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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2. 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

3. David Silva Michael Benedick
Marketing Manager Over 20 years’ experience in the
industry
@BlueLinkERP @ERPSoftware4RU

4. Agenda
What is Product Traceability?
Industries Involved
Food and Pharma/Medical Recall Statistics
Regulating Bodies in USA and Canada
How are Regulating Bodies Managing Traceability
Overview of Requirements
The Benefits of Traceability
Summary

5. 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

6. 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

7. Food and Pharma/Medical Recall
Statistics
2008 2009 2010 2011
December 16 28 24 54
November 12 34 29 30
USA October 19 28 27 38
September 20 25 25 27
August 13 24 51 22
July 13 58 36 18
June 14 30 28 29
May 14 25 22 38
April 21 134 22 38
March 28 120 58 44
February 28 272 25 31
January 19 147 43 38
217 925 390 407
“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

8. Food and Pharma/Medical Recall
Statistics
2008 2009 2010 2011
December 23 17 45 24
November 14 13 22 27
Canada October 24 10 20 24
September 24 10 18 39
August 38 27 23 22
July 16 16 26 20
June 9 21 24 35
May 14 17 19 25
April 5 34 21 29
March 22 29 42 17
February 10 37 11 15
January 7 25 15 21
206 256 286 298
“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

9. Regulating Bodies in the USA
FDA also deals with Medicine,
Medical Devices, Drugs,
Veterinary Products, Cosmetics
Motor Vehicle Consumer Products
Food and Beverage
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]

10. Regulating Bodies in Canada
The CFIA’s plans and priorities Transport Canada also deals Health Canada also deals with
link directly to the Government with Boats Pesticides, Medicine, Medical
of Canada’s. Devices, Drugs, Veterinary
Products and Cosmetics
Food and Beverage Motor Vehicle Consumer Products
“Traceability and Management is Canada’s weakest category.”
World Ranking 2010 Food Safety Performance

11. How are Regulating Bodies in the
USA Managing Traceability?
1926 2002 2009 2011
• Federal Food, • Bioterrorism • Food Safety • Food Safety
Drug and Preparedness Enhancement Modernization
Cosmetic Act and Response Act Act
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

12. How are Regulating Bodies in
Canada Managing Traceability?
1997 2012 Today
• Canadian Food • Safe Food for • CFIA’s Improved Food
Inspection Agency Act Canadians Act Inspection Model
“More than 200 diseases are spread through food.” WHO

13. Who is Responsible?
Farmer Manufacturer Distributor Supplier Vendor
“One forward and one back”
Hint: Every company along the supply chain.

14. Overview of Tracking Requirements
What Information
When to Track How to Track
to Track
Product Description All Movements
- Pack and size - Initial receipt of goods - Manually (pen and paper)
- Brand name - Used in BOM or kit - Spreadsheets
- Expiry date - Shipped - Software such as Blue Link
- Best before date - Adjusted
- Lot number - Transferred
- Serial number
Quantities Originally
Received
- Cases, Drums, Weights,
Gallons, etc.
“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

15. Benefits of Traceability
• 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

16. Using Software to Aid 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

17. 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

19. Summary
• 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]

20. Next steps…
• Slides can be downloaded from www.BlueLinkERP.com
• Download our Lot Tracking Whitepaper
• Contact us for additional information
Blue Link Associates
www.BlueLinkERP.com
1-877-258-5465 x230
sales@bluelink.ca

21. 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