Originally Published MX September/October 2003

BUSINESS PLANNING & TECHNOLOGY DEVELOPMENT

An audit that examines complaints deemed not worth investigating can expose system weaknesses and improve compliance. 

Mark Allen

No medtech company enjoys receiving product complaints, of course. Nevertheless, besides being necessary for maintaining compliance with industry regulations, complaint tracking is an essential tool for improving a manufacturing company’s performance. It is critical that the system for receiving and evaluating complaints be effective. But appraising the effectiveness of the complaint-handling system while continuing to meet the various expectations of company stakeholders —customers, employees, and regulators—can be a challenge.

The performance of a complaint system should be judged against stated objectives. These performance objectives can be formal or informal, but they should be well defined and documented.