Manage CAPA Line Investigation

Explanation

This activity is used for investigating a CAPA line and releasing it for action completion. A person responsible for investigating is identified and a target date is set, then the investigator will add notes and set the status to Investigated.

This activity contains a security checkpoint that can be activated by an administrator. With an activated security checkpoint on a function it is needed to authenticate the user again in order to fulfill the function. Additionally, whenever a security checkpoint is successfully passed, a security checkpoint log is written creating an audit trail of what is done.

Prerequisites

A CAPA line must exist in the Released status.

System Effects

As a result of this activity, the status of the CAPA line is changed to Investigated.

Window

Corrective and Preventive Action
Corrective and Preventive Actions

Related Window Descriptions

Corrective and Preventive Action
Corrective and Preventive Actions

Procedure

Corrective and Preventive Action window

  1. Click the Actions tab and select a record.
  2. Click the Enter Investigation Data link to work from a dialog, or fill in the fields on the line.
  3. In the Investigation Responsible ID field, enter the ID of a responsible person or click List to select a value from the List of Values. Entering a value in this field is required.
  4. Enter a value in the Target Investigation Date field. Entering a value in this field is required.
  5. In the Investigation Notes field, enter a note. Entering a value in this field is required.
  6. In the Action Responsible ID field, enter the ID of a responsible person or click List to select a value from the List of Values. Entering a value in this field is required.
  7. Enter a value in the Target Action Date field. Entering a value in this field is required.
  8. Click OK.
  9. Right-click and then click Investigate. The status of the corrective and preventive action record changes to Investigated. The system generates a time stamp for the investigation date as well as for the person who made the system state change.

Corrective and Preventive Actions window

  1. In the Investigation Responsible ID field, enter the ID of a responsible person or click List to select a value from the List of Values. Entering a value in this field is required.
  2. Enter a value in the Target Investigation Date field. Entering a value in this field is required.
  3. In the Investigation Notes field, enter a note. Entering a value in this field is required.
  4. In the Action Responsible ID field, enter the ID of a responsible person or click List to select a value from the List of Values. Entering a value in this field is required.
  5. Enter a value in the Target Action Date field. Entering a value in this field is required.
  6. Click OK.
  7. Right-click and then click Investigate. The status of the corrective and preventive action record changes to Investigated. The system generates a time stamp for the investigation date as well as for the person who made the system state change.

Note: if you want to revoke the investigation, you can right-click and then click Release. The Investigated Date and Investigated By fields will be cleared.