Stability study

Purpose

Stability studies are performed to examine the effects of different conditions, for example, temperature, humidity, and/or brightness on a product and on the properties of this product over a predefined period of time. To perform a stability study, you must form physical samples of the product and store these physical samples under controlled storage conditions.  Next, parts of these physical samples must be removed at planned, or unplanned, times during the stability study and tested according to predefined or flexible inspection specifications.  The stability study is integrated in the quality management processes (quality notification, sample management, inspection planning, and inspection processing), and also uses plant maintenance functions, for example, maintenance planning and scheduling.  This functionality works on quantitative characteristics only.

Some examples of business requirements in various industries are:

• Pharmaceutical and Chemical Industry
• High Tech Industry

• Expiry date determination
• Stability test in R&D
• Retest samples

  · Consumer Products Industry

• Expiry date determination
• Keeping quality tests of daily production batches
• Retest samples

  · Automotive Suppliers

• Stability tests of lacquers

• Reliability tests of electronic parts and semiconductors

          Prerequisites

                If you do not wish to use the predefined materials and characteristics, you will need to follow these steps.

         1) Create a material, copying SS001 in plant 3000. The setup of the QM view is required. A BOM is not required, but can be used.

          2) Create a batch.  This is necessary even if you are using the predefined inspection plan and material.

      3) Create an inspection plan.  This is where you will assign the various inspection characteristics or the master inspection characteristic.  It is important that all characteristics are here, due to the new functionality of flexible inspection planning.  You will have the ability to select which characteristics you want to test later, rather than having all the characteristics automatically default into the inspection lot.
In order to schedule the required inspections for the stability tests, at different points in time, you have to maintain maintenance packages for the single inspection operations. This can only be done using the Engineering Workbench (transaction CWBQM) for inspection plan maintenance.

Process Flow

Once a study has been opened, the process is divided into the following phases;

1. 1) Phase 1 – Initial Test
2. 2) Phase 2 – Stability Planning
3. 3) Phase 3 – Stability Tests

1. Procedure 1 – Initial Test
2. Procedure 2 – Stability Planning
3. Procedure 3 – Stability Tests

Procedure 1 – Initial Test

In this phase, you will create a study, create the initial sample, confirm the sample, create the inspection lot and complete the initial test.

Initial Test

1. Log onto R/3 using your own id.
2. Follow the menu path: Logistics ® Quality Management ® Stability Study ® Stability Study ® Create (or use transaction QM01)

       Enter the following data:

1. Choose .
2. Enter material your material (or enter SS001).
3. Enter plant 3000 and select .
4. Enter the Batch you created (or enter 1 for material SS001).
5. Select the Create Initial Sample in the Action Box.
6. Enter the following data:

1. Select the Save and Change Notifcation button.
2. Now select the Tasks tab.  This shows each step, as it is performed, and it’s status.
3. Select Confirm Initial Sample in the Action Box.
4. Select the Save and Change Notification button.
5. In the pop-up, enter Confirm Initial Sample in the Comments field.
6. Choose .
7. Select Initial Test Inspection Lot in the Action Box.
8. Enter Group 31 and Group Counter 1 and short text Initial Test Inspection Lot, unless you have created your own inspection plan.
9. Choose Create Inspection Lot button .

You now will receive a pop-up with the characteristics from your inspection plan.  This is new functionality called flexible selection.  It allows you to enter multiple characteristics in the inspection plan and then choose various characteristics, or all of them, at different times of inspection.

  Select the characteristics you wish to demonstrate and select Copy.  Make sure you have the row with the characteristic you want, highlighted.

1. Save notification.
2. Follow the menu path: Logistics ® Quality Management ® Stability Study ® Stability Test ® Test Results for Stability Study ® Record (or use transaction QE23)
3. The inspection lot and physical sample you just created should default in.
4. Select Enter. Select operation 0010 for Microbiology (0020 for Chromatography).
5. Select Enter again if necessary to verify the inspection point in the pop-up window.
6. Enter the following data in the results column:

      The above value ranges need to be followed for valuation of the lot.

   OPTIONAL:       Select next operation

if you selected this operation earlier

Enter the following data in the results column:

1. Save the results.
2. Accept the valuation.
3. Do not leave the „Record Physical Samples Results: Initial Screen“ and select the Create Usage Decision button.
4. Enter the U D Code 0010, Study will be executed.
5. Select Enter. Agree to force inspection completion if such pop-up appears.

1. Select  and press .
2. You can display what the usage decision was made on, by selecting the Physical Samples tab.
3. Save the usage decision.  This automatically completes the Initial Test.  If it doesn’t, you can go into the study and select Complete Initial Test in the

      Action Box.

Procedure 2 – Stability Planning

1. Follow the menu path: Logistics ® Quality Management ® Stability Study ® Stability Study ® Change (or use transaction QM02)
2. Enter your notification and select
3. Select Specify Storage Conditions in the Action Box.
4. Enter a quantity of 10 in each of the different storage conditions you wish to demo.  Explain that this is the condition under which the samples will be stored during testing. Select the lines where you entered a quantity and choose the Save and Change Notification button .
5. Now select Create Testing Schedule in the Action Box.
6. Enter the following data:

1. Select the Create and Change Notification button .
2. Select Change Testing Schedule in the Action Box.
3. Select „Yes“ to the pop-up regarding „Do you want to edit the testing schedule for the study and return to the study“
4. Select each line item, one at a time and go to the ITEM tab.  Enter the inspection plan Group number 31 and the group counter 1 (unless you have your own inspection plan).

Do this for each line and then save.

Please note that you can also use different inspection plans for the different storage conditions.

1. Follow menu path, Notification ® Print ® Notification.
2. Select the first line, Storage List, and enter an existing Output Device,(e.g. LP01).
3. Select the Print Preview button.

4.You will now have a preview of the Storage List, as seen below.

5. Press  and cancel the Select Shop Papers pop-up.

6.Select Store Stability Samples in the Action Box.

7.Change quantities to 5 and enter Sample Location, 000000000001, in each line.

1. Select all lines and hit the Save and Change Notification button .
2. Select Complete Test Schedule in the Action Box.
3. Select „Yes“ in the pop-up for setting the status „Test Scheduling Completed“.
4. Select Define Start Date of Study in the Action Box.
5. Leave in today’s date and select the Create and Change Notification button .
6. Select the Tasks tab and show the different tasks that have been completed and their statuses.
7. Select “Display Objects for Study” in order to see all related objects for the study (Inspection lot, samples, testing schedule and inspection lot)

Procedure 3 – Stability Tests

1. In the real world, the inspection lots for the stability study are now scheduled to be generated in 3, 6, 9 months and so on. In order to demonstrate the results recording for the inspection lots you may generate them before their scheduled timeframe: Follow the menu path: Logistics ® Quality Management ® Stability Study ® Stability Planning ® Testing Schedule ® Deadline Monitoring (or use transaction IP30)
   1. Enter your maintenance plan (Z.....) and enter 180 in the Interval forCall Objects for n Days field

2.    Execute.  The result is the sample size is calculated and the maintenance plan is scheduled, within that time frame of 180 days.

3      You can now enter results for each of the inspection lots, which would be the normal process.

4.    To show the inspection lots created, follow the menu path: Logistics ® Quality Management ® Stability Study ® Stability Test ® Inspection Lot ® Worklist ® Change Data (or use transaction QA32)

5     Enter the following data:

  6.   Execute.  This shows the inspection lots that were created for future tests.

  7. Select layout (Settings -> Layout -> Choose, or press Shift F11) and Choose “/MII” which includes the inspection lot short text. The short text contains the name of the study. So, it is easier for you to pick out the right inspection lots.

8  .If you have used the existing inspection plan, please note that the inspection lots created for 3 months contain 2 inspection operations whereas the inspection lots scheduled for 6 months contain only 1 inspection operation. This is because different maintenance packages are assigned to the inspection plan operations.

End of Demo