The QMN Weekly Bulletin

Survey: CAPA Systems in Need of Work

Aug. 1, 2008

Many devicemakers have ineffective or cumbersome approaches to corrective and preventive actions (CAPA), a recent industry survey concludes.

The survey included responses from 221 employees in the medical device industry, 26 percent of whom work for firms with more than $1 billion in revenue.

The survey was conducted by IT consultancy Cambashi, in conjunction with FDAnews, and was sponsored by Camstar Systems, IBS America, IQMS, Master Control and Pilgrim Software.

“In many companies, the focus once a CAPA is open is on how quickly it is closed. More fruitful metrics might be whether there were recurrences or whether problems occur at a higher or lower rate than expected based on the risk analysis” or failure mode and effects analysis (FMEA), Cambashi writes.

One respondent to the survey, who was identified as an employee of one of the most respected devicemakers in the industry, told Cambashi that the company’s CAPA system was so complex that it was impossible to use correctly or efficiently — let alone link it to an FMEA or process control system.

The survey, which has been published in Cambashi’s report “Risk Management: Best Practices for Medical Device Profitability,” can be accessed at