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Quality/CAPA Management
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Overview
The Quality Management module is a closed-loop Corrective and Preventive Action (CAPA) system that provides users with the ability to capture and route (for resolution) any product defects and issues. The Quality Management module consists of forms, reports, and alerts to classify and analyze product problems.

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 forms can contain data that describe the issue, define tasks to be accomplished and users responsible to facilitate closure of the issue, and electronic signoff for tracking user acceptance/approvals.


Initiating Quality/CAPA Items Top
To create a Quality/CAPA item, you must use the New Object Wizard.

Refer to the New Object Wizard for more information on creating objects.
Quality/CAPA Types Top
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, CAR/PAR Number format, and workflows. Quality Types are defined in the Administrator.
Quality/CAPA Form Top
The Quality/CAPA form is used to display data about all Quality/CAPA items regardless of the Type.



The Form contains three main areas:
Area Description
Banner Displays Number, current page indicator, current status and is visible from all Data Pages
Data Page Navigator Provides quick links to all available data pages
Data Page Area Lists all data for the currently selected data page
Quality/CAPA Banner Top
The Banner displays the following information:



Section Description
Copy Icon Clicking will copy the item to the system buffer (for subsequent Paste operations)
Name, Info, Action Menu Displays the current Quality/CAPA Number and Description. Placing mouse over will invoke form Action menu.
Status Area Indicates internal state of item (Pending, Awaiting Release, etc>). Status area will be blank for released items.

Return/Home Icon
Clicking the top left icon will redirect you to the Desktop Home Page.



Buffer Copy
Clicking the Copy icon will place the item to the system buffer (for subsequent Paste operations).



Action Menu
Placing mouse over the Number/Description will invoke form Action menu. The menu will contain the following commands:



Command Description
Refresh Refreshes/Reloads the form
Return to Desktop Home Redirects you to the Desktop Home Page
Search Database Redirects you to the Database Search form
Logout Logs you out of Desktop
Copy Item Places the item in the system buffer
Bookmark Item Bookmarks the form
Create New Like Invokes the New Like form

Page Commands
The top right section of the banner contains the following hyperlinks:



Link Description
Refresh Refreshes/Reloads the form
Home Page Redirects you to the Desktop Home Page
Data Page Navigator Top
The Data Page Navigator allows you to quickly jump to the different data sections of the Quality/CAPA form. Selecting an option from the list will update the data page pane to display that data section.





The Navigator page names can be modified using XML Dictionary files. Contact a qualified Omnify Application Engineer for more information on creating XML Dictionary files.
Data Pages Top
All Quality/CAPA forms contain the following data pages:

Page Data Contained
General Number, Type, Priority, Reason, Description, custom fields
Affected Items Items/Parts/BOMs affected by the Quality/CAPA item
Tasks Tasks assigned to resources
Attributes Use parameters to define additional information
Documents Documents for Quality/CAPA item
Comments General user and signoff comments
Associations Associated Changes and other CAPA objects
History List of changes that have occurred to the Quality/CAPA item (User, Date, Tool Used)
Signoff Users who are reviewing or are required to sign-off on this item
Training Associated training items
Releasing Quality/CAPA Items Top
Once all required users have approved the Quality/CAPA item it will then be available for release. To release, select the General page.



In the Status Area click the Change Status hyperlink. This will display the Change Status dialog box.



Set the Update Status drop list to Released.



Click the Update Status button.



The status will then be updated to a Released state. No further edits will be allowed on the form.