Event 11: seven (7) samples were returned for evaluation.All samples received were visually evaluated and it was noted that all the samples showed evidence of detachment due to insufficient solve on the pump segment cap.The reported defect was confirmed.Incidents of this nature are attributed to operator oversight during the solvent application process.Although our training procedures ensure that all employees are properly trained in their areas of responsibility, an oversight on the part of the operator can attribute to an incident of this nature.As a result of this occurrence a quality notification and retrain was generated for all associates involved in the hand assembly process.Retained units were evaluated and passed the internal testing.A review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.Additionally, review of the batch history records was also performed for the reported lot number and no non-conformances or deviations were noted during the manufacturing process or final inspections.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.
|