Q
quest
I hope I can explain this well enough.
All our product must be accepted at an AQL based final acceptance performed by QA.
Let's say we reject a lot of units. For this example, 1 is found to be missing a label, 1 is dirty. (Remember we rejected the lot based on an AQL level, so there are sure to be some acceptable units within the lot.) The lot is returned to production and the first thing they do is sort out the good ones. For this example lets say that after sorting there were 10 missing a label and 5 dirty out of 1000 units. They place labels on the 10 that that were missing and clean the 5 dirty units. Then the lot is resubmitted to QA final inspection and passed. Lot is shipped.
Here is my dilemma. We have a 'way' but not a good 'way' to record all that went on. We use a combination of MRB form and rework form. Neither form is used correctly. The MRB form is dispositioned use as is most of the time because the product that is returned after sorting/rework passes final inspection! I know that is not the proper use of the disposition use-as-is. The rework form tells production what to do ie, inspect lot, replace labels, etc. Then production records what they did and quantities on this form.
Any suggestions on how to handle this mess? Bear in mind we are building a very simple medical device and most rework includes actions like applying the proper label or lot number, replacing a wrong component, sealing a shipping polybag. Also most do not require CA that we are not already aware of and have CAPAs for. Very rarely do we have a reject for something that requires a full sit down with various departments to determine what to do and if CA is required.
Since I can not complain too much without having a proposed solution, how does this sound?
I think we should come up with a list of nonconformancies that require MRB. Only lots rejected for these reasons are quarantined and handled as official MRB product. All others should be recorded on some sort of nonconformance report, production be made repsonsible for sorting and fixing (reworking?) and then resubmittal of corrected lot back to QA final inspection.
I look forward to all your inputs.
in advance
All our product must be accepted at an AQL based final acceptance performed by QA.
Let's say we reject a lot of units. For this example, 1 is found to be missing a label, 1 is dirty. (Remember we rejected the lot based on an AQL level, so there are sure to be some acceptable units within the lot.) The lot is returned to production and the first thing they do is sort out the good ones. For this example lets say that after sorting there were 10 missing a label and 5 dirty out of 1000 units. They place labels on the 10 that that were missing and clean the 5 dirty units. Then the lot is resubmitted to QA final inspection and passed. Lot is shipped.
Here is my dilemma. We have a 'way' but not a good 'way' to record all that went on. We use a combination of MRB form and rework form. Neither form is used correctly. The MRB form is dispositioned use as is most of the time because the product that is returned after sorting/rework passes final inspection! I know that is not the proper use of the disposition use-as-is. The rework form tells production what to do ie, inspect lot, replace labels, etc. Then production records what they did and quantities on this form.
Any suggestions on how to handle this mess? Bear in mind we are building a very simple medical device and most rework includes actions like applying the proper label or lot number, replacing a wrong component, sealing a shipping polybag. Also most do not require CA that we are not already aware of and have CAPAs for. Very rarely do we have a reject for something that requires a full sit down with various departments to determine what to do and if CA is required.
Since I can not complain too much without having a proposed solution, how does this sound?
I think we should come up with a list of nonconformancies that require MRB. Only lots rejected for these reasons are quarantined and handled as official MRB product. All others should be recorded on some sort of nonconformance report, production be made repsonsible for sorting and fixing (reworking?) and then resubmittal of corrected lot back to QA final inspection.
I look forward to all your inputs.
in advance