The company Cardiac Science resolved a component obsolescence issue in their ECG monitoring component by developing a verification plan and releasing a new alternate component into inventory. They also resolved a backlight issue in 25% of their WIP by determining the root cause was a too small compensation capacitor and selecting a larger one. Additionally, they addressed a compliance issue and passed patient leakage testing by redesigning a high voltage charging transformer. The company Medtronic Diabetes resolved a 10% yield fallout in manufacturing of a glucose monitor by determining the root cause of cracked reed switches was interference from tooling on the line and resolving the issue.

1. Problem Accomplishment Result Company
Release new component in ECG Monitoring component.
Component obsolescence in ECG Manufacturing can continue with alternate components procured
Developed verification plan and documented release of new Cardiac Science
Monitoring component into inventory
component in Agile documentation system
Analyzed issue by measuring 5V regulator inrush current and
circuit analysis of current limit. Determined root cause to be a
25% of WIP failing for LCD compensation capacitor was too small in value for the electrical 25% of failing product on hold yielded 100% through
Cardiac Science
Backlight will not light current demand of the circuit on power up. Selected a larger manufacturing test following rework of compensation capacitor.
capcitor and released the change by performing verification
activities and updated the product BOM.
Identified compliance issues related to maximum allowable patient
Compliance patient leakage test leakage and defib proof labeling specified in IEC60601 standard.
Compliance testing passes for product enhancement. Cardiac Science
failed Redesign of HV charging transformer which reduced patient
leakage within limits.
10% yield fallout in manufacturing Determined root cause of reed switches cracking due to an
of glucose monitor for broken interference problem with tooling on the line. Resolved yield issue
reed switch by Manufacturing yield increased 10%. Medtronic Diabetes