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Patient 1
BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. AN INVESTIGATION WAS PERFORMED TO DETERMINE THE ROOT CAUSE ASSOCIATED WITH THE INVESTIGATION WAFER DISC DECENTRALIZATION, COMPLAINT MALFUNCTION (SKIN BARRIER STARTER HOLE IS DEFECTIVE, E.G. MISALIGNMENT OR OFF CENTER, LEAKAGE MAY OCCUR), FOR LOTS MANUFACTURED IN (B)(4). THE CAUSE AND EFFECT INVESTIGATION WAS PERFORMED.? IT WAS DETERMINED THAT THE FOLLOWING PROBABLE ROOT CAUSES AND OPPORTUNITIES WERE IDENTIFIED: MACHINERY IS THE ROOT CAUSE OF THIS INCIDENT.? IT IS CONCLUDED THAT ALL THE MACHINERY/ TOOLING ITEMS COMPLIED WHEN COMPARED AGAINST DRAWING SPECIFICATIONS, HOWEVER DUE TO THE DEMANDS OF THE PROCESS, THESE TOOLING REQUIRE A DIMENSION MODIFICATION TO REDUCE THE VARIABILITY OF THE PROCESS. OBSERVATIONS INCLUDE:? MISALIGNMENT OF THE WAFER LOADING PINS, MISALIGNMENT OF THE UPPER WAFER LOADING PLATE AND FIXATION OF THE UPPER WAFER LOADING PLATE AND LOWER WAFER LOADING PLATE. ACTUAL TESTING METHOD OF (RANDOM HOURLY SAMPLING) MAY NOT EFFECTIVELY CAPTURE THE DEFECTS PRIOR TO PACKAGING, IT IS SUGGESTED THE IMPLEMENTATION OF A CONTINUOUS TESTING METHOD TO ANTICIPATE TO ALL OF THE PEAKS. A CERTIFICATION OF THE OPERATORS WHO HAVE DIRECT INFLUENCE DUE TO THE ?FLANGE/WAFER LOADING? PROCESS IN OPERATIONS, TO REDUCE THE LEARNING CURVE EFFECT IN PROCESS AND GUARANTEE THE TRAINING EFFECTIVENESS. THIS SHOULD BE PERFORMED IN CONJUNCT WITH THE QUALITY INSPECTOR, PROCESS ENGINEER OF SUCH LINE AND THE SUPERVISOR. ACTIONS WILL BE TAKEN FOR EACH FACTOR AND WILL BE SUMMARIZED ON A CORRECTIVE ACTION / PREVENTIVE ACTIONS (CAPA) PLAN. THE INVESTIGATION ASSOCIATED WITH THIS EVENT IS APPROVED AND COMPLETE.? THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).