S
sweet1
I work for a Manufacturer of Class I Medical Devices. ISO13485:2016 (as of a week ago by the skin of our teeth). The products are very low risk, non sterile. Due to our somewhat antiquated machines and unstable processes, we tend to have a lot of cosmetic failures. We follow our NC process and all NCs are reviewed by the MRB group during a brief daily meeting as well as a more formal weekly meeting. I lead these meetings and assign investigation to the appropriate department managers.
Most of our internal NCs are due to production operators not paying attention or being unclear as to what constitutes as a failed product, even though we have documentation and training that they must sign off on. These failures are identified during a final release inspection. Many of our corrective actions refer to "retraining" on the production side, but the failures continue to occur so clearly it is not effective.
Our operations manager is assigned these NCs for investigation, but does NOTHING. We cannot close these out until an investigation, CA and verification are done. I have a large number of NCs where the goods have been dispositioned and I am only awaiting the corrective action. Is there any way around this or is it acceptable to not perform an investigation? I will be rewriting our NC process and can incorporate anything, but I need to make sure we are still compliant.
Any advise?
Thanks in advance. This is my first post, but I have been a lurker for about a year
Most of our internal NCs are due to production operators not paying attention or being unclear as to what constitutes as a failed product, even though we have documentation and training that they must sign off on. These failures are identified during a final release inspection. Many of our corrective actions refer to "retraining" on the production side, but the failures continue to occur so clearly it is not effective.
Our operations manager is assigned these NCs for investigation, but does NOTHING. We cannot close these out until an investigation, CA and verification are done. I have a large number of NCs where the goods have been dispositioned and I am only awaiting the corrective action. Is there any way around this or is it acceptable to not perform an investigation? I will be rewriting our NC process and can incorporate anything, but I need to make sure we are still compliant.
Any advise?
Thanks in advance. This is my first post, but I have been a lurker for about a year