J
jwendt2
CAPA- Where to Start
Ok, a little background first. I am an IT guy (formailly a process engineer)who primarily works on Manufacturing Execution Applications (MES). I am trying to put together a vision for our companies CAPA program. Right now we have three different wings of our quality organization pursuing this effor independently. One wing is looking at the customer complaint side. This side primarily utilizes data from a customer compaint database to analyze first 60 day complaints and compiles a top ten list. The second wing looks at supplier quality issues including non-conforming material issues. This wing looks at day-to-day supplier issues and strategic sourcing issues. The last wing is the lean manufacturing orgainization looking at process compliance, metric compliance (bowling charts) and safety compliance. Everyone seems to agree that we need a common system however I am struggling on how to document/determine what that system is. The forums have been very usefull for getting some insite on things like the 8D processes however it looks like most of the forum participants are from small to mid size companies. We are a 2Bil manufacturer. Any experience/thoughts on how to accomplish this. Are people standaridizing on one CAPA workflow for every type of CAPA (ie Supplier issues vs. process issues) or do you have different process flows for each type of CAPA? Also, do your companies typically have an "incident" reporting system that is a one to many relationship to a "corrective action" or do you typically just track corrective actions. How does the NCM (non-conforming material) tracking system relate to your corrective action system? Anyone else have an MES system that sits below their ERP that is resposible for the CAPA tracking? Sorry for the rambling...
John
Ok, a little background first. I am an IT guy (formailly a process engineer)who primarily works on Manufacturing Execution Applications (MES). I am trying to put together a vision for our companies CAPA program. Right now we have three different wings of our quality organization pursuing this effor independently. One wing is looking at the customer complaint side. This side primarily utilizes data from a customer compaint database to analyze first 60 day complaints and compiles a top ten list. The second wing looks at supplier quality issues including non-conforming material issues. This wing looks at day-to-day supplier issues and strategic sourcing issues. The last wing is the lean manufacturing orgainization looking at process compliance, metric compliance (bowling charts) and safety compliance. Everyone seems to agree that we need a common system however I am struggling on how to document/determine what that system is. The forums have been very usefull for getting some insite on things like the 8D processes however it looks like most of the forum participants are from small to mid size companies. We are a 2Bil manufacturer. Any experience/thoughts on how to accomplish this. Are people standaridizing on one CAPA workflow for every type of CAPA (ie Supplier issues vs. process issues) or do you have different process flows for each type of CAPA? Also, do your companies typically have an "incident" reporting system that is a one to many relationship to a "corrective action" or do you typically just track corrective actions. How does the NCM (non-conforming material) tracking system relate to your corrective action system? Anyone else have an MES system that sits below their ERP that is resposible for the CAPA tracking? Sorry for the rambling...
John