to our next question, and Jen, I'm going to come back to you for this. What does FSMA require FDA to do in terms of traceability? Put some framework around that for us.

Jennifer: As David mentioned, there are record-keeping requirements in place today related to traceability. Pre-FSMA, there were record-keeping requirements, and it does stem from the bioterrorism act-related regulations. It's the one up, one back: where did you get the products from? Where did you send the product to?

There are a few more details, but it isn't a terribly complex requirement when you read it on paper. In actuality, accomplishing the acquisition of records — where did you get specific products from, how did you use those product, where did those products go, and what did that handshake look like — as David mentioned, it becomes very complicated and cumbersome when you have these very complicated supply chains and people using a multitude of different systems even sometimes within their own facilities to collect this information.

The first thing that Congress required the FDA to do through FSMA was to do pilot studies to understand what works and what doesn't. What are those practices that, as we look at the variety of practices within the industry, seem to work? What are the technologies that seem to work? FSMA called out that the FDA needed to do two pilot studies: one related to processed foods, and one related to fresh produce — different categories of product, different types of supply chains, but both of which had issues.

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