Biomedical Engineering Reference
In-Depth Information
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34R
Framework for continuous
improvement
Abstract:
This chapter considers occasions that lead to the
continuous improvement of manufacturing processes and
programs in the life sciences industry, and to the revision
of SOPs. Several groups of stakeholders in the sphere of
FDA-regulated industry are identifi ed. Each of these
groups tends to be associated with particular kinds of
observations, observations of various deviations from the
anticipated manufacturing process and product. These
observations initiate an investigation and revising process
that varies in emphasis but that has an underlying logic.
An observation is typically escalated, triaged, and can
become the basis of an investigation and RCA. At the
conclusion of the investigation, programmatic remediation
can be proposed in the form of corrective actions and
preventive actions, and may ultimately lead to the revision
of a procedure. A diligent approach to revision promotes
the continuous improvement of the manufacturing
process.
Key words:
adverse event, change control, controlled
document, corrective action, customer quality complaint,
deviation investigation, good management practice,
management notifi cation, Notice of Event, preventive
34R
