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Automation Demonstrating its Downside in Product Recalls

ACConventional wisdom suggests that automation and robotics should make products safer by removing the potential for human error adding more precision to production. But some industries are finding that automation is a double-edged sword.

The food industry, in particular, has experienced a string of product recalls whose origins can be traced back to automated systems. Take factory farming, for example. Food Quality & Safety Magazine reports that the speed and efficiencies gained through automation are having the unintended side effect of exposing more food stock to pathogen contamination. Robotic manufacturing equipment has also resulted in more extraneous materials like wood parts, plastics and metals entering the food chain.

Similar issues are impacting the pharmaceutical industry. The Stericycle Recall Index, which tracks recalls across multiple industries each quarter, has seen significant increases in recall events for drug makers. Manufacturing woes are the main driver, which can be tied to the used of automated systems in production.

For example, failed specifications have been the top reason for pharmaceutical recalls for the past 11 consecutive quarters. Many of these failed specs were the result of automated equipment changes that introduced unforeseen modifications into production processes.

Current Good Manufacturing Practices (cGMP) have been a similar factor. cGMPs are regulations enforced by the Food and Drug Administration (FDA) to ensure proper design, monitoring and control of manufacturing processes and facilities. While automation and robotic systems should serve as solutions to achieving compliance, cGMP deviations have been the top cause for recalled pharmaceutical units (the total number of recalled drugs) for four of the last five quarters. 

These failed specs and deviations have resulted in misformulations and the introduction of foreign materials into drugs.

Automation of labeling systems has been another major source of recalls for both pharmaceutical products and medical devices. In the first quarter of 2019, mislabeling was the main source of nearly 15% of pharmaceutical recalls, and 31% of medical device recalls.

Defective manufacturing practices were the cause of the world’s largest automotive recall as well. Flawed quality control processes resulted in automotive airbags being produced using an ammonium nitrate compound without a critical drying agent. The resulting propellant burned too fast and caused the airbag inflator to explode in many cases, with the inflator sending shrapnel out of the airbag and into the cabin of the vehicle.

Automation problems don’t always result in threats to human safety. In 1997, the automated system that stiches logos into Nike’s athletic shoes resulted in an Air logo stitched into the shoes that was meant to look like a flame, but instead resembled the Arabic script for “Allah,” resulting in significant blowback from the Muslim community and the first recall in Nike’s history.

While there is no question that automation and robotics are a net-gain for enhancing the safety and quality of manufactured products, technological progress always encounters speed bumps along the way. The rapid pace of automation adoption has introduced some unintended consequences in production practices that ultimately resulted in unsafe products that needed to be recalled. As the technology advances, we expect automation problems to subside significantly.

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