As technology advances, human error in manufacturing becomes more and more visible every day. Human error is responsible for more than 80 percent of process deviations in the pharmaceutical and related manufacturing environments. Sadly, little is known about these events’ nature mainly because quality event investigations end where human error investigations should begin.
In this blog post, I explain (and reiterate here) if you work in an industry where Good Manufacturing Practices (GMP) apply, you need to address human error deviations not only because they are an inconvenience, but you must also do it because the regulations require it.
The Code of Federal Regulations (CFR) Title 21 subpart B, Organization and Personnel Sec. 211.22 “Responsibilities of quality control unit.” states “(a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated.”
Now, let’s look specifically at this section of the sentence: “…if errors have occurred, that they have been thoroughly investigated.” It’s important to note human error is NOT a root cause because it may be the reason for the error, but it doesn’t fully explain why the error occurred.
The European Commission is a little more specific in “The Rules Governing Medicinal Products in the European Union, Volume 4, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use.” Section 1.4 states, “A Pharmaceutical Quality System appropriate for the manufacture of medicinal products should ensure that: (xiv) An appropriate level of root cause analysis should be applied during the investigation of deviations, suspected product defects, and other problems…” then it continues “Where human error is suspected or identified as the cause, this should be justified having taken care to ensure that process, procedural or system-based errors or problems have not been overlooked, if present. Appropriate corrective actions and/or preventative actions (CAPAs) should be identified and taken in response to investigations. The effectiveness of such actions should be monitored and assessed, in line with Quality Risk Management principles.”
When we investigate quality events, the focus should be on explaining what happened in the process and how the product was affected. A human error usually explains the reason for the occurrence of the deviation; nevertheless, the reason for that error remains unexplained, and consequently, the CAPAs fail to address the underlying conditions for that failure. This, in turn, translates into ineffective action plans that result in non-value-added activities, wasting resources and eventually resulting in recurrences and repeated events.
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. We would never end an investigation with only “equipment failure.” We would explain exactly what the equipment failure was so it could be fixed.
To assure effective CAPA’s, human error events need to be fully investigated. Regulations require that errors be fully investigated, meaning that you identify the reasons why they occurred. In order to comply with this expectation, we need to understand how human behavior is affected by external variables as well as internal variables.
First, we need to understand what a human error is. Human error is defined in many ways. One definition that I like is “any action, performed by a person, which exceeds a system’s tolerance.” Human error is an error and not an intentional act for harm. Sabotage is not considered a human error unless the result of the actual intentions is different than was expected. So stating that a human error has occurred does not necessarily mean that it is the “human’s” fault.
We, as humans, do not operate in a vacuum. Behaviors are influenced by external as well as internal variables. In manufacturing environments, these variables can be divided into six major categories: procedures, human factors, training, supervision, communication, and the individual itself.
Individuals are undoubtedly responsible for their actions. But before we determine that internal factors like attitude or attention are accountable 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 5%of deviations. For example, if an employee overlooks defects because of a lack of appropriate vision, shouldn’t the organization make sure visual exams are performed regularly? Even in this example, we can see that a “fit for duty” system is weak.
On the other hand, training is usually used as a corrective action. Although training has proven to be effective for transferring knowledge, skills, and abilities (KSA’s), it will only work for new employees, new processes, or to instruct on changes to existing processes if the employees who perform the task lack the new KSA’s. In fact, training is responsible for less than 10 percent of the deviations related to performance, yet most of the organization’s efforts are directed towards less than 10 percent of the actual weaknesses. No wonder CAPA’s related to training end up being so ineffective.
The most effective way to control human error is to implement adequate systems. Systems take care of human factors (any aspect of the workplace or job implementation that makes it more likely for the worker to make an error) and external factors. We can start by:
Understand the difference between explaining an event and explaining a human error. Once the human error has been identified as a cause for the deviation, consider the human error itself as a new event that needs to be explained to assure conditions are identified and fixed.
Past behavior predicts future behavior if changes are not made. We need to perform an assessment of past events and assure the reasons for the error, besides the reasons for the event, are identified. Then we need to categorize these causes (conditions for error) in a systematic/uniform way. This allows you to analyze significant contributors and, based on priorities, create an action plan that addresses these conditions. For example, if most of your human error events were related to incomplete procedures, then revising them and adding the missing instructions would be an action to consider.
Human error will not be eradicated unless we are able to really identify what is causing humans to err. If eliminating or “fixing” the actual individual eliminates or potentially reduces the probabilities of making that mistake again, then addressing the employee would be effective. If we challenge ourselves, we can’t categorically assure that this will correct the problem; intervening with the individual will only create a liability to the organization, and we will end up in the same place we were at the beginning, trying to correct another individual’s same mistake.
What do organizations need?
CAPA’s will be effective when we can eliminate conditions (causes) that make people deviate from the expected outcome. Therefore, CAPA effectiveness should be measured by root cause recurrence and event recurrence. Most events, although different in nature, share the same causes. Real CAPA effectiveness will be achieved when the number of deviations decreases. Not when particular events fail to reoccur.
This way, we will be more productive and fairer to those who work to do a good job but end up being victims of weak systems.
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