"Cleaning Validation Process Scenario" in SAP PM/QM for Pharma Industry

Dear Gurus,
I have a client requirement in the Pharma Industry. The scenario needs to be mapped in SAP for which I need your help.
The scenario is that the company is making medicines (tablets/capsules). Whenever, there is a changeover of the product, there are certain regulatory requirements which the client needs to adhere to.
For example, a shutdown of machinery for 10-12 days may be planned during which the machines are cleaned with soap/cleaning agents. Now, during this cleaning process, the QA department would take samples of the soap water recovered after cleaning process. These samples would be inspected for residues of the previous product that was being run on the line.
If everything is ok, then the approval is given by QA to start the next product.
This process has to be mapped in SAP, maybe in PM or QM.
I thought over the following process. Please let me know your inputs to fine tune the below process -
1. As the shutdown for changeover will be a planned one, we can create a Maintenance Plan in IP42.
2. Schedule the Mantenance Plan by IP10.
3. Release the maintenance plan in IP10.
4. Preventive Maintenance order will be created. (Also assign an Inspection Type in config to this maintenance order so that inspection lot also is triggered. The doubt here is that the inspection lot would be triggered for all preventive maintenance orders which may not be required. How to control this?)
5. Carry out Result Recording in QA32.
6. Confirm Preventive Maintenance order in IW41.
7. Carry out Usage Decision in QA32. The status of order will now become TECO.
8. Order Settlement in KO88.
9. Business Completion of Order in IW32
Thanks for you time!
Regards,
Nitin

Hi,
For multiple samples we can use no of sample(SAmpling Procedure) to record more than one results and system will calculate the arithmetic mean of all results of all sample
For this we have to maintain control indicator of MIC . Single result radio button will enable us to record results based on the number of sample defined in sampling procedure
And if you have requirement like different target values at different level,
Then you can configure inpection point -
SPRO > Quality Management > Quality Planning > Inspection Planning > General > Define Identifier for Inspection Points
in this Field act - 2 and give description
Regards,
SandeepV

Similar Messages

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    Dear Gurus,
    I have a client requirement in the Pharma Industry. The scenario needs to be mapped in SAP for which I need your help.
    The scenario is that the company is making medicines (tablets/capsules). Whenever, there is a changeover of the product, there are certain regulatory requirements which the client needs to adhere to.
    For example, a shutdown of machinery for 10-12 days may be planned during which the machines are cleaned with soap/cleaning agents. Now, during this cleaning process, the QA department would take samples of the soap water recovered after cleaning process. These samples would be inspected for residues of the previous product that was being run on the line.
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    This process has to be mapped in SAP, maybe in QM or PM.
    I thought over the following process. Please let me know your inputs to fine tune the below process -
    1. As the shutdown for changeover will be a planned one, we can create a Maintenance Plan in IP42.
    2. Schedule the Mantenance Plan by IP10.
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    4. Preventive Maintenance order will be created. (Also assign an Inspection Type in config to this maintenance order so that inspection lot also is triggered. The doubt here is that the inspection lot would be triggered for all preventive maintenance orders which may not be required. How to control this?)
    5. Carry out Result Recording in QA32.
    6. Confirm Preventive Maintenance order in IW41.
    7. Carry out Usage Decision in QA32. The status of order will now become TECO.
    8. Order Settlement in KO88.
    9. Business Completion of Order in IW32
    Thanks for you time!
    Regards,
    Nitin

    Your ASIS Process 
    1. Cleaning is done by maintenance before change over
    2. Inspection is done to ensure that cleaning is acceptable
    3. Records of inspection are to be maintained
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        b. Create a inspection lot
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    1. The material is a dummy material
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    from unrestricted and then again to unrestricted.
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