Editing a CAPA from Any State
CAPA objects can be edited from any state in the workflow.
• Only users in the quality system manager role can perform this function. Users in other roles can view the structure, but they are not able to edit items.
• Use this feature to make minor changes such as correcting misspelled items or correcting information that was entered in the wrong field.
• Do not use this feature to add actions to the CAPA. Use the CAPA manager to add actions.
• If you change the value of decision-based fields, the workflow does not change if the CAPA has already reached that state. Decision-based fields include the following:
◦ Review: Evaluation Outcome and Further CAPA Investigation Required
◦ Evaluation: Action Required
◦ Plan: Approval Required
◦ Action: Change Notice Required?, Hold Until Plan Completed?, Confirmation Required, and Effectiveness Required?
1. Click the Structure tab of a CAPA object.
2. In the CAPA Object Structure tree, right-click an object and select an action from the menu.
◦ Right-click Site Information and select Enter Request Details.
◦ Right-click Affected Objects and select Enter Request Details or Enter Investigation Details.
◦ Right-click Related Personnel and Locations and select Enter Request Details.
◦ Right-click Request and select Enter Request Details.
◦ Right-click Review and select Enter Review Details.
◦ Right-click Investigation and select Enter Investigation Details.
◦ Right-click a plan and select Enter Plan Details.
◦ Right-click an individual action plan and select Edit Action Details, Enter Implementation Details, Enter Confirmation Details, or Enter Effectiveness Details.
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If you cannot perform an action on the object, the “No Actions to Display” message appears.
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3. Edit the fields you need to change.
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All attributes and tables are editable, with the exception of the Affected Objects table. This table is always editable in the Enter Request Details window, but it is only editable in the Enter Investigation Details window in the Creation, Review, and Investigation states.
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4. Click Finish. The system updates the details for the object in that state. The object does not move to the next state.
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If you edited the item to create a new request (such as an investigation, change notice, or action plan), the system does not create the request because it cannot move the item to the next state. If you need to add requests or additional tasks, you must create a completely new CAPA request.
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