Learning from Traceability Improvement – The Eggo Recalls of 2009 and 2016

2009 – The Year Kellogg Leggo of the Eggo

 On August 31st 2009, a laboratory test by the Georgia Department of Agriculture (GDA), found Listeria monocytogenes in a sample of Eggo waffles. 

 Kellogg Co. recalled 4 production runs totaling nearly 4,500 cases of  Eggo products In total. The discovery of the bacteria lead to an FDA inspection of the plant during the week of Oct 22nd 2009 and subsequent warning letter issued in Jan 2010.

 

“During the FDA inspection, investigators collected environmental samples from various areas in your facility. Five environmental swabs tested positive for L. monocytogenes. Pulsed Field Gel Electrophoresis (PFGE) testing results determined that three of the environmental swabs had a PFGE pattern that was indistinguishable from the positive sample collected by the GDA. This is significant because these three swabs were taken from three different locations in your facility…”

“…results reveal that L. monocytogenes may have been transported throughout your facility and may have established niche areas to colonize.”

 

What is Listeria? – The Zombie Bacteria.

Listeria is a bacteria that comes in lots of different flavors. It is thermally activated, that is to say Below 4 degrees c it can’t make a flagella to move… Once activated, Listeria latches onto nearby healthy cells injects its poison and essentially takes over the host.  Listeria then usurps the cytoskeleton of the host cell to move and further spread. Freaky!

If you ever ingest this zombie bacteria, usually your body identifies it and kills it. If your immune system can’t kill the bacteria on its own most cases are resolved oral anti biotics and a few days close to a toilet. If you get an aggressive strain you might have to get an intravenous antibacterial and may be hospitalized for at least 2 weeks.  A listeria infection can be very serious for people with weaker immune systems and can cause meningitis or even Death.

Back to Eggo.

Fortunately, no one even got sick from the 2009 Eggo recall. But it did raise concern that the production process had some serious quality and traceability issues. Why wasn’t the contamination caught sooner? And why did the issue stretch across multiple batches and two product lines?  I am sure that the quality teams worked extremely hard to resolve the issues and implement protective guards for the future. Earlier this year, their work to improve quality control and traceability paid off.

2016 – A bigger threat, with tighter containment.

On September 20th 2016 Kellogg Co. announced a voluntary recall of 2 production runs totaling 10,000 cases of Eggo waffles due to possible listeria contamination. A potential issue in a cleaning process introduced risk of Listeria monocytogenes. There are 2 important things to note here.

  1. Eggo quality control processes have improved

It was never reported that Listeria was actually found in the 2016 Eggo recall

 In Kellogg’s words:

“The recall is a result of tests, which identified the potential for contamination and a gap in our sanitation process.”

The recall was initiated because their quality process discovered a potential contamination risk. I imagine the Eggo production team had an improved system in place to catch contamination risks and trace them to end products. Think of how much trouble they would have saved themselves if they had the same system back in 2009?

      2. Eggo traceability has improved.

When compared to the 2009 recall, the 2016 recall included more than double the product, -4,500 cases in 2009 and 10,000 cases in 2016-. However, the 2016 recall was contained within only two production runs of a single product, while the 2009 recall involved 4 production runs and two Eggo products.

In summary, Eggo’s improved manufacturing traceability system allowed them to more accurately pinpoint affected batches, even though their batch sizes were larger.  Way to go Eggo!

We all have our industry specific threats to Manufacturing Quality.

Listeria is a challenge especially for food manufacturers that deal with refrigeration since the bacteria prefers cold, wet environments with food sources.  However, each industry segment of the Life Sciences has its’ own specific challenges that demand traceability.

Pharmaceutical, Biotech and Dietary Supplement manufacturers all require traceability to avoid contamination across all process activities. Medical Device manufacturers need traceability manage complex, revision controlled assemblies, especially when it comes to post market fleet management.

No matter what niche area of manufacturing regulated by the FDA you operate in. There is such a high consequence for poor traceability. You have to watch your risk areas like a hawk, and, if you ever find something out of spec in that area you need to be able to instantaneously put your arms all the way around the potential threat.

 Traditionally, the only way to achieve traceability was to build extremely rigorous process control into a decaying method – paper. I meet people all the time that feel like manual, paper-based traceability is just the way things are. They hate it, but they feel there is not a better way.

Somehow the logic persists that: If we write everything down, then somehow, we will be able to connect the dots as we dig through filing cabinets to get full traceability around any potential issue. I guess that as long as every record is stored, accurate, complete, legible, and I have enough time to filter through them manually then paper can provide the traceability you need. But at best paper is slow and at its worst you might find yourself in a 2009 Eggo recall situation.  

Fortunately there is Software designed specifically for the unique quality and regulatory business challenges of Life Science Manufacturing.  

People tend think that manufacturing traceability software is exclusive. They think that electronic batch record and computerized material traceability tools are reserved only for the top Life Science manufacturers traded on the NYSE.

That is simply a misconception.

I have been on the production floor of Life Sciences Manufacturing running CFR 21 part 11 electronic batch records with advanced, barcoded inventory management at companies with as little as 6 employees. The technology is available for all Life Science Manufacturers to leverage traceability automation. Traceability improvement is main difference between Eggo’s 2009 and 2016 recalls.