Bookshelf v7.8: About Managing CAPAs

This chapter describes recording and managing corrective actions and preventive actions for Siebel Adverse Events and Complaints Management (Siebel AECM). Table 44 defines and distinguishes these two terms. But generally, corrective and preventive actions are called CAPAs; this is how they will be referred to generically in this chapter.

Table 44. Terms Defined with Examples
Term	Definition from ISO 8402	Example
Corrective Action	Action taken to eliminate the causes of an existing non-conformity, defect, or other undesirable situation in order to prevent recurrence.	When devices were returned because of damage caused by electrostatic discharge (ESD) during assembly, the corrective actions were (i) implementation of ESD controls and (ii) ESD control training for operators.
Preventative Action	Action taken to eliminate the cause of a potential non-conformity, defect, or other undesirable situation in order to prevent occurrence.	When control charts indicated the diameter of a molded part was drifting towards the upper limit, the preventive action was to replace the mold and validate that the new parts met the specifications.

The CAPA record in Siebel AECM is designed to contain all information about a corrective or preventive action: from its creation through planning and implementation through authentication, closure and beyond.

Where to Find More Information

The following chapters describe other aspects of the complaints and adverse events management process:

Siebel Life Sciences Guide		Copyright © 2008, Oracle. All rights reserved.