Framework for continuous improvement - Quality Assurance - page 2

action, regulatory inspection, SISPQ, standard operating
procedure, stakeholders.

1.1 Introduction

There are events and situations that - when observed and
acted upon - initiate the revision of processes and procedures
addressed by good manufacturing practices (GMPs) in a
regulated industry such as that covered by the US Food
and Drug Administration (FDA) or other global regulatory
agencies. These events and situations can lead to two kinds
of revision of GMP processes. They can be either reactive
interventions such as corrective actions, or proactive
interventions such as preventive actions. An example of
a proactive intervention would be the organization's
response to tracking and trending data that suggest critical
action points will soon be exceeded. Another example
of proactive intervention would be an organization's
response to a “close call,” where a deviation did not actually
occur.
In either case, reactive or proactive intervention, systematic
pursuit of revision leads to continuous improvements.
Events and situations do not generate the intervention by
themselves. The key terms here are “when observed and
acted upon,” focusing attention on the major groups of
stakeholders that can initiate the chain of events leading
to the change. The persons occupying each of these
stakeholder roles must fi rst observe, then act, to occasion the
intervention.
There are fi ve major groups of these stakeholders. These
fi ve groups make up a map of the overall sphere of the
regulated life sciences industry. Each represents a different
facet of regulated industry, including the following:

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