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What will be the impact if I default SLED date

ssubni
Participant
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Hi Gurus

My client wants to default SLED date at the time of GR  for the raw materials as they are not sure of the SLED from the vendor ( they are sending different COA for the same lot) and change the SLED subsequently.

What will be the impact if  we default a date like 12/31/2999.

Thanks,

SS

Accepted Solutions (1)

Accepted Solutions (1)

former_member42743
Active Contributor
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It's hard to say without knowing the business or products.  If the raw material goes in food, chemical or pharmaceuticals, than this would be a major issue in most cases.

Otherwise, it might not be any issue.  And even in those industries above, it might not be a problem depending on what the actual raw material is and what it is used for. 

Even so, the default value should have a realistic value to it.  Using the year 2999 is stretching it.

Having almost any batch in your inventory that is more than three years old usually indicates a problem.  The stock might be slow moving, not stored properly so it's not getting selected for use, (i.e. not real FIFO), was ordered wrong, replenishment rules are not quite right. etc.. etc..

Storing and tracking inventory is expensive.  Anything that needs to be batch managed really should never get into a situation where batches aren't used up within three years.

Craig

ssubni
Participant
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Ours is pharmaceutical company  and this is for our components which goes into product. Normally we have total shelf life for each material, so if we do not have the SLED from vendor, system populates the shelf life automatically. But once we get the COA , sometimes it is less than the existing SLED for the lot but normally exceeds our proposed total shelf life. So  to avoid this confusion business wants to put a default date in future and change it once it has the correct SLED.

My only concern is if they forgot to update the SLED in batch master, will it be disastrous?

former_member42743
Active Contributor
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Absolutely it could be disastrous.  That is why I would error on the side of defaulting in a shorter shelf life.  If you defaulted in 1/1/2099 and the material has in reality a one year shelf life, and it gets "overlooked", and at 14 months you use it in production, you could have a serious issue.  If it's discovered, you could be looking a serious recall effort or at the very least destruction of current inventories.  If someone outside the company finds out, you could wind up with an FDA investigator reviewing your practices and issuing a consent decree.

The business should already have a process for reviewing expired material in place.  There is an expired material report MB5M.  This list should be reviewed at least weekly by someone who is held directly responsible for materials.  When you run it, you provide the "window" you want to look at.  I.e. all materials that expire in the next 90 days, or 120 days.  Whatever works for your site.  If you default in a very short shelf life, (say 4 months), when they research the materials on the list, they should be able to see by the short shelf life, which batches require investigation and updating. 

If you default in a date, I might also suggest you put this same date into say date field 4 of the batch record.  Then you can quickly run BMBC for date field 4 between 1/1/2014 and 1/1/2099 and get a list of the all the batches that have a default date in them. When some one goes in and puts in the real date in from a COA, they would be trained to blank out value in date field 4.

Craig

former_member1049397
Participant
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Hi SS,

Craig is correct , to answer to your question any how the SLED value in the batch master is incorrect ., so expiring the product with the default SLED is not logically correct.

Chance of failure :

If the SLED updated with default value there is chance to user might forget to change it to correct value , so that incase the actual expire date is prior to defaulted then they the expired batches still exists in system stock.

There is no reason for updating default SLED value with future date you can leave it as blank and update it once the actual SLED date is recvd from vendor

You can develop some enhancment to combine the vendor batch with SLED date , as soon as the COA is recvd from vendor the program should pass the relevant SLED date for the vendor batch to the batch master generated at your plant

If really your client dont want to leave the SLED date as blank then maintain SLED duration as 3 years ( based on ur business requirement ) then SLED will be calculated automatically as 3 years additon to the GR date and later you can change it with correct value ...but generally its not required

Hope this helps.

ssubni
Participant
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Thank you Craig / Gopi.

SLED date is mandatory at the time of GR> We are currently updating it with 3 or 5 years based on the material. But we are ending up getting shorter SLED  from COA below 3 or 5 years then only problem arises.

The Key is manual adjustment of the date. I do not want any manual intervention. Like Craig said, i need to have some kind of indicator, then I need to track/report based on the indicator and correct it periodically.

former_member587434
Active Contributor
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Why can't you activate 09 (recurring inspection type) in material master and define inspection interval in material master QM view. this will trigger 09 inspection lot on defined interval. (Example; System update next inspection date = GR date + inspection interval in batch master. If you recieve batch on 1st Jan and inspection interval is 31 days then system update next inspection date as 1st Feb. So when you run dead line monitoring (QA07 manual/ QA05 auto). System trigger 09 inspection type inspection lot.

You can use this inspection lot as trigger point to verify SLED date in batch master. Think about this concept, this should help in your scenario.

former_member42743
Active Contributor
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Nice idea!

That might work well provided there is no need for actual reinspection of the same received material.

Craig

ssubni
Participant
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Hi

Thanks for the idea. The problem will be you will be having two inspection lots for the same lot.

1. One for the GR with 01 inspection type

2. Another with 09 inspection type

This will lead to the following

1. Since it is an API, we need to document the reason for the second inspection lot and do the results  recording and it is an unnecessary labor and time.

2.We have a custom code to prevent UD if there is any open inspection lot for the same lot.

You can change the next inspection date and also change the SLED after UD  with 01 inspection lot itself procedurally. The question is user tends to forget .

We are using 09 for the real next inspection currently.

SS

former_member42743
Active Contributor
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If you wanted to catch this prior to the 01 having the UD done, what you could do is use the user exit

  QEVA0010 UD: Usage decision check                                   

If you default in a date at GR and you update that date into the DATE 4 field, (or anyone of those you aren't using), you can use the above user exit to check the DATE 4 field.  If null, it continues on, if not it pops up an error message to the user that they must exit the UD and update the expiration info and date 4 field in MSC2.

This isn't great as ideally you want to let them make the change directly in the UD screen.

If you can find a way however to flag those batches that default in a value at GR, and if the value has been changed/updated by someone, you can then let them make the change in the UD screen and have the exit check that the value(s) in UD screen is different than whats already in the batch record and allow the UD to be made.

Craig

Answers (1)

Answers (1)

duarte_melim
Explorer
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Hi,

I guess you could, but what do you mean in particular by impact?