WHO Technical Report Series, No. 981 - World Health Organization

WHO Expert Committee on Specifications for Pharmaceutical Preparations Forty-seventh report
The shading in the table represents an example of how the risk values
(sometimes called composite risk indices or risk index values) can be assigned a
high, medium or low status. The definition for each status should be predetermined
in the QRM process after consideration of the specific consequences for the
process undergoing risk assessment. These consequences can be split according
to the probability and impact scores, as exemplified in Table 2.
Table 2
Example of a consequences table for probability and impact
Score Probability Example Score Impact Consequence
1 Rare • Seen every
10–30 years
2 Unlikely • Seen every
5–10 years
3 Possible • Seen every
1–5 years
1 Negligible • No regulatory issue
• No effect on and not
noticeable by patient
2 Marginal • May require MRA
notification
• Decision to release
product not
compromised
3 Moderate • MRA inspection
may identify a
major concern but
deficiency quite
easily resolved
• Limited product
recall possible
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4 Likely • Seen to
occur more
than once a
year
5 Almost
certain
• Seen several
times a year
4 Critical • MRA inspection may
conclude serious
non-compliance
• Likely product recall
from one or more
markets
5 Catastrophic • Enforcement action
by MRA such as
consent decree,
product seizure
• Global product recall
MRA, Medicines regulatory authority.
Source: Based on reference 9. This table has been amended, but was originally produced within the
context of the Product Quality Research Institute (PQRI), 2107 Wilson Blvd, Suite 700, Arlington, Virginia
22201-3042, USA; web site: http://www.pqri.org/index.asp. PQRI has kindly agreed to the use of its
material.