Pharmaceutical Industry best practices - calibrations

[former_member835064]

Could someone point me to any current best practices, industry contacts, user groups or anything that can help me understand what is possible with SAP PM/QM in a pharmaceutical environment where instrument calibrations are very important and subject to external audits? What I have been presented so far by my IT department does not look workable. QM seems to require reinventing of the wheel to make it do calibrations whereas other software, like Maximo, has complete calibration solutions already. Do most companies just use a third party calibration tool and integrate it with SAP? Or are there some good best practices out there to use SAP PM/QM for calibrations?

[Narasimha]

SAP has best practices for Pharma. Have you tried LIMS? PM-Calibration is simple to use. Why does it is not fitting to customer requirements?

[former_member835064]

Thanks, Narasimha. I am not aware of the capability of LIMS. The solution presented so far to us is using QM integrated with PM. Much of the issue we have with QM is that it doesn't "speak the language" of calibration technicians. The QM lingo of Inspection Lots, Inspection Characteristics, etc. doesn't make any sense to experienced calibration technicians without explanation. Each calibration also seems quite difficult to configure. A long string of formulas is required to make it work. Often times more than one tolerance is used and at least three calibration points are checked. These hardcoded formulas for the calibration also makes it inflexible. Sometimes a calibration is done with a different input each time based on the ambient conditions. There doesn't seem to be a good way to do this in QM.

I am from the user/functional side and am brand new to SAP. What I am being shown looks very difficult to configure, sustain, and train users on. I am hoping I can find some resources to show me a better way that I can hopefully communicate to my IT department and work with them towards a better solution.

[former_member811373]

See if this helps

https://blogs.sap.com/2012/06/22/calibration-process-steps/

https://blogs.sap.com/2015/06/19/calibration-business-process/

[RAHEEL_BABAR]

Hi,

See Here Calibration Processing (‏32L‏)

Regards

[manaveamol]

Hi Joseph,

I somewhat agree to the limitations in the calibration solution offered by SAP. The only way Calibration engineers like SAP calibration solution is with the Custom Fiori applications which gives them a Single dashboard (with automated functions) where they can manage everything about calibration.

Please Note- main challenge in the current solution is the requirement of multiple data points like Equipement creation, Task list creation, maintenance plan creation, scheduling - TRY to "automate" these points after Equipment creation. I have seen calibration engineers lose interest the moment they see the number of transactions they need to make to setup a calibration for One equipment.

Discuss with your IT team on How and what can be automated. Based on the Equipment type, you can automate Task list, maintenance plan creation and scheduling.

Then, once you have the maintenance order and an Inspection lot Use Fiori applications for Results and UD. Also, With simple configuration you can automate closing of Maintenace order after the UD.

Key takeaway is to leverage Fiori applications to create your own Calibration Tool which uses the SAP data. You get the benefit of using highly integrated SAP tool with easy and intuitive screen transaction.

If you go with the Maximo - do consider the cost of having a third party tool, it's integration with SAP, maintenance and the overall costs your company has to pay. Also, show Maximo functionality to the IT team to get suggestions.

With automated Fiori dashboard for calibration, you can achieve the same level of ease if you do it smartly and correctly.

Regards,

Amol Manave

[former_member835064]

Thank you for this. We are using Fiori but certainly no automations as you are describing. The comments on this thread are focusing more on the business process of getting the calibration order created processed and closed. My bigger concern is the actual creation of the inspection lots and characteristics and the recording of the measurements and actions. For instance, a fairly basic example would be a temperature that measures from 0 to 100 degrees. This instrument must be checked at three points, say 10, 50, and 90 degrees. And each point must be compared against two tolerances. Exceeding tolerance 1 requires an adjustment of the field device and then a repeat check of all three points after adjustment. Exceeding tolerance 2 is a "failure" which requires some reporting, and also the field item must be replaced or adjusted and then re-checked at all three points. Configuring and capturing all of these checks and actions is what seems very complicated in SAP QM. Do you have any further advice on setup or execution of the actual calibrations as opposed to just the processing of the order? Thank you!

[manaveamol]

Hi Joseph,

I will talk about capturing measurements but I will start with creating an Inspection lots.

1. Creation of calibration Inspection lots requires HUGE master data setup, if you have seen all the master data transactions you will know What I mean, otherwise request a Demonstration from your IT team. That is why, I suggest to automate this process.

2. Capturing measurements - first - you don't need to capture everything you perform on the instrument. Only capture what you will use for reports or certificates or for audits.

Second - assuming you need to capture results against 2 tolerances, SAP has a concept of "Inspection point" which can be setup for Before and After measurements scenario. This will take care of a simple positive scenario.

If it needs replacements- configure to have a service notification and have 2 "action items" configured which will replace the instructions and will create a new maintenace cycle or create a new calibration order.

This will be a huge development all together. So check what you already get in Maximo.

Now, Again I will focus on the Fiori applications - SAP calibration requires lots of clicks on Multiple transactions, but with Custom Fiori apps you can minimise number of clicks and have your own Calibration Tool.

Just to give you an Idea - calibration process requires below transactions in SAP

1. IE01 - EQUIPMENT creation

2. IA01/IA05 - Task list creation - characteristics will be assigned here.

Measuring points creation (optional)

3. IP01- Maintenance Task list creation.

4 . IP10 - Maint plan scheduling.

5. Calibration order and Inspection lot is created automatically.

6. QE51N- Results recording.

7. Service notification handling

8. QA11 - Usage decision

I do not know if you have seen this whole cycle in SAP, so thought of including it here.

I am sure, we haven't concluded yet, but please let me know your feedback with certain insights about your calibration process.

Amol Manave

[former_member835064]

Thanks again for the reply. We are using Inspection Points so I guess we are on the right track there though this again adds massively to the HUGE master data effort as you stated. Also, being a pharma environment we generally do need to capture everything (if you don't document it, you didn't do it).

Your comments are essentially confirming for me two things: 1. The master data effort will be large (this is normally the case for any software of this type), but it additionally seems that to accomplish calibrations with SAP PM-QM the complexity and volume of master data goes exponential. 2. Without some customization we are likely to end up with a system that is difficult to use and maintain going forward.

[manaveamol]

You got it right.

Master data efforts will be large in such softwares. With SAP (Fiori or Custom transaction in Sap Gui) you can automate most of the Master data which reduces your efforts considerably.

And yes, without some customization, it will be difficult to use, as you have already stated.

That's the reason I suggest to use SAP (provided the company funds this value added project), once done, it will need less maintenance (after 6 months at least).