POINTS TO CONSIDER FOR COMMISSIONING AND QUALIFICATION OF MANUFACTURING FACILITIES AND EQUIPMENT - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 141

traceability of changes for future assessments could become a challenge. A well-
planned, organized project will reduce the potential for systems to be overlooked
or inadequately commissioned and qualified.
Once boundaries are defined and maintained on the P&IDs (piping and instru-
mentation diagrams), they should be managed as living documents and controlled
as part of the construction and/or engineering change control program. As many
changes will and do occur during construction, the change control programs must
accurately indicate the system and boundary in which the change occurs. Changes
during design and construction that are missed and inadequately addressed may
affect system performance and result in repeated testing and project delay.
It is not an efficient use of time and resources to continually modify CAD
(computer-aided design) red line drawings. A controlled program should be
employed to manage drawing red lines “on a stick.” Engineers should be able to
identify if the red line drawings reflect the most current approved changes or if
any approved changes are awaiting CAD modifications. Changes or modifications
to drawings that are not captured in change control may result in construction
issues or in commissioning and qualification problems. These may also result
in designs that are not in compliance with the approved basis of design, user
requirements, or regulatory expectations.
Project definitions such as mechanical completion or any other milestones
that indicate the completion of one operation and transfer of responsibilities and
deliverables to another functional area should be clearly defined. The definition of
mechanical completion usually indicates the finishing of a level or element of
construction and identifies that a system is ready for commissioning. However,
this does not necessarily mean that the system is functionally operable to per-
form the tasks linked to this activity. In some instances, it may not even indicate
that a system is completely installed. Depending on the interpretations, mechan-
ical completion may mean different things during the course of a project. The
definitions of these types of activities should be clear and not change to new defi-
nitions simply to claim completion of a milestone. Issues related to the definition
of project completions may include the following:
• failure to identify and control changes to critical systems;
• warranty and system ownership disputes;
• incomplete or inaccurate transfer of information needed for commissioning
and qualification; and
• delays in start-up, commissioning, and qualification.
Likewise, activities such as construction change control and engineering
change control have a direct impact on your risk-based strategy, particularly if
you are planning on leveraging documentation. It is important to understand
which changes occurred to a particular system within a defined system boundary,
so that material requests and approvals of changes have been documented and
are traceable. In some cases, it may be beneficial to employ quality approval
of those changes in the event the documentation will be leveraged into your
qualification.