Whitepaper: Does QRM + RMM = Better EM

Facilities perform environmental monitoring (EM) to demonstrate a state of control.

EM can also help assess the effectiveness of a cleaning/disinfection program and identify data trends, which may allow early detection of potential microbiological problems. A quality risk management (QRM) approach provides a holistic way to manage EM risks in a facility. Locations, sampled during room/equipment qualification, are evaluated during a risk assessment to identify the areas at greatest risk of introducing particulate or microbial contamination. Once these areas are identified, risk reduction activities can be conducted to concentrate sampling at those high-risk locations.