UD based on Inspection Point Valuation

[Sara_Br]

Hello, I am wondering if there is any standard configuration that can achieve the following:

1) AUTO UD is based on Inspection Point Valuation (currently AUTO UD is based on one inspection result being valuated as Accept per MIC. But I want all MIC's in all Inspection Points to be completed).

2) COA will not print results from Inspection Points that were valuated as Reject. (portions of batches that do not meet specifications are discarded and not sent to the customer)

I have searched, but can't quite find a solution.

Thanks,

Sara

[former_member42743]

I think question 1 was asked in a previous question I replied to.

Typically we don't report results from 03 lots, (in-process inspections) on COA's. In your case, if you have 5 inspection points, which value is to be reported?

Usually, we create an 04 lot, copy the last results or median result from the 03 lots automatically. If the results are all in inspect the lot is Auto UD'ed and the COA results come from either the 04 inspection lot or the batch record.

Craig

[Sara_Br]

Hi Craig,

Thanks for the response.

I am not actually only speaking about 03 lots. We use inspection points for other types of lots.

For point 2:

In the case of an 04, there might be 100 samples drawn throughout the duration of the process order and sent to the Quality lab, and so 100 inspection points are made in the 04 lot. However, if 6 of those samples failed (heads and tails of the run which are discarded) the user has to go mark each MIC in each of those 6 samples as Outlier. This is too much work. I am thinking there must be a way to take the Inspection Point valuation into account. (an obvious work around would be to copy good results to a new 89 lot, but Quality manager does not want to do this)

For point 1:

Similar idea, can we make the Auto UD base its decision on the valuation of the Inspection Point rather than the valuation of characteristics?

Thanks,

Sara

[former_member42743]

1) For an auto UD to be performed on other inspection types (01,04, etc..) using inspection points all of the required MIC's have to be completed, for all created inspection points. You must be somehow setting up you MIC's as optional or skips.

2) It's hard to give you an definite answer on this one since I don't know exactly what you are doing there or how or what you are reporting because you talk about giving these to the customer. I can't reconcile the original question #2 with the comment you provided about question #2. In the original question you seem to say that values from rejected points are not printed. In the comment you seem say that point valuation isn't used. So I'm not sure.

What I can say, is there are a lot of places you can use FM's to insert your own logic. I.e in the COA, which you might have already done, (BTW: don't change the COA program, use FM's and enhancement points). In how the UD valuations are done and which points are considered and how the UD valuation is done.

Also, that said, a pharma/chemical person, I'd be concerned about not getting all the data. If you truly have outliers in the beginning and end, there are probably other things I'd recommend doing before marking points as outliers and not providing that info. Probably things that your production people wouldn't like to hear cause it would more than likely cause them more work!!! :- ) But us QA people usually never are the most popular people in the plant.

[Sara_Br]

Hi Craig,

1) In our system AUTO UD does run if only one inspection point's required MIC's are completed. I am assuming this is because once one MIC is valuated, the status for that MIC in QA13 changes to 5 - Processing is Completed. I have just tested in our system to confirm (created 5 inspection points, only entered results for one, ran QA10, Auto UD carried out). I cannot find any config that would alter this.Which just leaves me wondering - what is the purpose of Inspection Point Valuation? The AUTO UD does not seem to take into account if there are unvaluated inspection points. I have also tried QA16, as I know this is a similar idea (mass UD) but a different program. However, QA16 doesn't seem to work with inspection points. Perhaps there is some other program that is made for this purpose?

2) I would agree around concern over results! However, consider a process like distilation - the first runnings from the still would contain harmful chemicals that are always discarded. These chemicals are not in the final product, so you would hardly want them averaged into a final COA result. My thought would be, the first runnings sample would be marked as Rejected, and then be excluded from the COA. Though, perhaps the idea of using a "Process Batch" would be more suitable?

[former_member42743]

And you verified that all your MIC's are set up as "required" in the control indicators?

I don't have inspection points set up anywhere but I test with physical samples and that doesn't allow the auto UD unless all samples are processed.

Craig