Biomedical Engineering Reference
In-Depth Information
For example, the P&ID section will list the drawings associated with that
particular system and then document the location of the commission execution
attachment that lists the P&IDs that were walked down and required red lines.
P&IDs listed in the qualification document, but missing from the commissioning
documentation would then require a deviation to resolve the discrepancy. Like-
wise, any P&ID that is missing from the qualification document will also require
a deviation to resolve the discrepancy.
Another suggestion would be to utilize the installation verification portion of
the protocol. This section should list each system and component assessed as crit-
ical with the associated criticality assessment and will list what will be attached
or reference back to the commissioning documents. All applicable sections of the
protocol should be presented in an approved template so that all tests included
meet the expectations of your organization. Similar critical components should
have the same level of qualification or attributes inspected and qualified. The
component-level assessments discussed earlier can be used to find similarities in
common systems and assure a consistent qualification approach.
It is possible to streamline the installation qualification process through use of
commissioning and information. However, the qualification process works best
when it is aligned with the commissioning process. Discrepancies need to be
resolved, reviewed, and approved before close of the protocol. These discrepan-
cies are resolved using an approved deviation process, which can have the ability
to consume time and adversely impact time and cost savings. One way these dis-
crepancies can be avoided is by ensuring that they are adequately addressed in
the punch listing process, which should be included as an aspect of construction
and/or engineering change control. A method should be employed to track the
deviations by deviation types. Metrics can be established to track the occurrences.
This can provide the ability to see what types of deviations and how many of
each type occurred during execution.
This also provides the opportunity to focus on the “low-lying fruit” and
develop mitigation plans that eliminated those deviations. Rather than focus-
ing on the most painful deviations that seem to draw attention and resources
from the project team, consider focusing on the deviations that had the largest
numbers and relatively fastest corrective actions. These deviations usually can
be quickly and easily mitigated by minor adjustments in strategies, policies, or
procedures resulting in a dramatic gain of efficiencies.
7.3.16 Operational Qualification
Operational qualification provides assurance that the facility and equipment func-
tion in a reliable manner to the level of performance needed to support the
process. This involves the development of test functions, studies, and acceptance
criteria designed to challenge the system through its intended operating ranges.
The functions to be tested and the ranges of operation should be based on support
of those process steps that can affect product quality. These tests can be based
on information uncovered during the impact and risk assessments.
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