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Stability Study With SAP Quality Management
Stability Study With SAP Quality Management
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
The preconfigured user status profile has limitation to the fixed process for stability study. You can copy and
configure custom status profile as per the business requirement.
Add/Remove/Modify the business transaction for a status by double clicking the status.
1.3. Notification type and the Action box
There are standard preconfigured notification type available. You can refer the same and use it as a reference to
create a custom notification type. Also, you can add/remove/modify the action box for the notification type.
1.4. Primary Packaging
Definition: The packing material which is in direct contact with the product is considered as primary packaging.
There may be container (bottle, ampule), closure (bottle cap) and desiccant (silica gel)
Follow the menu path IMG >> Quality Management >> Stability Study >> Basic Data >> Define Primary
Packaging
1.5. Physical Sample Container
You need to define the physical sample container for physical sample
Definition: The containing material in which the samples are placed in stability chamber.
E.g.
10 strips are packed in carton and placed in stability chamber then the carton is the physical sample container
10 strips (Aluminum and PVC blister) are placed in the stability chamber then the Aluminum and PVC blister is the
physical sample container
Follow the menu path IMG >> Quality Management >> Quality Inspection >> Sample Management >> Define
Physical-Sample Container
1.6. Storage Condition
You need to define the storage condition for Physical sample. It is the most important configuration for stability
study
Definition: The temperature and humidity level in which the physical samples are placed is called the storage
condition
E.g. Temperature 25°C ± 2°C and Relative Humidity 65% ± 5% is one of the storage condition. It can be a long
term/real time storage condition for a zone or it can be an accelerated storage condition for a zone. The storage
condition has nothing to do with Long term / Intermediate / Accelerated storage condition. These word should not be
the part of the description of a storage condition.
Follow the menu path IMG >> Quality Management >> Stability Study >> Basic Data >> Define storage Conditions
1.7. Physical Sample Storage Location
You need to define the physical sample storage location for physical sample.
Definition: The stability chamber in which the samples are placed is called Physical sample storage location.
E.g. it has nothing to do with the material storage location. It is the identification of a stability chamber. It is
helpful to have tractability of the sample
Follow the menu path IMG >> Quality Management >> Quality Inspection >> Sample Management >> Define
Physical-Sample Locations
It is a plant specific configuration. You need to first define a plant for which you are maintaining the stability
chamber. If you have a common chamber for multiple plant. You need to create the same stability chamber for each
of plants.
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.
2.2. Material Master and Inspection type
You must assign and activate inspection type for a material which you intended for stability study.
You must assign inspection type 16 (Inspection lot for Storage condition), 1601 (Initial inspection lot) and 1602
(Manual or additional inspection lot) or custom inspection types substitute for each one.
You need to have inspection plan for inspection processing for stability study
I hope everyone on this forum for Quality Management must be aware of the inspection plan. So, I will not describe
the same in details. But, the following points must be considered.
No Dynamic Modification Rule work for stability Study as the task list usage is 3-universal
The inspection plan should have sample drawing procedure in order to support the physical samples
The most important part is to assign the maintenance strategy and maintenance package to the inspection
plan which decide the planned stations for the particular storage condition.
2.4. Assign Maintenance Packages to the Inspection plan
You must assign a maintenance strategy and required maintenance package to an inspection plan in order to create
maintenance plan with the required planned stations.
E.g. you need to assign maintenance packages 3 Months, 6 Months, 9 Months and 12 Months for an Accelerated
stability study.
Also, you need to create different inspection plan for each strategy. E.g. if you are planning for Long
term(3,6,9,12,18,24,36 months), intermediate(3,6,9,12,18,24 months) and Accelerated (3,6,9,12 months) strategy.
You need to create three different inspection plan for each one of them.
Run the transaction CWBQM or follow the menu path SAP Menu >> Logistics >> Quality Management >>
Stability Study >> Stability Planning >> Inspection Planning >> Workbench (CWBQM)
You get the first screen as follows to select either Header area or Operations area for the inspection plan workbench
Enter the selection criteria and execute. E.g. Material, Plant, Task list type (always Q-Inspection plan), Group and
Group Counter and execute (load task lists)
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.
Also, don’t forget to save and exit from the transaction.
This will add maintenance packages in your inspection plans. That decides the planned stations for the storage
condition for which the inspection plan is assigned.
Use Transaction QM01 and Notification Type QS-Stability Study with Material
In Below Screen, Enter the material and plant and hit enter key. The system will open up the batch number field
In below screen, enter the batch number and Save
Notification is created
3.2. Create Initial Sample
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.
3.3. Confirm Initial Sample
In below screen, in Action Box, Click on Action Confirm Initial Sample
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 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.
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.
3.7. Create Testing Schedule
In below screen, in Action Box, Click on Action Create Testing Schedule
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.
E.g. If you have 3, 6, 9, 12, 18, 24, 36, 48, 60 months stations and if you define the scheduling period as 60
Months. The System will create the test schedule till 48 months and will not show 60 Months station. Because
the system consider 1 month = 30 days and if you calculate 30 days x 60 Months = 1800 days. So, if your start
date is 12.07.2016 then you are scheduling up to 1800 days i.e. till date 16.06.2021. But as per the time-key
date strategy it should be 12.07.2021 which is greater than 16.06.2021. So, the system do not create schedule
for 60 months station. Although, the system will generate the inspection lot for 60 Months when 12.07.2021
date is reached. So, it is up to you to follow the same or not.
But, I recommend to use my suggestion if you are using the scheduling data for reporting purpose.
3.8. Change Testing Schedule (Assign Inspection Plan)
In below screen, in Action Box, Click on Action Change Testing Schedule (here I have changed the text for the action to fit to my client’s requirement)
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.
In below screen, you can see the details of the maintenance item.
Click on Cycle Item, you will see nothing in that tab.
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
Now, use the Navigation buttons to navigate between items.
Now, Click on Save on below screen.
The System saves the maintenance plan and navigates back to the notification screen.
3.9. Store Stability Samples
In below screen, in Action Box, Click on Action Store Stability Sample
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.
3.10. Complete Test Scheduling
In below screen, in Action Box, Click on Action Complete Test Scheduling
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.
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
You need to process the generated inspection lot for Result recording and Usage Decision.
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.
Also, you can Use Actions Display Objects for Study to see the object linked to the stability study notification. It shows Quality Notification, Initial Physical Sample, Initial
Inspection lot, Physical Samples for Storage Conditions and Their inspection lots and Maintenance Plan.
You can use the action Display Stability History to display all the result recording history till date for the stability study. This action is also available while result recording of the
stability study inspection lot. There is a command button below the sample.
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.