Como Reducir El Error Humano

An FDAnews White Paper

Even in organizations with successful quality programs, minimizing human error is an ongoing challenge.
Experienced people working on established processes sometimes make costly errors in spite of the most
diligent efforts to avoid them. Human error is often the primary contributor to failures or adverse events in
the pharmaceutical industry, leading to qualityproblems that require expensive solutions. 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 studies have now shown that training — or
lack thereof — is responsible for only about 10 percent of the human errors that occur. While training typically is effective whenthere is a need for a new skill set or the implementation of a new task, it is not an
effective response to a human error that is not caused by a lack of knowledge. So, if human error is the
cause but training is not the reason behind it, then what is? This FDAnews White Paper examines how organizations can get to the bottom of events and determine what is behind the errors being committed byoperators.

Manufacturers Can Control,
Investigate Human Error
Research shows that 80 percent of human error can be controlled by managing human factors.
This can be done by managing any aspect of the workplace or job that makes it more likely for a worker
to make an error. In other words, human factors must be implanted into systems used by employees.
The remaining 20 percent of human errorscan be controlled by managing the acquired behaviors of
humans, otherwise known as habits. As a result, controlling human error is done 80 percent by managing
systems and 20 percent by managing people.
Organizations can combat problems by identifying system weaknesses and making them stronger. This
can be done by finding minor events that could be the precursors to much larger events — thosethat have not
yet resulted in losses. Then, pinpoint the reasons why these minor events happened and correct them. It is
very similar to what is known in safety systems as “near misses.”
However, if a human error does occur, it must be investigated. When investigating human errors,
what often happens in the investigation process is an event is identified and the technical part of the
event isinvestigated. Whenever there is a possibility that human failure is the root cause, however, a
(See Control, Page 2)

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HOW TO REDUCE HUMAN ERROR BY MANAGING HUMAN FACTORS

Control, from Page 1
human error investigation must be undertaken to
comply with the FDA regulations.
Thus, once the root cause analysis investigation is complete, a new investigation starts
— the human errorinvestigation. Human error
investigators are people who have specific
skills and abilities designed to understand human behavior and understand conditions that
could impact behavior in a negative way, leading to human error.
In a typical investigation process, the organization gathers and analyzes data, determines the
causal factors behind an event, determines the
root cause(s), andcategorizes and codes those
causes. Next, corrective and preventive actions
are designed and developed, followed by
monitoring and trending of the root causes.
Based on the data, the effectiveness of the
corrective and preventive actions (CAPA) can be
measured, allowing the organization to predict if
it has a problem with one of its systems.

INSIDE THIS ISSUE

For example, an organizationdiscovers it is
experiencing human errors related to one of its
procedures. The human error investigators identify that the procedure was not being used because
it did not exist. Then, if they determine that most
of the human error-related events are related to
that root cause, the organization can predict that
at some point, if it doesn’t create a procedure, a
mistake will once again be...