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.