Biomedical Engineering Reference
In-Depth Information
1.0
Is there a hazard with
the open container
Microbial contamination can
be introduced into the open
contaimer
Yes
2.0
Do preventive measures
exist?
The air is HEPA filtered and
personnel are gowned
Yes
4.0
Could hazard occur
or increase to
unacceptable
levels?
3.0
Is step specifically
designed to
eliminate likely
occurrence?
No
Not a CCP
No
The HEPA filtered air and
protective gowns do not
specifically control or
eliminate the likely
occurrence of microbial
contamination into the open
container
Controls are adequate to
prevent microbial
contamination from
increasing to unacceptable
levels in the open container
Figure 11.5
CCP decision tree analysis for process step 4.0, charge mill.
The information is documented. Table 11.2 is an example of a CCP decision
chart used to document the results of the decision tree analysis. The responses
will indicate if the identified hazard is a CCP. The table includes the response to
each question, the conclusion of the analysis whether the step is a CCP or not a
CCP, and a place to record any notes. The CCP decisions can also be recorded
on the hazard analysis chart illustrated in Table 11.1.
As shown in the chart for process step 4.0, the answer to question 1, is there
a hazard with the open container, is recorded as “Yes.” There is a hazard that
microbial contamination can enter the open container. If the answer to question
1.0 is “Yes,” the step could be a CCP and question 2.0 is addressed. The answer
to question 2.0, do preventive measures exist, is also recorded as “Yes.” Filtered
room air and gowned personnel are preventive measures taken in an effort to
reduce the likelihood of microbial contamination. If the answer to 2.0 is “Yes,”
the step could be a CCP and question 3.0 is addressed. The answer to question
3.0, is the step specifically designed to eliminate the likely occurrence, is recorded
as “No.” Filtered air and protective gowns do not specifically control the likely
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