The QMN Weekly Bulletin

Management Support Critical to an Effective Internal Auditing Program

Aug. 10, 2007

The most essential element of an effective internal manufacturing audit program is management support and accountability, according to Susan Reilly, a consultant with Reilly & Associates.

“If management is not willing to provide the time, the resources, the technical expertise [and] the training, you may be the best auditor or auditors in the world and the program is just not going to be effective and efficient,” Reilly said during an FDAnews medical device audioconference.

Although internal auditing, an FDA requirement, is often viewed by upper management as simply a cost of doing business, Reilly said that manufacturers can gain other benefits from having a robust audit program outside of regulatory compliance.

Firms can use their audit results to identify redundancies in their manufacturing systems. An efficient auditing program can identify areas where a company has added more requirements than are needed from both a regulatory and a business perspective, Reilly said.

Sometimes manufacturing operations generate information that is not being used efficiently, appropriately or at all, such as data that show a relatively high scrap rate for incoming materials, Reilly said.

The audioconference, “Medical Device Quality Audits: 10 Must-Haves to Meet QS Requirements,” can be accessed at