Traceability and Product Recalls
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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
Transcript of Traceability and Product Recalls
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
Traceability, Lot Tracking and Recall
Webinar
“About 1 in 6, or 48 million people (in the US), get sick each year from contaminated food, with 128,000
hospitalizations, and 3,000 deaths annually.” Center for Disease Control
Michael Benedick
@ERPSoftware4RU
David Silva
@BlueLinkERP
Over 20 years’ experience in the industry
Marketing Manager
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
What is Product Traceability?
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
source
Industries Involved
Any industry you can think of is involved!
“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
Food and Pharma/Medical Recall Statistics
“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
2008 2009 2010 2011December 16 28 24 54November 12 34 29 30
October 19 28 27 38September 20 25 25 27
August 13 24 51 22July 13 58 36 18June 14 30 28 29May 14 25 22 38April 21 134 22 38
March 28 120 58 44February 28 272 25 31January 19 147 43 38
217 925 390 407
USA
“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.”
Health Canada
Canada
Food and Pharma/Medical Recall Statistics
2008 2009 2010 2011December 23 17 45 24November 14 13 22 27
October 24 10 20 24September 24 10 18 39
August 38 27 23 22July 16 16 26 20June 9 21 24 35May 14 17 19 25April 5 34 21 29
March 22 29 42 17February 10 37 11 15January 7 25 15 21
206 256 286 298
Regulating Bodies in the USA
FDA also deals with Medicine, Medical Devices, Drugs, Veterinary Products, Cosmetics
Motor Vehicle Consumer Products
Pesticides Boats
“It is a widely reported fact that over 20 million people have at one time taken a drug that was eventually recalled.” Resource for the People [USA]
Food and Beverage
Transport Canada also deals with Boats
“Traceability and Management is Canada’s weakest category.” World Ranking 2010 Food Safety Performance
Motor VehicleFood and Beverage
Health Canada also deals with Pesticides, Medicine, Medical
Devices, Drugs, Veterinary Products and Cosmetics
Consumer Products
Regulating Bodies in Canada
The CFIA’s plans and priorities link directly to the Government
of Canada’s.
1926• Federal Food,
Drug and Cosmetic Act
2002• Bioterrorism
Preparedness and Response Act
2009• Food Safety
Enhancement Act
2011• Food Safety
Modernization Act
“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?
“More than 200 diseases are spread through food.” WHO
How are Regulating Bodies in Canada Managing Traceability?
1997
• Canadian Food Inspection Agency Act
2012
• Safe Food for Canadians Act
Today
• CFIA’s Improved Food Inspection Model
Hint: Every company along the supply chain.
Who is Responsible?
Farmer Manufacturer Distributor Supplier Vendor
“One forward and one back”
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
• Information when needed during a recall – Odds are you will be involved
someday • Minimize impact on business
– Only recall necessary products • Customer satisfaction • It is the law
– Regulating bodies require it
“Coordinating recall issues with suppliers and distributors is a real concern for almost 70% of executives surveyed.” Supply Chain Digest
Benefits of Traceability
• Identify specific lots to avoid recalling all products
• Ability to manage product expiry dates• Gain your customers’ confidence• Easier certification approval• Technology grants for traceability
investments
Using Software to Aid Traceability
Recall Report
“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
• Recalls are not going away• More regulatory action/involvement• Everybody has to track• One back and one forward • Software helps!
“Contaminated foods cost the US economy nearly $7 billion annually.” The Washington Times [USA]
Summary
Next steps…
Blue Link Associates www.BlueLinkERP.com1-877-258-5465 x230
• Slides can be downloaded from www.BlueLinkERP.com• Download our Lot Tracking Whitepaper• Contact us for additional information
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
