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

Annex 2
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The level of effort, formality and documentation of the QRM
process should be commensurate with the level of risk.
In addition to the two principles above, the following principles are also
part of the QRM methodology:
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When applied, processes using QRM methodologies should be
dynamic, iterative and responsive to change.
The capability for continual improvement should be embedded in the
QRM process.
This guidance describes the WHO approach to QRM, using the concepts
described in ICH Q9 (6) and illustrated in Figure 1. The emphasis on each
component of the framework might differ from case to case but a robust process
will incorporate consideration of all the elements at a level of detail that is
commensurate with the specific risk.
Figure 1
Overview of a typical quality risk management process
Reproduced from reference 5: ICH Q9: Quality Risk Management.
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