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1 | Precondition | Objective | ||
2 | This test case requires the following to be true in order to run: * The app this test case is referring to has been created, configured, and is ready for verification * The user has access to a player that is authenticated to the instance the app is on and the player is able to run the app o Due to the nature of this test case it might be wise to have two separate players running (or even two testers) to reduce the logging in/out of the instance * The user is familiar with the Quality Event workflow as the test script will be high level and won't go into detail about the specifics of performing the actions | Terms: * Quality: the point person for managing deviations * Owner: the person assigned to a deviation whose input is required in order to move the event forward The objective of this test is to verify the following aspects of Deviation Management: 1.1.1 - The Description Field Exists and is required to proceed 1.2.1 - The Immediate Actions Taken Field Exists and is required to proceed 1.3.1 - The Source Field Exists and is required to proceed 1.4.1 - Event ID is created after Report Event. 1.5.1 - The closed quality event has a link to the ID of the newly created CAPA 2.1.1 - The Description Field can be amended if the Edit Description status is assigned. 2.1.2 - When the status of the Quality Event is ‘Needs More Information’ the user should not be able to advance unless changes to the Quality Event are made 2.2.1 - If you click change status you are given the option to manage the workflow 3.1.1 - If “Needs More Information” is chosen, you are provided the option to make a comment. 3.1.2 - If under investigation is chosen, you are prompted with Assign Owner and Due Date. 3.1.3 - It should request Signature if you choose Cancel. 3.2.1 - Confirm you can choose owner from a drop down list 3.3.1 - Confirm due date populates with +30 days, by default 3.3.2 - Confirm due date can be edited. 3.3.3 - Confirm that the due date cannot be set as a date earlier than the QE ‘Created Date’ 4.1.1 - Investigation Summary field exists and is required. 4.1.2 - Investigation Summary field can be edited if Review is Rejected. 4.2.1 - Root Cause field exists and is required. 4.2.2 - Root Cause allows Owner to select from a drop down. 4.3.1 - Root Cause Description field exists and is required 4.3.2 - Root Cause Description can be edited if Approve step is rejected. 4.4.1 - CAPA Proposal field exists and is required 4.4.2 - CAPA Proposal can be edited if Approve step is rejected. 4.5.1 - Confirm the contents of all fields are saved and editable. 4.6.1 - Confirm event status is changed to "In Review" when submitted. 4.6.2 - When the Review is rejected, the user should not be able to advance unless changes to the Investigation Summary are made 5.1.1 - Upon accept, you are prompted with "Is CAPA required?" 5.1.2 - If CAPA is needed you are prompted with Make CAPA. 5.1.3 - If CAPA is not needed you are prompted with Signature 5.2.1 - Upon Reject, a comment is required. 5.2.2 - Owner populates with current owner but it editable. 5.2.3 - Due date populates with current due date but is editable. 5.2.4 - The event's status changes back to "Under Investigation" after the rejection. 6.1.1 - Confirm the CAPA workflow pre-populates Root Cause description and CAPA proposal from the quality event workflow. 6.2.1 - Confirm owner can be chosen from a drop down list. 6.3.1 - Confirm due date populates with +30 days, by default 6.3.2 - Confirm due date can be edited. 6.4.1 - Confirm CAPA ID is created when submitted. 7.1.1 - Confirm signature is requested for both Accept with and without a CAPA. | ||
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