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 routine process

Delay in production process

The most common implication of human error is the delay in the production process, and it affects the organization’s ability to deliver products in a timely manner. The production process is frequently delayed and loses its pace in achieving its target. Human errors in an organization also prompt the quality to increase testing to prevent defective products from reaching the hands of the end user. Increased testing increases the time to manufacture a product and the associated costs.

Human error can destroy a compelling product and make it unable to provide the required therapeutic effects. It can also make a successful, tested, quality process incapable of producing an approved pharma product.

Increased cost of corrective actions

Human errors increase the frequency of corrective action for a product and process and the associated aftermath, such as breakdown, material consumption and personnel expertise. It creates a sense of vulnerability in the higher management and results in more investigative studies.

These studies require extensive resources, tools and time for their success, and more often, production is not resumed until the outcome of these studies is approved and implemented.

Un-planned downtime

Human errors in the pharma industry also result in unplanned downtime. Because sensors and instrumentation can measure the machine's behaviour and can predict failure before it occurs. However, there is no mechanism for human errors to predict them before their occurrence.

It increases the breakdown frequency of a plant, process, equipment or area, forcing the organization to opt for reactive maintenance. This also hampers the organization to focus on the latest maintenance strategies, such as predictive maintenance.

Additionally, maintenance due to unplanned downtime also reduces the effectiveness of preventive maintenance executed at a fixed frequency. The time spent on preventive maintenance and the resultant production breakdown is an additional cost that pays a pharma manufacturer due to unplanned downtime due to human errors.

Quality Issues

Human errors can also compromise the quality principles and procedures for a given product or process. A pharma manufacturer can face compliance issues due to human errors and trigger regulatory actions if not corrected promptly. 

Human errors could result due to mistakes in executing a well-maintained process. Forgetting a process or executing unapproved can lead to quality issues in a final product. Some quality issues related to human error include, but not limited to 

• Laboratory errors – tests performed in the laboratory to determine chemicals and their composition in a sample. 

• Inspection errors – inspection is an integral part of the quality improvement process in the pharmaceutical industry and is used to verify the required product characteristics before the product is packaged. Human errors in inspection can lead to defective products or products being released into the market, making the entire inspection process inefficient and useless. 

• Errors in documentation – documentation is an integral part of the quality process, which proves the effectiveness, utilization and execution of quality procedures in routine manufacturing operations. A human error in documentation could result in incomplete or erratic documentation, resulting in outdated documentation. This makes trouble for a pharma manufacturer during a routine inspection.

Tips on preventing human errors

Let’s discuss how these errors can be prevented and humans can become a valuable asset for pharma organizations

Training

Training is an effective way to train the human workforce and minimize errors. It enhances their capabilities in dealing with risky situations and effectively managing disaster situations. Some areas in that human workforce can be trained include

• Knowing the importance of existing processes and standard procedures for executing a process

• Identifying deviations in executing the process and the final product

• How to react in case of unplanned downtime, product deviation, process change and quality disapproval

Printed copy of important instructions and operating procedures

Always keep a printed copy of essential instructions and operating procedures such as machine operation, safety issues and what to do in case of accidents. Furthermore, these instructions and operating procedures must be in the native language, which the human workforce understands. 

This becomes helpful because the human brain quickly forgets processes that are not repeated. Secondly, focusing more on production issues can distract the human brain from other issues, which can be neglected. A written procedure that can too in an easily accessible place helps human brains to focus on these side issues also. 

Effective assignment of jobs

When devising job execution responsibilities for the human workforce, such as machine operators and quality analysts, always assess their capabilities. Based upon the assessment, assign their jobs and departments. Additionally, if a person does not enjoy their job and is only doing it for financial reasons, it can also result in inattentiveness and human errors.

For this purpose, assign a job they can take a personal interest in. The assessment can be performed during the time of hiring by the human resource department. Additionally, assessment can be performed during the job when an employee has spent specific time in his current role.

Improve Supervision

Adequate supervision becomes handy in avoiding human errors in the pharma industry. Always design an effective supervision hierarchy so that one’s work can be monitored, supervised and corrected on-site in no time. The supervisors should also give instructions and guidance at the start of the production day or cycle.

Effective supervision results in the timely detection of human errors and makes it easy to remove deviation. It also prevents the problem from going long in a process system.

Additionally, the workforce must be trained to immediately bring any trouble or malfunction to the notice of their supervisors to seek timely guidance and prevent further process disruption. 

About the Author

Muhammad Asim Niazi has a vast experience of about 11 years in a Pharmaceutical company. During his tenure he worked in their different departments and had been part of many initiatives within the company. He now uses his experience and skill to write interested content for audiences at PharmaSources.com.