As a contract medical device component manufacturer we have been using the C=0 sampling plan matrix for determining what the AQL will be at various stages of our manufacturing. We have been using this for over 20 years. We recently implemented a variation on that theme. Our Final Inspection department is our gate keeper to the Customer and our Final inspectors are very critical, which isn't a bad thing but, with all the Nonconforming Material Reports generated due to finding 1 NC pc in a 4.0 sample was stifling our Quality Engineering department and overburdening our MRB process. To ease this burden we implemented a 'find 1 pc in sample, take another sample and check for previous found NC. If no more found, scrap the 1 sample and move on. If 1 or more found for that same NC in the second sample, write up the NC' process. This has drastically reduced our time in MRB and has not had an appreciable effect on Customer Complaints.
I do understand that the processes of Nonconforming material and Material Review is there to help implement process improvements and what I have stated above tends to speak against this but we have not eliminated the NC and MRB all together.
Is this still considered C=0? When asked by our Customers during audits we proclaim to use the C=0 sampling plan. I guess, technically, we are using that sampling plan.
Your thoughts?
I do understand that the processes of Nonconforming material and Material Review is there to help implement process improvements and what I have stated above tends to speak against this but we have not eliminated the NC and MRB all together.
Is this still considered C=0? When asked by our Customers during audits we proclaim to use the C=0 sampling plan. I guess, technically, we are using that sampling plan.
Your thoughts?