Biomedical Engineering Reference
In-Depth Information
be included as part of the purchase agreement to avoid misunderstandings later
in the project.
7.2.8 Other Types of Information Leveraging
Aside from leveraging of information from vendor and contractor sources, com-
panies may find it useful to leverage information from similar equipment testing
and qualification, previous qualification testing, and historical performance of
this equipment or of similar equipment.
Information from these sources may be beneficial in supporting the qualifi-
cation effort, in deciding if a system is qualified, or in determining if particular
functions or conditions pose a risk to product quality.
When deciding whether or to what extent to use this information, consider the
following:
• the credibility of the source;
• its accuracy of information;
• the controls in place when it was generated;
• any changes that may have occurred since it was generated; and
• the relevance it has to the equipment, system, or function being qualified.
7.2.9
Information Management as a Tool for Risk Management
A challenge to the use of accurate information comes from mistakes or omissions
in recording and transferring information between phases of the commissioning
and qualification of the project, just as inaccurate information and transmis-
sion mistakes without further controls can result in a risk to project execution
efficiency as well as a risk to product quality. An interactive project informa-
tion management database is helpful for the efficient capture and transfer of
information from design through engineering, construction, commissioning, and
qualification, and ultimately transfers that information to operations for inclusion
in maintenance and operational procedures. The project information management
system should be designed to assure accurate transfer of information, including
changes to the appropriate project teams on a timely basis. Seamless transfer of
information should result in a more efficient use of resources, but will also result
in less data-transcription-related errors.
Automated project information management systems can reduce the risk of
inaccurate or incomplete information because of errors in transmission and tran-
scription, as well as, and therefore, reduce deviations. Project information man-
agement systems can be used to capture and transfer changes, thereby reducing
risk of errors, omissions, and deviations.
Project information management systems are typically automated, often
web-based applications that can facilitate architectural/engineering/construction
project management by providing a single repository of project-related
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