From Alzheimer’s to Zebrafish: Eclectic Science and Regulatory Stories 134
all employees. Problem solving and good quality thinking are essential skills for employ-
ees to attain, now more than ever.
Training should be industry-specific. Employees should be encouraged to pay
attention to detail, avoid behavior that results in unwanted outcomes and focus on past
experiences of dealing with past problems. Once employees become aware of the basic
principles, they are often able to apply experience from their own work to find practical
ways to reduce the risk of error. Recognition that adverse influences (rather than indi-
vidual shortcomings) are the intent of training reassures employees that the company is
concerned with finding constructive ways to avoid error rather than blaming people.12
Training programs could begin with this oft-cited quotation by Voltaire, the noted French
philosopher: “No problem can withstand the assault of sustained thinking.”
Checklists
One means to minimize errors is to use a checklist, otherwise known as work procedures
or conformation check sheets.13 Checklists are now being aggressively promoted in medi-
cal literature and the popular press, and rightly so.14–16
Many hospitals have started to implement more comprehensive checklist procedures
in the operating room, aimed at increasing compliance with practices known to reduce
complications and enhance teamwork. The World Health Organization has reported that
such checklists cut surgical morbidity and mortality almost in half.17 A recent controlled
study showed that the implementation of a comprehensive checklist in six regional and
tertiary care centers in the Netherlands improved outcomes substantially. The study also
provided insights into why checklists work and should be considered by medical device
manufacturers.18
Quality teams should review each process and all reported errors to determine
whether a checklist would prove beneficial. When creating a checklist for steps in a pro-
cess, it is a good idea to first prepare a flow chart to determine what the steps are and how
they should be sequenced.
Flow Charts
Flow charts are diagrams that use graphic symbols to depict the nature and flow of steps
in a process. They have a number of benefits:
• promoting the understanding of the process
• providing a training tool
• identifying problem areas and opportunities for improvement
• depicting customer-supplier relationships
Flow charts are similar in style to cause-and-effect diagrams, which are defined as graphic
tools that help identify, sort and display possible causes of a problem or quality char-
acteristic. A cause-and-effect diagram uses an orderly, easy-to-read format and helps to
determine root causes, encourages group participation, indicates possible causes of varia-
tion and, most importantly, increases knowledge of the process.
A Procedure for Mistake Proofing
A mistake proofing procedure should be developed that includes a flow chart of the
process when possible. Each step of a particular process should be reviewed to determine
where or when human errors are likely to occur. The procedure should require working
back through the process to find the source of each potential error. It may be possible to
eliminate an error by omitting the step that causes it or by replacing that step with one
that is error-proof. The procedure should also include methods of detecting errors that
are impossible to prevent and specify ways to minimize their effects, including inspection
all employees. Problem solving and good quality thinking are essential skills for employ-
ees to attain, now more than ever.
Training should be industry-specific. Employees should be encouraged to pay
attention to detail, avoid behavior that results in unwanted outcomes and focus on past
experiences of dealing with past problems. Once employees become aware of the basic
principles, they are often able to apply experience from their own work to find practical
ways to reduce the risk of error. Recognition that adverse influences (rather than indi-
vidual shortcomings) are the intent of training reassures employees that the company is
concerned with finding constructive ways to avoid error rather than blaming people.12
Training programs could begin with this oft-cited quotation by Voltaire, the noted French
philosopher: “No problem can withstand the assault of sustained thinking.”
Checklists
One means to minimize errors is to use a checklist, otherwise known as work procedures
or conformation check sheets.13 Checklists are now being aggressively promoted in medi-
cal literature and the popular press, and rightly so.14–16
Many hospitals have started to implement more comprehensive checklist procedures
in the operating room, aimed at increasing compliance with practices known to reduce
complications and enhance teamwork. The World Health Organization has reported that
such checklists cut surgical morbidity and mortality almost in half.17 A recent controlled
study showed that the implementation of a comprehensive checklist in six regional and
tertiary care centers in the Netherlands improved outcomes substantially. The study also
provided insights into why checklists work and should be considered by medical device
manufacturers.18
Quality teams should review each process and all reported errors to determine
whether a checklist would prove beneficial. When creating a checklist for steps in a pro-
cess, it is a good idea to first prepare a flow chart to determine what the steps are and how
they should be sequenced.
Flow Charts
Flow charts are diagrams that use graphic symbols to depict the nature and flow of steps
in a process. They have a number of benefits:
• promoting the understanding of the process
• providing a training tool
• identifying problem areas and opportunities for improvement
• depicting customer-supplier relationships
Flow charts are similar in style to cause-and-effect diagrams, which are defined as graphic
tools that help identify, sort and display possible causes of a problem or quality char-
acteristic. A cause-and-effect diagram uses an orderly, easy-to-read format and helps to
determine root causes, encourages group participation, indicates possible causes of varia-
tion and, most importantly, increases knowledge of the process.
A Procedure for Mistake Proofing
A mistake proofing procedure should be developed that includes a flow chart of the
process when possible. Each step of a particular process should be reviewed to determine
where or when human errors are likely to occur. The procedure should require working
back through the process to find the source of each potential error. It may be possible to
eliminate an error by omitting the step that causes it or by replacing that step with one
that is error-proof. The procedure should also include methods of detecting errors that
are impossible to prevent and specify ways to minimize their effects, including inspection