Final Inspection lot failures - AQL based final acceptance

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. :bonk: 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.

:thanks: in advance
 
S

Sohail

I assume that your QMS is based on ISO 9001:2000. Now your problem is that you are mass producing a medical device which is accepted on AQL basis. Since most of the rejection by your QC is mostly treated as US AS IS because of very minor problems like cleaning , tag missing etc you dont want to get your self stucked in documentation by treating them as a non-conforming product.

Now here is the place where your mandatory NON CONFORMING OF PRODUCT procedure comes in. You have to define the controls, the authorities and bounderies of treating your non conforming product and it is here that you should declare what types of errors, rejections are to be treated as non conforming product.

As a thumb rule, the product whose rework cause material loss, deviation from the customer or organizational or legal requirements or other loss of resources, requires to be dealt as NON CONFORMING PRODUCT.

Again you should clearly draw a line between non conforming product and routing rectification of problems in your non conformance procedure.

2ndly you can carry out pareto analysis of your lots to prioritize the problems which are mostly resulting in the rework activities and according take corrective and preventive actions. This will add in your support for not treating them as non conforming product.
 

Bev D

Heretical Statistician
Leader
Super Moderator
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.

First: all nonconforming product should be identified as such for as long as it is non conforming, regardless of severity.

Second: Another approach to your basic siggestion is to create standard dispositions and rework flows for specific known failures. Like the label missing or dirty conditions. When QA rejects a lot for these things, the material can move automatically to the rework flow. (with proper documentation of course. No need to be quarantined and go thru a MRB decision. You cna then specify that anything else besides the standard rework failures must go to MRB. (I think it is harder to list the possible failures that would require MRB consideration than it is to list those you know dont' need it because you already know what to do....)
 
S

Sohail

Yup, you must identify the problem and declare whether the product be treated as non conforming product or routine rectification or alternatively list the problems which require rectifification procedure, whichever is easier.

But again, procedure is the place where you should clearly state ur organizational requirements.
 
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