PHARMACEUTICAL PRODUCT MANUFACTURING - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 296

on answering five questions at each step that has an identified microbial hazard.
The use of the decision tree tool promotes structured thinking and a consistent
approach at each process step. The five-question decision tree is illustrated in
Figure 11.4.
Figure 11.4 graphically illustrates the CCP decision tree.

1.0
Is there a hazard?

Not a CCP No

Yes

Not a CCP

No

2.0
Do preventive measures
exit?

Needed for safety? No

Add control

Yes

Yes

4.0
Could hazard occur or
increase to unacceptable
levels?

3.0
Is step specially designed
to eliminate likely
occurrence?

Not a CCP No No

Yes

Yes

CCP

5.0
Will subsequent step
reduce hazard to
an acceptable level?

Not a CCP Yes No CCP

Figure 11.4 CCP decision tree.