Changing the inspection based on goods receipt

[ssubni]

Hi Gurus,

Our client has a requirement and I want to know whether it can be done through standard Process.

Our customer is pharma company and they  want to receive the items under quality during GR with an inspection lot. For certain components (labels, vials etc) they want to change the inspection ( normal to reduced)based on no of goods receipt against this vendor not based on the release of the product for the vendor and also every year (after 365 days)the inspection should be flipped back to normal inspection.

Currently our system has Q info record assigned with Profiles based on the material and vendor and the system is flipping from Normal inspection to reduced inspection based on the release of the product in Usage decision . for example, if the UD is accepted for 5 times, then 6th receipt will be reduced inspection. but the users could not keep up the timeline as they receive next receipt for the same product from the same vendor before the UD happens for the receipt. So system could not flip it or maintain the inspection. Also we do not have nay function to flip the inspection to normal after 365 days.

Any suggestions are appreciated.

Thanks

SS

[busyaban7]

Hi Subramanian,

I think, to have a regular inspection after 365 days, you should have an inspection plan where the DMR rule is not active. For example -

1. Reduced Inspection - Valid From: 01.01.2014 - Valid To: 31.12.2014 => DMR managed at inspection lot level.

2. Normal Inspection - Valid Form 01.01.2015 - Valid To: 31.12.9999 => DMR Rule not added at Inspection lot level.

With this setup active, when the inspection lot will be created, it will pick the correct inspection plan and the subsequent flows will be according to it. Please can you test this part and feedback.

Please correct my understanding of your process -

IL01 => At Inspection lot creation - Quality level updated. (DMR ex => X5)

             At Inspection Lot UD = "A" - Quality Level Updated.

...

...

IL04 => At Inspection lot creation - Quality level updated. (DMR ex => X5)

             At Inspection Lot UD = "A" - Quality Level Updated.

IL05 => At Inspection lot creation - Quality level updated. (DMR ex => X5)

             At Inspection Lot UD - UD NOT DONE!!

IL06 => At Inspection lot creation - Quality level updated. (DMR ex => X5)

             At Inspection Lot UD - UD not done yet for IL05 and IL06.

As the UD for IL05 is not done yet, hence the IL06 is also coming under normal inspection, and I think this is normal SAP behavior.

Sorry, I do not have a direct answer to your query. Let's wait for some expert feedback on this topic to fix this part.

Thanks,

Arijit

[ssubni]

Hi Arijit,

Thanks for your reply.

The scenario is correct. But I did not understand the reduced inspection part. My client wants the system to flip the inspection from reduced to normal inspection after 365 days for the particular vendor material combo.

Ex. Material A is received against the vendor from Jan to April, after the maintained receipts (per Q info profile), the inspection changed from normal to reduced assuming all the UD are accepted. But after 365 days, if we receive anything from the vendor , it should automatically flip the inspection to normal.

SS

[former_member42743]

Please review this thread:

It should apply to resetting to full testing as well.

Full testing would be your first stage, reduced testing your second stage, and you'll need a third stage that would be a skip stage.

When the seond stage (reduced testing), hits the yearly requirement, (maximum days), it will go to the next stage.  Since SAP will NOT allow it go to a skip stage if it's coming off a change due to the maximum number of days, it then takes the stage specified for a failure which should, in your case be the first stage.

You first should see what can be done to complete testing faster.  If some tests take a long time, (like micro or sterility testing), you might consider making those tests long-term characteristics. That way a conditional UD is made based on the short-term characteristics.  If you get a failure on a long-term characteristic and need to fail the lot, then you would need to look at what came in afterwards and maybe do some additional testing on subsequent lots as well as reset your quality levels.  Since you're a pharm company, some type of investigation and review would need to be done anyway for a failed UD.

Craig

[ssubni]

Thank you Craig.

I would  love to test this,

But can we do this without using DMR as we are controlling the stages through Q-info status profile and after it reaches the final stage it  changes to the reduced inspection. Can we set up a duration on the status profile such that after the first reduced stage, to start the count and after 365 days flip to the initial stage (normal inspection). Is it standard?

Also since our company is controlled through FDA , QA will not release product on conditional UD so we cannot have long term characteristics and release it on condition. Our biggest bottleneck is the testing time, before we finish the testing , we will get  the new receipt that mess up the profile status.

can we control the status profile based on lot creation instead of UD. Anyway, if any lot is failed, it will flip it back to initial stage.

Thanks a lot and appreciate your feedback.

SS

[former_member42743]

Ok.. first..conditional releases are allowed by the FDA for all except the final end packaged product.  I've worked for numerous pharamaceutical firms and they all utilized conditional releases to some extent to allow manufacturing "at-risk".  This includes EU and US production processes.   So that is a requirment of your companies QA people, not the FDA.  No less a requirement for you, but don't let the site people tell you it's an FDA requirement unless it is for actual final product release, (i.e, labelled, blister packed or bottle, sealed, stamp, palletized for end customer delivery).  And that is even often conditionally released if long shipping times, (i.e. freighter across the ocean), are involved.

Raw materials or purchased bulk, (which I believe is what you are talking about for receipts), can be used to your hearts content.  BUT!  You must have procedures in place as to what happens when an issue is found and how you'll identify and isolate all products that used that failed item.  It usually comes to a risk/reward analysis if conditional release is allowed by a firm which has to take into account the mfg process, actual rejection failure, financial risk, time to market, expiration dates of products, etc..etc..  I have worked at and done QM design at four of the top ten Pharma firms in the world.  It's NOT FDA required. Yet I hear that a lot!  Sorry..I'll get off my soap box now! 

As far as getting material in before the previous UD is done.  Yes.. that is standard functionality.  But whether you change quality levels at lot creation or lot UD you can have potential issues with either. When you have it at lot creation, the quality level is advanced to the next level on the assumption that the lot you just created is going to pass.  Therefore, the next lot could be created with reduced testing even though the previous lot might fail.  If you wait until the UD, you might remain at full testing longer than you should because the quality level isn't updated before the next lot.  MOST sites use at UD because it is USUALLY the most conservative choice.

Further, if you have "documentation required" checked on in the QM veiw of the plants material master, and you are usnig the status profiles, you CANNOT do a GR for new material until the UD is made on the previous lot.  I usually recomment that documentation required be turned on for most Pharma firms.

Status profiles were set up for a specific process.  Plese read this:  Status Profile for Releasing Supply Relationships - QM in Procurement (QM-PT-RP-PRC) - SAP Library

It is used to change the inspection plans used because each inspection type can have their own inspection plan usage.

The DMR is used to change number of samples required to be inspected for a given quantity of material.

Two different things.  Maybe we need to understand better exactly what you want to modify.

Craig

[former_member217872]

subramanian sankaran wrote:

Hi Arijit,

Thanks for your reply.

The scenario is correct. But I did not understand the reduced inspection part. My client wants the system to flip the inspection from reduced to normal inspection after 365 days for the particular vendor material combo.

Ex. Material A is received against the vendor from Jan to April, after the maintained receipts (per Q info profile), the inspection changed from normal to reduced assuming all the UD are accepted. But after 365 days, if we receive anything from the vendor , it should automatically flip the inspection to normal.

SS

You can use Dynamic Modification rule to control this, just maintain a Reset period of 365 days, as soon as the period is reached, the quality level reverts to the initial inspection stage i.e. normal inspection.

[former_member42743]

Daniel,

Sorry, that is incorrect.  A reset period of 365 only resets to the initial stage if no new lots are created and no UD's are done.

Craig