6 Ways to Reduce Human Errors in GMP Environments

The paradox is that, as technology progresses at breakneck speed, human error becomes more obvious, particularly in the production process. Product recalls, customer complaints, batch rejects, variances and negative audit findings are frequently attributed to human error.

Human Error Reduction in GMP Manufacturing

The good news is that such costly and dangerous errors can be avoided by adhering to a few basic and practical guidelines.

  1. Understand Human Behavior and the Psychology of Human Error
  2. Human error explains human behavior. So, examining why and how we respond in specific situations can assist to explain why we do what we do.

    Why are women superior to men in some tasks? Why do we only see the things we want to see? Why do we all make assumptions that cause us to make errors? How can you avoid making blunders because you're bored? What "situations" and "tasks" truly stimulate the brain to make a error?

    Understanding the psychology of human error holds the key to unlocking the solutions.

  3. Adopt a 'Blame-Free Attitude and Culture'
  4. Every error is a free and priceless lesson in how not to do things in the future! Provided you learn from your errors and don't repeat them!

    According to all evidence, organizations that adopt a "blame-free" culture are more effective. It's simpler to learn from errors (since individuals own up to them without fear) and hence increase performance if you can truly make the transition.

    Human error is rarely random. It is linked to the tools, tasks, and surroundings. That is to say, it can frequently be expected and, in some cases, is unavoidable. You can go a long way toward preventing those deviations that keep reappearing by providing a blame-free atmosphere where errors can be acknowledged and prevented.

  5. Simplify Complexity at Every Level
  6. As the level of complexity rises, so does the number of errors. Unneeded and costly complexity encourages people to make errors. What is the solution? Keep things as straightforward as possible! You will see actual gains if you take the time to analyze and streamline your processes, procedures, and systems (while bearing in mind the psychology of human error).

  7. Ensure Environment Conducive to Proper Performance
  8. Even if they had previously completed the work perfectly, environmental pressures might influence a person's capacity to perform and lead to errors.

    Because of multiple shifts in focus, the chance of an error increases when operators multitask or are frequently interrupted. This will be expressed as a problem at times, but not always - especially in resource-constrained contexts where operators believe their concerns have gone unheard.

    In this case, management plays a vital role. The assignment and alignment of work and projects, the timing of meetings, the use of operators to give training, and other factors all have an impact on how an operator works and concentrates on the tasks at hand. While these are instances of human error, they are caused by the manager's judgments and the amount of functional oversight and process control in place.

  9. Target Training to the Root Cause of the Problem
  10. Regular and rigorous pre-job and on-the-job training is required. You can explain to employees that training is taking place because of an action or omission that resulted in an unfavorable result when training is focused directly to the underlying causes of problems as revealed in thorough RCAs. The technique and execution of a fully effective RCA will be detailed, allowing trainers to provide highly focused training that tackles the root causes. Employees are more likely to pay attention and seize opportunities for improvement if we treat them like the lifelong adult learners, they are by explaining the cause, value, and intended consequences.

    Management support for training is vital. Leaders cannot simply issue a directive and then claim that the training does not apply to them. Leadership must demonstrate the behavior they wish to see in their employees. They should go through the training and be ready to explain why it was beneficial and why they believe it would be beneficial to employees.

  11. Use the Power of 5 Whys
  12. A simple root cause analysis method called "5 Whys" is a quick and straightforward way to figure out what's causing a deviation. With one simple question, ask the first of five "Why?" questions, raising options beyond human error that could have caused the failure.

    Problems that appear to be caused by human error should always be investigated further. Human error is frequently a symptom of an underlying problem rather than the cause. The "5 Whys" method can be used to identify the root cause of a problem. You begin to grasp what caused the problem - and eventually discover the core cause - by continually asking "Why?" To get to the fundamental reason, you usually need to ask a series of five "Why?" questions.

    A "5 Whys" analysis can assist you meet the regulatory requirement of determining whether flaws with processes, procedures, or systems contributed to a human error. You can be confident in - and able to justify - your evaluation of human error as the main cause if you go through the analysis and discover nothing but the operator making an honest error.

    To summarize, we don't work in a vacuum as people. External as well as internal elements influence behavior, and by taking control of these difficulties, we may be able to open up a new set of opportunities not before contemplated. Human error prevention is the key. By so doing, we will not only be more productive, but we will also be fair to individuals who go to work intending to perform a decent job but who end up as victims of ineffective processes.