The fingerprint results are negative. The shelves are empty. Forty-nine products are missing. It is believed that is known that he had contact with 72 persons in 30 states. The impact was severe: 34 hospitalizations. 300,000 cases were shipped to Danville, Virgina. What happened? Who is it? It is none other than E.Coli 0157:H7.
Where did this bad actor come from? How did he travel? We still don't know. It remains a mystery. That is our story.
It is a sticky situation. It should not be the way that the cookie crumbles. But, for Nestle, the recall of cookie dough products on June 19th is the first act in a long play on the stage of a time of change for the food and beverage industry. Unraveling the facts to get to the root issue of the problem is like solving a mystery. It's sort of like playing the game of Clue, where as a child, I believed that it was Professor Peacock in the Study with a lead pipe only to find out that it was a revolver in the library. Right now we only know that the bad actor was E. Coli 0157:H7 and that the products were produced at Nestle's Danville, Virginia facility. We do not know where he came from or how he came to be.
Solving a mystery like this is slow. Too slow for the consumer. Too slow for the impact on the bottom line. It will be painful for Nestle. As they work through the cookie dough recall, they will lose millions of dollars, face lawsuits, and watch their 41% market share decline.
What we do know: FDA inspectors have been working round the clock testing environmental and production records and testing samples, but there is no trace of the bad actor E Coli 0157:H7 at the Danville Plant. The microbial fingerprints do not match.
In prior plant inspections of 2005 and 2006, the Nestle plant officials denied access customer complaints or inspect it's program to prevent food borne illnesses to FDA inspectors officials in plant inspections 2005 and 2006. This is changing. The House of Representatives bill R 274—The Food Safety Enhancement Act of 2009—is slowly making it's way through the House of Representatives. It has been approved in committee. In parallel, the Senate is working on S. 510, the FDA Food Safety Modernization act, which is sponsored by Senators Kennedy, Durbin, Burr and Gregg. These bills would give the FDA more control and guarantee document access to FDA inspectors during inspections. The Center for Disease Control estimates that 76 million Americans become ill, more than 300,000 are hospitalized, and 5,000 die each year from food-borne illness. President Obama has included $1 billion in his proposed budget for the FDA to spend on addressing food safety.
A lot has changed in the world of food safety. A year ago, we published a report on food safety with a call to action for the food industry to get serious about the problem. Companies felt good about their capabilities. Our study of 220 food manufacturers clearly showed that their positive beliefs were not warranted; yet, over 70% of companies rated themselves as excellent or very good in capabilities across the supply chain.
Companies feel good about their capabilities. They should not.
It is only a matter of time before it is their turn for a recall. They, like Nestle, will find themselves on the world stage fighting the daily press issues on a food borne illness issue.
Change is slow, but is occurring. Last year when we published our study on food traceability, few companies wanted to talk about it. But, today, our calendars are filled with inquires on how to improve traceability one step forward and one step back in four hours. A step forward, but not far enough.
Yes, legislative change is coming. But, can supply chains change fast enough to avoid costly recalls? Here are our thoughts:
HAACP needs to be part of the product design
Hazard Analysis and Critical Control Points (HACCP) methodology is a systematic preventive approach to food safety focused on prevention rather than finished product inspection. HACCP is used in the food industry to identify potential food safety hazards, so that key actions, known as Critical Control Points
(CCPs) can be taken in consideration to reduce or eliminate the risk of the hazards being realized. It is mandated for manufacturing by the FDA and USDA for perishable foods like juice, seafood, meat and poultry with the techniques being used on a voluntary basis for other food and beverage categories. So, as a reader, you might say, "SO what is wrong with that?"
The answer is that it does not go far enough. It is applied ONLY in manufacturing. There are critical control points all along the value chain including the consumer's home. Remember the Banquet pie recall of 2007? ConAgra claimed that the pies were safe if they were cooked well-enough. The oven was the critical control point. The pies were only safe if they were cooked well enough, but the instructions were not followed. The pies were eaten without sufficient cooking, making the consumer sick.
In this case, almost all of the illness is associated with eating cookie dough raw. I love to bake cookies. For me, scraping the bowl and eating cookie dough off of the spoon is part of the ritual. There is a high likelihood, that the product was not designed to be safe enough to meet this critical control point.
This is Tread Act deja vu
Remember the public bruising the automotive industry received from the high-failure rates of Firestone tires fitted on Ford SUVs? 700 injuries and 200 deaths occurred before the Transportation Recall Enhancement, Accountability, and Documentation (TREAD) Act was mandated by the US Congress. Signed into law in 2000, TREAD brought sweeping business process changes to the automotive industry. At the heart of the legislation were requirements forcing vehicle manufacturers to report information on defects and product safety to the National Highway and Transportation Safety Administration (NHTSA), which, in turn, would perform analysis, identify trends, and subsequently warn consumers of potential defects in vehicles. It also created criminal liabilities for vehicle manufacturers that violated these requirements.
The lesson learned? With the TREAD Act, vehicle manufacturers quickly learned that in order to turn pain into gain, simply improving the access, analysis, and reporting of compliance and warranty data was not enough. Having data and not being able to use it effectively in a timely manner can be worse than never having the data in the first place.
Who is really responsible?
When David McKay, Kellogg CEO, testified before Congress on food recalls on March 19th, 2009, he was asked who in his company had ownership for food safety. The answer was a list of many individuals. Kellogg like many food companies has the responsibility delegated to everyone, which means nobody. In food and beverage manufacturing we are all responsible, but there needs to be one leader. A single person in the organization to drive leadership and change.
We need to communicate to the consumer at the shelf
The Nestle shelves for cookie dough in the recall were bare. They did not have to be. The industry does a horrible job of communicating to the consumer at the shelf—where they need it most—during a recall.
QR codes, used frequently in Japan, enables consumers to use their picture phone to scan a code and access updated information—where the product was manufactured, the current state of the product on a recall or validation of a claim (organic, allergen free, range free, etc.)—in near real-time. Last month, FoodLogi Q launched a mobile application (mobilemarQit) that is in pilot tests with two customers to interface with the customer at the shelf. Mobile device communication with the consumer has the potential to change the buying experience.
Similarly,TraceGains, a provider of traceability technologies, has launched a similar application that tracks back to their e-affidavit that can track 255 attributes in a web-based form. Suitable for field to fork initiatives, it is fed through their e-affidavit system from the field.
Our systems are not up to the change
To meet the proposed standards of the upcoming legislation requires a process redesign. We follow 110 consumer products companies, and only three companies that we follow are up to the test. A major gap is the availability of a product data model and the convergence of the product data model with the process data model to convert product specification information into master recipe and local plant control plans. Most companies have implemented Enterprise Resource Planning (ERP) and feel comfortable that they have what it takes. They don't. And, will find the testimony in front of Congress about why they cannot track products across product transformation steps—cutting, drying, mixing, curing—to be painful.
This week, Kalypso, a system integrator of research and development technology consulting, launched a rapid-deployment program to implement Oracle Process PLM, termed PLM VIVO. I loved their three-level product data model. It is this type of definition to enable master data for food traceability that companies need and they do not know that they need it. Unfortunately, most of the master data focuses today have been in transactional data MDM projects to improve order to cash and procure to pay. Important work, but it does not help the industry solve this problem.
Let us know what you think. Do you believe that the industry is ready for the new legislation. That the current processes and technologies are equal to the change? Let us know. Please give us your comments.
How Safe Is Your Food Supply Chain?
Food and Beverage Manufacturers: Avoid TREAD Act Déjà Vu and Get a Grip on Quality Now