“Blood” on Tortillas? How did that happen?

A major customer was surprised to find a blood-like substance on tortillas during a recent shipment. When called, the manufacturer's first reaction was "Blood on tortillas! Are you serious?" Although some complaints are surprising, trust your customer. You do not know what happened, and you will need their help. So instead of voicing the initial reaction, a better response is, "I don't know how this may have happened, but I'll look into it immediately. I will get back to you within two hours."

This incident is purely fictitious; with any similarity to real events being purely coincidental, however there are lessons to be learned: How did it happen? What can be learned? What are some practical solutions to prevent a similar incident happening to you?
 

The Investigation. After obtaining the needed information (affected product, lot numbers, shipping and receiving information), the investigation started at the manufacturing plant with product retention samples. These samples showed an inconsistent number of small, irregularly shaped red pieces inside the package on the tortillas, but not in the tortillas. Other retention samples did not show the red substance.

Some of the red pieces were sent to the plant lab for closer examination, where the substance was determined to be fingernail polish. An investigator went to the packaging lines looking for a possible contamination source. Because the wearing of gloves was optional, many workers were not wearing them, and one hand washing station was available. However, the investigation revealed no evidence of the nail polish—or any other red substance.
 

The Cause. How did the polish get on the tortillas? Production records showed the day in question to be a "red" day celebrating the start of the school year, and it was discovered that packaging employees had worn the nail polish that day. But because the customer had had a superior receiving inspection program, the suspect tortilla shipment was rejected, contamination was verified, and the product was destroyed. Additional product in the plant warehouse was also destroyed—for what turned out to be very expensive fingernail polish!
 

The Solutions. The first solution is prevention through the banning fingernail polish in the plant, the wearing of clean (disposable) gloves, and frequent hand washing. But what about contamination that cannot be seen? Ongoing training must educate employees of the consequences of not following GMPs. At this plant, employee hygiene training was generalized, not specific. Although training records were complete, the management attitude was non-committal, focused more on "Let's get this meeting over with and get back to work."

Management also had to deal with a "red" event on a busy day. Be cautious and alert to problems associated with unusual days, whether they be special promotions, high production, or downtime. Distractions from normal activities can lead to higher food safety problems and risks.

An urgent Good Manufacturing Practices (GMP) audit following the incident identified a root cause beyond that of nail polish; that is, there was a lackadaisical attitude on the following of GMPs in general. A food safety incident may be the tip of an iceberg of systematic failure. Thus, in this case another solution was correcting the GMP attitude. Although the plant performed well with customer visits and third party audits, the unannounced GMP audit uncovered "games" that were being played to keep the plant looking good in audits. This was, in part, because the manufacturer had initiated management incentives based around performance in these visits and audits.

To correct this, an unannounced audit program was put in place. Conducted by a reputable independent consultant, it held an even greater incentive for performance. Of importance to remember, is that the FDA is not likely to schedule an appointment for its arrival.

After the incident, plant management also faced repercussions: the plant manager was required to provide an audit action response to QA corporate within one week. The plant QA manager was required to provide employee training tailored to the audit response within one month. The production manager was required to conduct monthly unannounced food safety self-inspections on rotating shifts. During monthly plant management meetings, food safety was the first item on the agenda to emphasize its priority.

Plant employees observe whether management walks the talk and talks during the walk. Is food safety really a top priority or does it come after other operational demands? Food safety must be an essential prerequisite for food operations, similar to GMPs being an essential prerequisite for an effective HACCP system. Conduct a food safety inspection during a night shift to judge the strength of your food safety system. Just as a chain is only as strong as its weakest link, the strength of your food safety is only as strong as your weakest employee or management leadership.