Biomedical Engineering Reference
In-Depth Information
2.4.2.2 Benefits When it is important to document a company's knowledge
of a system or process, it is beneficial to use an FMEA. When risks in a
well-defined system need to be prioritized, use FMECA. It is also beneficial
to use FMEA/FMECA when there is little past experience with failure modes,
for example, a new process or when it is desirable to identify potential risks
early in the development of a product or process. FMEA or FMECA is also a
good choice when it is important to identify potential process problems, process
controls, or to prospectively identify what could go wrong before the scale-up
of a process. This will allow the opportunity to mitigate problems before they
occur.
2.4.2.3 Limitations An FMEA or FMECA is not a good tool for analyzing
interactions between failure modes/causes. FMEA is not a good tool for reac-
tive or retrospectively initiated risk management processes for pharmaceutical
manufacturing.
2.4.2.4 Examples Table 2.3 provides an example of an FMEA/FMECA anal-
ysis of a chemical reaction vessel. Additional references to include examples on
how to conduct a FMEA/FMECA include The Quality Toolbox Second Edition
[5] and The Basics of FMEA 2nd Edition [6]. You can also see examples in
Chapters 6, 7, 8, and 13.
2.4.3 Hazard and Operability Analysis (HAZOP)
2.4.3.1 Definition Hazard operability analysis (HAZOP) is based on a theory
that assumes that risk events are caused by deviations from the design or operating
intentions. It is a systematic brainstorming technique for identifying hazards using
the so-called guide-words. Guide-words (e.g., no, more, other than, part of, etc.)
are applied to relevant parameters (e.g., flow, temperature, pressure) to help
identify potential deviations from normal use or design intentions. It always uses
a team of people with expertise covering the design of the process or product
and its application [7].
A HAZOP is a very thorough and creative process requiring experienced
persons knowledgeable in the system to be involved. The process requires looking
at deviations from the design or operating conditions. The system to be analyzed
must be defined. The objective of the HAZOP is to identify potential hazards in
the system. Hazards involved may include both those essentially relevant only
to the immediate area of the system and those with a much wider sphere of
influence. Identifying the causes of the operational disturbances and production
deviations help identify safeguards and recommendations [7].
2.4.3.2 Benefits The primary benefit of the HAZOP is the identification of
critical operations within the system. Identifying these critical operations allows
for the opportunity to redesign to remove the hazard, incorporate safety devices
to reduce the harm from the hazard, or include warning devices that allow for
notification of potential hazards.
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