Testing Schedule 
Testing Schedule
Definition
An object for planning the scope and frequency of the stability tests. The testing schedule specifies:
Use
You create a testing schedule for a stability study in which you intend to test the storage conditions in pre-defined intervals. This testing schedule is explicitly assigned to the stability study for which it is intended and cannot be assigned to any other study. You
create the testing schedule by means of a follow-up function in the stability study. The system then automatically creates a new item in the testing schedule for each storage condition specified in the stability study. In the testing schedule, you assign an inspection plan to each storage condition.Structure
A testing schedule consists of the following elements:
The header primarily contains scheduling information from the
maintenance strategy, which must be assigned to the testing schedule when you created it. This information includes the time-based testing frequencies and the various scheduling parameters.
The assignment of the strategy to the header simply informs the system which intervals will be available for use in this particular testing schedule. You assign the individual intervals to the various storage conditions at the item level of the testing schedule. The strategy QSTABI is provided as an example or copy model in the standard system.
The system automatically creates an item in the testing schedule for each storage condition in the stability study. This normally occurs automatically, when you create the testing schedule by means of a follow-up function in the stability study. The object entered for a testing schedule item is the physical sample that is associated with the storage condition in this stability study.
If you specify additional storage conditions in the stability study after the testing schedule has been created, you must manually create the items for these additional storage conditions in the testing schedule.
For each physical sample associated with a storage condition, you must maintain the following data for the testing schedule item:
The frequencies you select from the strategy and assign to the operation level of the inspection plan, determines the dates when this operation will be tested. For example, you may have maintained an operation in such a way that it will be tested only once after three months for a particular storage condition. The system determines the dates when a storage condition will be tested and the types of tests to be performed for a storage condition after you have assigned an inspection plan, in which testing frequencies have been maintained at the operation level, to a testing schedule item.
Integration
The testing schedule is a special type of
maintenance plan. A testing schedule is always a time-based strategy plan with a maintenance plan category that supports physical samples as a reference object and inspection lots as scheduling call objects. In the standard system, the maintenance plan category ST is provided as a testing schedule category. Use this testing schedule as a copy model, if you want to define your own testing schedule types in QM Customizing for Stability Study.
Deadline Monitoring
The calculation of the test dates (scheduling) for the testing schedule occurs automatically when you
define the start date for the stability study using a follow-up function in the study. On the basis of this date, the system first calculates all of the test dates for the entire duration of the study.The creation of call objects (inspection lots) for a specific date occurs at a later time, either on the planned date or at an earlier date based on a user-specified lead time generated by a periodically running batch job. For each storage condition to be tested on this date, the system creates an inspection lot with the physical sample for the storage condition and the exact inspection operations from the inspection plans that have been planned for this date.
For more information, see
Scheduling and Deadline Monitoring.