Biomedical Engineering Reference
In-Depth Information
Table 2.7
Elements of the program logic model
■
Input variables: a set of qualitative or quantitative variables that
describe the initial state of the program (e.g., level of cleanliness
of controlled areas; level of bioburden of controlled areas, etc.).
■
Program preconditions: relatively invariant program elements
without which the program could not exist (e.g., cleaning and
sanitizing budget, GMP facilities, etc.).
■
Input criteria: a set of ranges or values for the input variables and
preconditions that establish cutoff points for program functioning.
■
Program process: a set of program elements that act upon the
variables and transform the initial program states into terminal
program states. These process elements include the corrective
actions and the preventive actions.
■
Output variables: the set of variables descriptive of intended program
change as well as a record of the terminal state of the program.
■
Program objectives: (formally output criteria), which represent the
standards against which program performance is to be compared.
The
Preconditions
for the cleaning and sanitizing program
include the cleaning and sanitizing budget, GMP facilities,
personnel, availability of the requisite time, place, and
materials (e.g., sanitizing agent, yarn mops, personal
protective equipment), etc.
Under
Process
, cleaning activities include the removal
of debris and soiling to decrease the bioburden by
removing organic material, as well as inorganic material
that harbors organic material. The cleaning activities
precede sanitizing procedures. Sanitizing activities
include preparing the sanitizing agent, using the
double bucket method, using the appropriate personal
protective equipment, etc. Process criteria include the specifi c
solution of the cleaning agent, the specifi c solution of the
sanitizing agent, appropriate use of personal protective
equipment, etc.
