Publication Date: 11/12/2024
![]() ![]() ![]() ![]() |
||||||
The Extension Tab will display information regarding any extensions (if applicable) that were granted for the Audit Steps.
The following information/options are available in this window: Item The Step number. Status The current status of the Step. If the Step is completed and needs to be closed, select the ‘Closed’ status from the Status drop-list. Finding Date The date that the Audit is performed (the date that the status of the Steps are adjusted). Not Required radio button Select this radio button if an extension for the audit steps is not required. Granted radio button Select this radio button if an extension for the audit steps has been granted. Denied radio button Select this radio button if an extension for the audit steps has been denied. Finding Extension Enter the number of days for the Second Extension. Finding Extension (Number of) Days The number of days is the total number granted. This number of days is not added to the previous number of Corrective Action Due days. The number of days in the Finding Extension will override the Corrective Action Due days. The system will add the number of Finding Extension days to the Finding Date to create a new due date. This date will then be the next due date for the Audit. The Audit Tracking Reports will indicate this. Extension Letter Received checkbox Select this checkbox if an extension letter regarding the audit steps was received. Second Extension checkbox Select this checkbox if a second extension has been granted for the audit steps. Note: This checkbox only appears if the Extension Letter Received checkbox has been selected. Second Extension (Number of) Days This is the new number of days to be granted for the second extension. The system will add the number of Second Extension days to the Finding Extension days and the Finding date to create a new Due date. This date will then be the next due date for the Audit. The Audit Tracking Reports will indicate this. Note: This field only appears if the Second Extension checkbox is selected. Audit Step (Reference) The instructions (text) associated with this Step (as per set up in Settings/Explorer/System Transaction Code/QA - Audit Type). Note that the status of all Steps must be ‘Closed’ before the Audit can progress to the next stages. Audit Element The related Audit Element (Class1, Class2, etc. as per set up in Settings/Explorer/System Transaction Code/QA/Audit Element). Audit Finding The Findings related to this Audit or Step. Finding Level The Finding level associated with this Audit or Step. The number of days associated with the Finding Level will automatically appear in the Corrective Action Due field (as per setup in Settings/Explorer/System Transaction Code/ QA/ Finding Level) and can be overridden if necessary. Corrective Action Due If corrective action is due, enter the number of days that the action must be performed in. The number of days associated with the Finding Level will automatically appear in the Corrective Action Due field (as per setup in Settings/Explorer/ System Transaction Code/QA/Finding Level) and can be overridden if necessary. Due Date This date will appear upon saving the record. It is automatically calculated based on the number of days specified in the Corrective Action Due field. This date will then be the next due date for the Audit. Immediate Corrective Action checkbox Check this box to enter notation regarding any immediate corrective action due. ICA Status Immediate Corrective Action status. ICA Resolution Date The date of the Immediate Corrective Action resolution. Root Cause checkbox Check this box to enter notation regarding any Root Cause related to this transaction. The Root Cause Classification selection will also appear. Root Cause Classification You can choose a predetermined Root Cause Classification for this transaction from a pop-up window selection. The predetermined list is set up in Settings/Explorer/System Transaction Code/QA – Root Cause. Comprehensive Corrective Action checkbox Check to enter notation regarding any Comprehensive Corrective Action. CCA Status Comprehensive Corrective Action status. CCA Resolution Date The date of the Comprehensive Corrective Action resolution. Repeat Finding Check if this is a Finding that has been accounted for more than once. Closed Date The date that status of the Audit Step was changed to ‘Closed.' Note that ALL Steps must be CLOSED (Status field) before the Audit itself can progress to the next stages. Primary Responsible Manager The manager responsible for the Finding. _____________________________________________________________________________________ |
||||||
Top of Page |
Publication Date: 11/12/2024
![]() ![]() ![]() ![]() |
|||||