Audits & Analytics – Know for Sure

Emily Sohn’s column Peanut Butter’s Checkered Food Safety History chronicles the recent history and scope of bacterial contamination and recalls focusing on four food products – peanut butter, cantaloupe, ground beef and spinach.  Each food stuff has its particular problems be it the rough rind on cantaloupe or the multiple animal sources of ground beef plus their own favorite pathogen problems with Salmonella, E. coli or Listeria.

She rightly points to the large scale extended and complicated food supply chain as a major contributor to the outbreak problems we face in today’s food market. Our experience suggests that best first line defense is the current Food Safety Management System model contained in standards and regulations such as ISO 22000, the Food Safety Modernization Act and the Global Food Safety Initiative.

These depend on a well defined system bolstered by analytics and real-time role specific reporting for timely and well informed decision making. This is summarized by a three step program:

  • Know your production and quality systems
  • Know your supply chain
  • Know for sure – verify with audits and use analytics to get maximum results from audits.

In our direct experience we have observed that integrating HACCP programs and SPC improves food safety results and in the case of ground beef purchase by the National School Lunch Program results in supply chains that delivered ground beef that never tested positive for the pathogens monitored. We also believe the additional step of extracting actionable information from audits with analytics helps maximize the food safety outcome.

Will these strategies eliminate all possibility of food safety events? No. Will they give us the best chance of a good outcome? Yes.

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

Process Control and the Food Safety Modernization Act

We have now had about 6 months to study the Food Safety Modernization Act (FSMA). This time has allowed some of the dust to settle. There are several more interesting parts to the act. One part includes the use of the word “verification,” which is mentioned 16 times. The big question is: How will the U.S. Food and Drug Administration (FDA) define verification for interpretation of the regulations? Verification can be defined in several ways.  The new regulations will require verification that the food safety system is working effectively. Finished product testing and environmental testing will be included in the verification process. These verification activities must be recorded, and the records must be made available to FDA upon request.

Read article in Food Safety

FDA Warning Letters: Lessons for Industry

David Acheson has begun a regular feature in the Leavitt Partners blog where he be examining the warning letters that the FDA has issued to the food industry. As he discusses, these should provide an insight into enforcement behavior as the Food Safety Modernization Act comes to bear.  It is instructive that among the FDA warning letters from January 1, 2011 to May 24, 2011. the largest category is for current Good Manufacturing Practices (cGMP) violations. This implies that food processors will be well advised to have their food safety plan up to snuff and that they have implemented a competent Food Safety Management System.

You can view a recording of a webinar “Comprehensive Strategies to Protect Your Brand” we did with David on these topics.

 

 

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.

Convergence – Industry Standards and Government Regulations

“The Food Safety Modernization Act’s preventive approach to food safety may seem obvious in hindsight – and it is already a food industry norm, FDA’s deputy commissioner for foods said on Thursday.” Food Navigator 20-May-2011

 
Industry standards (ISO 22000, GFSI) and government regulations such as the Food Safety Modernization Act all have at their core an auditable HACCP-based Food Safety Management system. Much of the kvetching about FSMA in the popular press has missed the point that the convergence of regulation and good industry practice is a done deal and that all parties recognize that “science based” systems are the best way to maximize food safety.
 
You can view a summary of our webinars on this topic at http://bit.ly/jiUR8t .

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.