Outgoing Certificate of Analysis - display average of multiple inspection points / samples

[Former Member]

We have a requirement to generate certificates of analysis for batches of finished goods and semi-finshed goods.  The requirement on the form is to display each characteristic once with a value that is the average of the results of all inspection points (2-3 samples usually).

In the certificate profile, Result Selection Level 01 provides summary results using only the most recent inspection point, and Result Selection Level 02 provides the results for every inspection point.

Does anyone know a way to display the average result of a characteristic across multiple inspection points?

Example

Insp Point 1 (first sample)

MIC 0001 - 5.0

MIC 0002 - 100

Insp Point 2 (second sample)

MIC 0001 - 10.0

MIC -0002 - 20

On Certificate

MIC 0001 - 7.5

MIC 0002 - 60

I don't believe batch derivation will work in this case, because transfer of inspection results from inspection lot to batch record only takes into account the most recent inspection point, it does not transfer an average.

[former_member42743 · Accepted solution]

Are you using 03 or 04 inspection lots?

With 03 lots you can select (using the IP identifier configuration) to report either the average of the last "N" inspection points or just the last IP.

With 04 lots you can only get the value for the last inspection point.

If you think about it, it makes sense.  In 03 lots you are inspecting every two hrs or every so many units produced. 

When you get to the 04 you are supposed to be inspecting the whole batch.  The 04 was never originally designed to use inspection points.  I think it was primarily extended to the 04 lots in order to allow repeat testing not necessarily the averaging of results.

Do the 03 inspection lots with inspection point averaging for your raw/intermediate material.  After the UD the average result will be on the batch record.  The batch record is updated each time an IP is valuated.  Many places don't even make UD's on 03 lots but you should. If you do, this ensures the final summarized value is copied to the batch record.

If you want to have an 04 lot for this raw/intermediate, do not include the MIC's being averaged by IP's in the 03 lot.  Instead include a characteristic like "03 lot reviewed and UD made"  as a required pass/fail characteristic.  This would prompt the analyst to make sure the 03 UD is done which copies the summarized results of the 03 to the batch record.

Then when you receive your FG batch, you can use batch derivation to copy the results from the raw/intermediate to the FG batch.  Alternatively, you can set up the result recording copy function to copy the raw/intermediate batch values into the FG 04 inspection lot. 

Then set the Cert up to report the batch values from the FG.

FF

[Former Member · Accepted solution]

Thanks for the response, but I unfortunately left out an important detail.  We are using sample management, and inspection points for sample management have the No. of IP for char. summarization field greyed out.

I think the only option we are left with is to display all the inspections points on the certificate.

[former_member42743 · Accepted solution]

Yes.. that was a key point to make.

I had a client where we had to use some user exits to get the average of the inspection points to the batch because they were using 04 inspection lots with inspection points which don't support inspection point averaging either.

It was not easy, but it was accomplished.  Look at the following user exits.  Since you're using sample management you might not be able to use the same exits we did.

QEEM0003	User exit: add. functions after valuating insp. characs
QEEM0004	User exit: add. functions after valuation of partial samples
QEEM0006	User exit: add. functions after closing inspection characs
QEEM0007	User exit: add. functions after completing partial samples
QEEM0011	User exit: add. functions before valuating insp. characs
QEEM0012	User exit: add. functions before valuating partial samples
QEEM0015	User exit: add. functions after entering individual results

I believe we used QEEM003 to re-average the batch values each time a new value was recorded.

Then we did it again after the UD with a batch job submitted from a follow-up action.

FF