POINTS TO CONSIDER FOR COMMISSIONING AND QUALIFICATION OF MANUFACTURING FACILITIES AND EQUIPMENT - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 136

along with the critical success factors. Some items such as a defined organiza-
tional structure, list of assumptions and dependencies, and business risks would
be critical aspects of the plan. Work streams should be outlined on the basis of
the project's principal activities. These should align with the existing business
units as it is helpful to organize specific work streams with multidisciplinary
resources, focused on certain project activities.
Development of milestones should be identified. This is an important project
area that is sometimes overlooked. The title of the milestone should be defined, as
well as the extent of the deliverable. Key items such as mechanical completion,
care, custody, and control should be clearly defined, especially where there will be
a transfer of task ownership during commissioning and qualification. For example,
consider the impact to the schedule and budget if resources were planned and
mobilized to start commissioning and qualification activities only to find that the
definition of mechanical completion does not support the systems being in an
operational state.
Many aspects of the project contain interrelated activities. These activities may
need to be managed using an automated business tool or interactive data base, so
other teams can more easily sort through, utilize, and leverage the information
as needed. For example, changes in a particular system during construction and
commissioning may require additional assessment related to the design, and this
may change the approach to qualification of that system.
The plan should define project roles and responsibilities, identifying those
responsible for project controls, scheduling, overall project strategy, document
or study review and approval, change control, document preparation, study execu-
tion, punch list resolution, failure investigation, and other critical project planning
and execution activities. In order to clearly understand and outline roles and
responsibilities, process maps can be utilized. These process maps are helpful,
because they can easily identify main process steps as well as any changes in
ownership with the process steps outlined. As the project plan progresses, the
process map matures and helps outline even more detailed deliverables, durations
of activities, department specific activities such as review and approvals, criti-
cal inputs into building an effective schedule. A signature matrix should present
documents that require review and approvals. Each department, along with the
individuals responsible for those activities, is listed. Each department should
develop service-level agreements with all suppliers, vendors, and contractors.
Critical commitments such as review and approval of documentation should
be captured in the service-level agreement. By doing this, expectations are more
clearly defined rather than suggested or assumed. This document is particularly
useful, because people, commitments, and expectations over the term of the
project change as resources may be reassigned or added to the project.
7.2.2 Project Controls
A sound project control system can help ensure the qualification project is exe-
cuted efficiently. A poorly controlled qualification project may be prone to errors,