General
General
Overview
The General Page contains the following sections:
To modify any of the general fields, click the Add/Edit toolbar button. This will invoke the Add/Edit Field panel.
To modify a field, select the fields from the drop list.
You can then set the value and click the Assign, Assign & Next or Assign & Close button to set the value.
Quality/CAPA Numbers
Quality/CAPA Numbers represent the key field by which all information is tracked. Each Quality/CAPA item will have a unique Number. Numbers can be manually assigned by typing directly into the Number field, or automatically generated by the system. When using the automatic number generator, Desktop will read the Number from the existing Quality/CAPA items in the system (based on the selected Type).
To use the Automatic Number Generator, first select a Type.
To retrieve the next number you can click the Get Next Number icon.
Quality/CAPA Types
Quality forms can be created and classified to represent any type of problem, such as Corrective Actions (CAR), Preventive Actions (PAR), Supplier Corrective Actions (SCAR), Non-Conforming Materials Report (NCMR), Customer Complaints, etc.
Quality form types can determine custom fields, required fields, Quality/CAPA Number format, and workflows. Quality Types are defined in the Administrator.
Owner
The Owner setting is a way that you can define who is responsible/overseeing the closure of the issue. When editing the Owner field, you will be able to browse for an Empower user.
Priority
The Priority setting is a way that you can use to alert users to the importance of a specific Quality/CAPA issue.
Due Date
The Due Date field can be used to define the target closure date of the issue. When editing the Due Date you will be able to browse for a date.
Description
The Description field is an open text field. You can type in any characters and use carriage returns in this field.
You can use the formatting toolbar to enhance the text and add hyperlinks.
Reason
The Reason field is an open text field. You can type in any characters and use carriage returns in this field.
You can use the formatting toolbar to enhance the text and add hyperlinks.
Status
The Status field will indicate the internal status of the Quality/CAPA items (such as: Draft, Pending, Awaiting Release, Released, etc.).
Based on the current status, different action buttons will be available to change the status (Release, Cancel, Reinstate).
Refer to the Releasing Quality/CAPA Items section for more information on releasing Quality/CAPA Items.
Custom Fields
You can create Custom fields that will be displayed on the General page of the Quality/CAPA form.
Custom fields are defined in the Administrator and can be open text fields or pick list options. Each Quality Type can have a different set of custom fields. For example, Corrective Action forms can have different fields than Non-Conforming Material forms.
Business Units
Business Unit associations provide you with a way to link items and business units for searching, classification, signoff workflows, and/or permission purposes. You can define multiple business units for any item, and multiple items can appear under the same business unit.
Business Units are associated to Quality Items on the General page of the form. To add a Business Unit, click the Edit button. This will invoke the Modify Business Units panel.
To add a business unit, select a business unit from the Add Business Unit section. The business unit be added to the Assigned list.
You can search for the desired business unit in the Add Business Unit section.
To remove a business unit, click the Remove button on the Assigned list.
To apply the changes, click the Update Business Units button. Business units that appear in the Assigned list will be applied to the object.
Projects
Projects associations provide you with a way to link items and projects for searching, classification, signoff workflows, and/or permission purposes. You can define multiple projects for any item, and multiple items can appear under the same project.
Projects are associated to Quality Items on the General page of the form. To add a Project, click the Edit button. This will invoke the Modify Projects panel.
To add a project, select a project from the Add Project section. The project be added to the Assigned list.
You can search for the desired project in the Add Project section.
To remove a project, click the Remove button on the Assigned list.
To apply the changes, click the Update Projects button. Projects that appear in the Assigned list will be applied to the object.
Escalation
The Escalation area allows you to create an associated Change/ECO or Quality/CAPA object. The system will automatically assign the same Affected Items and create the Association link when creating a new object from the current form.
To create an associated Change/ECO or Quality/CAPA item, click the Escalate button. This will invoke the Escalate panel.
From the Escalation area, select the target action (Change or Quality).
Once the target object is selected, the Type list will display the available types for that object.
To create the new object, click the Escalate button.
This will launch the New Object Wizard. All affected items and associations will be carried over to the new object.