We have, of course, focused extensively on traceability issues, and an important part of that coverage came from Gary Fleming when he was working as Vice President of Industry Technology and Standards at the Produce Marketing Association.
Here are some of the pieces Gary has contributed in the past:
Late last year, PMA announced that Gary would be leaving PMA. This is how PMA’s President and CEO shared the news with the PMA board as soon as Gary tendered his resignation:
From Bryan Silbermann, PMA President & CEO
Gary Fleming, our much-valued Vice President of Industry Technology & Standards, will be resigning from his staff position effective November 3. Gary has been an integral part of the PMA management team for the past six years and has done so much to assist us in enhancing members’ use of data standards and efficiency tools. His most recent work of course has been to provide the essential staff expertise for the Produce Traceability Initiative. Gary will be speaking at PMA’s Fresh Connections in Charlotte, NC on November 3.
I asked Gary for permission to share with you his own words explaining the reason for his departure, which is related to balancing demands of work and family. Earlier this year he married Charla, who, to quote him, “has brought a new and exciting dimension to my life. While I am still focused on my career, I am seeking an opportunity to travel minimally and to perhaps start something where Charla and I can work together. My plan is to create my own business focused on supply chain efficiencies, project management, facilitation and general consulting, alongside my wife.”
You may recall that in my State of the Industry address in Anaheim, I mentioned how Gary has been on the road almost nonstop this past year. As most of you know, Gary has been based out of a home office in Denver.
Since Gary just tendered his resignation today, we have not had time to explore the various ways in which PMA might continue to have access to his expertise. Gary is leaving the PMA staff team on very good terms and has offered to remain engaged with PMA on a consulting basis. As we have much respect for one another and understand the rationale for his decision, please know that we will explore all reasonable options.
Many in the industry, though certainly understanding Gary’s personal motivations, did find the timing of his resignation surprising in light the Sisyphean task ahead to ensure the implementation of the Produce Traceability Initiative.
Gary, along with his wife, has launched a new consultancy, the Symbolon Group, which, as Bryan mentioned, is focused on helping companies/industries with supply chain efficiencies, traceability, facilitation roles and general consulting.
We reached out to Gary to see if he might be willing in his private capacity to contribute to the industry by speaking bluntly on the issue of traceability in general and the Produce Traceability Initiative in particular. He has been generous enough to contribute three separate pieces, which will run serially here at the Pundit. All are on the topic of the Produce Traceability Initiative (PTI).
Below you will see the first part of this three-part series, titled “Absent the PTI”. The second part of the series will discuss an assessment of both the IFT report, funded by the FDA, as well as the public hearing held December 9th and 10th in Washington, D.C. The third part of the series will look at the best practices created as part of the PTI and why they are necessary for effective implementation.
Before we run Gary’s piece, though, we thought it would good to get a little more insight into his purpose in leaving PMA and in his general thoughts on PTI. We asked Pundit Investigator and Special Projects Editor Mira Slott to raise some questions:
Indian Hills, Colorado
Q: Why did you leave PMA, and what is your new mission?
A: I left PMA on November 3rd in order to pursue running my own company along with my wife. Having my own company allows me to pursue the things for which I have passion and to exercise my own innovation to solutions.
Q: Tell us about your new company… could you describe the services you provide, the scope of clients, who could benefit from your services, etc.
A: My new company is called Symbolon Group (www.symbolongroup.com). We provide services such as group facilitation, project management, consultative services and boot camps for traceability, recall readiness, supply chain efficiencies, best practice development and activity-based modeling for ROI studies. We also provide a free monthly newsletter that updates the industry on issues related to traceability that is concise, to-the-point, and in a manner by which people can understand.
Q: How instrumental were you in development of PTI? Were you the original architect of the concept? How did the strategy unfold?
A: While at PMA, I was the lead architect of the PTI and the lead staff for the initiative between the sponsoring three trade associations. Having been formerly employed by GS1, I have a keen understanding of their standards and their approaches. I was then able to come up with a basic plan based upon our industry’s needs and practices, as well as the implementation of these standards in other industries.
As a group, and with the strong leadership of Cathy Green of Food Lion and backing of the three sponsoring trade association boards, we then refined the plan, along with 48 companies representing the produce supply chain, to what is now the milestones and timelines that make up the PTI Action Plan.
Q: How committed are you to the implementation of PTI and why? Do you see any other viable alternatives/traceability solutions? How critical and urgent is it for the industry to move forward with PTI at this time?
A: I am fully committed to the implementation of the PTI as I believe in it 100%. Traceability will not go away. It is needed right here, right now. Companies have to realize that having an internal traceability system of their own is not enough. They need to enable the FDA (the only company responsible for doing a traceback investigation from beginning to end) to link these different systems together.
One of the many great characteristics of the PTI is that it does not require you to have one system. You can still keep your own system, as long as it is augmented with a case identifier (GTIN) and a lot/batch number, which most systems should already have. It is not reliant upon one vendor’s solution. Almost every vendor system out there can use the GS1 standards needed for the PTI.
Q: What are the greatest challenges to achieving true traceability, and how will PTI be able to overcome those challenges?
A: I would define “true traceability” as the ability to trace and track a case of product from harvest to store. I specifically indicated “case” and not “item”, as every handler of the product from harvest to store uses the case, not the item inside the case. The only ones that see the item inside the case are the ones that packed it and the ones that open the case at store level.
The FDA needs to track every handler, not just the ones that pack the case and open the case. As far as challenges of the PTI, I believe the challenge is attaining 100% use. The PTI is a voluntary program that enables whole chain traceability. If companies do not do this on their own, we will have gaps in the traceability link. I believe most companies are awaiting word from their key customers and/or government before they do anything. The industry needs both to push this toward 100% compliance.
With that as an introduction, we will let Gary speak for himself:
Absent the PTI
So what would the traceability scene look like without the PTI? Let’s take a candid and practical look as if the PTI never existed.
There are plenty of software/hardware vendors that have traceability solutions. As much as the hardware/software vendor community would like to think that every company will buy their product, it is impractical and unrealistic to think so. Too much money has already been spent by individual companies on systems that can handle their internal traceability needs just fine. If you agree with this point, read on.
As such, imagine each company with a different traceability system. Each system could have different informational requirements, different system requirements, different hardware requirements, and different software requirements, making it hard to connect one company’s system to another. Although these systems might take care of a company’s internal traceability needs just fine, they do not incorporate information needed by subsequent or previous handlers. The only way to alleviate this problem would be to have all previous and subsequent handlers use the same vendor’s system. Again, impractical and unrealistic.
Now, put yourself in the shoes of the FDA. The FDA is the only organization in the produce industry that needs to be able to create the whole traceability path, from harvest through packing through distribution through transportation and arrival at the store. Now imagine yourself having to contact each of these handlers about the implicated product. One company might not have electronic records, requiring manual effort to retrieve the needed information, elongating their traceback investigation. One company might not have the information needed, creating a break in the traceability link, complicating the investigation further.
This is not too far from the state in our industry, as was seen in the Health and Human Services report done in March of 2009. Each company might have a different number for the item (e.g., supplier number, distributor number, retailer SKU, different descriptions, etc.), further elongating their traceback investigation and disabling the advantage of having electronic records. Another company might need specific information germane to their system — information that subsequent handlers nor the FDA has, further elongating their traceback investigation.
Each company might have different formats by which to deliver this information to the FDA, causing the FDA to cross reference and massage the data, further elongating their traceback investigation. This continues on and on, further delaying the FDA’s ability to conduct their investigation. The longer it takes the FDA to do their full investigation, the longer the product remains out of commerce and off of shelves, which continues to erode consumer confidence in the commodity and the category overall.
Another practical reality: in the world of food recalls, you are guilty by association until proven innocent, especially in commodity-based industries such as produce. If you are not part of a process that can clear you and all subsequent handlers of your product, your product will remain in question until the FDA concludes their investigation. Just because you can prove that your product was clear while inside your own four walls does not mean that the subsequent handlers of your product are also clear. As such, your product will continue to be implicated until the FDA concludes their investigation. This is yet another reason as to why we need to help the FDA perform their investigation as quickly as possible.
Now that we have taken a practical look at what things would look like without the PTI (Produce Traceability Initiative), let’s now take a look a practical look at the future of traceability by asking some basic questions. Let’s begin by making a few assumptions:
Assumption #1: The FDA wants electronic records and a 24- to 48-hour response time on inquiries. It has not been a secret that, at minimum, the FDA has wanted these two important elements. It has been stated publically in many different forums. They have not voiced opinions on “how” to accomplish either of these, but have been vocal about their desire to have these.
Assumption #2: Congress has been considering legislation that has components of electronic records. Most of the proposed legislation before Congress already contains this language. Congress is strongly considering the FDA position on these points (see Assumption #1), as the FDA will be the regulators of what is passed.
Assumption #3: Traceability will be needed, at minimum, to exist at the case level. The case is handled by everyone in the supply chain (grocery retail and foodservice), whether you are a grower, shipper, packer, processor, distributor, wholesaler, retailer, operator or transporter. As each of these handlers creates a possible point of infestation, records are needed at each handling point. This is not the situation for the item level. The only parties that handle the item are the ones who pack the item into a case, and the ones that open the case. The balance of subsequent handlers of the product will never see the item that is inside the case (e.g., shipper, distributor, wholesaler, transporter, etc.), as they do not open the case. Each of these handling/storage points could be the possible point of infestation and need to be included in the traceability path.
Based upon these assumptions, the likelihood of legislation being passed with these components at minimum is fairly high. If legislation with these components is passed, ask yourself the following questions:
1. How will we get the information needed for traceability off of the case and into our systems (i.e., databases)?
PRACTICAL ANSWER: It can be done manually or in an automated fashion.
a. Manually would require an individual to read and key into your systems information needed for each case that comes into and out of your facility. This could bring your entire receiving, shipping and administrative operations to a crawl. Think of any buyer receiving more than 50,000 cases into one distribution center per week. Now multiply that by the number of distribution centers.
b. Electronically capturing information off of each case would mean the use of automated tools such as barcode scanners or RFID readers. Barcodes have been around for over 35 years and are used in most every distribution center around the world. RFID, although a strong possible solution, still has some challenges in the way of costs, water and metal. The only key buyer using RFID in the food industry even agreed that barcodes was a better means by which to capture data off of cases at this time.
PRACTICAL CONCLUSION: Barcodes
2. What type of barcode should be used?
PRACTICAL ANSWER: the one that is most widely used around the world. The barcode standard that is most widely used around the world is the GS1-128 barcode. It is used in over 145 countries, over 25 different industries, by more than two million companies. It is not practical to reinvent the wheel, especially when the wheel accommodates what is needed and is already being used by most companies. In addition, in order for everyone to be able to read this barcode, there would have to be one standard barcode being used to ensure companies have the right scanners to read the barcode.
3. What information should be put into the barcodes?
PRACTICAL ANSWER: minimal information needed for traceability. The minimal and necessary pieces of information cover (1) what the product is and (2) where it came from.
a. “What is the product?” If we are to have electronic records of this information and if we are to capture it electronically, we cannot rely on a product description. As any IT person will tell you, a free-format description cannot be used effectively for locating records in a database. Primary reason is that each company might have a slight deviation when describing the product (i.e., a different spelling, different abbreviation, different attribute, etc.), each of which would be treated as separate items in a database. A standard number that has a defined length and type is needed not only for storing and retrieving information from a database, but also putting this information into a barcode.
b. “Where did it come from?” Every fresh food sector relies on a batch or lot number to get back to where the product was either harvested, processed or packed. As such, the Lot/Batch Number is not new to the industry and is a key element of traceback.
c. Any additional information would most likely require a subsequent barcode and/or a different type of barcode that can hold more information. Both of which would create more costs and/or slow things down. In addition, if industry members do not know precisely what will be encoded in the barcode, how will they know how to build their storage databases to store the information captured off of the barcode?
4. What standard numbering protocol should be used to identify the product?
PRACTICAL ANSWER: the one most widely used around the world. The GS1 standards, as mentioned above, are the most largely implemented standard in the world, giving each company that exports or imports product the possibility that the same standard is or can be used for commerce. The standard number protocol used by GS1 for identifying cases is called the GTIN (Global Trade Item Number). It is equivalent to their numbering standard used on the item (the ubiquitous U.P.C.), and uses the exact same Company Prefix.
The same practical look as above was taken when considering things such as the format of the information, the required pieces, the optional pieces, what to store, how long to store, what label to use, etc.
The PTI went through the same scenarios and questions and came up with the same practical answers. These answers were incorporated into an action plan with specific milestones shown on the PTI website (www.producetraceability.org). No single person has a magic, crystal ball to see what will happen in the future. Nor will every company agree with the conclusions made or the practical answers given above. However, when taking the emotion out of the equation, it would be difficult to justify something different.
We can change the outlook on the future of traceability by asking different questions, but then we wouldn’t be addressing the climate and the need we have for traceability right here, right now. The Produce Traceability Initiative does not suggest companies will have no costs, but it does suggest a process that can work while considering the needs of the FDA and the investments already made by a large number of companies around the world.
Gary has an incisive mind and it enables us to cut through a great deal of the mist — and myths — surrounding produce industry traceability.
Although Gary makes a persuasive case, the question we need to answer may be whether ANY voluntary program can provide industry-wide traceability that will both satisfy the FDA and ensure the industry doesn’t get a black eye from actors that do not take supply chain responsibilities seriously.
As long as it is not legally required, non-compliant product will be available and often less expensive — thus tempting even large buyers to purchase it so they can compete effectively. Smaller buyers, not members of PMA, United or CPMA, will continue with business as usual, creating a competitive environment difficult for the big buyers to afford the expense of PTI.
So the technical logic that Gary defines so well may not translate into economic logic if such traceability is not required by law. Of course, if one believes it will eventually be required, preparing now would be a prudent step.
Certainly if one wants to proceed, one could do a lot worse than to work with Gary. We wish him every success in his new endeavor.