Biomedical Engineering Reference
In-Depth Information
The second benefit of using QRM is more efficient management of resources.
Qualification and validation activities for change controls require a significant
amount of resources (manufacture, testing, and documentation). Focusing only
on the parameters that are important to product quality (critical aspects) leads to
a reduction in non-value-added activities, which provides a benefit to resources
at all levels.
A third benefit is improved compliance. QRM provides a method by which
product knowledge can be leveraged to deliver a rational and consistent approach
for supporting change. It is a compliance benefit to have change control docu-
ments that can stand up to any future inspection by the regulatory authorities.
A properly documented change request package does not rely on the memory
of those involved to provide the rationale and justification for changes during
agency inspections.
These resource and compliance benefits ultimately lead to improved efficiency.
Short-term benefits may not be so obvious, because at first glance it may seem
that the extra effort taken to document the risk management process is counter-
productive. In the long run, however, this documentation process constitutes a
small investment upfront, which yields a time savings later, in improved com-
pliance and accessibility to information. Long-term benefits include avoiding the
costs of later quality concerns by thoroughly addressing the change upfront. Over
the long term, a good change control system will result in both improved quality
and compliance, as well as avoiding unnecessary future costs.
13.4 ONE QRM TOOL: FMEA
FMEA is a method that can be used for analysis of potential failure modes within
a system as a result of a change, in order to determine the effects on the system.
The potential failure modes and effects are then quantified and analyzed in order
to answer two main questions:
• Is the potential failure mitigated to an acceptable level?
• If not, what additional measures can be taken to further mitigate the potential
failure?
In the context of change control for patient safety, the failures can easily be
construed as any event that could affect quality and/or regulatory compliance.
Mitigation is any control added to the system that aids in the prevention of the
failure.
FMEA was formally introduced in the late 1940s for military use by the U.S.
Armed Forces [3]. It was later used in the 1960s, during the space race, in
order to safely put a man on the moon. Industry in the United States adopted
FMEA in the 1970s, in part because of industrial disasters such as the chemical
plant explosion in Flixborough, the United Kingdom, in 1974. One reason for
the widespread popularity of the FMEA tool in industry may be the systematic
approach used to aid in the mitigation of risk.
Search WWH ::




Custom Search