Biomedical Engineering Reference
In-Depth Information
1.0
Is there a hazard with
wet equipment?
Moisture helps to
support microbial
growth
Yes
2.0
Do preventive
measures exist?
Drying procedure
and visual check
for dryness
Yes
3.0
Is step specifically
designed to eliminate
likely occurrence?
Yes
CCP
Steps for drying the
equipment and the
visual check for dryness
are designed to
eliminate microbial
contamination
Figure 11.6
CCP decision tree analysis for process step 4.1, dry equipment.
occurrence of microbial contamination. If the answer to question 3.0 is “No,” the
step could be a CCP and question 4.0 is addressed. The answer to question 4.0,
could the hazard occur or increase to unacceptable levels, is recorded as “No.”
Filtered room air and protective clothing do not directly control the likelihood that
microbial contamination would not occur, but they would prevent the microbial
levels from increasing to unacceptable levels. If the answer to question 4.0 is
“No,” the step is not a CCP and the decision process is complete. The answer to
question 5.0 is recorded as “not applicable (N/A)” and “No” is recorded in the
CCP column.
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