133
Other reasons for making mistakes in the workplace are similar to those made by
healthcare practitioners who use medical devices. The errors are described in an FDA
guidance document for human factors engineering.7 Like healthcare personnel, individu-
als working for medical device companies vary greatly in their physical, sensory and
mental abilities. The latter refers to higher mental phenomena such as memory, informa-
tion processing, use of rules and strategies, hypothesis formation and problem solving.
An employee’s performance can be compromised by noise, poor lighting, glare-producing
surfaces, excessive heat, improperly used cleaning products, electrical interference, poorly
written procedures, inadequate training, a wide array of equipment used, stress and
fatigue. Risk influencing factors (RIFs) worsen natural tendencies to make errors.
Poka Yoke and Six Sigma in Device Manufacturing
Quality personnel focusing on defect prevention can use principles embodied in mistake
proofing or poka yoke. The system involves the use of any automatic device or method
that either makes it impossible for an error to occur or makes the error immediately
obvious once it has occurred.8 Unfortunately, poka yoke is not implemented by medical
device companies as often as it should be. Neither ISO 13485:2003 nor the quality system
regulation (QSR) under corrective and preventive action references problem solving or
error proofing. These topics are, however, included in ISO 16949:2009, the quality manage-
ment standard that contains particular requirements for the application of ISO 9001:2008
for automotive production and relevant service organizations. The standard suggests
that organizations incorporate error-proofing methods into corrective action policies
and implement a defined process for problem solving designed to identify and eliminate
root causes. No guidance is given for implementation, however. The recently issued final
document on corrective and preventive action and related QMS processes from the Global
Harmonization Task Force does not directly refer to problem solving or error proofing
techniques however, it does describe a number of statistical and nonstatistical techniques
to be used for analysis.9
The training section of the QSR states that personnel should be made aware of device
defects that may occur from improper performance of their specific jobs. Personnel who
perform verification or validation activities must be made aware of defects or errors that
may be encountered as part of their job function.10
Such notification requirements are admirable. But without addressing error proof-
ing, they are insufficient. The Six Sigma problem-solving approach known as DMAIC is a
road map that can be followed for all projects and process improvements.11 It includes the
following steps:
• D—Define the overall problem.
• M—Measure the problem to gather accurate and sufficient measurements and
data.
• A—Analyze the data to see whether they are consistent with the problem defini-
tion and use these data to identify a root cause.
• I—Improve processes. Once a solution is identified, it must be implemented and
the results must be verified with independent data.
• C—Control the solution. A verification of control must be implemented. A robust
solution will be easier to keep in control than a qualitative one.
Education and Training
Only a few well-established programs that deal with aspects of thinking have taken
hold in universities. Critical and creative thinking, reflective and metacognitive thinking
(awareness and understanding one’s own thought processes), self-regulation, decision
making, problem solving and other disciplinary forms of thinking are taught and prac-
ticed. Such programs should also be part of career development initiatives and offered to
Human Error and Quality Control in Medical Devices
Other reasons for making mistakes in the workplace are similar to those made by
healthcare practitioners who use medical devices. The errors are described in an FDA
guidance document for human factors engineering.7 Like healthcare personnel, individu-
als working for medical device companies vary greatly in their physical, sensory and
mental abilities. The latter refers to higher mental phenomena such as memory, informa-
tion processing, use of rules and strategies, hypothesis formation and problem solving.
An employee’s performance can be compromised by noise, poor lighting, glare-producing
surfaces, excessive heat, improperly used cleaning products, electrical interference, poorly
written procedures, inadequate training, a wide array of equipment used, stress and
fatigue. Risk influencing factors (RIFs) worsen natural tendencies to make errors.
Poka Yoke and Six Sigma in Device Manufacturing
Quality personnel focusing on defect prevention can use principles embodied in mistake
proofing or poka yoke. The system involves the use of any automatic device or method
that either makes it impossible for an error to occur or makes the error immediately
obvious once it has occurred.8 Unfortunately, poka yoke is not implemented by medical
device companies as often as it should be. Neither ISO 13485:2003 nor the quality system
regulation (QSR) under corrective and preventive action references problem solving or
error proofing. These topics are, however, included in ISO 16949:2009, the quality manage-
ment standard that contains particular requirements for the application of ISO 9001:2008
for automotive production and relevant service organizations. The standard suggests
that organizations incorporate error-proofing methods into corrective action policies
and implement a defined process for problem solving designed to identify and eliminate
root causes. No guidance is given for implementation, however. The recently issued final
document on corrective and preventive action and related QMS processes from the Global
Harmonization Task Force does not directly refer to problem solving or error proofing
techniques however, it does describe a number of statistical and nonstatistical techniques
to be used for analysis.9
The training section of the QSR states that personnel should be made aware of device
defects that may occur from improper performance of their specific jobs. Personnel who
perform verification or validation activities must be made aware of defects or errors that
may be encountered as part of their job function.10
Such notification requirements are admirable. But without addressing error proof-
ing, they are insufficient. The Six Sigma problem-solving approach known as DMAIC is a
road map that can be followed for all projects and process improvements.11 It includes the
following steps:
• D—Define the overall problem.
• M—Measure the problem to gather accurate and sufficient measurements and
data.
• A—Analyze the data to see whether they are consistent with the problem defini-
tion and use these data to identify a root cause.
• I—Improve processes. Once a solution is identified, it must be implemented and
the results must be verified with independent data.
• C—Control the solution. A verification of control must be implemented. A robust
solution will be easier to keep in control than a qualitative one.
Education and Training
Only a few well-established programs that deal with aspects of thinking have taken
hold in universities. Critical and creative thinking, reflective and metacognitive thinking
(awareness and understanding one’s own thought processes), self-regulation, decision
making, problem solving and other disciplinary forms of thinking are taught and prac-
ticed. Such programs should also be part of career development initiatives and offered to
Human Error and Quality Control in Medical Devices