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Reduce Human Errors in the Pharmaceutical Industry

Reduce Human Errors in the Pharmaceutical Industry

Humans Make Mistakes

It’s a statement that is frequently heard in the pharmaceutical industry.

We’re not robots, we do not have a perfect memory and tend to make our own assessments. The high percentage of deviations of which 70% is caused by humans seems to reinforce these assumptions and companies incur huge expenses as a result of these human errors.


I would like to invite you to examine the deviation-list of your company. There is a very high chance that it lists causes such as; “the procedure was not followed, the employee received insufficient training, the procedure was ambiguous”. The preventative actions will usually require the QA department to rewrite procedures and to train on procedures. These actions are easy to execute but aren’t we fooling ourselves by taking the easy way out?

The GMP guidelines have not remained ignorant to the fact that human errors are not as simple as they appear. You are expected to look below the surface to make sure that underlying causes do not remain undetected.

The only question is; how do I do that?

We will present three questions that you can ask whilst attempting to reduce human errors.

Human Error Reduction 1: How does my organization perceive human errors?

Behavioral psychologists have researched the “human error”. It was believed that you should simply get rid of the “rotten apples”, that you could tell people to pay attention and that you should simply replace the person who was performing badly. At first, these seem like really easy solutions but we’ve learned that these techniques do not work. These techniques create other problems themselves and the “rotten apple” theory makes you lose sight of the underlying cause(s).

People believed you should simply get rid of the “rotten apple”.

The new perspective on human errors focuses on WHAT is responsible for the outcome, instead of WHO. The label “human error” should lead to further investigation rather than a conclusion. The error is seen as a symptom and not as a cause. Every symptom has an underlying story. The outcome of this new perspective is that employees will be more open and forthcoming on what has happened which enables a proper investigation. After all, people do not show up at work to do a bad job.

Human Error Reduction 2: Do we have a STRUCTURED analytical process to enable effective actions?

Performing a thorough analysis can be challenging. You encounter many components of the organization that often transcend your own responsibilities. A proper categorization, a step-by-step approach and a Human Error Analysis Checklist ensure that nothing is forgotten during your analysis.

Human Error Reduction 3: Is our policy effective in addressing Human Errors?

In most organizations, most resources are devoted to potential problems. This is a very reactive approach. We perform extensive analyses, implement separate job functions and propose costly solutions to fix errors. Far less time is spent on proactive solutions to Human Errors. A smart question to ask would be “why is this going well?”. Risk analysis is another proactive approach to eliminate the causes of human errors. Needless to say that having knowledge of how humans think and operate is of the utmost importance to ensure the right factors are examined.

It all comes down to willpower!

Reducing Human Errors is all about the willingness of those who work in an imperfect system. Only those organizations that realize under which circumstances they have their employees perform their jobs will be able to succesfully reduce the percentage of human errors.

Knowledge of human behavior as well as an open and guilt-free culture are of the utmost importance. Human error reduction requires you and others to see, without bias, what is really going on in your organization.

Jaap Koster
Jaap Koster

Jaap Koster has 39 years of experience in the pharmaceutical industry in North- and South America, Asia, Africa and Europe. Jaap is the CEO of PCS.

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