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

[Former Member]

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 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.

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

[Former Member]

Nithin,

Whatever you mentioned the flow will exactly work for your scenario. All you need to do is,

Create a seperate category for this process or use the standard one meant for test equipments.

Create a general task list with inspection points assigned to it.(300 or 310) and list all the operations to be performed

for cleaning process. Make this task list exclusively for this process and this can be used for several equipments which has the similar process.

Assign the inspection type 14 to maintenance order type (PM05) to trigger the inspection lot. Please note inspection lot will trigger only if you assign the inspection points in task list and inspection type in order type. So you can control inspection lots generation only for the orders whic has the inspection points set up at task list level which is associated to maintenance plan.

Rest of the all you have mentioned in your list.

Mahee

[Former Member]

Dear Mahee,

Thank you for the detailed reply...want to know one more thing as I have asked FF in my previous post.....how to take care of result recording of multiple samples in the system.....as you say, using inspection points would help be able to address this problem?

Thanks again!

Regards,

Nitin

[Former Member]

Dear FF and Mahee,

There's one more doubt....how can i track the sample size in the system? say 50 ml samples are taken ... but since this process is similar to calibration cycle, the sample size would be fixed as 1 for the for the inspection lot of the equipment ..... so do i need to track the sample size for each of the mulitple samples of waste water in some dummy fields?

Regards,

Nitin

[Former Member]

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

4. Information is to be sent to concern regarding quality testing and its status

5. Change over performed

You can MAP this by Notifications also. Follow the steps

1. Create a new notification type ( config)

2. Ensure you have following mapped in the action box (config)

a. Send a mail

b. Create a inspection lot

c. Create a QM order

d. Close Notification

The process will be as follows

1. Create a dummy material and activate insp type 08 in the QM set up.

2. PM creates the notification (t-code QM01) (New notification & triggers a mail (Action box) which is delivered to QC as information regarding the start of process .

3. QC on looking at the information creates the inspection lot through the notification (action box) the QTY specified in the notification is moved from unrestricted to Quality .

3. Perform RR & UD and post stock to unrestricted

4. Close the notification giving your remarks or set the notification for further processing if required .

Note :

1. The material is a dummy material

2. The intial stock can be one qty which is posted to quality -

from unrestricted and then again to unrestricted.

Deepak

[former_member42743]

I like your process.

The cleaning of the equipment is technically a maintainence issue anyway.

The one thing I might suggest is to maybe create a specific order type for this. And maybe consult with the securty team as to how you can conttrol security on these. I would think that the cleaning process is done by specific, trained personnel, and not your regular PM guys from the shop. So you might want to have some securtiy around who can complete and process those orders.

You might also need to consume specific cleaning supplies against the order as well and you should be able to pick up costs against this.

FF

[Former Member]

Dear FF,

Thanks for your valuable inputs....I have also thought on similar lines as you have suggested...i.e. create a separate order type for cleaning validation....this would work exactly the same way as in calibration sycle.....However, one doubt is that in case I need to take multiple samples, say i take the first sample and in that i find the residue is present above the acceptable limits....i'll inspect and record these results in the system....then again after another round of washing, i record results for a new sample....so how can this be worked out?

Regards,

Nitin

[Former Member]

Hi Nitin,

As I understand, your scenario is you are not sure how many times the inspection needs to be done?

I would suggest, do the results recording and send the information to the concerned department. If the residual level is more then acceptance level, then add one more characteristic in the same lot. You can record the result with this new characteristic. You can continue like this till you get desired results.

Regards,

Rahul

Edited by: barrah on Sep 24, 2011 10:14 PM

[Former Member]

Dear All,

Thank you so much for sharing your view points on my scenario. I guess, I have got a start with these invaluable inputs given by you all. I'll be talking to my client and try to design the process within the framework that we have just discussed.

As my project is in the To-Be phase, there might be changes to the overall process to meet the business requirement.

I'm closing this thread now. Further, I've also assigned points for everyone.

Thanks again for your time!

Regards,

Nitin

[former_member42743]

Nitin,

Look at using measuring points in PM with your order.

See this link for a description:

http://help.sap.com/saphelp_45b/helpdata/en/9b/4461cc454711d189430000e829fbbd/content.htm

These are similar to inspection points used in QM but these are specific to PM and equipment. You should be able to record multiple values for these until you reacht he desired tolerances, in your case 0 active product.

FF

[Former Member]

Can you not use manual inspection with Inspection tyep 89 ? You can create Insepction lot as per your requirement.In the task list you can maintain parameters for residue Inspection.

[Former Member]

Hi Sujit,

Correct me if i'm wrong....for creating an inspection lot, i'll meed either a material code or equipment number or functional location.....as the SAP help says....

now in my case, i do not have a material code for the waste water (sample of which has to be tested for residue)....even if i give a material code for it, then how will i create the stock for quality inspection....?

Please elaborate on your thoughts...

Regards,

Nitin

[Former Member]

Anyway you would have require to create Equipement master for Inspection in PM-QM.So you can create any generic material.You can create waste water or any type of material for inspection.

Even calibration cycle is also not stock relevent.Important here is result.Anyway stock will never come into picture.