POINTS TO CONSIDER FOR COMMISSIONING AND QUALIFICATION OF MANUFACTURING FACILITIES AND EQUIPMENT - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 137

which can affect the schedule and budget, but may also distract the efforts of
execution personnel and could therefore lead to errors by omission and possible
project quality issues.
Project controls should include the means to assure test functions and studies
are executed and completed in the proper manner and sequence and deviations
are addressed before release of the system for PV or commercial use. Systems
that represent higher risk to product quality, through impact of failure, probability
or occurrence, or control strategy should have more robust control measures that
assure satisfactory completion.
It would be difficult to manage any project without specific project controls.
These project controls not only address budget concerns but also the ability
to easily and effectively communicate the progress and status of activities that
impact the project. The development and use of dashboards or project summary
by the project team also requires the development of performance metrics (e.g.,
earned value curves, etc.). The dashboard is a one-page presentation that contains
all of the information needed to senior management to understand the current
progress of the various project work streams.
7.2.3 Project Performance Metrics
A good qualification program will include methods for monitoring the effort to
assure that the plan is being properly executed. The monitoring program should
be designed to uncover problems early, when it is less costly to make modifica-
tions to program design, schedule, and execution. This involves the development
of project performance metrics for the determination of performance based on
project quality, schedule, budget, safety, and effectiveness or compliance. Project
control systems should be in place to track, analyze, and report all relevant
project metrics. Clear project expectations may be one way to mitigate the risk
of inaccurate information and errors.
Performance metrics should be developed to easily help identify areas of con-
cern by listing certain high level project activities. For example, many projects
have a multitude of documents that require drafting, review, approval, and execu-
tion. The performance metrics should outline progress based on planned activities
completed versus actual activities completed within a specific timeline. It is help-
ful to add an outline of what is expected by the next update. Any metrics that
identify areas of concern may require corrective actions summarized at the end
of the dashboard.
7.2.4 Schedules
Schedules are an important tool employed in the management of any project. It
is important that agreed on durations and specific deliverables outlined from each
perspective work stream be included in the schedule. Selecting the appropriate
level of schedule detail is essential to the development of a useful schedule.
Information should not have too high or too low of a level of detail, such that