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Siebel Life Sciences Guide > Managing Corrective and Preventative Actions >
About Managing Corrective and Preventative Actions
This chapter describes recording and managing corrective actions and preventive actions (CAPAs) for Siebel Adverse Events and Complaints Management (Siebel AECM). Table 34 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 34. Terms Defined with Examples
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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. Related Topics
Capturing Adverse Events and Complaints
Investigating Adverse Events and Complaints
Recording Product Analysis for Adverse Events and Complaints Management
Regulatory Reporting
Communicating with Customers for Adverse Events and Complaints Management
Closing Adverse Events and Complaints
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