135
levels and techniques. This could include successive inspections of self and source. The
procedure should be discussed at each training program to ascertain how it can be used
more effectively. The book Quality Toolbox 2nd Edition provides an excellent section on
mistake proofing that can be used to write the procedure and to understand inspection
methods. It also includes a sample flow chart.19
Conclusion
It is common knowledge that errors committed by employees can be extremely costly
from both regulatory and litigation perspectives and can cause irreparable damage to a
company’s image. More importantly, these errors can cause injuries to patients or users of
devices. It is astonishing that companies spend so little time training employees to think
about thinking and to adopt mistake-proofing and problem-solving methods. This is espe-
cially perplexing in light of the techniques that are readily available to management. Six
Sigma and poka yoke programs are two examples that companies can use to reduce costs
and improve quality. Such programs can also be used to train employees on mistake-proof
methods and awareness.
References
1. Deming WE. Out of the Crisis (Cambridge, MA: MIT Press, 1986).
2. Evans JM. “Look for Trouble,” Quality Progress 39, no. 12 (December 2006): 56–62.
3. Treason H. Human Error (Cambridge, UK: Cambridge Univ Press, 1990).
4. Zimmer C. “The Brain Stop Paying Attention: Zoning Out is a Crucial Mindset,” Discover Magazine, (July/
Aug 2009): 24–25.
5. Raghunathan A. “How to Improve Your Thinking,” Psychology4All.com available from Internet: www.
psychology4all.com/Thinking.htm. Accessed 31 January 2012.
6. Ibid.
7. “Do It By Design” FDA available from Internet: http://www.fda.gov/downloads/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/UCM095061.pdf. Accessed 31 January 2012.
8. Tague NR. Quality Tool Box 2nd Ed., (Milwaukee, WI: ASQ Quality Press, 2005).
9. “Quality Management System-Medical Devices-Guidance on Corrective Action and Preventive Action and
Related Processes,” Global Harmonization Task Force Final Document, Study Group 3, November 2010.
10. 21 CFR Part 820.25 (b)(1) and (b)(2).
11. Brussee W. Statistics for Six Sigma Made Easy (New York, NY: McGraw-Hill, 2004).
12. Op cit 2.
13. Op cit 8.
14. Ritchhart R, Perkins DN. “Learning to Think: the Challenges of Teaching Thinking” in The Cambridge Handbook
of Thinking and Reasoning, ed. KJ Holyoak and RG Morrison, (New York: Cambridge University Press, 2005).
15. Pronovost P et al. “An Intervention to Decrease Catheter-Related Bloodstream Infections in the ICU,” NEJM
355 (2006):2725–2732.
16. Pronovost P, Vohr E. Safe Patients, Smart Hospitals: How One Doctor’s Checklist Can Help Us Change Healthcare
from the Inside Out (New York, Hudson Street Press, 2010).
17. Gawande A. The Checklist Manifesto: How to Get Things Right (New York: Metropolitan Books, 2010).
18. Haynes AB et al., “A Surgical Safety Checklist to Reduce Morbidity and Mortality in a Global Population,”
NEJM 360 (2009):491–499.
19. Op cit 11.
Further Reading
Problem-solving techniques are readily accessible. One of the first systematic methods was put forward by in
Charles Kepner and Benjamin Tregoe in their work, called the New Rational Manager. In addition, a recent book
by Greg Fainberg, How to Solve Just About any Problem: Timeless Practices for Solving Problems, provides comprehen-
sive practical information useful in solving problems. It includes guidance, insights, checklists and templates. He
believes that teaching people to think effectively, solve problems and make better decisions are the most important
enterprises in the world today. Medical device companies that have not already done so should adopt his philoso-
phies and suggestions as part of their training programs
Reprinted with permission from Medical Device +Diagnostic Industry, “Human Error and Quality Control in Medical
Devices,” May 2011. Copyright © 2011 UBM Canon.
Human Error and Quality Control in Medical Devices
levels and techniques. This could include successive inspections of self and source. The
procedure should be discussed at each training program to ascertain how it can be used
more effectively. The book Quality Toolbox 2nd Edition provides an excellent section on
mistake proofing that can be used to write the procedure and to understand inspection
methods. It also includes a sample flow chart.19
Conclusion
It is common knowledge that errors committed by employees can be extremely costly
from both regulatory and litigation perspectives and can cause irreparable damage to a
company’s image. More importantly, these errors can cause injuries to patients or users of
devices. It is astonishing that companies spend so little time training employees to think
about thinking and to adopt mistake-proofing and problem-solving methods. This is espe-
cially perplexing in light of the techniques that are readily available to management. Six
Sigma and poka yoke programs are two examples that companies can use to reduce costs
and improve quality. Such programs can also be used to train employees on mistake-proof
methods and awareness.
References
1. Deming WE. Out of the Crisis (Cambridge, MA: MIT Press, 1986).
2. Evans JM. “Look for Trouble,” Quality Progress 39, no. 12 (December 2006): 56–62.
3. Treason H. Human Error (Cambridge, UK: Cambridge Univ Press, 1990).
4. Zimmer C. “The Brain Stop Paying Attention: Zoning Out is a Crucial Mindset,” Discover Magazine, (July/
Aug 2009): 24–25.
5. Raghunathan A. “How to Improve Your Thinking,” Psychology4All.com available from Internet: www.
psychology4all.com/Thinking.htm. Accessed 31 January 2012.
6. Ibid.
7. “Do It By Design” FDA available from Internet: http://www.fda.gov/downloads/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/UCM095061.pdf. Accessed 31 January 2012.
8. Tague NR. Quality Tool Box 2nd Ed., (Milwaukee, WI: ASQ Quality Press, 2005).
9. “Quality Management System-Medical Devices-Guidance on Corrective Action and Preventive Action and
Related Processes,” Global Harmonization Task Force Final Document, Study Group 3, November 2010.
10. 21 CFR Part 820.25 (b)(1) and (b)(2).
11. Brussee W. Statistics for Six Sigma Made Easy (New York, NY: McGraw-Hill, 2004).
12. Op cit 2.
13. Op cit 8.
14. Ritchhart R, Perkins DN. “Learning to Think: the Challenges of Teaching Thinking” in The Cambridge Handbook
of Thinking and Reasoning, ed. KJ Holyoak and RG Morrison, (New York: Cambridge University Press, 2005).
15. Pronovost P et al. “An Intervention to Decrease Catheter-Related Bloodstream Infections in the ICU,” NEJM
355 (2006):2725–2732.
16. Pronovost P, Vohr E. Safe Patients, Smart Hospitals: How One Doctor’s Checklist Can Help Us Change Healthcare
from the Inside Out (New York, Hudson Street Press, 2010).
17. Gawande A. The Checklist Manifesto: How to Get Things Right (New York: Metropolitan Books, 2010).
18. Haynes AB et al., “A Surgical Safety Checklist to Reduce Morbidity and Mortality in a Global Population,”
NEJM 360 (2009):491–499.
19. Op cit 11.
Further Reading
Problem-solving techniques are readily accessible. One of the first systematic methods was put forward by in
Charles Kepner and Benjamin Tregoe in their work, called the New Rational Manager. In addition, a recent book
by Greg Fainberg, How to Solve Just About any Problem: Timeless Practices for Solving Problems, provides comprehen-
sive practical information useful in solving problems. It includes guidance, insights, checklists and templates. He
believes that teaching people to think effectively, solve problems and make better decisions are the most important
enterprises in the world today. Medical device companies that have not already done so should adopt his philoso-
phies and suggestions as part of their training programs
Reprinted with permission from Medical Device +Diagnostic Industry, “Human Error and Quality Control in Medical
Devices,” May 2011. Copyright © 2011 UBM Canon.
Human Error and Quality Control in Medical Devices