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1. Configuration
1.1. Inspection types
Although the inspection types for stability are preconfigured in SAP QM. Still, you can configure the custom
inspection types for stability.
Follow the Path: IMG >> Quality Management >> Quality Inspection >> Inspection Lot Creation >> Maintain
Inspection Types
16
Inspection for Storage Condition (Stabi)
1601 Initial Test (Stability Studies)
1602
2. Master Data
2.1. Maintenance Strategy
You need to create a maintenance strategy for stability study. It is the most important master data for the
stability study
Run Transaction IP11 or follow the menu path SAP Menu >> Logistics >> Quality Management >> Stability
Study >> Stability Planning >> Strategy >> Edit (IP11)
The important part is the scheduling indicator. You need to select 1-Time-Key date to get the schedule on
key date. E.g. if you start the study on 12.07.2016 and you have 1month, 2 months, 3 months, 6 months, 9
months and 12 months stations, you will get 12.08.2016(1month), 12.09.2016(2months), 12.10.2016(3months),
12.01.2017(6months), 12.04.2017(9months) and 12.07.2017(12months). For remaining two options (time and
2-time-factory calendar) you will not get the stations on the key date.
You get the below screen. Here you have all the inspection plan against the selection criteria. Select the
required inspection plan and scroll horizontally to your right.
You scroll horizontally to your right till you get see the column for Strategy like below screen. Enter/choose the
same maintenance strategy (e.g. QSTABI) for all the selected inspection plan(s).
Now Follow the menu path Task List >> Maintenance Packages like below screen.
The system will navigates to below screen in which you can assign the required packages. You can assign and
navigate to other selected inspection plans using navigation buttons on the transaction tool bar.
In Below Screen, Enter the material and plant and hit enter key. The system will open up the batch number
field
Notification is created
The system should show a pop-up dialog box for initial sample. On the pop-up dialog box, Enter Primary
Packaging, Sample Container and the sample quantity (the total sample quantity for the stability study i.e. total
of all the storage condition sample). Storage Condition and Storage Location is optional as this is the initial
sample. If the product required to be kept in particular storage condition (e.g. product need refrigeration) then
you must define the same as the product need to be kept inside the refrigerator before placing into the stability
chamber.
Click on Save and change notification. This will create the initial sample for the stability study.
Note: You must create initial sample when you decide to do stability study as the system do not allow
to start the study in back date.
The system should show a pop-up dialog box for the sample confirmation with all the details.
Click on save and change notification button. The system should show another pop-up dialog box for physical
sample drawing confirmation
The system shows a pop-up dialog box for specification selection. Enter the Group and Group
counter and put Initial Inspection lot as Short Text and click on Create Inspection lot.
The System show another pop-up dialog box for flexible specification selection screen where you can select
the required test as well as change the specification of the test as per the requirement and click on copy to
create inspection lot. Alternatively, you can click on copy all button to copy all the specification if you are using
the required inspection plan.
The system should create the inspection lot. You need to process the inspection lot separately.
I hope everyone on this forum for Quality Management must be aware of the inspection lot result recording and
Usage Decision. So, I will not describe the same in details.
If you use custom UD codes without follow up action, you need to click on the action box for Complete Initial
Test as per below screenshot
The System shows a pop-up dialog box for defining the storage conditions. Select the required Storage
Conditions and distribute the sample quantity for the selected storage conditions. Click on save and change
notification button to save the same.
The system shows a pop-up dialog box for create test schedule. Select the Maintenance Strategy and Define
the Scheduling period and Click on create Testing schedule, save and change the notification button to create
the testing schedule.
Note: You must define the scheduling period greater than last station. E.g. If you are planning for 3, 6,
9, 12, 18, 24, 36, 48, 60 Months then you must put value greater than 60 Months.
In this case I am putting 72 Months (I always ask the client for the maximum period for stability study
and ask them to standardize a fixed value to be defined as scheduling period to avoid any confusion)
E.g. if client say that they do stability maximum up to 60 Months, I tell them to standardize 72 Months. If
they say 36 Months then I tell to standardize 48 Months.
The system shows a pop-up dialog box asking for Do you want to edit the testing schedule for
the study and return to the study? click on Yes.
Here, you select the Maintenance Item (each maintenance item represents a storage conditions selected in
previous step) and click on Item Tab
In below screen, you can see the details of the maintenance item.
Come back to Item tab. Enter Group and Group Counter (basically assign the inspection plan to a storage
condition) then navigate to cycle item tab to see the assigned time points
The System saves the maintenance plan and navigates back to the notification screen.
The system shows a pop-up dialog box for Store stability Sample. Select all the storage conditions and choose
the sample location and click on save and change the notification button to store the sample.
The System shows a pop-up dialog box asking for Do you want to set the status "Test Scheduling
Completed" and return to the stability study? click on yes.
The system shows a pop-up dialog box for defining start of cycle. Check / Change date and click on Save and
Change notification button to complete the action.
Note: The dates are very important for the stability study. Below is the order for the different dates. If
you deviate from the order then you will mess up the stability study notification and you may need to
close the same and create new one for the same.
Initial Sample Creation Date <= Initial Sample Confirmation Date <= Store Stability Sample Date <= Start
Date of Study.
You cannot define the start date of the study as back date (if initial sample is created on current date) /
Future date
I hope everyone on this forum for Quality Management must be aware of scheduling a background job as well
as inspection lot processing. So, I will not describe the same in details.
There are many other things that you can customize as per your requirements.
I hope this document will be helpful. There are many possibility in the stability study with SAP QM. You can
explore the same.
Regards,
Dipeshkumar Bhavsar