No sample was returned for investigation.The supplier stated they could not review the device history record during their investigation because the lot number was not provided.However, supplier reviewed their records for the last 2 years and did not find anything abnormal.According to the supplier, or towel is made of cotton, so cotton fiber is born.The supplier is continuously working with cardinal health to better control the linting and have implemented several measures to improve it: suctions machines have been installed in grey cloth rolling process, dyeing process and cutting process.The suction process was added before product's final folding, and workers do it according to standard operation procedure requirement.Linting test method and acceptable criteria was stipulated to see the suction results.(=0.38 g/10 pieces).In the folding process, supplier used one cloth pad under 100 pieces semi-finished products to avoid linting stuck onto the products during product's transfer.From the investigation, no abnormal situation happened in production; therefore, the root cause could not be determined.The complaint information was shared with the relevant sectors for their awareness.There is no action taken at this time, but the supplier will continue to monitor trends for this type of incident.
|