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Scenario for Managing Corrective and Preventive Actions

This scenario is an example process performed by the Siebel administrator, and the corrective and preventive action team. Your company might follow a different process according to its business requirements.

This process is designed to illustrate the functionality of Siebel AECM.

The Siebel Administrator

The administrator sets up the activity templates that the corrective and preventive action team members use in the course of planning, implementing, and verifying corrective and preventive actions.

Before creating these templates, the administrator consults with the corrective and preventive action team. It is very important that the activities defined by the template accurately and completely reflect the company's policies and procedures for the handling of corrective and preventive actions.

The administrator also checks the necessary codes for CAPA have been set up as appropriate for the company's business needs.

The Corrective and Preventive Action Team Members

The product analysis team has alerted the CAPA team that some of the cartridges used in the new blood analyzer are out of tolerance and that this is causing them to jam in the analyzer. The CAPA team is responsible for correcting this problem.

The CAPA manager creates a corrective action record. He fills in all the information known about the problem and its root cause, including the associated product analysis and product issue records. The CAPA team use this record as the project file, referring and adding to it throughout the life cycle of the CAPA.

All information associated with the CAPA is stored and accessible from this record. The information takes a variety of forms, from short comments where employees share information about recent actions and findings, to longer notes (both public and private), and large documents such a reports and specs that are saved as file attachments.

The CAPA manager uses the activity template to generate a standard set of activities that outline the team's standard operating procedure for implementing corrective and preventive actions. He assigns the activities to members of his team. The manager uses the list of activities to monitor the progress of the CAPA; noting the start and end dates and which activities have been completed and which are still to be done.

CAPA team members are assigned activities, with start and due dates. They carry out their assigned activities, recording the tools and parts used, how long each activity takes to complete, and the results and measurements obtained.

Major milestone dates, both target and actual, are recorded on the main form of the CAPA record. Also the approval history of the CAPA record is tracked as changes in the CAPA's status are made, from Open, through Approved, to Verification.