Boar’s Head: Root cause

Disclosure: The information about Boar’s Head below is based on information from the company’s website, news reports, and a USDA non-compliance report.

As you may know, Boar’s Head, a 5^th generation family-owned business with annual revenues over $1B, recently recalled 7.2MM pounds of contaminated meat because at least 9 people had died and at least 50 were hospitalized as a result of a product-caused listeria outbreak.

Between 8/3/23 and 7/27/24, the USDA recorded 69 incidents of regulatory non-compliance. Problems included visible mold on the ceiling, blood pooling on floors, meat and fat residue on walls, ceilings, and equipment.

The company’s website says, “First and foremost, our investigation has identified the root cause of the contamination as a specific production process that only existed at the Jarratt facility and was used only for liverwurst.”

I highlighted “root cause” in the above because, based on my experiences with two FDA-regulated clients, I am 99.99% sure that the root cause was almost certainly not the production process but was actually management’s failure to implement a system for ensuring accountability for product safety. (Clearly, the USDA also bears some responsibility for allowing non-compliance.)

The story of what I found and did at my Turnaround of the Year client will illustrate at least some of what likely occurred and may need to occur at Boar’s Head.

Publicly held, FDA-regulated PML was the 3^rd largest supplier of culture media (most common form, agar agar in a petri-dish) in North America.

When I arrived

• The 26-year-old company with 8 locations in the US and Canada had never had a perfectly clean FDA audit and was having product contamination issues. PML culture media was contaminated when it reached medical lab customers.
• PML had multiple dings from the most recent FDA inspection.
• No employee was assigned responsibility for FDA compliance—not the Director of Quality Assurance and not the Director of Regulatory Compliance.
• Neither person had the skills needed to monitor, correct, and prevent the problems.

Steps to address the shortcomings: Most important, the CEO was wise enough and selfless enough to recognize that he did not have the right skill set to fix the challenges facing the company, so he gave me full operating authority from day one.

My actions

• Instead of having two people with overlapping roles, created one position that clearly assigned both responsibility and authority for maintaining FDA compliance
• Appointed one highly qualified person to fill this role: microbiologist by training; lab manager by experience; operationally strong, worked well with others
• Her target was to have no—NO—dings when the next FDA audit occurred, and she began, in concert with manufacturing, to take corrective actions immediately.
• Shortly before I ended my engagement at PML, I staged a fake FDA audit—Falsely notified the new manager as well as all employees that the FDA had arrived at company headquarters to do an inspection. Oh, my! An exciting day.
• Ultimate result of all these changes? A month after I left the company, PML had its first perfectly clean FDA audit in company history.

As I have stated in published articles, webinars, and email newsletters, when companies have problems, the underlying cause is almost always operational mismanagement of the people, the processes, and the systems. Mismanagement—not the production process—was clearly the “root cause” at Boar’s Head.

Renee’s Rule^TM:  The numbers are the symptom. The disease—almost always—is mismanagement of the people, processes, and systems through which companies provide their products and services.