Human Error and its Impact on the Pharmaceutical Industry

The paradox is that as technology advances in leaps and bounds, human error becomes more and more visible especially where the manufacturing process is concerned. It is estimated that manufacturing sites generate an average of about a thousand deviations per year. While this depends on a variety of factors such as the type of the production process, how many new processes were introduced over various time periods, the size of the manufacturing plan and the number of product changes, there are still (at last count) millions of pharma deviations across the globe that are attributed to “human error.”

So what is “human error?” How can it be defined with the context of the pharmaceutical industry? Some state that human error is “action performed by a human that results is something different than expected.” Another definition adds that human error is “any human action, or lack of action that exceeds a system’s tolerance.” Despite all these qualifications and awareness, the industry still falls short in recognising and correctly addressing types of human error.

The common misconception is that poor training or lack of proper training is the number one cause of human error. However closer studies show that training (or lack thereof) is responsible for only about 10 percent of the human errors that occur. Another issue that crops up when attributing human error to investigations is the atmosphere of blame and fear that is created. When seen from the perspective of blame, any interaction between coworkers and management becomes fraught with trust issues and further failure. This in turn leads to a lack of awareness of any systemic weaknesses which will ultimately result in more mistakes.

Keeping in mind that we can only do so much to control human behaviour, there are some areas that can definitely be worked upon instead.

Our first area of evaluation should be the work environment. Systems such as management processes, documentation, risk and project management are important areas where one can create a strong foundation to minimise error. Work areas need to designed keeping in mind human capabilities. Factors such as temperature control, layout, housekeeping, and monitoring can all have either a positive or negative impact on human behaviour.

Next on the list is training. Pre-job and on the job training needs to be regular and intensive. Critical tasks and activities need to be supervised and monitored by a number of people and not just the responsibilities of a few. Management needs to be active on the floor and in real time and not just bogged down with paper work in offices. A clear cut plan of action needs to be shared with employees on a day to day basis to improve communication and impress upon GMPs and acceptable codes of conduct. Transform the role of trainers from tactical focus to business focus where more emphasis is placed on performance improvement overall than pure skills training.

Creating cultural change is another big takeaway in the management of human error. If we change the culture to one with a focus on the importance of improving reliability and consistency rather than blame and error, a positive work environment is automatically created. This subtle shift in perspective can help educate people in human performance and risk management and new tools and techniques to understand human error can then be implemented. An open work culture that promotes transparency rather than fear can help track the underlying causes and trends in human error. Prevention can soon become the norm rather than the exception.

And finally, with the help of effective investigation techniques and the expertise of internal and external specialists, an in depth root-cause analysis of each investigation can take place. Once the true cause of these mistakes are discovered, a lesson-learned process needs to be disseminated across the workforce. This implementation of this learning across the network should be mandatory to make a real and lasting difference.

We as humans don’t operate in a vacuum. Behaviours are influenced by external as well as internal variables and by taking control of these issues, we can perhaps open up a new set of opportunities not considered before. Prevention is the key. This way, we will not only be more productive, but also be fair to those that go to work with the intention to do a good job but who end up being victims of weak systems.

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