O'Reilly logo

Quality Assurance by G Welty

Stay ahead with the world's most comprehensive technology and business learning platform.

With Safari, you learn the way you learn best. Get unlimited access to videos, live online training, learning paths, books, tutorials, and more.

Start Free Trial

No credit card required

2

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 ...

With Safari, you learn the way you learn best. Get unlimited access to videos, live online training, learning paths, books, interactive tutorials, and more.

Start Free Trial

No credit card required