POINTS TO CONSIDER FOR COMMISSIONING AND QUALIFICATION OF MANUFACTURING FACILITIES AND EQUIPMENT - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 156

For the purpose of this example, consider the lighting in a semi-manual inspec-
tion booth, where inspectors look for particulates and defects in vials of a product.
On the basis of this assessment, the system, the inspection booth, and the
lighting in the booth would be deemed critical according to affirmative answers
to #5 and #6. Utilities that support the booth, such as electrical power, would
be deemed as having indirect impact. So the booth and the lighting should be
qualified. The decision to qualify the electrical power source would depend on the
amount of variation in the power source, the effect on lighting intensity that such
a variation might have, and the effect of intensity variation on product quality or
the ability of the inspector to see and reject defective units.

7.3.8 To What Extent Would it be Qualified?

Once a system or component has been classified according to level of impact, a
decision should be taken as to how to assure the correct function of that system.
This can be done by asking the question—what could go wrong and what would
cause such a situation or failure? Tools such as fault tree analysis, partially
illustrated in Figure 7.5, and fishbone analysis, partially illustrated in Figure 7.6,
can be helpful in identifying those process steps or conditions that pose a risk to
product quality. These tools are designed to break the process into smaller steps
where risk can more effectively be addressed and reduced.

Inability to
effectively
inspect units

Lighting
failure

Human
error

Unit
vibration

Shadowing
effects

Broken or
missing
bulbs

Control
system
malfunction

Variation in
power supply

Improper
set up

Excessive line
speed

Inadequate
wiring

Corroded
connections

Figure 7.5 Fault tree analysis example.