POINTS TO CONSIDER FOR COMMISSIONING AND QUALIFICATION OF MANUFACTURING FACILITIES AND EQUIPMENT - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 138

each work stream cannot effectively manage the respective deliverable. Each
work stream should be scheduled to sufficient level of detail to manage the day-
to-day tasks and have available data to generate performance metrics. These work
stream schedules should then be fed into a higher level project schedule. The
higher level schedule would then be the driving force during multidepartmental
work stream meetings typically held on a daily basis in a “war room” setting.
Other strategies should be defined within the project plan so that all associated
work streams understand how any preceding work may impact their ability to
meet their commitments to the project. Defining the scope of your risk approach
as listed in the project charter or plan to a level where the assumptions, depen-
dencies, and constraints is a key to project success.
It is important to define project deliverables and understand the associated
process step dependencies. For example, clean room sanitization qualification
may include sampling of surfaces before cleaning, while clean room environment
qualification may include monitoring of the room after cleaning. Performing the
environmental study before the sanitization study could result in an ineffective
qualification and possible project delay. Another example might be the sampling
of clean steam condensate from the distribution loop before qualifying the clean
steam generator. In this case, the source of a failure would be difficult to discern,
as it could be from failure of the generator or failure of the distribution loop.
Other examples of schedule dependencies include the sealing of walls, block-
ing views of mechanical installations, or the installation of insulation on piping
before sloop verification. In these cases, improper scheduling could result in fail-
ure to adequately inspect the system and might result in risk to product quality.
Projects that fall behind schedule or exceed the budget may be subject to
resource or sequence compromises. These compromises could pose a risk to
product quality if the project is not executed properly. More care and control
may need to be placed on projects that have fallen behind schedule or budget to
assure that “corners are not cut” to the point where product quality is at risk.
7.2.5 Program-Level Alignment
Once the definition of the scope of work is complete, a list of all procedures
and policies to manage the project activities from one phase to another should be
developed. Each phase may be owned by a few different functional groups, which
would provide a detailed view of related activities. Usually, these functional
groups are related to the different phases of a project and therefore assigned
accordingly. Provided here is a list of typical functional areas, which is followed
by the activities, policies, and processes that will be the mechanism that provides
the information required to satisfy your qualification program.
It is important to know the “big picture.” Understanding the strategy being
employed by a preceding activity is critical to developing an overall project
execution program. Adjustments may be made to work streams to mitigate any
possible risks. Table 7.1 presents a list of interrelated activities, all of which are
programs and deliverables managed by various functional groups that can have an