How Paper Based Traceability for the Food Industry Became “Non”-Legal and a Major Liability

Guest Blog by

Dave Miller, President
Mobia Soultions
 davemiller@mobiasolutions.com
864-881-1505

When the Food Safety Modernization Act (FSMA) was first passed many initially interpreted it to mandate electronic traceability.  Given the industry push, the FDA’s often stated complaint about the ineffectiveness of paper traceability and the obvious preferences in the bill’s wording – that conclusion was understandable.  A closer reading showed that FSMA implied electronic traceability but stopped short of specifically requiring it.  But while FSMA did not directly specify the type of traceability technology required , it does require that the chosen technology work and work reliably – and that is where this story takes a sharp turn.

The concept of “efficacy” (working reliably) is an intrinsic part of every law and regulation that requires a specific function be performed. So, for instance, if you are required to keep grass below 6 inches high you don’t have to use a mower to keep the grass low, but if you are subsequently caught with high grass, then saying that you were using  “alien crop circles  to do it for you” would not be a valid defense. In the case of FSMA, there is no electronic traceability requirement per se, but your technology does have to work well and reliably – And now there are governmental and commercial studies are coming to light that prove paper traceability is not even close to meeting the efficacy standard.

In the absence of proof to the contrary – we as an industry have been assuming that manually searching of paper records for “words of interest”, such as lot numbers, item numbers, vendors, customers, etc.  , was slower, more costly, and a “little less accurate” than electronic searches. Until now that accuracy assumption had never been but to the test and we really had no idea of how much data was being missed in our manual searches.  Those tests have now been done – and the results ain’t pretty. There is now reliable proof that individual manual searches are only about 50% effective. 

To give you some idea of the problem, let’s do a simple test. Read the follow sentence one time, at your normal reading rate, and count the number of “f”s as you read.

 FINISHED FILES ARE THE RESULT OF YEARS OF SCIENTIFIC STUDY COMBINED WITH THE EXPERIENCE OF YEARS.

Unless you went letter by letter counting, you likely found three, and even if you’ve found all six, most people don’t.  Now consider how well you would do if you were reviewing boxes and boxes of documents.

According to several governmental and private sector studies1,2, manual searches of paper documents were only able to find  40% to 60%  of “words of interest” known to be in the documents. And unlike these studies, in real world conditions we never know how many times the “words of interest”  appear in our documents so we never know how many were missed.

So what affect does a 50% find rate have in a manufacturing environment? If, for example a vendor told us they had shipped bad lots, but after searching all of our boxes of documents we correctly identify only 50% of the actually received vendor’s lots, then have the same “failure to find” rate for the manufactured lots made from those vendor’s lots  and then the ship to customers as well   – we are down to identifying a mere 12.5%  (50% * 50% *50%) of actual impacted shipments!

cascade of error rates

 

 

 

 

 

 

 

Even the 50% search loss only includes the losses encountered when searching correct, clean typed text pages.  Now assume the search was of hand written documents and included transcription errors. With imperfect data collection and documents the 12.5% effectively rate can easily be assumed to drop below 10%.  If other members of the supply chain used paper traceability as well, their loss of accuracy would be multiplied by this loss of accuracy.  So potentially a find rate as bad as  12.5% * 12.5% = 1.56%.

The FDA’s experience with paper seems to backup this grim finding. Until now paper traceability has survived because electronic solutions were outside of the practical cost range of many organizations. But the recent appearance of low cost, online inventory management systems, such as Mobia, effectively removes what was a valid claim by companies that they could not afford nor technically support an electronic system.

It is no secret that many companies are more motivated by potential business risks than criminal concerns. Here too, paper traceability is a significant liability.  Given the demonstrably poor performance of paper traceability vs. electronic traceability –  paper based systems cannot be reasonably called  “current good practices”. In the event of an “incident”, the damage caused by a food company’s inability to reliably track product due, to paper’s limitations, would dramatically increase the likelihood and size of “punitive damages”.   “Foreseeable Risk” may become you least favorite term.

Two other non-criminal concerns are insurance and commercial accreditations such as Global Food Safety Initiative (GFSI). Up until now insurance companies and underwriters have assumed traceability was their insured company’s internal matter. After recent contamination events, the insurance companies began to be concerned that their exposure may not be limited to just their insured’s activities but their insured’s entire supply chain. As such underwriters are now beginning to seek waivers or to make traceability demands on their insured’s entire supply chain.

As for GFSI and other accreditation organizations, they have always required that companies meet all pertinent food laws as a requirement to achieve their certification.  In other words, for US food companies, if you aren’t meeting FSMA requirements, such as effective traceability, your GFSI and other accreditations are at risk.

In the end, while FSMA didn’t directly mandate electronic traceability – it seems obvious that paper traceability is a functional failure.  At the very least companies with paper traceability will have an enormous disadvantage in proving compliance and efficacy.  And legal or not would you like to risk your business and freedom, let alone the safety of your customers and perhaps family, on a safety system that was 10% reliable?

(You can view a recording of Dave’s webinar, “The Impact of New Regulations and Standards on Packaging Traceability” )

1 Richmond Journal of Law and Technology Vol. XVII, Issue 3 ; New York Times

2 John Markoff “Smarter Than You Think” March 4,2011

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EU ag ministers hold emergency E.coli summit

European agricultural ministers meet for summit on E.coli outbreak. Much like the previous US salsa outbreak, the claimed culprits have changed from Spanish cucumbers to German bean sprouts and none have proved positive. Demonstrates the difficulty of epidemiology with perishables. The EU food safety system is very good, but even the best food safety system can fail. Therefore, we need to plan for failure when the outlier is reached.

How Should Packaging Be Addressed in Your Food Safety Program?

The role of packaging in food safety systems and audits seems to be a current front and center issue.  This is probably the result of  food processers working down the list to packaging venders during the last year as they work through their supply chain and what they need for their own GFSI audits.

Rick Stier has contributed to the discussion with his article in the April/May issue of Food Safety Magazine, “How Should Packaging Be Addressed in your Food Safety Program?”   A good comprehensive and pragmatic article.

Webinar – The Impact of New Regulations and Standards on Packaging Traceability

Consumer, commercial and regulatory concerns require an effective track and trace system for all food products. On April 28, David Miller, President, Operations Technologies, will present an overview of the requirements and solutions for food packaging traceability.

Supply chain traceability links the physical flow of products with the flow of information about them.  All items must be uniquely identified and the information made available to all supply chain partners. Successful traceability depends on the design and production of packaging coupled with effective data collection and reporting systems. Mr. Miller will discuss:Dave Miller

  • Industry standards such as GS1 Global Trade Item Number (GTIN) and mpXML
  • Impact of new regulations including the Food Safety Modernization Act (FSMA)
  • Technology overview
    • Labeling
    • Data collection
    • Data management and exchange including internet based systems
    • Operational implications and capital and operating costs including consumables

Mr. Miller will present “The Impact of New Regulations and Standards on Packaging Traceability” on Thursday, April 28 at 11AM Pacific, 2PM Eastern time. Register at: http://www.nwasoft.com/PACKwebinar2.htm .

About David Miller

David Miller is the president and founder of Operations Technologies and its Mobia subsidiary. He is an industry recognized expert in technology, inventory management, and traceability and an internationally recognized expert on food traceability. He has been asked to speak before the US Congress, Institute of Food Technologists (IFT), Society of Manufacturing Engineers (SME), American Dairy Products Institute (ADPI), American Butter Institute (ABI), American Production and Inventory Control Society (APICS), and American Food Safety Institute (AFSI).

 He is an “Inc 500” award winner and has degrees in Math and Computer Science from Georgia Tech and Armstrong Universities.

Symposium Explores the Impact of New Food Safety Regulations and the Global Food Safety Initiative on Food Processors

Portland, Oregon (June 07, 2010) – New food safety regulations moving through the U.S. Congress, combined with the Global Food Safety Initiative (GFSI), demand greater safety management by food processors. At the 2010 Institute of Food Technologists Annual Meeting, Symposium 171, “The Operational Implications of New Food Safety Regulations and GFSI” will explore the issue. The Symposium will be presented Monday, July 19, 2010, at 1:30 PM – 3:00 PM, in room S404 in Chicago’s McCormick Place.

Food processors now face the need to implement a modern Food Safety Management System (FSMS). Both the pending U.S. food safety legislation now in Congress, and the commercial requirements of GFSI compliance, create food safety and traceability management demands that overwhelm any paper-based, non-automated system.  The cost-effective and time-efficient way to meet these requirements is an integrated electronic system that automates the operational functions of food safety and quality management, traceability and compliance. Not only does this approach make a compliant FSMS more efficient and effective, it also reduces corporate risk and total cost of ownership.

The symposium contains four presentations by industry experts:

  • 171-01. Increasing Verification Effectiveness of Prerequisite Programs, John G. Surak, Surak and Associates., Clemson, SC
  • 171-02. Automated HACCP and Quality Management, Jeffery L. Cawley, Northwest Analytical Inc., Portland, OR
  • 171-03. Track and Trace Compliance with Food Safety Regulations, David Miller, Operations Technologies, Greenville, SC
  • 171-04. Boost Safety and Lower Risk through Effective GFSI and New Safety Regulations Record Management, Deborah Kacera, Pilgrim Software, Inc., Tampa, FL

A preliminary form of this session, “Implementing Food Safety Management Systems to Meet Regulations and GFSI Standards,” was presented March 30, 2010, as part of Pilgrim Software’s Educational Webinar Series for 2010. The recorded webcast and presentations are available at: http://bit.ly/c3LHbL .

About Surak and Associates

John Surak is principal of Surak and Associates, a full service food safety and quality consulting service. He works with the food processing industry in developing food safety and quality management systems, designing and implementing process control systems, and implementing Six Sigma and business analytics systems. http://www.stratecon-intl.com/jsurak.html

 About Northwest Analytical

Northwest Analytical is the leading provider of quality and food safety management systems and SPC software to the food industry. With the NWA Quality Information System, food processors successfully handle applications ranging from HACCP program management to fill weight control and process improvement. NWA Quality software enables food companies to produce higher-quality, safer products while maximizing efficiency and profitability. Additional information is available at www.nwasoft.com/appnotes/ind-food.htm.

About Operations Technologies
Operations Technologies provides inventory, production, and “track& trace” management software to the food and pharmaceutical industries. The software is highly configurable, expandable and easily integrated into standard ERP and Accounting systems. Operations Technologies’ products can be “self hosted” or provided as Cloud (SaaS) Internet based subscription software services. Core functionality includes warehouse management, production management, traceability, shop floor interfaces and distributed labeling systems. Customers include a cadre of large and small industry leaders such as Cargill, Dairi Concepts, Dairy Farmers of America (Borden’s), Nestle, Organic Valley and Roche Pharmaceuticals. For more information, visit the company online at www.MobiaSolutions.com .

About Pilgrim Software

Pilgrim Software is a world-leading provider of Enterprise Quality, Safety and Compliance Management solutions for the Food & Beverage, Life Sciences, and other FDA-regulated industries. Pilgrim has pioneered effective, integrated software solutions used by more than 300 customers globally, and more than 750,000 end users, to meet the diverse challenges of the world’s highly competitive marketplace.  Pilgrim’s fully web-based solutions, built on industry best practices, help businesses centrally manage domestic and international operations to ensure product safety and quality, reduce manufacturing costs and improve customer satisfaction.  www.pilgrimsoftware.com

For further information, contact:

Jeffery Cawley, VP Market Development
Northwest Analytical, Inc.
jcawley@nwasoft.com
888-692-7638 or 503-224-7727 X112
www.nwasoft.com