dead line monitoring set up

[former_member211669]

Hi, I am having raw material for which dead line monitoring set up is there I,e. inspection type 09 and an inspection lot is getting generated based on next inspection date with the same batch number. Can I get the same inspection lot with different batch number for this inspection type? If not, can we do through any enhancement?

[former_member42743]

ok.. I'm guessing the reason for this requirement is that you use either generic batch numbers for some of your raws, or you have fairly large batches that need reinspecting but you don't want to block them from being used by production while inspection is being done.  Is that correct?

You can handle this by some simple changes in running QA07.  First, give yourself enough of a window for these materials so that you can get inspection completed.  Set up QA07 batch job just for these specific materials and run it first before any other jobs on a nightly basis.

When you run it, select "To inspection stock on inspection date".  If it takes ten days to inspect the material, set the program with a window of say 15 days, or even 20.

When the lot is created that should give you ample time to inspect the material.  The batch will remain in unrestricted until the batch's next inspection date.  If you don't get it done in time, on the "next inspection date" for the batch, it will go into QI where I'm sure it will become a priority!  🙂

FF

[former_member211669]

Hi,  my requirement is to generate new batch number in recurring inspection, that means whenever a new inspection lot will be generated against next inspection date , it should pick up  new batch number.

[former_member42743]

Ok.. this does not make any sense!!!!  In one reply you say the batch number is important since this is pharmaceutical.  That is true!!    You said   "they dont depend on inspection lot, batch number is important for them"

But then you say they maintain different files for this and they want a new batch number generated for this!!!  That doesn't make sense!!  Your quote: "but they maintain different files for it. for that purpose, pharma clients are demanding different batch number for this."

Yes.. most QA departments do keep different files... the original release of a batch.. maybe the reinspection, stability study if the batch is placed on stability, investigation if an issue, etc. etc.. But the file number is not kept in the inspection lot as a the batch number.  The batch number should never change!!  The batch number in the inspection lot has to match the batch number on the label that is adhered on the product/material that is being inspected.  If that is not done, you will NEVER pass any audits of your system.

If they get a new batch number in the inspection lot, how can anyone looking in the system know what actual material/batch the inspection is for?  How do they know what to go out and sample?  I'm not sure how this could ever pass an audit.

FF

[former_member211669]

Dear FF,  Just I want to explain you in a more detailed manner:  In MM02, they maintain inspection type as 09, Performing dead line monitoring. after some days an inspection lot is getting generated against next inspection date. till here, its fine. whatever the new recurring inspection lot is getting generated, result recording and usage decision is done against that one. Now, what they are doing is material to material transfer in mb1b, giving different batch number manually as receiving batch  number. In this way they are changing batch number for recurring inspection lot. Now requirement is that whenever recurring inspection lot is getting generated for Raw materials and packaging material, system should give new batch number. we cannot do this in standard SAP. Can we do this through ABAP development? Apart from this, can we give any other solution for this requirement?  Thank You.

[former_member42743]

No.

I guess I am still hung up on why they are creating these new batch numbers.  I can not fathom this process!

You have a material that is labelled, whether it is a raw material, packaging component, active ingredient, finished product, whatever.

Once you change the batch number using MB1B are you re-labeling the physical material?  Since on most pharmaceutical products, (if not all), the batch number is printed on the label and physically attached to the bottle, printed on the box, etc.. re-labeling is an expensive proposition.

If you are not re-labeling, I cannot see anyway that an auditor would allow such an inspection process.  If you are truly doing a MB1B to a new batch number, there is no way your stock overviews can match what is on your shelves in your warehouse.  Impossible.  How could you do a physical inventory?  If you have a recall how are you going to track back to all the inventory?  if you have to scrap or destroy damaged inventory how will you know what to scrap in SAP?

I guess if you really wanted to change the batch number you could use a user exit like

QPL10001

QM: Inspection lot creation - editing work area on creation

to intervene in the process and assign a new batch number.

But once again, your process has me totally baffled!  I've not heard or seen anything like this and I've been on pharma SAP projects with several of the major ones and I've worked in pharma myself before I got into SAP.

FF

[former_member211669]

Dear FF,  Once you change the batch number using MB1B are you re-labeling the physical material?  yes, after moving to another batch, they are changing the label physically on the material also.  Thanks

[former_member42743]

Wow!  That is an amazing amount of extra effort to relabel in both labor and label supplies.  This is the first time I've heard of a company anywhere that relabels as matter of normal business processes.  That seems highly inefficient.

But if that is your process, that is your process.

Unfortunately the SAP standard processes, I'm sure, were never designed with the idea of having to go find material and relabel the material as part of standard process.  You will as a result probably find many areas of SAP that will not work well for your process, one of which would be the deadline monitoring process.

I can say, with little fear of any significant arguments, that this is most definitely not a good business practice.  Especially for pharmaceutical firms.

Good luck with that. 

FF

[former_member207800]

As I know, it is not possible within SAP standard system.

You can add your logic into enhancement such as QAAT0001.

Anyway I don't recommend this process because shelf-life monitoring should be performed for each batch.

I would recommend you check the process of batch creation at first.

Regards, DoWook KIM

[Former Member]

Stability Material Check can be done with reference to Material & specific batch. For the same batch, if you want to do material check, deadline monitoring functionality will be activated by mentioning Material, Batch & Next Inspection date for that combination.

Here, why do you want to change the batch?? For another batch, the next inspection date will be different.

[former_member211669]

Hi,  In Pharma, they maintain different files for every inspection they do. they dont depend on inspection lot, batch number is important for them. Through recurring inspection, a new inspection lot is getting created with same batch number, but they maintain different files for it. for that purpose, pharma clients are demanding different batch number for this. Please suggest me regarding the same.