RISK-BASED CHANGE CONTROL - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 369

TABLE 13.2 Risk Ranking Definitions—Example
Severity Detection a Occurrence

High Direct (primary) impact to CQA or CPP of

product, process, or utility; could result in
critical (AQL) defect; potential for harm to
patient health; microbial/foreign
contamination; significant change to
regulatory filing (preapproval) or master
production record; direct product contact
item; critical instrument

Potential exists for the event to
frequently recur, process
incapable (process capability
CpK < 1.00)

Event is difficult to detect, or not
frequently tested, or not tested;
not likely to be detected before
product release

Medium Indirect (secondary) impact to CQA or CPP;

could result in a major AQL defect; likely to
result in customer dissatisfaction or product
complaint; minor change to regulatory filing
(changes being effected) or master
production records

The event may occur but only
occasionally; process is capable
with tight control
(CpK = 1.00 - 1.33)

Event may be detected by 100%
human visual inspection or
other administrative type of
control; might be detected
before product release

Low No impact to CQA or CPP; may result in only

a cosmetic complaint; no or minimal change
to regulatory filing (annual report) or master
production record; no impact to patient
health; could result in minor or cosmetic
AQL defect

The event is rare and unusual;
process is capable
(CpK > 1.33)

Event is 100% detected by
engineering type of controls
(electronic vision system, metal
detection); defect is obvious;
would be detected before
product release

a Note that a detection level of high means there is low detectability, and thus high risk.