QSIT Points To Consider-Design ControlFINAL

POINTS TO CONSIDER WHEN PREPARING FOR AN FDAINSPECTION UNDER THE QSIT DESIGN CONTROLSSUBSYSTEMMAY 15, 2003Bringing innovation to patient care worldwide1200 G Street NW, Suite 400Washington, DC 20005–3814Tel: 202 783 8700Fax: 202 783 8750www.AdvaMed.org

ACKNOWLEDGEMENTThis document was authored by Frederick F. Schweitzer, Welch Allyn, Inc.Assistance was provided by:Annette HillringHillring & Associates, Inc.Frances AkelewiczPractical Solutions, LLCNancy SingerAdvaMedPamela J. WeagraffMediSpectra, IncMany other people also contributed to the ideas contained in the document.We thank the following industry officials for serving as members of the review committee:Mark Allen, NetRegulusRichard Andersen, Siemens Medical SolutionsMary Armstrong, Armstrong ConsultingEdwin Bills, Hill-Rom Company, Inc.Dia Black, AdvaMedFranklin Bost, Porex Surgical Inc.Christine Driscoll, Abbott LaboratoriesRichard Franko, MediSpectra, Inc.Bruce Haggar, MedQ Systems, LLCSusan Jacobs, QMS ConsultingBetsy Lavin, AdvaMedBernie Liebler, AdvaMedShelley Looby, Cerner Corp.Kathleen Lundberg, Guidant Cardiac Rhythm ManagementTony Maganini, Edwards Lifesciences Corp.Joseph Mertis, Cardinal Health Medical Products and ServicesMichael Morton, Sorin-Cobe CVRegina J. O’Meara, Beckman Coulter, Inc.George Phariss, Abbott LaboratoriesGary Price, Olympus America, Inc.Melanie Reeves, Kinetics Concepts, Inc.Susan C. Reilly, Reilly & AssociatesTim Rew, M.D., Terumo Medical Corp.Keith Rohrbach, Ph.D., MedQ Systems, LLCAhmad Sajadi, Alaris Medical SystemsMichael Santalucia, Bausch & Lomb, Inc.Ronald Schardong, Ethicon Endo-SurgeryRobert Turocy, Philips Medical SystemsTim Wells, Wells & AssociatesWe also thank officials in the FDA for their time and effort in reviewing this document.2 of 21

IntroductionBackgroundEffective June 1, 1997, the Food and Drug Administration (FDA) revised the Current GoodManufacturing Practice (CGMP) requirements for medical devices and incorporated them into theQuality System Regulation. The FDA conducts inspections of medical device manufacturers todetermine if they are complying with the requirements of the Regulation. In an attempt to decreaseinspection time and increase the focus of medical device inspections, the FDA, in consultationwith the medical device industry, developed an approach for conducting inspections under theQuality System Regulation called the Quality System Inspection Technique (QSIT).Under QSIT, the Regulation’s quality system requirements are divided into subsystems. The FDA,by directing its attention to the subsystems in a firm’s quality system, is able to determine moreefficiently if the firm’s quality system is operating in a state of control. QSIT focuses on four ofthe major subsystems in the Quality System Regulation: Management Controls, Design Controls,Corrective and Preventive Actions, and Production and Process Controls. This document onlydiscusses the Design Controls Subsystem.The FDA’s August 1999 “Guide to Inspections of Quality Systems” (the QSIT Manual) states:“The purpose of the design controls subsystem is to control the design process to assure thatdevices meet user needs, intended uses, and specified requirements. Attention to design anddevelopment planning, identifying design inputs, developing design outputs, verifying that designoutputs meet design inputs, validating the design, controlling design changes, reviewing designresults, transferring the design to production, and compiling a Design History File (DHF) helpassure that resulting designs will meet user needs, intended uses and requirements.”As with any effective process, it is essential that appropriate methods and controls be establishedto ensure that critical functions are carried out, including appropriate steps along the way todetermine whether resultant outcomes or outputs meet the proposed inputs and requirements.Design control stages should be understood to enable an integral approach rather than beingdiscrete steps in the over

6 of 21 The FDA investigator would usually be most interested in the devices of highest risk, but the investigator’s decision may be affected by whether a device has been subject to one or more recalls and/or MDRs. The FDA investigator should not be inspecting a device under the requirements of design controls to determine whether the design was appropriate or safe and effective.