Risk Based approaches to setting environmental monitoring (EM) programs: (#14)
Science-based risk assessments provide an effective means for the determination of viable (microbial)/non-viable risks present within a facility and its activities. They can be used to establish and justify the structure of an EM program along with the control measures put in place.
Risk assessments can be used for:
- drafting an initial EM qualification study enabling it to provide meaningful alert and action limits,
- selecting appropriate sample sites and setting the frequency for routine monitoring,
- targeting of post-qualification monitoring programs to gain detailed information relating to a facility or products,
- providing a framework for assessing potential new products,
- highlighting worst case areas and practices,
- assigning appropriate monitoring techniques to different surfaces.
- selecting sites which serve as the most sensitive control indication for an area.
Risk assessments can therefore be used effectively at every stage of an EM programs life-cycle to demonstrate the control of a facility and its environment.