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John Stigi, director of DSMICA |
Strong management control is central in establishing an organized quality system. The manager with executive responsibility (MER) has the ultimate responsibility to set up and change a companyÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂs procedures that comply with the Quality System Regulation (QSR). The QSR is the organizational structure, responsibilities, processes, and means for establishing quality management.
"The buck stops with the individual named MER," said John Stigi at an MD&M West conference on Monday afternoon. Stigi is the director of the Division of Small Manufacturers, International, and Consumer Assistance at FDA. Many tasks fall under management control. The MER, who doesnÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂt have to be the CEO or president of the company, must provide adequate resources for operations and monitor the quality system to ensure that itÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂs running properly.
Management control is one of seven main controls subsystems of the QSR covered by FDA investigators during a routine inspection, and the MER is at the heart of this organizational structure. In addition to management control, the subsystems are:
• Design• Production and Process
• Corrective and Preventative Action
• Documents, Records, and Change
• Material
• Facility and Equipment
If a manufacturer is visited by FDA, it should expect that at least management, design, and production and process control are inspected the first time around.
The first thing an FDA investigator will confirm is that the MER has set up a quality policy and quality procedures. Management representatives should be in place to establish and report on the quality system. The MER also needs to make sure that employees are trained and that staffing levels are adequate.
The MER should also conduct and document audits. Once the MER has established the roots of the quality system, there should be more organization throughout the rest of the control subsystems.
There are more than 1700 classified device groups but less than 100 are exempt from the QSR, according to Stigi. Manufacturers must adhere to this regulation if they want to keep their device on the market and pass FDA inspection successfully.
"You canÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂt send bad products out the door and fix them later," said Stigi. "Fixing it while in the field isnÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂt an option for a medical device firm." If manufacturers want to get through an FDA inspection smoothly, they canÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂÃÂt overlook having a well-organized MER.
