Biomedical Engineering Reference
In-Depth Information
The sloop verification was performed well and accurately documented as part of
the system close out. Several weeks later, the HVAC contractors moved into
the same space as the process lines. In order to move around in the confined
space they were constantly bumping up against, leaning on, and in a couple of
instances standing on the process lines. This activity could have and in this case
did change the sloop of some of the lines. The result could have been process
failure during cleaning or contamination control. Mitigating this risk of failure
could have been accomplished by more schedule coordination, training, HVAC
contractor selection, notices, or subsequent and final sloop verification as part of
qualification at the end of the project.
Utilization of information is a risk management exercise in and of itself. A key
element of a successful qualification program is being able to efficiently leverage
information from different sources. However, the information must be accurate.
The key to accurate information is making sure the prerequisite support programs
are in place. These include vendor quality systems and training, construction,
and engineering change. Definitions must be clear and consistent. Procedures for
maintaining qualified systems must be in place. Can the quality unit allow the
acceptance of vendor-generated information? Do they have enough confidence
in the accuracy of the information? Is the information accurate and is it useful?
The ASTM E2500-07 Standard Guide suggests that “
...
if inadequacies are
found in the vendor quality system, technical capability, or application of GEP,
then the regulated company may choose to mitigate potential risks by apply-
ing specific, targeted, additional verification checks or other controls rather than
repeating vendor activities and replicating vendor documentation [12].”
If inaccurate information is found, then how does that affect all of the other
leveraged information? This, again, may depend on the level and cause of the
inaccuracy. To mitigate the risk of inaccurate information, the following steps
have to be taken.
• Audit vendors.
• Monitor vendor performance.
• Provide vendor personnel training.
• Communicate expectations to vendor personnel.
• Choose vendors with relevant experience.
• Provide quality unit review of critical studies.
Having said this, companies using vendor-provided information should be
careful not to overreact to inaccuracies or errors, as well as overrely on accuracy
of the information. Information from vendors, including FAT and SAT, should
be useful, as well as accurate. The information needs to fit the objective of
the qualification. To assure that relevant qualification information can be gleaned
from FAT and SAT, prepare and communicate qualification test functions, studies,
and acceptance criteria to the vendor as soon in the project as practical. The
requirement for this information as well as expected documentation quality should
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