POINTS TO CONSIDER FOR COMMISSIONING AND QUALIFICATION OF MANUFACTURING FACILITIES AND EQUIPMENT - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 161

TABLE 7.8 Example of a Three Point Qualitative Risk Priority Rank Determination [14]
Ranking Risk Factors

Severity Occurrence Detection

HIGH Impact of the unwanted event

is severe

Occurrence is often Process failure will almost

certainly escape detection

MEDIUM Impact of the unwanted event

is moderate

Occurrence is periodic Controls may detect the

existence of a process failure

LOW Impact of the unwanted event

is low

Occurrence is seldom Process failure is obvious and

readily detected

DETECTION*

OCCURRENCE LOW MEDIUM HIGH

This cause is likely to occur, but
when it does it will be
detected. If we are certain it
will be detected it is low risk,
but if we are not certain then
it should be a Medium Risk

This cause is likely to occur and the
detection is not certain. It is a High
Risk

This cause is likely to occur and is
not likely to be detected. It has a
High Risk

HIGH

This cause could occur, but if it
did it would be detected.
Depending on the frequency
of occurrence and the
confidence in the detection, it
is a Low or a Medium Risk.

This cause could occur and it could be
detected. Depending on our
confidence in the detection its risk
wouldbeMediumorHigh

The cause may occur and it will not
be detected. The Risk is High

MEDIUM

This cause is not likely to occur
and if it does it will be
detected. This is a Low Risk

The cause is not likely to occur and if
it did it may be detected. Depending
on the frequency of occurrence and
confidence in detection methods, it
would be Low or Medium Risk

The cause is not likely to occur, but
if it did occur it would probably
not be detected. The Risk is
Medium

LOW

Note: This example involves aseptic process risk—where severity is a constant HIGH and therefore not factored. If severity is a variable it should be factored
on an additional analysis.