The document discusses configuring SAP Quality Management for stability studies. Key points include:
1. Configuring inspection types, user status profiles, and notification types for stability studies.
2. Defining primary packaging, physical sample containers, storage conditions, and storage locations.
3. Creating a maintenance strategy, assigning inspection types and plans to materials, and assigning maintenance packages to inspection plans to generate planned stations.
4. The standard process of creating a quality notification to start a stability study.
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SAP
Titre original
323234961 Stability Study With SAP Quality Management
The document discusses configuring SAP Quality Management for stability studies. Key points include:
1. Configuring inspection types, user status profiles, and notification types for stability studies.
2. Defining primary packaging, physical sample containers, storage conditions, and storage locations.
3. Creating a maintenance strategy, assigning inspection types and plans to materials, and assigning maintenance packages to inspection plans to generate planned stations.
4. The standard process of creating a quality notification to start a stability study.
The document discusses configuring SAP Quality Management for stability studies. Key points include:
1. Configuring inspection types, user status profiles, and notification types for stability studies.
2. Defining primary packaging, physical sample containers, storage conditions, and storage locations.
3. Creating a maintenance strategy, assigning inspection types and plans to materials, and assigning maintenance packages to inspection plans to generate planned stations.
4. The standard process of creating a quality notification to start a stability study.
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 L ot Creation >> Maintain 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 Profile The preconfigured user status profile has limitation to the fixed process for st ability study. You can copy and configure custom status profile as per the business requirement. Run Transaction BS02 to access the status profiles. Add/Remove/Modify the business transaction for a status by double clicking the s tatus. Generated by Jive on 2016-07-26Z 1 Stability Study with SAP Quality Management Generated by Jive on 2016-07-26Z 2 Stability Study with SAP Quality Management 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. Generated by Jive on 2016-07-26Z 3 Stability Study with SAP Quality Management Generated by Jive on 2016-07-26Z 4 Stability Study with SAP Quality Management Generated by Jive on 2016-07-26Z 5 Stability Study with SAP Quality Management 1.4. Primary Packaging You need to define the primary packaging for Physical Samples 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 (sil ica gel) Follow the menu path IMG >> Quality Management >> Stability Study >> Basic Data >> Define Primary Packaging Generated by Jive on 2016-07-26Z 6 Stability Study with SAP Quality Management 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. 1. E.g. 10 strips are packed in carton and placed in stability chamber then the carton i s the physical sample container 10 strips (Aluminum and PVC blister) are placed in the stability chamber then th e Aluminum and PVC blister is the physical sample container Follow the menu path IMG >> Quality Management >> Quality Inspection >> Sample M anagement >> Define Physical-Sample Container Generated by Jive on 2016-07-26Z 7 Stability Study with SAP Quality Management 1.6. Storage Condition You need to define the storage condition for Physical sample. It is the most imp ortant configuration for stability study Definition: The temperature and humidity level in which the physical samples are placed is called the storage condition 1. E.g. Temperature 25C 2C and Relative Humidity 65% 5% is one of the storage cond ition. It can be a long term/real time storage condition for a zone or it can be an accelerate d 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 con dition. Follow the menu path IMG >> Quality Management >> Stability Study >> Basic Data >> Define storage Conditions Generated by Jive on 2016-07-26Z 8 Stability Study with SAP Quality Management 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 Phys ical sample storage location. E.g. it has nothing to do with the material storage location. It is the identifi cation of a stability chamber. It is helpful to have tractability of the sample Follow the menu path IMG >> Quality Management >> Quality Inspection >> Sample M anagement >> 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. Generated by Jive on 2016-07-26Z 9 Stability Study with SAP Quality Management 2. Master Data 2.1. Maintenance Strategy You need to create a maintenance strategy for stability study. It is the most im portant master data for the stability study Run Transaction IP11 or follow the menu path SAP Menu >> Logistics >> Quality Ma nagement >> Stability Study >> Stability Planning >> Strategy >> Edit (IP11) The important part is the scheduling indicator. You need to select 1-Time-Key da te to get the schedule on key date. E.g. if you start the study on 12.07.2016 and you have 1month, 2 month s, 3 months, 6 months, 9 months and 12 months stations, you will get 12.08.2016(1month), 12.09.2016(2mont hs), 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. Generated by Jive on 2016-07-26Z 10 Stability Study with SAP Quality Management Generated by Jive on 2016-07-26Z 11 Stability Study with SAP Quality Management 2.2. Material Master and Inspection type You must assign and activate inspection type for a material which you intended f or 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. Generated by Jive on 2016-07-26Z 12 Stability Study with SAP Quality Management 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 inspec tion 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 pa ckage to the inspection plan which decide the planned stations for the particular storage con dition. Generated by Jive on 2016-07-26Z 13 Stability Study with SAP Quality Management 2.4. Assign Maintenance Packages to the Inspection plan You must assign a maintenance strategy and required maintenance package to an in spection plan in order to create maintenance plan with the required planned stations. 1. 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 yo u are planning for Long term(3,6,9,12,18,24,36 months), intermediate(3,6,9,12,18,24 months) and Accelera ted (3,6,9,12 months) strategy. You need to create three different inspection plan for each one of the m. Run the transaction CWBQM or follow the menu path SAP Menu >> Logistics >> Quali ty Management >> Stability Study >> Stability Planning >> Inspection Planning >> Workbench (CWBQM ) You get the first screen as follows to select either Header area or Operations a rea for the inspection plan workbench Select always Q_TSK_000000000010 - Insp. plan, mater.-routing alloc., lock and c lick 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) Generated by Jive on 2016-07-26Z 14 Stability Study with SAP Quality Management You get the below screen. Here you have all the inspection plan against the sele ction criteria. Select the required inspection plan and scroll horizontally to your right. Generated by Jive on 2016-07-26Z 15 Stability Study with SAP Quality Management You scroll horizontally to your right till you get see the column for Strategy l ike below screen. Enter/choose the same maintenance strategy (e.g. QSTABI) for all the selected inspection plan(s). Generated by Jive on 2016-07-26Z 16 Stability Study with SAP Quality Management Now Follow the menu path Task List >> Maintenance Packages like below screen. Generated by Jive on 2016-07-26Z 17 Stability Study with SAP Quality Management The system will navigates to below screen in which you can assign the required p ackages. You can assign and navigate to other selected inspection plans using navigation buttons on the tran saction tool bar. Generated by Jive on 2016-07-26Z 18 Stability Study with SAP Quality Management Generated by Jive on 2016-07-26Z 19 Stability Study with SAP Quality Management Generated by Jive on 2016-07-26Z 20 Stability Study with SAP Quality Management Also, dont forget to save and exit from the transaction. This will add maintenance packages in your inspection plans. That decides the pl anned stations for the storage condition for which the inspection plan is assigned. 3. Stability Study Processing The standard stability study process flow is as below Generated by Jive on 2016-07-26Z 21 Stability Study with SAP Quality Management 3.1. Create Quality Notification Use Transaction QM01 and Notification Type QS-Stability Study with Material Generated by Jive on 2016-07-26Z 22 Stability Study with SAP Quality Management In Below screen, Enter notification type QS. In Below Screen, Enter the material and plant and hit enter key. The system will open up the batch number field Generated by Jive on 2016-07-26Z 23 Stability Study with SAP Quality Management In below screen, enter the batch number and Save Generated by Jive on 2016-07-26Z 24 Stability Study with SAP Quality Management Notification is created Generated by Jive on 2016-07-26Z 25 Stability Study with SAP Quality Management 3.2. Create Initial Sample Open the notification in change using transaction QM02 Generated by Jive on 2016-07-26Z 26 Stability Study with SAP Quality Management In Below screen, enter the notification 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 dia log box, Enter Primary Packaging, Sample Container and the sample quantity (the total sample quantity f or the stability study i.e. total Generated by Jive on 2016-07-26Z 27 Stability Study with SAP Quality Management 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 t he stability study. Note: You must create initial sample when you decide to do stability study as th e 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 Generated by Jive on 2016-07-26Z 28 Stability Study with SAP Quality Management The system should show a pop-up dialog box for the sample confirmation with all the details. Generated by Jive on 2016-07-26Z 29 Stability Study with SAP Quality Management Click on save and change notification button. The system should show another pop -up dialog box for physical sample drawing confirmation Click on continue to confirm the sample Generated by Jive on 2016-07-26Z 30 Stability Study with SAP Quality Management 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 specification selection. Enter the Grou p and Group counter and put Initial Inspection lot as Short Text and click on Create Inspectio n lot. Generated by Jive on 2016-07-26Z 31 Stability Study with SAP Quality Management The System show another pop-up dialog box for flexible specification selection s creen where you can select the required test as well as change the specification of the test as per the req uirement and click on copy to create inspection lot. Alternatively, you can click on copy all button to copy a ll 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. Generated by Jive on 2016-07-26Z 32 Stability Study with SAP Quality Management I hope everyone on this forum for Quality Management must be aware of the inspec tion 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 Notification 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. Generated by Jive on 2016-07-26Z 33 Stability Study with SAP Quality Management Generated by Jive on 2016-07-26Z 34 Stability Study with SAP Quality Management If you use custom UD codes without follow up action, you need to click on the ac tion box for Complete Initial Test as per below screenshot Generated by Jive on 2016-07-26Z 35 Stability Study with SAP Quality Management 3.6. Define Storage Conditions In below screen, in Action Box, Click on Action Specify Storage Conditions 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 condition s. Click on save and change notification button to save the same. Generated by Jive on 2016-07-26Z 36 Stability Study with SAP Quality Management 3.7. Create Testing Schedule In below screen, in Action Box, Click on Action Create Testing Schedule Generated by Jive on 2016-07-26Z 37 Stability Study with SAP Quality Management The system shows a pop-up dialog box for create test schedule. Select the Mainte nance 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 y ou 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 per iod 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 t o standardize 72 Months. If they say 36 Months then I tell to standardize 48 Months. Generated by Jive on 2016-07-26Z 38 Stability Study with SAP Quality Management 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 defi 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 t han 16.06.2021. So, the system do not create schedule for 60 months station. Although, the system will g enerate 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 r eporting 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 clients requirement) The system shows a pop-up dialog box asking for Do you want to edit the testing s chedule for the study and return to the study? click on Yes. Generated by Jive on 2016-07-26Z 39 Stability Study with SAP Quality Management The system navigates to Change Maintenance Plan screen. Here, you select the Maintenance Item (each maintenance item represents a storag e conditions selected in previous step) and click on Item Tab Generated by Jive on 2016-07-26Z 40 Stability Study with SAP Quality Management In below screen, you can see the details of the maintenance item. Click on Cycle Item, you will see nothing in that tab. Generated by Jive on 2016-07-26Z 41 Stability Study with SAP Quality Management Come back to Item tab. Enter Group and Group Counter (basically assign the inspe ction plan to a storage condition) then navigate to cycle item tab to see the assigned time points Generated by Jive on 2016-07-26Z 42 Stability Study with SAP Quality Management Generated by Jive on 2016-07-26Z 43 Stability Study with SAP Quality Management Now, use the Navigation buttons to navigate between items. Generated by Jive on 2016-07-26Z 44 Stability Study with SAP Quality Management Generated by Jive on 2016-07-26Z 45 Stability Study with SAP Quality Management Generated by Jive on 2016-07-26Z 46 Stability Study with SAP Quality Management Now, Click on Save on below screen. The System saves the maintenance plan and navigates back to the notification scr een. Generated by Jive on 2016-07-26Z 47 Stability Study with SAP Quality Management 3.9. Store Stability Samples In below screen, in Action Box, Click on Action Store Stability Sample Generated by Jive on 2016-07-26Z 48 Stability Study with SAP Quality Management 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 stor e the sample. Generated by Jive on 2016-07-26Z 49 Stability Study with SAP Quality Management 3.10. Complete Test Scheduling In below screen, in Action Box, Click on Action Complete Test Scheduling Generated by Jive on 2016-07-26Z 50 Stability Study with SAP Quality Management The System shows a pop-up dialog box asking for Do you want to set the status "Te st Scheduling Completed" and return to the stability study? click on yes. The system perform the action of completion of test scheduling. 3.11. Define Start Date of Study In below screen, in Action Box, Click on Action Define Start Date of Study Generated by Jive on 2016-07-26Z 51 Stability Study with SAP Quality Management 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 f or the different dates. If you deviate from the order then you will mess up the stability study notificatio n and you may need to close the same and create new one for the same. Initial Sample Creation Date <= Initial Sample Confirmation Date <= Store Stabil ity 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 3.12. Deadline Monitoring for Due Stations You need to schedule a daily background Job with Transaction IP30 with proper va riant to create inspection lot for the stability. You need to process the generated inspection lot for Result recording and Usage Decision. Generated by Jive on 2016-07-26Z 52 Stability Study with SAP Quality Management 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 Stabi lity Study to complete the study. 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 recor ding history till date for the stability study. This action is also available while result recording of the sta bility 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 stabilit y study with SAP QM. You can explore the same. Regards, Dipeshkumar Bhavsar Generated by Jive on 2016-07-26Z 53