Re-Planning CAPA Implementation

If the verification of implementation is unacceptable, the CAPA implementation owner receives email notification . Users with the appropriate roles have access to the workspace options on the CAPA/NC Workspace and/or CAPA Coordinator dashboard.

From the CAPA/NC Workspace, click the Plan CAPA Implementation link to the appropriate CAPA.
Result: The Plan CAPA Implementation window is displayed.

Enter the information in the following fields:

Field	Description
Plan CAPA Implementation Task Information	Displays the Plan CAPA Implementation Task Owner and the Due Date. Click the Change Task Owner link to assign this task to another user. For additional information, see Changing the Task Owner.
Action Plan(s)	Enter the information in the following Proposed Action Plans section fields: Plan Type* - Select a Plan Type option. Default plan types include the following: Corrective - This option is typically used in a CAPA coming from a failure. Preventive - This option is typically used in a CAPA created to prevent a potential failure from happening. NOTE: For more information on configuration, see Plan Type. Plan No. - Enter the plan number of the action plan, such as 1, 2, or 3. This option does not have any business logic tied to it and is only used as a reference number. Action Plan* - Enter the action plan. Action Plan Description* - Enter a description of the action plan. Justification - Enter the justification for the action plan. Assigned to Role* - Enter or zoom to select the user role for the user to be assigned to the action plan. NOTE: For more information on configuration, see Roles. Assigned to User* - Enter or zoom to select the user assigned to the action plan. NOTE: For more information on configuration, see Users. Due Date* - Enter the due date for the action plan. Checklist - Zoom to select a checklist to be used for this action plan. For more information on configuration, see Checklists. Is Plan Complete - Select whether or not this action plan is complete. No - This will later require the action plan to be signed off by the assignee. Yes- The action plan is signed off. The use must specify whether or not there is confirmation and objective evidence that the specific requirements have been fulfilled. The user must also enter information in the Completed By, Completed Date, and Comment fields. Skipped - The action plan is skipped and will not need to be signed off once the investigation has been approved. A comment must be entered.
Attachments	If needed, the CAPA Implementation Owner can add attachments prior to signing off the implementation.

Field

Description

Plan CAPA Implementation Task Information

Displays the Plan CAPA Implementation Task Owner and the Due Date. Click the Change Task Owner link to assign this task to another user. For additional information, see Changing the Task Owner.

Action Plan(s)

Enter the information in the following Proposed Action Plans section fields:

Plan Type* - Select a Plan Type option. Default plan types include the following:
Corrective - This option is typically used in a CAPA coming from a failure.
Preventive - This option is typically used in a CAPA created to prevent a potential failure from happening.

NOTE: For more information on configuration, see Plan Type.

Plan No. - Enter the plan number of the action plan, such as 1, 2, or 3. This option does not have any business logic tied to it and is only used as a reference number.
Action Plan* - Enter the action plan.
Action Plan Description* - Enter a description of the action plan.
Justification - Enter the justification for the action plan.
Assigned to Role* - Enter or zoom to select the user role for the user to be assigned to the action plan.

NOTE: For more information on configuration, see Roles.

Assigned to User* - Enter or zoom to select the user assigned to the action plan.

NOTE: For more information on configuration, see Users.

Due Date* - Enter the due date for the action plan.
Checklist - Zoom to select a checklist to be used for this action plan. For more information on configuration, see Checklists.
Is Plan Complete - Select whether or not this action plan is complete.
No - This will later require the action plan to be signed off by the assignee.
Yes- The action plan is signed off. The use must specify whether or not there is confirmation and objective evidence that the specific requirements have been fulfilled. The user must also enter information in the Completed By, Completed Date, and Comment fields.
Skipped - The action plan is skipped and will not need to be signed off once the investigation has been approved. A comment must be entered.

Attachments

If needed, the CAPA Implementation Owner can add attachments prior to signing off the implementation.

Click the Sign-off button.
Result: The Sign-off window is displayed.
Enter your user ID and password and then click the Sign-off button.
Result: The Result window is displayed. The Result window is a window that displays after implementation that asks the user where they would like to go next, such as to the CAPA Detail or back to the Portal Page. If the user is assigned the role for the next step in the workflow, such as Approve CAPA Plan, then the user will see the option to enter the next step.