How A Team Led By Medtronic Quality Experts Plans To Stand Up To 'A Monster Called CAPA' – And Make It 'Cool'

11 Apr 2019

• By Shawn M. Schmitt

The so-called "#makeCAPAcool" group wants to recast corrective and preventive action as a continuous learning tool, rather than a place where problems often go to linger, be ignored and never die. A new voluntary CAPA framework developed by the team and piloted by a handful of device-makers will be rolled out later this year.

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 $150m 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,...