Framework for continuous improvement

Five groups of stakeholders in the sphere of FDA-regulated industry are identified: operational employees, quality unit auditors, regulatory investigators, health care providers, and patients.

The kinds of observations that tend to be associated with each of these stakeholders 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 root cause analysis.

This article considers occasions that lead to the continuous improvement of GMP processes (Good Manufacturing Practices) and the revision of SOPs (Standard Operation Procedure).