Stability Study With SAP Quality Management

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Dipeshkumar Bhavsar
July 15, 2016 14 minute read
Stability Study with SAP Quality Management

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3 Likes 6,886 Views 8 Comments
Stability Study with SAP QM
1. Con guration
1.1. Inspection types

Although the inspection types for stability are precon gured in SAP QM. Still, you can con gure 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 Manual Insp. Lot for Storage Cond (Stab)
https://blogs.sap.com/2016/07/15/stability-study-with-sap-quality-management/ 1/44
1.2. User Status Pro le

The precon gured user status pro le has limitation to the xed process for stability study. You can
copy and con gure custom status pro le as per the business requirement.
Run Transaction BS02 to access the status pro les.
Add/Remove/Modify the business transaction for a status by double clicking the status.
1.3. Noti cation type and the Action box

There are standard precon gured noti cation type available. You can refer the same and use it as a
reference to create a custom noti cation type. Also, you can add/remove/modify the action box for
the noti cation type.
1.4. Primary Packaging

You need to de ne the primary packaging for Physical Samples
De nition: 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 >> De ne
Primary Packaging
1.5. Physical Sample Container

You need to de ne the physical sample container for physical sample
De nition: The containing material in which the samples are placed in stability chamber.
A. 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
>> De ne Physical-Sample Container
1.6. Storage Condition

You need to de ne the storage condition for Physical sample. It is the most important con guration
for stability study
De nition: The temperature and humidity level in which the physical samples are placed is called
the storage condition
A. 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 >> De ne
storage Conditions
1.7. Physical Sample Storage Location

You need to de ne the physical sample storage location for physical sample.
De nition: 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 identi cation of a stability
chamber. It is helpful to have tractability of the sample
Follow the menu path IMG >> Quality Management >> Quality Inspection >> Sample Management
>> De ne Physical-Sample Locations
It is a plant speci c con guration. You need to rst de ne 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.
2.3. Inspection plan

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 Modi cation 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.
A. 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 di erent 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 di erent 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 rst screen as follows to select either Header area or Operations area for the inspection
plan workbench
Select always Q_TSK_000000000010 – Insp. plan, mater.-routing alloc., lock and click on
Continue
You get the below screen.
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.
3. Stability Study Processing
The standard stability study process ow is as below
3.1. Create Quality Noti cation

Use Transaction QM01 and Noti cation Type QS-Stability Study with Material
In Below screen, Enter noti cation type QS.
In Below Screen, Enter the material and plant and hit enter key. The system will open up the batch
number eld
In below screen, enter the batch number and Save
Noti cation is created
3.2. Create Initial Sample

Open the noti cation in change using transaction QM02
In Below screen, enter the noti cation number and enter
In below screen, in Action Box, Click on Action Create Initial Sample
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 de ne the same as the product need to be
kept inside the refrigerator before placing into the stability chamber.
Click on Save and change noti cation. 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. Con rm Initial Sample

In below screen, in Action Box, Click on Action Con rm Initial Sample
The system should show a pop-up dialog box for the sample con rmation with all the details.
Click on save and change noti cation button. The system should show another pop-up dialog box
for physical sample drawing con rmation
Click on continue to con rm the sample
3.4. Create Initial Inspection Lot

In below screen, in Action Box, Click on Action Initial test Inspection lot
The system shows a pop-up dialog box for speci cation 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 exible speci cation selection screen where you
can select the required test as well as change the speci cation 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 speci cation 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.
3.5. Complete Initial Inspection Lot

You need not to perform the this action from the Quality Noti cation action box if you use the
standard UD code provided for making usage decision for stability study as those UD code contains
the follow up action to do this. You can see the same in the below screen shots.
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
3.6. De ne Storage Conditions

In below screen, in Action Box, Click on Action Specify Storage Conditions
The System shows a pop-up dialog box for de ning the storage conditions. Select the required
Storage Conditions and distribute the sample quantity for the selected storage conditions. Click on
save and change noti cation 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 De ne the Scheduling period and Click on create Testing schedule, save and change the
noti cation button to create the testing schedule.
Note: You must de ne 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 xed value to be de ned 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.
Now, you should be have a question in your mind “Why????”
Because, if you are using time-key date in maintenance strategy then system will not create last
station in maintenance schedule.
E.g. If you have 3, 6, 9, 12, 18, 24, 36, 48, 60 months stations and if you de ne 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 t 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.
The system navigates to Change Maintenance Plan screen.
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.
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 noti cation 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 noti cation 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.
The system perform the action of completion of test scheduling.
3.11. De ne Start Date of Study

In below screen, in Action Box, Click on Action De ne Start Date of Study
The system shows a pop-up dialog box for de ning start of cycle. Check / Change date and
click on Save and Change noti cation button to complete the action.
Note: The dates are very important for the stability study. Below is the order for the
di erent dates. If you deviate from the order then you will mess up the stability study
noti cation and you may need to close the same and create new one for the same.
Initial Sample Creation Date <= Initial Sample Con rmation Date <= Store Stability
Sample Date <= Start Date of Study.
You cannot de ne the start date of the study as back date (if initial sample is created on
current date) / Future date
3.12. Deadline Monitoring for Due Stations

You need to schedule a daily background Job with Transaction IP30 with proper variant to
create inspection lot for the stability.
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.
3.13. Complete Study and Reporting

Once all the stations are completed, you can use action box item. Complete Stability Study to
complete the study.
Also, you can Use Actions Display Objects for Study to see the object linked to the stability
study noti cation. It shows Quality Noti cation, 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.
Regards,
Dipeshkumar Bhavsar
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Assigned tags
PLM Quality Management (QM) | SAP ERP | enterprise resource planning | qm | quality |
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8 Comments
You must be Logged on to comment or reply to a post.
Arijit Banerjee
July 15, 2016 at 7:15 am

Good one. Keep it up!!
Like (0)
Dipeshkumar Bhavsar | Post author
July 15, 2016 at 7:35 am

Thanks Arijit.
Like (0)
Former Member
July 18, 2016 at 11:07 am

Very good document…This is gonna be very helpful…Thanks a lot!
Like (0)
ANIKET GAUTAM
July 19, 2016 at 8:53 am

Nice Document. Thank you for sharing
Like (0)
Former Member
July 29, 2016 at 12:15 pm

Hi Dipesh
Great e ort.
Thanks for sharing the knowldege.
Regards
Suresh.M
Like (0)
Former Member
August 2, 2016 at 5:52 am

Thanks Dipesh…
Like (0)
rajesh akkaladevi
July 25, 2017 at 10:26 am

Hi Dipesh,
Excellent explanation on process ow of Stability Studies. Thanks.
Regards,
Rajesh
Like (0)
Former Member
September 13, 2017 at 9:13 pm

Hello,
Great document. I have been using the stability study process for a while, however does anyone know how
to get multiple physical sample containers and not the just one? Our requirement is to track each one.
Like (0)
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Stability Study with SAP QM

1.1. Inspection types

16 Inspection for Storage Condition (Stabi)

1601 Initial Test (Stability Studies)

1602 Manual Insp. Lot for Storage Cond (Stab)

1.2. User Status Pro le

Run Transaction BS02 to access the status pro les.

1.3. Noti cation type and the Action box

1.4. Primary Packaging

1.5. Physical Sample Container

1.6. Storage Condition

1.7. Physical Sample Storage Location

2.1. Maintenance Strategy

2.2. Material Master and Inspection type

2.3. Inspection plan

2.4. Assign Maintenance Packages to the Inspection plan

You get the below screen.

Also, don’t forget to save and exit from the transaction.

3. Stability Study Processing

The standard stability study process ow is as below

3.1. Create Quality Noti cation

In Below screen, Enter noti cation type QS.

In below screen, enter the batch number and Save

Noti cation is created

3.2. Create Initial Sample

In Below screen, enter the noti cation number and enter

In below screen, in Action Box, Click on Action Create Initial Sample

3.3. Con rm Initial Sample

Click on continue to con rm the sample

3.4. Create Initial Inspection Lot

3.5. Complete Initial Inspection Lot

3.6. De ne Storage Conditions

3.7. Create Testing Schedule

Now, you should be have a question in your mind “Why????”

3.8. Change Testing Schedule (Assign Inspection Plan)

The system navigates to Change Maintenance Plan screen.

Click on Cycle Item, you will see nothing in that tab.

Now, use the Navigation buttons to navigate between items.

Now, Click on Save on below screen.

3.9. Store Stability Samples

3.10. Complete Test Scheduling

The system perform the action of completion of test scheduling.

3.11. De ne Start Date of Study

3.12. Deadline Monitoring for Due Stations

3.13. Complete Study and Reporting

Related Blog Posts

Useful Customization Transactions for SAP Quality Management (QM) Module

Stability Study linkage

Message BS001 when usage decision with stability study

Usage for Inspection plan and Stability Noti cation

By Former Member , Sep 05, 2017

You must be Logged on to comment or reply to a post.

July 15, 2016 at 7:15 am

Dipeshkumar Bhavsar | Post author

July 15, 2016 at 7:35 am

July 18, 2016 at 11:07 am

July 19, 2016 at 8:53 am

July 29, 2016 at 12:15 pm

Thanks for sharing the knowldege.

August 2, 2016 at 5:52 am