Biomedical Engineering Reference
In-Depth Information
Program logic model of cleaning and sanitizing
program
Figure 2.6
Finally, under
Outputs
, the criteria include the visually
determined cleanliness of the controlled area and EM data
that now fall within acceptable limits.
Once the program has been documented in a program
logic model, planned changes can be examined in a
straightforward manner.
9
The CAPA, in this illustrative case,
amounts to an increase in the concentration of the sanitizing
solution. All the other
Variables, Preconditions
, and
Criteria
would remain the same, so the effect of the planned change
could be observed. Should the output not change, then the
CAPA has failed. Moreover, the fully developed program
logic model highlights the possibility of unintended
consequences of the CAPA intervention.
