The pharmaceutical industry is currently undergoing a significant transformation in its approach to addressing the age-old problem of human errors, especially within operational domains—a field commonly referred to as Human Error Reduction (HER). Human errors have plagued human endeavors throughout history, with numerous factors such as fatigue, stress, inadequate training, distractions, and more contributing to their occurrence. Infamous disasters like the Chernobyl nuclear meltdown and the Space Shuttle Challenger explosion serve as stark reminders of the catastrophic consequences that can result from human errors.
Within the pharmaceutical sector, human error has long been a persistent challenge. Quality Management Systems have been established as a foundational defense against human errors, incorporating measures such as material testing at various production stages and batch record reviews. Nevertheless, these safeguards cannot provide an absolute guarantee of patient safety.
Human errors represent a consistent problem for the industry, indirectly contributing to the rising costs of medicines. Even seemingly minor errors can trigger rejection, rework, or re-processing of a product, necessitating detailed investigations and testing to ensure safety standards are met. Historically, addressing human errors primarily involved training enhancements, regulatory adjustments, and procedural refinements. These efforts aimed to reduce errors through repetitive processes, stringent protocols, and increased oversight. While these methods did lead to some improvements, they could not entirely eliminate human errors, given the inherent limitations of human cognition and the increasing complexity of pharmaceutical systems.
As the pharmaceutical sector advances toward the production of more intricate medications, conducting additional testing often becomes impractical, increasing the likelihood of opting for the safer route of materials rejection. In light of these challenges, a contemporary approach emerges: Delve Deeper into Investigations.
When conducting investigations into human errors, surface-level causes often include inadequate procedures, insufficient training, or the absence of a second check. While these factors may serve as immediate triggers for human errors, organizations must delve deeper to truly address this issue. Root cause analysis may reveal multiple contributing factors, such as personal or familial issues, equipment-related problems, complex instructions, or a lack of knowledge.
Human errors can result from both intentional and unintentional actions, with each action carrying its own unique backstory. Consider a scenario in a pharmaceutical company where a crucial decision leads to an unexpected error. Initially, it might appear that an inadequate procedure or inadequate training caused the mistake. However, akin to unraveling the layers of a complex puzzle, a comprehensive investigation often unveils a more nuanced truth.
In this case, the employee’s unintentional error might trace back to convoluted instructions that were unclear due to their lack of familiarity. Yet, as the investigation progresses, it becomes evident that the employee was also grappling with personal challenges, significantly affecting their focus and decision-making abilities. This added layer of personal stress, combined with the task’s complexity, exposes a contributing factor that would have remained hidden with a superficial analysis. This narrative underscores the importance of going beyond the apparent procedural flaws and inadequate training, as addressing human errors necessitates peeling away the surface to reveal the intricate amalgamation of factors truly underlying these errors.
In the realm of pharmaceuticals, the challenge of human errors persists, even as the industry evolves. By embracing comprehensive investigations that dig beneath the surface, organizations can uncover the intricate factors contributing to errors, thus paving the way for safer practices and enhanced operational efficiency.