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QUALITY SYSTEM INSPECTIONS REENGINEERING:

History: Since late 1997 a team has been working to reengineer the inspection process used by the agency to perform quality system (GMP) inspections at medical device manufacturing facilities. After numerous meetings with stakeholders and quality system experts in late 1997 and early 1998 a proposed inspection technique was developed. A proposal was brought before an open public meeting in May 1998 and a study was performed using the technique in late 1998 and early 1999. A validation study was performed and sufficient data existed to convince the agency to move forward with the new inspection technique called the Quality System Inspection Technique (QSIT).  A copy of this validation study is available for downloading. A training program was developed in 1999 for the field investigators, and implemented in fall of 1999. A new compliance program which incorporates QSIT was developed and published for comment in summer of 1999. A series of industry workshops are being conducted nationwide in fall of 1999.

Mission: The mission of the reengineering effort was to develop an inspection program covering the quality systems regulation, which results in more focused and efficient inspections. The effort should help FDA investigators focus in on key manufacturing and quality areas at the manufacturer during inspections, in order to determine their state of compliance with the Quality Systems Regulation. We believe that this effort will lead to increased compliance with the Quality Systems Regulation, and thus improved medical device product quality. Improved medical device product quality could result in fewer problems with medical devices. In addition, fewer enforcement actions may be needed for Quality Systems Regulation violations, and better public health should result. Since several aspects of this program have been derived from the Global Harmonization Task Force's document entitled Guidelines for Regulatory auditing of Quality Systems of Medical Device Manufacturers, a third benefit is harmonization.

The QSIT reengineering team is developing a new inspection technique and approach for quality systems inspections. The approach will allow for comprehensive as well as more limited inspections of medical device manufacturers. The primary focus of the inspections is to determine compliance with the Quality Systems Regulation.

The Team. The members of the team consist of Office of Regulatory Affairs (ORA) field investigators, ORA HQ staff, and CDRH personnel. Core members of the team bring strong inspection and regulation knowledge. Others within the Agency have also participated in the reengineering effort. The team set out to achieve this goal by working closely with industry.

Ad Hoc Group. An Ad Hoc group of industry representatives was formed to provide recommendations to the group on this effort. Members of this group were drawn from the medical device trade associations and from experts in the quality system area, including former FDA leaders. This ad hoc group met with the FDA group in Washington on several occasions. Recommendations from the group on the inspection process were provided to the team.

Proposal. After developing a model for quality system inspections, an open public meeting was held in Rockville, MD in May, 1998 to obtain more input from industry and other interested parties on the new proposed inspection process. Significant input was provided to the agency at the meeting, which was used to further modify the model.

Handbook. The team has developed a document called the Guide to Inspections of Quality Systems, [PDF] August 1999  (formerly called the QSIT Inspection Handbook). This document provides the field investigator with the Quality System Inspection Technique (QSIT).

QSIT. While the QSIT approach to inspections was derived from the theory that there are seven sub-systems in the quality system regulation (21 CFR, Part 820), four primary areas were chosen to focus the inspection. The chart below shows the subsystems. The four top subsystems chosen for the QSIT inspection are Management Controls, Design Controls, Corrective and Preventive Actions (CAPA) and Production and Process Controls. The remaining three subsystems are covered via "linkages" within the QSIT Guide.

The Seven Subsystems

Study. A study of the QSIT technique was conducted in fall of 1998 and early 1999. The study involved a compliance officer and a small group of investigators from three districts: Los Angeles, Denver and Minneapolis. A report of the study is available. (PDF). Other documents related to the study are available by contacting QSIT team members.

Compliance Program. In order to incorporate QSIT into the inspection process a compliance program was developed. A federal register notice announcing the availability of a revised draft document entitled "Draft Compliance Program Guidance Manual: Inspection of Medical Device Manufacturers "(PDF) which explains the use of the QSIT was published in summer of 1999. This compliance program also provides guidance on three other inspection programs: Medical Device Reporting (MDR), Corrections and Removals, and Tracking. The QSIT Guide provides guidance on inspecting those programs in addition to the QS/GMP inspection guidance. Sterilization inspection guidance was also developed and placed into the QSIT Guide.

Training. The agency has developing a training program to provide knowledge about QSIT to compliance officers and investigators. The Office of Regulatory Affairs has the lead in the training programs for field staff. The QSIT training is being conducted via CDROM.

Workshops. Thirteen industry workshops were held to provide industry an opportunity to learn about QSIT. A federal register announcement provides the details for the workshops.  Copies of the slides that were presented at these workshops are available:

Contact us. While the QSIT program is being rolled out in the field, the agency continues to seek input from interested parties about the technique, as we have throughout the reengineering process. You may contact us at the address mentioned below:

Quality Systems Inspections Reengineering Team
2094 Gaither Rd., HFZ-300
Rockville, MD 20850
Phone: (301)594-4616 (Tim Wells, Team Leader)
Internet: TRW@CDRH.FDA.GOV

Updated September 1, 2000

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