- How does commissioning our facility benefit our validation
process?
It identifies problems early, saving considerable validation
effort time and expense. When the validation team arrives at
your facility, they expect that all of the systems are operational
and working to their design intent. Our experience has shown
that this is often not the case. Validation teams are forced
to completely test validated systems and report the failures
to the project. The project team is then required to research
the problem and look for the responsible party that can assist
with its resolution. The commissioning process is designed
to uncover improperly designed or installed equipment as
early as
possible in the design and construction phases. At that point
in time, problems are far easier to detect and correct, saving
considerable validation effort, time and expense.
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- How can the commissioning process save time with
our validation process?
Since we work in tandem with a validation firm starting
in the planning phase, our Outcome CV™ will ensure that the
validation
team will have acceptable data. Upon commencement of validation,
commissioning data will be utilized the as assurance that the
systems are operating per the design intent. This will allow
greater confidence that the facility is ready for validation.
By meeting at strategic times during the design and construction
phases of the project, the commissioning and validation teams
will understand the testing requirements for each activity.
By developing a thorough understanding of the validation
requirements,
the commissioning team can structure its testing and measurements
of facility systems in accordance with the validation requirements.
This will give the validation team the option of accepting
the data from a properly performed and witnessed commissioning
test.
This will save valuable validation time.
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- How does finding problems at the commissioning phase
benefit my project?
Once the contractor and engineer are not on the site, problems
found at later stages are more difficult to rectify and to
document. At this point, the responsibility for identifying
system problems,
collect data and assign responsibility rests solely with the
owner. In a commissioned project, the commissioning team will
assist with all aspects of problem identification, and will
assist the owner in assigning responsibility for the system
shortcomings.
Construction Phase Commissioning is performed during the
final phases of construction. At this point in time, most
project participants
are close at hand, on the project site and available to meet
and discuss technical or logistical issues. Commissioning heavily
involves the contractor, engineer and site operating personnel,
who should work to ensure systems are delivered to the design
intent. Commissioning is a process that ensures this process
occurs. Without a guided process and an impartial third party,
system problems will not be properly documented and system
performance will not be verified.
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- Is Outcome CV™ really just about better commissioning?
Outcome CV™ is really a synergistic process whereby
two necessary and critical processes are performed in consideration
of each
other. Therefore, the commissioning team is fully aware of
the validation requirements and the validation team is charged
with
guiding the commissioning team to design and perform inspections
and tests as the validation will require. In essence, Outcome
CV™ is better commissioning, where the efforts are directed
towards allowing our clients to start production more quickly
via an
informed and collaborative effort between the validation and
commissioning teams.
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- How is validation thinking brought into the process?
By Thinking Better Outcomes®, and considering the
desired result, we have taken the validation process into
account,
starting in the design phase of a project and preparing a
plan for commissioning
that includes key elements for validation.
The Outcome CV™ development team fully understands the critical
nature of the validation process. The team has determined key
points in the facility design and construction process in which
to meet and develop the commissioning plan to fully consider
the requirements and tests to be performed in validation.
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- How much more money is this going to cost me?
Outcome CV™ should result in substantial savings to our clients.
Our experience, and client surveys have indicated, that validation
is often delayed due to non-functioning equipment and the lack
of documentation. Outcome CV™ is designed to allow the validation
to proceed more smoothly and on schedule, resulting in lower
validation costs and less time to market for the client.
Your commissioning cost may increase to between ½ and
1% of the project cost but, your ultimate project cost at
the end of the day will go down by approximately 15%. This
doesn’t
even address revenue lost from a project still in validation.
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-
Validation is sort of an FDA
audit function. Aren't you compromising the validation
effort by blurring
those lines?
Not at all. Our team works to create vastly improved results
by a collaborative effort, with a validation firm partnership
(BioMetics, Inc.) where compromises are not made, yet results
are achieved through planning and an understanding of the client
validation requirements. Commissioning is performed to assure
that validation can be performed more accurately and on schedule.
Outcome CV™ enhances the validation process by solving technical
issues early in the facility construction process. Validation
protocols will still be strictly adhered to.
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- Do you do validation
as well as commission?
Yes, our team can perform either function for our clients.
We have considerable expertise in both areas, which is the
source
of the tremendous value in Outcome CV™. When clients
engage Syska Hennessy Group and BioMetics, Inc. in an Outcome
CV™ project,
they realize the power of both teams who possess a thorough understanding
of our client’s objectives. The uniqueness of Outcome CV™
is on the process of our integration and it not easily uncoupled.
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