18 May, 2018 Ginette Colazzo, President, Ginette M. Collazo Human Reliability Consultancy
As technology advances, human error in manufacturing becomes more and more visible every day. Human error is responsible for more than 80 percent of failures and defects. Sadly, little is known about the nature of these events mainly because the quest for answers ends where human error investigations should begin. This situation has become very evident to regulators and good manufacturing practice (GMP) enforcement agencies as they are being more critical of the approach, result and effectiveness of corrective action and preventative actions (CAPAs) when dealing with human performance issues. In order to successfully achieve this goal, we have to understand how to improve the way we deal with these types of situations.
Usually the focus of error investigations relies on explaining what happened and who was involved. This is necessary to understand the problem. Nevertheless, this is not enough when it comes to addressing these kind of failures. Instead, we need to explain the reason why it happened.
GMPs clearly state in the U.S. Food and Drug Administration's 21 CFR Part 211.22 that “[the quality control unit has] … the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated.” Let’s analyze this statement. If the FDA expects that errors be fully investigated, it is safe to assume that the term error is not a root cause. That’s why it needs to be fully investigated, hence determine the root cause of the human error.
The reality is that people make mistakes because they can. Our systems allow humans to incorporate their natural unreliability into processes that should be protected by systems in organizations. The problem basically relies in the fact that most of the systems do not directly consider human error prevention as part of the design, and human factors and capabilities are usually ignored when it comes to people.
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A Road Map for Addressing Quality and Manufacturing Challenges in Life Sciences (LNS Research)
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Human error is about explaining human behavior. Chemical engineers explain product behavior, mechanical engineers explain equipment behavior, industrial engineers explain process behavior, but who explains human behavior?
Human behavior is complex and just like equipment, product and process, it needs to be analyzed in depth. Human error has few definitions. One is “that action performed by a human that results is something different than expected.” This one refers directly to the individual itself. Another definition is that human error is “any human action, or lack of action that exceeds a system’s tolerance.” It should be added that in human error there is no harm intended. An intention of harm is considered sabotage, and sabotage is not considered a human error, unless something goes wrong during the actual act of harm. So stating that a human error has occurred does not necessarily mean that is the human’s fault or that there is, by default, an intention of creating a problem.
Despite the industry's awareness of human errors, companies still frequently fail to substantively and correctly address errors. The typical response to a human error is retraining, but this often fails to produce the desired result. Training (or lack thereof) is responsible for only about 10 percent of the human errors that occur, since it basically takes care of issues related to lack of knowledge, skill or ability. If the error was not due to one of these, then training is practically useless. Also, many companies are still taking the blame approach to human error, which appeals to the individual’s sense of fear.
The blame perspective only leads to less trust from people to bring up issues that can lead to failures, which in turn results in management being less aware of system weaknesses that eventually result in more mistakes. A systemic view (for human error), instead, assumes that some degree of error is inevitable and puts systems in place to detect, prevent and correct it.
What can we do to address human error? Let’s take a look at the environment. We cannot change human condition, but we can change the conditions where humans work, so let’s review our systems and operation control. Some areas to evaluate are:
- Management systems: Documentation control, investigation management, risk management and project management are important to set the bases for the rest of the operation.
- Procedures: These need to be accurate, human-engineered, available and enforceable.
- Human factors engineering: Work areas need to be designed with human factors and human capabilities in mind. Excessive monitoring, mental calculations, housekeeping and work layout, among others, become the main reasons for error in this category.
- Training: Training needs to include the why's as well as the what's and how's. Also, on the job training and qualification (OJT) is necessary, especially for critical tasks and activities.
- Immediate supervision: Pre-job briefs, walk-throughs and presence and instructions to workers are necessary. We need to have supervisors on the floor, not in the office.
- Communication: Between groups, shifts, radio communication rules and training. Employees should know what needs to be achieved daily and the proper way to do it.
- Individual performance: Evaluate conditions that could potentially form cognitive overload that creates attention and memory failures. Some of these conditions include available time for the job, fitness for duty or fatigue management and complexity and task design.
In conclusion, human error can be prevented. Good and accurate administrative management systems that assure that there are controls for providing clear, accurate procedures, instructions and other aids are crucial for human error prevention. In addition, human factors, such as engineering of control systems; appropriate processes and work environment; job-relevant training and practice; appropriate supervision; good communications; and individual personnel performance, are all part of the formula human error prevention. Humans have more things in common than differences, and after visiting many places in the world, I can say that the areas requiring improvement are practically universal.
We as humans don’t operate in a vacuum. Behaviors are influenced by external as well as internal variables. Individuals are certainly responsible for their actions. But before we determine that internal factors, like attitude or attention, are responsible for the mistake, we as organizations are responsible for eliminating the possibilities of external factors influencing human behavior. Individual performance in manufacturing is proven to be responsible for less than five percent of deviations. And people want to do things right.
2018 should be a year dedicated to recovery. Human error can be prevented. The cost of error can be avoided. Taking control of these issues opens a new set of opportunities not considered before. Companies lose billions of dollars because of avoidable human mistakes; sadly, we don’t understand the cost of the errors until they have already happened. Prevention is the key. This way, we will not only be more productive, but also fair to those that go to work with the intention to do a good job but who end up being victims of weak systems.
Dr. Ginette Collazo obtained her Ph.D. in industrial/organizational psychology from the Interamerican University of Puerto Rico.She has over 15 years of experience in the pharmaceutical industry in the technical training, organizational development and human reliability fields. Collazo's work experience is with Bristol Myers Squibb, Johnson & Johnson, Schering Plough and Wyeth, and she holds specialized studies in human reliability and has authored various publications on this topic.
Currently, she is the president of Ginette M. Collazo (GMC), a firm that works with organizations around the world to improve productivity by helping them identify and implement innovative strategies to ensure that business objectives and results are met and exceeded.
Collazo has been a guest speaker on these topics in several professional conferences including, American Institute for Chemical Engineers Global Conference, Center for Chemical and Process Safety, American Society for Quality, California State Lands Commission, Interphex PR and NY, and FDA News. She can be reached at email@example.com or www.ginettemcollazo.com.