January 2015

Open Access

Total Quality's Leader

by Watson, Gregory H.

Remembering Armand V. Feigenbaum, integrator of quality into organizational management...


Separate Steps

by Arter, Dennis

Mixing corrective and preventive actions results in ineffective use....


Dissecting the Details

by Mehta, Bob

Risk mitigation has been a salient requirement for the design, development and manufacture of medical devices that are safe and effective. But the tools employed in the pursuit of effective risk management have varied significantly....


Narrow(er) Focus

by Kotterman, James R.

When teaching failure mode and effects analysis, I start by determining who in the class has participated in creating one. Typically, more than half of the students raise their hands. Next, I ask how useful or accurate their FMEAs were....



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