Part 2 of 3
According to the 2022 Edition 2 Recall Index published by Sedgwick Brand Protection, by the end of the 2nd quarter of this year, there were 230 recalls related to FDA-regulated products. Compare this to a total of 270 recalls in 2021. Knock on wood that your company is not involved in a foodborne illness outbreak and/or recall, especially considering the average recall costs $10,000,000 (not all of those costs covered by recall insurance). However, in the event your company is involved, you should be prepared to respond with accurate traceability data.
Are you playing the Telephone Game?
In our last post, we talked about the FSMA Final Rule: Requirements for Additional Traceability Records for Certain Foods (FDA’s Food Traceability Final Rule), the Food Traceability List (FTL), and how traceability systems relate to the “Telephone Game” where at the end of the game the final message was often completely different than the original message.
Many companies rely on handwritten and physical documents, Excel spreadsheets, and/or multiple systems (electronic and manual) to trace products. The more “human touches” within a traceability system, the greater chance for human error and broken links in the food chain. This results in misinformation on product identification, loss of visibility to certain elements of a food product’s path from source to table, difficulty identifying food products involved in foodborne illness outbreaks, and large-scale recalls that could have had a narrower scope with better traceability systems in place.
Electronic data requirements may be a pain point for some food handlers and processors
While recording traceability information on paper documents is still acceptable according to this new Final Rule, the requirements to provide that data to FDA could prove onerous with manual systems. For example, if FDA requests traceability documentation, your company must provide it to them, along with any additional information required for them to understand your documentation, within 24 hours after the request has been made. While you can provide photocopies, scans, or other electronic records and FDA may provide some leeway with the 24-hour requirement, if the request is made due to a foodborne illness outbreak or other health hazard, FDA may enforce the 24-hour requirement. In addition, all traceability information must be provided in an electronic sortable spreadsheet. Any company using paper documentation would have to enter all that data into a single spreadsheet within the allotted timeframe (e.g., 24 hours).
If you do not have a robust traceability system in place – one that does not rely on multiple “human touches” – this is the time to invest in one.
Contact Kidder Consulting Services at (800) 918-8788 or firstname.lastname@example.org to start the development and implementation process for your new traceability recordkeeping procedures, Traceability Plan, and supporting documentation.
See FDA’s website for further details on FDA’s Food Traceability Final Rule.
Kidder Consulting Services
Kidder Consulting Services works with food companies and private equity firms (clients in the food industry) to bring a strategic, risk-based, proactive approach to food safety challenges. With over 20 years in industry, our experience includes food safety, regulatory compliance, supply chain management, operations, and due diligence work. Call or email us today to find out how we can help you address your food safety needs.