Chief Auditor Employee #

The identification number of the employee, who will be the chief auditor.

The system allows solely the lead auditor (and no other employee) to modify the audit schedule dates in the “Maintain Quality Audit Schedules” activity.

Help facility available

Default Numbering Type for ‘Adhoc Report’

Use the drop-down list box to specify the default numbering type for Adhoc reports. The system displays the numbering types defined for the Transaction Type “Audit Report” with the Default flag set to “Yes”, in the Document Numbering Class component .

Default Numbering Type for ‘Direct Report’

Use the drop-down list box to specify the default numbering type for Direct reports. The system displays the numbering types defined for the Transaction Type “Audit Report” with the Default flag set to “Yes, in the Document Numbering Class component ”.

Standard Duration for Corrective Action (Days)

The normal / permitted duration for implementing corrective action, in days.

Confirmation of Audit Report

Use the drop-down list box to indicate whether confirmation of an audit report is mandatory  in the Edit Quality Audit Report activity prior to approval of the audit findings.

The system defaults this field to “Required”.

Approval of Non-conformities

Use the drop-down list box to indicate whether approval of audit findings/non-conformities is mandatory  in the "Record Quality Audit Findings" page.

The system defaults this field to “Required”.

Approval of Corrective and preventive Actions

Use the drop-down list box to indicate whether approval of corrective and preventive actions in the “Record Corrective and Preventive Action” activity is mandatory.

The system defaults this field to “Required”.

Editing of Root Cause Info during CAPA Recording

Use the drop-down list box to allow/disallow modifying of the root cause information in the “Record Corrective and Preventive Action” activity.

The system defaults this field to “Not Allowed”.

Editing of Root Cause during Process NC/Reports

Use the drop-down list box to allow/disallow modifying of the root cause information in the “Process Non-Conformities / Reports” activity.

The system defaults this field to “Not Allowed”.

Auto Closure of Report on all NC Closure

Use the drop-down list box to allow/disallow closure of an audit report automatically when all the NCs are closed in the “Process Non-Conformities / Reports” activity.

The system defaults this field to “Not Allowed”.

Allow Closure of NC during CAPA for:

Select the check box,

• "Direct Reports", to allow closure of NCs for Direct reports in the “Record Corrective and Preventive Action” activity.

Audit Category

Use the drop-down list box, to specify the category of audit. The system displays the quick codes defined under the quick code category "Audit Category" in the "Maintain Quick Codes" activity.

Reference Element

The reference element for the audit, such as work order and part.

The reference elements or documents are used for audit trails and are specific to the audit category.

Mandatory?

Use the drop-down list box to indicate whether the reference element/document is mandatory for the audit.

• “Yes”, to make the reference element mandatory. When a reference element is made mandatory, the system ensures valid details are provided against the reference element during confirmation of audit findings.

• “No”, to make the reference element non-mandatory.

The system defaults this field to “No”.

Instructions

Any guidelines for the audit process.

Last Modified by

The number and name of the employee who most recently set the parameters.

Last Modified Date

The date on which the parameters were set.