How a Team Led by Medtronic Quality Experts Plans to Stand Up to ‘a Monster Called CAPA’—and Make It ‘Cool’

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By Shawn M. Schmitt

When Medtronic PLC officials looked across the company to determine what they call the firm’s “cost of poor execution,” they made a shocking discovery: the device giant was spending upwards of $150 million to conduct corrective and preventive action (CAPA) activities at its various manufacturing sites.

Under its “cost of poor execution” initiative, Medtronic calculates “the dollars associated with poor-quality things that happen,” said Luann Pendy, senior VP of global quality for the

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