When related to Environmental Monitoring (EM), risk management often refers to a complete understanding of
how often and how severe a process can be affected by external factors. The development of this knowledge, a
risk assessment, is the culmination of multiple party's efforts, including Quality Engineers, Microbiologists, and
Production staff. Actions involved in completing a risk assessment start at the very beginning of new cleanroom
construction with the identification of product impact sources. The relative risk to product quality is given
hierarchy using well-established assessment tools.
In order to prepare for this process, it is important to attain a strong base of EM knowledge.