POINTS TO CONSIDER FOR COMMISSIONING AND QUALIFICATION OF MANUFACTURING FACILITIES AND EQUIPMENT - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 158

TABLE 7.4 System Risk Determination
Question Answer or Consideration Risk Ranking

A What is the impact on product
quality if the visual
inspection process step fails?

Particulates could be
overlooked and therefore
cause vascular damage
and clotting

HIGH

B How important is the system or

component lighting to the
success of the visual
inspection process step?

This is a manual system,
dependent on lighting
conditions

HIGH

C How robust is the visual

inspection process? How
much lighting variance can
the process take and still be
effective?

There needs to be adequate
lighting, but that covers a
relatively broad range

MEDIUM

D How effective or reliable are

the systems in place to
control the process within
acceptable levels of variation
and prevent failure?

Lights are not adjustable
and there are no meters,
but the procedure requires
a check that all
lights/bulbs are
functioning and turned on

MEDIUM

E How effective are the ways to

detect a visual inspection
failure before it adversely
affects the quality of the
product or patient safety?

Statistical sampling and
testing of finished product
is performed before
shipment

MEDIUM

F What is the mitigation strategy

for reducing the risk and
assuring that process results
remain in specification?

Use of rheostats and light
meters to set the level of
lighting and design of
system with adequate
lighting sources

LOW

Table 7.4 presents the questions, considerations, and answers. Where high risk
potential is identified in any of the questions, it would be prudent to seek ways
to mitigate or reduce that risk through process design changes. Risks that remain
higher than desired may require additional qualification and validation efforts to
provide assurance of adequate process control.
In this case, qualifying the lighting may be of moderate but not high impor-
tance, because the process is relatively robust and the likelihood of failure of the
system going undetected (i.e., bulb out) is low. The qualification would involve
confirmation that rheostats and meters are operating correctly and that lighting
system, bulbs and background materials, have been installed as per specifica-
tion. With these systems confirmed, the PQ might involve running sets of defects
through the inspection system and confirming trained inspector performance given