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Although Food, Medical and Pharmaceutical industries most readily come to mind when thinking about traceability and product recalls, there are many other industries involved. Whether you are a manufacturer, distributor or retailer, it is your responsibility to ensure that the integrity of the supply chain is not compromised due to improper product tracking. Regulatory bodies such as the FDA and CFIA have recently launched initiatives to increase accountability for traceability and product recalls. This presentation provides the following information: - What is product traceability? - What industries does it apply to? - Food and Pharma/Medical Recall statistics - Regulation bodies in the US and Canada - How regulatory bodies are enforcing traceability - Benefits of traceability - Traceability methods and next steps
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Transcript
Webinar
• Use the Question Pane in the GoToWebinar Console to Ask Questions!
• The webinar will be starting promptly at 2pm EST • Please phone in using the number below.
– Dial In Phone #: 416-507-1603– Access Code: 5726147– Press *6 to mute your line
Agenda1 What is Product Traceability? 2 Industries Involved3 Food and Pharma/Medical Recall Statistics4 Regulating Bodies in USA and Canada5 How are Regulating Bodies Managing Traceability 6 Overview of Requirements 7 The Benefits of Traceability 8 Summary
Wikipedia Definition – Traceability refers to the capability for tracking goods along the distribution chain on a batch/lot number or series number basis.
Why is it Important?- To recall product(s) deemed as unsafe/adulterated- Allow regulating bodies to track product(s) back to the
“There was a total of 2,363 recalls across all industries in the US or about 6.5 recalls a day in 2011. This was almost a 14% increase in the number of recalls from 2010.” USA Today
“According to RASMAS National Recall Center analysts, the top three product domains [in the health care industry] with the most activity by product count [for number of recalls] were
pharmaceuticals, food and operating room products.” Noblis
“The number of recalls in Canada has increased every year for the last several years. Health Canada expects that the rate of increase will likely remain more or less the same.”
“One of the most far-reaching food recalls in US history came in 2009, when the Peanut Corporation of America recalled in total 3913 different products from roughly 361 different
companies. “ MSNBC
How are Regulating Bodies in the USA Managing Traceability?
What Information to Track When to Track How to Track
Product Description All Movements
- Pack and size - Brand name - Expiry date - Best before date - Lot number - Serial number
- Initial receipt of goods - Used in BOM or kit- Shipped- Adjusted- Transferred
- Manually (pen and paper)- Spreadsheets - Software such as Blue Link
Quantities Originally Received
- Cases, Drums, Weights, Gallons, etc.
Overview of Tracking Requirements
“59% of the food facilities surveyed did not meet FDA’s requirements to maintain records about their sources, recipients, and transporters.” Office of Inspector General
“1/4 of the food facilities surveyed were not aware of FDA’s records requirements, others highlighted practices designed to improve traceability.” Office of Inspector General
References• Centre for Disease Control www.cdc.gov• USA Today www.usatoday.com• The Number of Product Alerts and Recalls Affecting Healthcare Industry Continue Upward Trend – RASMAS National Recall
Centre. • Health Canada www.hc-sc.gc.ca• CFIA www.inspection.gc.ca• FDA www.fda.gov• Resource for the People www.resource4thepeople.com• World Ranking 2010 Food Safety Performance – Johnson-Shoyama Graduate School of Public Policy • MSNBC www.nbcnews.com• World Health Organization www.who.int• Traceability in the Food Supply Chain - Office of Inspector General • Supply Chain Digest www.scdigest.com • The Washington Times www.washingtontimes.com