Description of Event or Problem · 1
THE CUSTOMER CALLED AND REPORTED LEAKING AT THE CONNECTOR. THE CUSTOMER RETURNED TWO OF THE AFFECTED SAMPLES FOR FURTHER INVESTIGATION. OF THE TWO SAMPLES RECEIVED ONE WAS CONTAMINATED AND CONNECTED TO THE BAGS. THE SECOND SAMPLE WAS A BAG THAT WAS ALSO BEING INVESTIGATED. NO BATCH NUMBERS WERE AVAILABLE. DURING INVESTIGATION A FREE FLOW, TIGHTNESS, VISUAL AND A NON-CONTAMINATED SAMPLE WAS TESTED. DURING TESTING THE LEAKAGE WAS FOUND AT THE GLUING POINT BETWEEN THE PVC TUBE AND THE GREEN CONNECTOR. DURING THE VISUAL INSPECTION OF THE CONTAMINATED SAMPLE, THE GREEN CONNECTOR WAS SEPARATED FROM THE SIK TUBE. THE COMPLAINT WAS FORWARDED TO THE PRODUCTION FACILITY FOR ADDITIONAL INVESTIGATION. THE BATCH NUMBER IS UNKNOWN, THEREFORE, PRODUCTION DOCUMENTS CANNOT BE CHECKED FOR DEVIATIONS OR RETAIN SAMPLE TESTING. THE ROOT CAUSE WAS DETERMINED PER THE PRODUCTION FACILITY. THE ERROR ON THE GLUING INSERTION POINT BETWEEN THE PVC AND GREEN CONNECTOR OCCURRED DUE TO INATTENTIVENESS OF THE EMPLOYEE DURING THE GLUING PROCESS. THE SEPARATION OF THE GREEN CONNECTOR AND SIK TUBE IS A KNOWN ERROR AND IS UNLIKELY TO OCCUR DURING PRODUCTION. THE ERROR MOST LIKELY IS A RESULT OF USE ERROR WHILE THE UPPER PORT WAS BEING USED TO ADMINISTER MANUAL BOLUSES, DUE TO THE SAMPLES BEING TOO HIGH CAUSED EXERTED FORCE ON THE JUNCTIONS OF THE SILICONE TUBING. CORRECTIVE ACTION TAKEN WAS A TEAM BUILDING WORKSHOP TO ESTABLISH, ANALYZE AND IMPROVE THE PROCESS. AS A RESULT THE PARAMETERS OF THE GLUING PROCEDURE WERE ADJUSTED AND AN IMPROVED DISPENSER WITH AN AUTOMATIC GLUE LEVEL SENSOR WILL BE IMPLEMENTED. ALSO NEW STANDARDS WERE DEFINED FOR THE TUBE STORAGE AND TROLLEY DESIGN TO AVOID POSSIBLE DEFORMATIONS OF THE TUBES. IN CONCLUSION THERE IS NO PRODUCT DEFICIENCY.