Biomedical Engineering Reference
In-Depth Information
Training
• Risk assessors should be qualified and trained [6].
8.3 TYPICAL QRM TOOLS USED
QRM is a good way to proactively analyze a process to improve the process
understanding needed for PV and CV [8-10]. Common QRM tools used in
PV, process transfer, and CV can range from general qualitative-risk-based
approaches (e.g., checklist, decision tree, risk ranking, and filtering, techni-
cal/scientific rationale based on historical data, prior experience, etc.) to specific
risk scoring methodologies (e.g., preliminary hazard analysis (PHA), failure
modes and effects analysis (FMEA), hazard analysis and critical control point
(HACCP), etc.). Refer to Chapter 4 for details on various RA tools. Per ICH Q9,
risk is defined as “the combination of the probability of occurrence of harm, if
at all possible, and severity of that harm” [11]. Risk management should focus
as much as possible on reducing the probability of occurrence, reducing the
severity of harm, if at all possible, and fast detection capabilities. Some of the
scoring RA tools involve the use of detection as a third component, in addition to
severity and probability of occurrence. The detection component (although it is
not a part of the ICH definition of “risk”) factors in the ability to recognize a risk
and manage it appropriately before it can cause harm, the detection component
becomes especially important in risk management if the risk cannot be managed
by further reduction of severity or probability of occurrence of harm.
NOTE: Probability of occurrence, frequency, and likelihood are used interchangeably
in this chapter .
The detection component plays an important role in PV because of the nature
of the drug inspection and quality review processes. For example, the ability to
detect or monitor the drift in a CPP and CQA before it approaches a limit could
be a factor in the evaluation. The degree of criticality aids in determining the
amount of control and/or detectability of the CPP and CQA. If the risk can be
found and the defects removed before they impact product quality and/or reach
the user, then there is minimal risk to patient safety.
• Some techniques do not use detection [11]. In these two-component risk
analysis, severity and probably are used. The degree of probability of a
hazard or failure mode occurring and causing harm will be dependent on
the degree of an existing detectability. However, the ability to detect does
not change probability of occurrence, but it can help mitigate the overall
risk to an acceptable level if the level of detection is sufficient. For example,
with a known sensor or alarm in place, the probability of an OOS causing
harm could be assessed as very unlikely.
Search WWH ::




Custom Search