RISK-BASED CHANGE CONTROL - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 367

The various risk assessment tools are used widely; each has its particular
strengths and weaknesses. An FMEA is a versatile tool that can be used to
leverage process knowledge and experience in an organized manner, in a team
environment. Possible failure events and their causes are determined qualita-
tively. A second step then quantifies the risks associated with the failure event
by assigning values for the FMEA risk elements of severity, occurrence, and
detection. FMEA is one of the common methods that incorporate detection into
the risk measurement equation. This analysis may lead to recommendations that
decrease the probability that the failure will occur.
13.5 KEYS TO SUCCESSFUL IMPLEMENTATION
The importance of integrating QRM into change control may not always be
recognized, because of the initial perception that it requires extra effort with no
apparent benefit.
Not integrating QRM may ultimately lead to disparate failures, including
product rejections, recalls, and regulatory agency observations associated with
documentation or questionable rationales for addressing a change.
Building a solid cross-functional team and obtaining management commitment
and support for the QRM program are the first, most obvious requirements for
successfully integrating QRM into a change control system.
Successful change control teams must follow basic rules for conflict resolution,
i.e., mutual respect, participating, and listening to each other in order to reach,
ideally, consensus. A leader must facilitate the team's dynamics and promote
active participation. Individual commitment is obviously crucial, as the final
decision cannot be made if one or more of the members do not fulfill their
role. Quality must be an active participant in the process, as patient safety is the
main focus.
Although changes must be addressed in a timely matter, no artificial time con-
straint should be imposed to reach the final decision. Addressing the change using
QRM should naturally lead to a quick decision and identification of appropriate
actions.
Firms should have a documented approach to using risk management in change
control. FDA's Q9 Guidance [1] does not mandate a specific QRM methodol-
ogy. A formal scientific approach supplemented by comprehensive risk templates
(FMEA, PHA, etc.) is recommended.
Finally, it is important to track the items in the agreed-upon implementation
plan to completion.
13.6 USE OF A RISK ASSESSMENT TOOL IN CHANGE CONTROL
A step-by-step procedure for completing a risk analysis using the FMEA approach
is presented here.