Process and manufacturing industries worldwide are prone to human errors, the most common error type faced by these industries. The Pharma industry is not exceptional because humans are the key decision makers in all stages of drug manufacturing – from raw material sourcing to distribution of final finished drugs.
What is a human error in the pharmaceutical industry?
Human error is a term used to indicate instances in which the final result deviates from the intended or desired result. The pharmaceutical industry is a humanly controlled instance in which the outcome of any process related to quality, production, maintenance, supply chain, marketing, warehousing and other departments fails to achieve the desired outcome. If an error occurs in an automated process, it is not considered a human error.
Studying and identifying human errors in the pharma industry is necessary because, despite technological advancement, humans are still the key decision-makers. Because technology and innovation are in their initial phases and are not considered reliable when making decisions.
Common human errors in the pharmaceutical industry
Common human error can be divided into slips, mistakes, and violations in the pharmaceutical industry. Let’s briefly discuss these error types
Slips
Slips are error that occurs by experienced professionals due to mistakes. The personnel has no intention of damaging the process or product. It occurs because the process is incorrectly carried out.
These errors occur as a result of
Personnel’s inability to pay attention to the process for which they are responsible. There can be many reasons for inattentiveness, such as being overburdened with work, less workforce for a given task, and labour absent from work.
Memory failure to remember the process and result is the missing an essential step
Distraction due to external factors such as noise, personal matters, un-necessary talking, and extreme working conditions
Pressure to deliver the desired productivity in a given time due to the urgency of a task or to seek the attention of seniors
Mistakes
These errors are due to in-efficient planning, found to be correct at the time of planning. However, during practical implementation, these decisions were found to be incorrect and failed to deliver the required results. When this error occurs, the entire process for which the solution is planned is discarded or reversed back and requires the planner to return to the drawing board for a sustainable solution.
These errors occur due to
Lack of knowledge in implementing the solution or process and failure to understand the routine process.
It also indicates that personnel responsible for planning have failed to understand the problem, which is the leading cause of the problem.
Lack of training for problem-solving skills
Sticking to only one solution and not considering alternative solutions
Violations
Violations are deliberate deviations from standard processes, operating procedures and quality principles. It is more commonly related to human behaviours despite providing all the necessary guidance, tools and resources. When a violation occurs, it is followed by some actions against the human workforce involved in the process.
These errors are caused by
Poor judgement by the incapable workforce and inability to understand the process.
Lack of motivation in performing routine tasks due to salary issues, benefits, non-supportive staff and supervisor.
They intentionally make the error to damage the product and the organization’s reputation.
Implications of human error in pharmaceutical industry
Let’s discuss some implications of human error and how they affect the normal rou...
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