QUALITY SYSTEM INSPECTION TECHNIQUE - IMDRF

1 QSIT QUALITY SYSTEMINSPECTIONTECHNIQUE Robert L. Turocy May 6, 2002 WHAT SPECIFICALLY DOYOU WANT OR NEED TOKNOW ABOUT QSIT?? MANAGEMENT QUALITY & REGULATORY ENGINEERING PRODUCTION, - - - , SERVICEWHAT IS QSIT? QSIT IS AN OPTIONAL FDAINSPECTION PROCESS QUALITY SYSTEM ORIENTED TOP DOWN VERSUS BOTTOM UP PRE- INSPECTION ACTIVITIES SAMPLING FOCUS ON MANAGEMENTQSIT PILOT INSPECTIONSFDA 483s0102030405060MC P DO M = C = CAPA50 P = PAPC45 D = DESIGN26 O = OTHER22 WHY DOES THE FDA USEQSIT? QSIT IS FOCUSED, HARMONIZED, EFFICIENT,INCREASES COMPLIANCE, & MOSTIMPORTANT, QSIT ASSISTS IN THEPROTECTING THE PUBLIC FROM UNSAFEMEDICAL DEVICES USED TO DETERMINE IF A MANUFACTURER SQUALITY SYSTEM IS CONFORMING WITHREGULATIONSWHO DEVELOPED QSIT? FDA REENGINEERING EFFORT ASSISTED BY INDUSTRY, TRADEASSOCIATIONS, ANDCONSULTANTS FDLI FACILITATED MEETINGS, IS QSITIMPLEMENTED?

2 LEVEL 1, (Abbreviated) CAPA + 1 OTHER SUBSYSTEM LEVEL 2, (Baseline) MGMT CONTROLS, DESIGN CONTROLS,CAPA, PAPC, AND RETURN TO MGMTCONTROLS LEVEL 3, (Compliance Follow-up toOFFICIAL ACTION INDICATED)WHEN IS QSIT USED? MANUFACTURER S COMPLIANCEHISTORY IS THE MAJOR FACTOR RISK OF DEVICEDOES QSIT WORK? YES!!! PILOT INSPECTION RESULTS QSIT IS HARMONIZED WITH THEEU PROCESS OF INSPECTIONS QSIT REDUCED IN-PLANT TIMEFROM APPROXIMATELY 67 HOURSTO 28 IN PLANT HOURSBREAK DOWN OF 28 HOURS051015202530 MDC P T M = MGMT D = DESIGN C = CAPA P = PAPC T = TOTAL IN-PLANT HOURSEQUALS 1 DAYQSIT DOES REVIEW THE QUALITY SYSTEM VALIDATE ESTABLISHED REVIEW MANAGEMENTQSIT DOES NOT ELIMINATE FOR CAUSE INSPECTIONS FIND AN INFINITE NUMBER OFPRODUCT PROBLEMSMANAGEMENT CONTROLS QUALITY POLICY MANAGEMENT REVIEW INTERNAL QUALITY AUDIT QUALITY PLAN QUALITY SYSTEM PROCEDURES MANAGEMENT REPRESENTATIVE SUITABLITY & EFFECTIVENESS ORGANIZATIONAL STRUCTURE,RESPONSIBILITY, AUTHORITY, &RESOURCESDESIGN CONTROLS WHEN ARE DESIGN CONTROLSREVIEWED?

3 SUBMIT PDP? SUBMIT IRB? SUBMIT IDE? SUBMIT 510(K)? SUBMIT PMA? MARKET DEVICE?DESIGN CONTROLS cont. DC PROCEDURES DESIGN PLAN DESIGN INPUTS ACCEPTANCECRETERIA DESIGN OUTPUTS DESIGNVERIFICATION DESIGN VALIDATION SW VALIDATION RISK ANALYSIS PRODUCTION UNITVALIDATED DESIGN CHANGECONTROL DESIGN REVIEWS DESIGN TRANSFER DESIGN HISTORYFILECORRECTIVE & PREVENTATIVEACTION (CAPA) CAPA PROCEDURES INFORMATION SOURCES IDENTIFIED INFORMATION ANALYZED COMPLETE, ACCURATE, & TIMELYINFORMATION STATISTICAL METHODS FAILURE ANALYSIS VERSUS RISK ROOT CAUSE ANALYSIS APPROPRIATE CAPA TAKEN & DOCUMENTED SHARE INFORMATION MANAGEMENTREVIEWPRODUCTION & PROCESSCONTROL (PAPC) PAPC PROCEDURES CONTROLS & MONITORS DEVICE HISTORY RECORDS NON-CONFORMING ACTIONS EQUIPMENT ADJUSTMENT,CALIBRATION, & MAINTENANCE VALIDATION OF PROCESSES SW VALIDATION PERSONNEL QUALIFICATIONSLINKAGES TO OTHERSUBSYSTEMS MATERIAL CONTROLS RECORDS/DOCUMENTS/CHANGECONTROLS FACILITY & EQUIPMENTCONTROLSMEDICAL DEVICE REPORTING(MDR) A SATELITE TO CAPA MDR PROCEDURES MDR FILES ESTABLISHED MDR INFORMATION COMPLETE DEATHS, SI & SI, ANDMALFUNCTIONSCORRECTIONS &REMOVALS (CAR) ASATELITE TO CAPA CAR PROCEDURES CARs SUBMITTED CARs COMPLETED CAR FILE ESTABLISHEDMEDICAL DEVICETRACKING A SATELITE TOCAPA FAILURE CAUSES ADVERSE HEALTHCONSEQUENCES OBLIGATION FOR TRACEABILITYSAMPLING CONFIDENCE LIMIT OF (.)

4 99) MEANS THAT WE ACCEPT A 99%PROBABILITY THAT NO MORE THAN 10% OF THE REMAININGCASES DO NOT MEET OUR EXPECTATION. THIS IS BASED ON THEFACT THAT WE FIND O BAD CASES OUT OF 51 2 BINOMIAL UCLE21 OUT OF1 OUT OFO OUT OFSTERILIZATION PROCESSCONTROLS A SATELITE TOPAPC STERILIZATION PROCEDURES PROCESS VALIDATED PROCESS CONTROLLED & MONITORED APPROPRIATE HANDLING OF NON-CONFORMANCES EQUIPMENT ADJUSTMENT, CALIBRATION, &MAINTENANCE SW VALIDATION PERSONNEL QUALIFIED & TRAINEDQSIT REFERENCES 21 CFR 820, Preamble & Regulation **QSIT HANDBOOK GUIDE CD ROM COMPUTER BASEDTRAINING INSP. DEVICE MFGRS. CP