Recording summary of observations while recording corrective and preventive tab

Recording summary of observations while recording corrective and preventive

The “Summary of Observations” tab page appears by default on launch of the “Record Corrective and Preventive Action” page.

Note: The system does not allow the following:

1. Deletion of already existing observations in the multiline.

2. Addition of new rows in the multiline if the Audit Report is Checklist Based.

Note: For checklist based Audit Report, if you wish to add new reports you have to

add new rows in the Update Audit Findings tab first.

The multiline displays the following:

Ques ID	A user defined identification number for the questionnaire.
Observations	The description of the observation.
Recomm./Obsv. Status	The status of the recommendation / observation, such as Pending and Actioned.
Action Reqd.?	Indicates whether any action is necessary to implement the recommendation / observation.
Recommendation Category	The category of the recommendation.

Action By Date	The date on or before which the action required for the recommendation / observation is to be taken (Date Format).
Action	Use the drop-down list box to specify the action. The system displays the following values: Report Conformance, Request Extension and, Close. However, the Close option is available only if for the report type in the “Set Options” activity, the “Allow Closure of NC during CAPA” option is checked.

The system displays the following field in the multiline:

Action By

The employee code of the person who is responsible for any action, if required.

Auditee Remarks	Any comments by the auditee on the recommendation / observation and related action.
Updated By	The employee code of the person who last modified the record (Alphanumeric, 30). Help facility available
Updated Date	The date on which the record was last modified (Date Format).
CAPA Approver #	The employee code of the CAPA approver, (Alphanumeric, 15). Help facility available
File Name	The document associated with CAPA. You can select the “View File” link to see the document. Help facility available

The multiline displays the following:

Requirement	The question text.
Check Point	The broad classification based on which question is asked like for example, Safety, Security and so on.
Question Type	The type of question in the checklist.
Question Category	The category to which the question belongs
Mandatory?	Indicates whether the given question is mandatory to be responded while auditing which could be “Yes” or “No”.
Checklist #	A unique code identifying the checklist used for auditing
Seq #	The sequence number in which the questions need to appear in the checklist.
Line #	A system generated number indicating the line number of the entry in the multiline.

To proceed

Select the “Non-Conformance Report” tab to record details of the non-conformance report.
Select the “Reference Details” tab to record details of references.