This video explains the concept of Stability Studies in the SAP S/4HANA Quality Management (QM) module. Here are the key points:
- Stability Studies: The video explains that stability studies or shelf life studies are performed in industries like chemical, pharmaceutical, and food to examine how different environmental conditions affect a product or a batch over a specified period of time. These studies are performed to calculate the expiry date of a material or a product.
- Shelf Life of a Product: The video outlines how stability studies are carried out to determine the shelf life of a product. The product is stored under controlled conditions for the duration of the study, and at specified intervals, physical samples are removed and tested according to predefined inspection plans.
- Storage Conditions and Duration: The video demonstrates how products are stored under specific environmental conditions for a particular duration. At different intervals, samples are taken out and tested. If the results are failing after a certain period, that period is determined as the expiry period.
- Stability Study Process: The video describes the stability study process, which consists of three main phases: initial test, stability planning, and stability test. Each phase involves specific tasks such as creating initial samples, defining storage conditions, creating a testing schedule, and performing tests.
- Creation of Stability Study: The video shows how to create a stability study in the SAP system. This is done through a quality notification, and involves creating an initial sample, confirming the initial sample, and optionally assigning a stability-relevant material.
- Initial Testing and Stability Planning: The video explains how initial testing is performed for the initial sample by generating an inspection lot. If the initial testing is successful, the stability planning phase begins, where storage conditions are defined, stability samples are stored, and a testing schedule is created.
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