Biomedical Engineering Reference
In-Depth Information
Engineering/construction/installation
Commissioning
User
requirement &
basis of design
development
Qualification
Design review
Design
qualification
Equipment
fabrication
Factory
acceptance
testing
Equipment
installation
Installation
verification/
qualification
Site
acceptance
testing
System
start-up
Engineering
studies
Operational
verification/
qualification
Process
performance
qualification
Figure 7.2
Relationship between engineering, commissioning, and qualification.
the systems and equipment are fabricated and installed. Commissioning repre-
sents the phase which establishes that the systems and equipment are designed
and functioning as intended. Qualification represents the phase which confirms
or proves that the systems are suitable for and capable of functioning correctly.
There is overlap between phases and activities within each phase. This overlap
provides the opportunity to share and leverage information. The degree of over-
lap and which activities fall into each phase will in large part depend on the
company's experience and confidence in the people performing these activities
and the systems in place for controlling these activities.
Healthcare product companies have an obligation to manufacture and distribute
products that are safe and effective. There is a regulatory requirement that these
companies assure that procedures and processes are in place to do so consis-
tently [6]. To meet this requirement, manufacturing processes affecting product
quality must be designed to control variables to the extent that the outcome is
predictable and consistent. The processes must be validated to prove that these
control measures are effective. A validated process relies on mechanical systems
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