EMERGO SUMMARY OF KEY POINTS:

• FDA Quality System Regulation (QSR) inspections occur on an unannounced, “surprise” basis.
• FDA quality inspection methods and approaches are laid out in the Quality System Inspection Technique (QSIT) guidelines.
• Manufacturers should conduct internal audits of their quality systems on a regular basis to ensure 21 CFR Part 820 compliance and address any issues before an actual FDA inspection occurs.

Because the US Food and Drug Administration conducts inspections of US medical device market registrants’ quality management systems only on a “surprise” basis, manufacturers’ compliance with US Quality System Regulations is expected to be consistently up to date.

According to a recent Emergo whitepaper, knowing what to expect during an unannounced FDA QSR inspection can go a long way toward ensuring a positive outcome for a manufacturer; preparing for such an inspection, even when a firm doesn’t know when it will occur, is crucial.

Know your QSIT

Fortunately, the FDA’s method of conducting QSR inspections is no secret—the agency’s Quality System Inspection Technique (QSIT) has long been available for public download, and explains inspectors’ approach to reviewing registrants’ quality systems.

The QSIT guidance focuses on four major quality subsystems—Management Controls, Corrective and Preventative Actions, Design Controls, and Production and Process Controls—that serve as a basis for how FDA inspectors review registrants’ processes and procedures, according to Richard Vincins, Emergo Vice President of Quality Assurance Consulting and author of the whitepaper.

“The FDA published the QSIT guide to demonstrate what they will review during and inspection; therefore, organizations should read and study the QSIT guide and apply its principles when they review and audit their quality system,” Vincins writes.

Inspection structure and timeframes

The whitepaper addresses how a typical FDA QSR inspection is structured, as well as how long the process usually takes.

Usually, manufacturers can expect FDA inspectors to spend one full day on each of the four QSIT subsystems; firms based in the US, however, should also keep in mind that inspectors may extend review times if they identify any quality issues that warrant more in-depth examination.

Preparation: before, during and after

Successfully undergoing an FDA QSR inspection entails various efforts before, during and after the process, according to Vincins:

• Firms can and should conduct their own internal quality system audits on a regular basis, and with an adequate degree of rigorousness. “To prepare for an inspection, your internal audit program should challenge the documentation system, ensuring documents can be provided (to an FDA inspector) in a timely manner,” Vincins writes.
• During an inspection, a manufacturer should appoint an appropriate staff member as its “Inspection Coordinator,” and document all aspects of the inspection as well.
• If a manufacturer receives one or more Form 483 Observations from an FDA inspector, the firm should reply promptly and provide all information and documentation necessary to address quality issues.

For in-depth information on what to expect during an FDA QSR inspection as well as preparatory steps for medical device companies, download our full whitepaper on the topic.