Human Error occurs in all settings. In the world of pharmaceutical manufacturing, the result of that error can result in loss of product or at the most extreme, injury to patients. Human is a frequent occurrence in pharmaceutical manufacturing. It occurs even when every obvious preventive action have been employed such as effective compliance documentation development and training. Unfortunately, sometimes these actions are not adequate to prevent these errors from occurring. "Human Error" is sometimes not the cause of issues even though relegated/assigned as the root cause of adverse events with reasons assigned such as "lack of attention to detail" or "failure to follow procedure." Corrective action in these instances often involves re-training or disciplinary action. These approaches do not seek to understand really why the error(s) occurred.

This webinar will explore the definition and causes of human error, the process of standardization and why it is important to human error reduction, and how to apply standardization effective to the enterprise in terms of the tasks that workers perform. Human error prevention works when task performance is repeatable, consistent, and standardizied.

There are many causes of human error and just as many potential remediation approaches and methods that can be applied. Standardization is defined by the International Organization for Standardization as “the process of formulating and applying rules for an orderly approach to a specific activity for the benefit and with the cooperation of all concerned, and in particular, for the promotion of optimum overall economy, taking due account of functional conditions and safety requirements.” 

Standardization is about everyone performing a task in the same way, about performing that task to a best practice that has been tested to result in flawless performance, and finally providing performers with user support tools so that individual task steps do not need to be committed to memory.

Standardization is also one of the relatively easiest mitigating options that can be taught to the workforce and applied quickly across the enterprise.  It is truly the starting point for human error reduction.