From Alzheimer’s to Zebrafish: Eclectic Science and Regulatory Stories 132
Human error is a broad category that includes the clearly identifiable, easily diagnosable
and seemingly excusable mistakes we all make. Error encompasses all those occasions in
which a planned sequence of mental or physical activities fails to achieve its intended out-
come, and these failures cannot be attributed to the intervention of some chance agency.
The definition of error may be complex but the outcome in the workplace, where accuracy
is paramount, is not.
Human errors are often simple mistakes that can be catastrophic to those responsible
and, more importantly, to the user or patient. Avoiding mistakes is an important consider-
ation for companies striving to reduce errors.
Error reduction was addressed more than 30 years ago by W. Edwards Deming, a
quality expert. He cited the need to seek a fresh approach to reduce mistakes and defec-
tive workmanship.1 Deming noted that in many organizations, human error accounts
for more than half of unnecessary business expenses. Of that portion, the rule of thumb
is that about 85% result from automatic errors of execution, the causes of which remain
inadequately understood and addressed.2 One of Deming’s quotations is worth repeating:
“Defects are not free. Somebody makes them and gets paid for making them.”
There are a number of articles and several recent books that deal with human errors,
how they occur and what to do about them. Many such resources can be used for training
purposes. This article discusses why we make mistakes, the concept of poka yoke (mistake
proofing), and various means to reduce mistakes, including training methods, checklists
and flow charts. The article also provides suggestions for procedures designed to address
a major cause of recalls or other corrective action.
Why We Make Mistakes
One reason for making mistakes involves the power of first impressions. Most people
stay with an initial choice for an answer to a test question at least 70% of the time, even
when they learn that the answer is incorrect. Nearly 80 years of research on answer
changing shows that most people who change their answers usually improve their test
scores.3 Moreover, most people let their minds wander more often than they might think.
According to one study, students reported that their minds wandered an average of 5.4
times in a 45-minute session. Depending on the experiment, people tend to spend up to
half their time working on a task while thinking about other things, even when they have
been explicitly told to pay attention.4 Another reason is that most of us are not equipped
for multitasking. The number of things we can do at once is extremely limited. In general,
the human memory cannot retain more than five unrelated items at one time many of us
retain even fewer. Multitasking is not thinking—it impairs the ability to think. Thinking
means concentrating on one thing long enough to develop an idea about it.5 Individuals
do their best thinking by slowing down and concentrating. Furthermore, individuals often
blame the wrong cause, and thus learn little from a mistake experience.
To develop a quality error reduction program it is critical to understand what constitutes
errors of thinking. Some researchers categorize five different types of erroneous thinking:6
• Partialism—The thinker observes problems through one perspective only.
• Adversary—The thinker believes that because someone else is wrong, he should
be right (e.g., some politicians use this to sway voters).
• Time Scale—The thinker sees a problem from a limited timeframe.
• Initial Judgment—The issue or problem is not considered objectively.
• Arrogance and Conceit—The thinker believes that his or her solution is absolute
and no better one exists.
All of this information should be considered in the company’s training program and
accompanied by lessons learned from US Food and Drug Administration (FDA) Form
483s and other Warning Letters.
Human error is a broad category that includes the clearly identifiable, easily diagnosable
and seemingly excusable mistakes we all make. Error encompasses all those occasions in
which a planned sequence of mental or physical activities fails to achieve its intended out-
come, and these failures cannot be attributed to the intervention of some chance agency.
The definition of error may be complex but the outcome in the workplace, where accuracy
is paramount, is not.
Human errors are often simple mistakes that can be catastrophic to those responsible
and, more importantly, to the user or patient. Avoiding mistakes is an important consider-
ation for companies striving to reduce errors.
Error reduction was addressed more than 30 years ago by W. Edwards Deming, a
quality expert. He cited the need to seek a fresh approach to reduce mistakes and defec-
tive workmanship.1 Deming noted that in many organizations, human error accounts
for more than half of unnecessary business expenses. Of that portion, the rule of thumb
is that about 85% result from automatic errors of execution, the causes of which remain
inadequately understood and addressed.2 One of Deming’s quotations is worth repeating:
“Defects are not free. Somebody makes them and gets paid for making them.”
There are a number of articles and several recent books that deal with human errors,
how they occur and what to do about them. Many such resources can be used for training
purposes. This article discusses why we make mistakes, the concept of poka yoke (mistake
proofing), and various means to reduce mistakes, including training methods, checklists
and flow charts. The article also provides suggestions for procedures designed to address
a major cause of recalls or other corrective action.
Why We Make Mistakes
One reason for making mistakes involves the power of first impressions. Most people
stay with an initial choice for an answer to a test question at least 70% of the time, even
when they learn that the answer is incorrect. Nearly 80 years of research on answer
changing shows that most people who change their answers usually improve their test
scores.3 Moreover, most people let their minds wander more often than they might think.
According to one study, students reported that their minds wandered an average of 5.4
times in a 45-minute session. Depending on the experiment, people tend to spend up to
half their time working on a task while thinking about other things, even when they have
been explicitly told to pay attention.4 Another reason is that most of us are not equipped
for multitasking. The number of things we can do at once is extremely limited. In general,
the human memory cannot retain more than five unrelated items at one time many of us
retain even fewer. Multitasking is not thinking—it impairs the ability to think. Thinking
means concentrating on one thing long enough to develop an idea about it.5 Individuals
do their best thinking by slowing down and concentrating. Furthermore, individuals often
blame the wrong cause, and thus learn little from a mistake experience.
To develop a quality error reduction program it is critical to understand what constitutes
errors of thinking. Some researchers categorize five different types of erroneous thinking:6
• Partialism—The thinker observes problems through one perspective only.
• Adversary—The thinker believes that because someone else is wrong, he should
be right (e.g., some politicians use this to sway voters).
• Time Scale—The thinker sees a problem from a limited timeframe.
• Initial Judgment—The issue or problem is not considered objectively.
• Arrogance and Conceit—The thinker believes that his or her solution is absolute
and no better one exists.
All of this information should be considered in the company’s training program and
accompanied by lessons learned from US Food and Drug Administration (FDA) Form
483s and other Warning Letters.