Biomedical Engineering Reference
In-Depth Information
becomes more diffi cult as the process becomes more complex.
This is because increasing complexity increases uncertainty
about a process, “uncertainty due to combination of
incomplete knowledge about a process and its expected or
unexpected variability.” Since risk identifi cation “provides
the basis for further steps in the quality risk management
process,”
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increased complexity of a process, as well as the
associated detectability of the various hazards, makes the
risk analysis
- the second of the three questions, involving an
estimation of risk associated with an identifi ed hazard -
more diffi cult.
The third question raises the issue of the
criticality
of the
process. The Criticality Task Team of the ISPE Product
Quality Life-cycle Implementation (PQLI) initiative has
provided the following comments on the concept of criticality
and its measurement.
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A component of a system is
categorized as potentially critical, in contrast to some other
component that is categorized as non-critical, in terms of
the severity and probability of risk that component poses
to the safety, effi cacy, and quality of the product, and
harm to the patient. The relative level or degree of risk a
component poses is assessed relative to the probability of
occurrence, detectability, and potential harm to the product
or the patient.
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The more critical the process or component, the more
severe the consequences should something go wrong. In
brief, a procedure for supplier quality control (QC) is more
complex than an SOP for signature cards; a procedure that
provides guidance to a process that “touches the product” is
more critical than an SOP for cartonizing a secondary
package. As the International Conference on Harmonisation
(ICH) has expressed it: “the level of effort, formality and
documentation of the quality risk management process
should be commensurate with the level of risk.”
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Thus, the
