Biomedical Engineering Reference
In-Depth Information
2
1
2
3
4
5
6
7
8
9
110
1
2
3
4
5
6
7
8
9
220
1
2
3
4
5
6
7
8
9
330
1
2
3
34R
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 model,
remediation, root cause, triage.
2.1 Triage and escalation
Resources are limited - resources such as staff who are
experienced in conducting investigations, resources such as
34R
