Recording corrective and preventive action
Select the Audit Report # hyperlink in the “Search Results” multiline of the “Select Quality Audit Report” page.
or
Select the “Record Corrective and Preventive Action” link in the “Record Quality Audit Findings” page.
The “Record Corrective and Preventive Action” page appears.
The system displays the following field:
Date & Time Format |
The format in which the date & time fields are displayed in this page. This format is displayed from the "User Preferences" business component based on the login user ID. In case the format is not defined, the system displays the date and time format from the "Enterprise Modeling" business component by default. |
The “Audit Report Details” group box displays the following:
Audit Report # |
The identification number of the audit report. |
Report Type |
The type of the audit report, such as Scheduled, Adhoc and Direct. |
Audit Status |
The status of the audit report: “Pending Action”. |
CAPA Approver # |
The employee code of the CAPA approver (Alphanumeric, 15). Help facility available |
Audit Category |
The category of the audit report. |
Audit Schedule |
The identification number of the audit schedule |
Reference Doc. Type |
The type of the reference document associated with the audit report. |
Reference Doc. # |
The identification number of the reference document. |
User Status
|
Use the drop-down list box to specify the user status of the audit report. The system displays quick codes defined under the Quick Code Category “User Status” in the “Maintain Quick Codes” activity and whose status is “Active”. |
Checklist Based? |
Use the drop-down list box to indicate whether the audit schedule is based on a checklist. You can select from the options “Yes” or “No”. |
Operator Code |
The operator code of the maintenance operator. |
Reference Doc. Details |
In-depth information on the reference document. |
The “Audit Findings” group box displays the following.
Audit Findings |
Details of the audit recommendations / observations. |
Total Recomm. / Obsv. Count |
The sum total of recommendations / observations. |
Total NC Count |
The sum total of NC. |
The system displays the following field in the “Record Statistics” group box:
Created By |
The name of the user who created the audit report. |
Created Date |
The date on which the audit report was created. |
Last Modified By |
The Login User name who modified the audit report. |
Last Modified Date |
The date on which the audit report was modified. |
Select the “Summary of Observations” tab to record response details and actions on observations.
Select the “Non-Conformance Report” tab to record response details and actions on NCs.
Select the “Reference Details” tab page to view reference details.
Select the “Record Action” pushbutton to save the CAPA details.
Select the “Confirm Action” pushbutton to authorize the CAPA details.
Note: You must click the “Record Action” pushbutton before proceeding to “Confirm Action”.
Ensure that you specify the “Action” for the given NCR # in the Non-Conformance Report ab page
Ensure that action has not already been taken and confirmed on a given record. In the Summary of Observations Details tab page.
To proceed
Select the “Edit References” link to record the details of reference documents.
Select the “Upload Documents” link at the bottom of the page to upload documents or attach files for reference.
Select the “View Associated Doc. Attachments” link at the bottom of the page to view details of the documents attached for reference.
The “Record Corrective and Preventive Action” page enables users to record details of any action required to implement the recommendation / observation made by the auditor.
The audit brings to light any deviations that occur in the audit entity (processes / departments) in the form of non-conformities. The recommendations / observations and non-conformities as made by the auditor may or may not require any action.
If any action is specified, the date by which the action is to be taken must also be specified.
You can also close the audit report using this page. However, this is possible only if you have checked the “Allow Closure of NC during CAPA” option in the “Set Options” activity for the report type.