Investigations, root cause analyses and CAPAs
Abstract:
This chapter considers the organizational response to observations, particularly those occurring in manufacturing and quality lab areas. Observations are either triaged or they are escalated. A number of observations that will likely result in escalation are listed, as well as a number that will likely be triaged because they are non-GMP issues. Next, this chapter addresses the process of investigation and root cause analysis (RCA). Finally, it discusses the corrective action and preventive action (CAPA) that are the outcome of the investigation.
Key words
corrective action
deviation investigation
escalation
human error
Ishikawa diagram
Notice of Event
preventive action
program logic ...
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