Investigation summary: it has been received 1 picture for investigation.On visual inspection of the picture received it can be observed the barrel broke in the base of the tip.Ten retained samples of lot 1705220p are evaluated.On visual inspection of these ten retained samples, no damage or molding defect can be observed in any of them that could be related to the alleged defect.Dhr of lot 1705220p is reviewed not finding any annotation or deviation regarding the alleged defect.The areas where pieces run in manufacturing area are protected to avoid damage on the product.The ten retained samples evaluated are filled with water and empty using a vial and a 14g needle, not observing any breakage in the syringes.On inspection at 10x no damage or molding defect can be observed in the tip of these syringes.Tip and thread verification is done with an iso594 reference gauge and the ten syringes meet iso594.Transport of product in manufacturing area is protected to avoid damage in the product.During manufacturing process, final products are sampled and subjected to visual inspections according to procedures since no incidence has been found during manufacturing process related to this defect, no defect has been found in the ten retained samples evaluated, and the alleged defect cannot be reproduced, the root cause cannot be determined.Investigation conclusion: defect: barrel damaged/broken (damaged/ broken).It has been received 1 picture for investigation.On visual inspection of the picture received it can be observed the barrel broke in the base of the tip.Ten retained samples of lot 1705220p are evaluated.On visual inspection of these ten retained samples, no damage or molding defect can be observed in any of them that could be related to the alleged defect.Dhr of lot 1705220p is reviewed not finding any annotation or deviation regarding the alleged defect.The areas where pieces run in manufacturing area are protected to avoid damage on the product.The ten retained samples evaluated are filled with water and empty using a vial and a 14g needle, not observing any breakage in the syringes.On inspection at 10x no damage or molding defect can be observed in the tip of these syringes.Tip and thread verification is done with an iso594 reference gauge (#10-419/1 and #10-413) and the ten syringes meet iso594.Transport of product in manufacturing area is protected to avoid damage in the product.During manufacturing process, final products are sampled and subjected to visual inspections according to procedures (jg-301, jg-302, jg-303 and jg-304).Process: visual inspection printing 30 samples per hour, after any intervention in the equipment or once at the beginning of the shift.Assembly: 30 samples per hour, after any intervention in the equipment or once at the beginn:ing of the shift packing: 1 step per hour, after any intervention in the equipment, after a stop of more than 1 hour, once at the beginning of the shift, when film or paper roller are changed, after maintenance.Packaging: 1 shelf-package per pallet.Since no incidence has been found during manufacturing process related to this defect, no defect has been found in the ten retained samples evaluated, and the alleged defect cannot be reproduced, the root cause cannot be determined.Equipment used for testing/investigation: instrument: iso 594 compliant reference gauge (tip) #10-419/1; iso 594 compliant reference gauge (thread) # (b)(4); microscope nikon # (b)(4); calibration period: 12-jan-2016 / 31-jan-2018; 12-jan-2016 / 31-jan-2018; 25-jul-2017 / 31-jul-2018.Root cause description: since no incidence has been found during manufacturing process related to this defect, no defect has been found in the ten retained samples evaluated, and the alleged defect cannot be reproduced, the root cause cannot be determined.
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