Human error is inevitable, but root cause analysis of issues tells us that there are risk control elements which can reduce human error and mitigate the impact when it does occur. Although the need to reduce human error is apparent, and is frequently discussed in our industry, very little has been presented regarding actionable control strategies, or to make the business case for implementing these preventive actions.  While most of us recognize the need for controls like effective procedures and training, we don’t always appreciate how those two elements integrate with the other critical controls to drive predictable human performance.

In many ways, today's pharma and biotech facilities share the same problem that many of the factories that supported the war effort during World War II had – a shortage of skilled and qualified operators and technicians. This lack of a skilled workforce in the early 1940’s was a crisis that the U.S. Government War Production Board responded to quickly with one of the first emergency services to be established: Training Within Industry or TWI. As many skill laborers went off to war, the service was designed to boost industrial production of war material born out of the need to rapidly train new, unskilled workers entering the war production workforce. The impact of TWI was instrumental to the United States’ victory in World War II, but it also had a far-reaching impact on the post-war rebuilding of Japan. Although this program was built on long accepted principles, it was very effective because managers and supervisors were “drilled” in “how to do it."  It began with the recognition that the organizational environment and the organization’s management systems had to establish the framework by which humans are expected to succeed. TWI worked to solve a problem that the nation faced in the 1940’s by focusing on training unskilled workers and minimizing human error, and this remains the objective for the pharma and biotech workforce today.

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How a knee jerk reaction can waste time, money, and leave the problem unsolved.

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A tale of why read and acknowledge is a failed method of operator training.