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Strong management control is central in establishing an organized quality system. A manager with executive responsibility has the ultimate responsibility to set up and change a company's procedures to comply with the quality system regulation (QSR) requirements.

“The buck stops with the named [manager],” said John Stigi at a session at the MD&M West conference. Stigi is the director of the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at FDA.

Many tasks fall under management control. A company's manager with executive responsibility does not have to be the CEO or president of the firm. However, this manager must provide adequate resources for operations and also must monitor the quality system to ensure that it's running properly.

Management control is one of seven main control subsystems of the QSR covered by a routine FDA inspection. The manager with executive responsibility is at the heart of this organizational structure. The additional subsystems are the following:

• Design.

• Production and process.

• Corrective and preventive action.

• Documents, records, and change.

• Material.

• Facility and equipment.

If FDA visits a manufacturer, the manufacturer should expect at the very least, management, design, and production and process control will be inspected.

The first thing an FDA investigator will confirm is that the designated manager has set up a quality policy and quality procedures. Management representatives should be in place to establish and report on the quality system. Employees must be trained and staffing levels must be adequate. This manager is also responsible for conducting and documenting audits.

There are about 1700 classified device groups, but fewer than 100 are exempt from the QSR, according to Stigi. Manufacturers must adhere to the QSR if they want to keep their device on the market and pass FDA inspection successfully.

“You can't send bad products out the door and fix them later,” said Stigi. “Fixing products while they're in the field isn't an option.” A manager that has implemented a well-organized system will help his or her company get through an FDA inspection smoothly.

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