RISK-BASED CHANGE CONTROL - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 364

assure that planned actions and documentation are sufficient. As part of this
review, the team should verify the impact of the change on the existing risk
assessment document for the impacted product or process. If this is not available,
then a new risk assessment may have to be performed.
Once all items are deemed acceptable including the change implementation
plan, the change request is approved as “OK to implement.”
The change is then implemented according to the approved plan. Unanticipated
events may prevent the implementation from going exactly according to plan.
When this happens, the team (including QA) needs to be made aware of any
significant deviations, and any further actions that may be required (such as
deviations or Corrective and Preventive Action (CAPA)).
Lastly, when the change has been implemented and all significant deviations
and actions addressed to the satisfaction of the change review team, the change
request documentation can be reviewed and closed out.
13.3 BENEFITS OF USING QRM FOR CHANGE CONTROL
The main advantage of integrating QRM into the change control process is the
quality and speed of the change review. The risk ranking format promotes objec-
tivity in the decisions, and each change submitted to the Change Review Board
can be addressed with a dependable and rational approach. After completing the
risk assessment, the change can be implemented on the basis of a sound, scientif-
ically documented rationale. This can provide a considerable improvement from
the “tribal knowledge” decision making that is often used to determine change
implementation plans.
When a change is addressed with QRM, the immediate benefit is the ability to
make timely, science-based decisions. First, on the initial review of a submitted
change, changes defined as out of scope can be immediately removed from the
formal change control process. In addition, routine low risk changes that are
already allowed through SOPs can be removed. The impact analysis of these
low risk changes is predetermined and accepted, and no further discussion is
required during a formal change control meeting. As a result, the process for
implementing these types of changes is clear, and can be immediately launched.
Use of score-based risk tools (e.g., FMEA, PHA, etc.) can lead to faster
assessment and scientific decision making because of a clearer understanding of
relative risks associated with the change. The formality of the documented review
process (using a risk assessment template) allows an immediate understanding
and appreciation of the change and its impact on the product. The risk assessment
discussion focuses on the risk resulting from the change and its impact on the
identified critical parameters. The structured format and scientific approach for
addressing the changes contributes to thorough and timely decision making.
Once the decision to accept the change has been made, the benefit of QRM
is to reduce the time to implement the change. Activities adding no value to
the product quality are avoided, and the change can be effected in a timely and
efficient matter.