The presentation addresses the regulations that define the necessity of qualification in the GMP and GDP environment and includes general topics on quality risk management and the importance of risk analysis in the pharmaceutical sector. The practical example illustrates how risk analysis can be used in warehouse operations to identify potential hazards early on, enabling their prevention or mitigation. The goal is to ensure that warehouse operations run smoothly, safely, and efficiently. Risk assessment also plays a key role in the subsequent mapping strategy, helping to identify and address critical points in the warehouse at an early stage, which in turn determines the number of monitoring sensors required.