**4.5 PHEC-19 and RM**

During this emergency, the industry has two main objectives. On one side, ensuring normal market supply and, on the other, at the same time impede the contamination of personnel and products by SARS-Cov-2.

As shown in **Figure 2**, the objective of the RM process that we are describing is determining if PHEC-19 has led to an interruption or a disturbance of the manufacturing activities and, if this occurred, assess its importance and, accordingly, apply the appropriate corrective actions in order to ensure product quality. Following is described a practical approach to this process.

As, in principle, we can suppose (and hope) that PHEC-19 will be time-limited, the need for revisions can be deemed as restricted. However, any change in the data used for the risk assessment has to be known and evaluated.
