Recording Non-Conformance report while recording corrective and preventive action (tab)

Recording Non-Conformance report while recording corrective and preventive action

Select the “Non-Conformance Report” tab in the “Record Corrective and Preventive Action” page.

The “Non-Conformance Report “ tab page appears:

The multiline displays the following.

NCR #	The identification number of the non-conformation report.
NC Description	The name/description of the non-conformation report.
Proposed Action-Auditor	The action planned for resolution of the NC.

Enter the following:

CAPA Plan

The proposed Corrective and Preventive Action Plan submitted for Auditors approval

The system displays the following.

NC Status

The status of the NC.

Enter the following:.

Action

Use the drop-down list box to specify the action required for correcting the NC. Select

“Pending Action”, to indicate Corrective and Preventive action is pending
“Cancel”, to indicate to cancel the Non- conformance

Note that if no value is saved for this field and if the “CAPA Plan Required” field in the “Set Options” activity of the current business component is set as “Yes”, the system displays the default value in this field as follows:

1. “Propose CAPA” if the NC Status is either "Pending", “Deferred", "Proposal Accepted", or "Proposal Rejected"

2. “Report Conformance” if NC Status is “CAPA Rejected”.

Note that if no value is saved for this field and if the “CAPA Plan Required” field in the “Set Options” activity of the current business component is set as “No”, the system displays the default value in this field as follows:

3. “Report Conformance” if NC Status is “Pending” or “Deferred”.

NC Category

Use the drop-down list box to specify the NC category. The system displays quick codes defined under the Quick Code Category “NC Category” whose status is “Active” in the “Maintain Quick Codes” activity.

Note that the system displays “Blank” as an option only if this quick code has been selected as “No” for the field “Mandatory?” in the “Set Options” activity of the current business component.

Note: Ensure the following:

If the option “CAPA Plan Required” in the “Set Options” activity is set as “Yes”, then ensure the following for each of the records selected:

1. A value other than “Report Conformance” is selected as the “Action” when the NC Status is “Pending”.

2. A value is specified in the “CAPA Plan” column when “Propose CAPA” is the “Action”.

3. That the NC Status is specified as “Pending” when “Propose CAPA” is the “Action”.

4. The NC Status is "Proposal Accepted"/"Deferred"/"CAPA Rejected" if “Request Extension” is selected as the “Action”.

If the option “CAPA Plan Required” in the “Set Options” activity is set as “No”, then ensure the following for each of the records selected

1. The NC Status is "Pending", "Deferred", or "CAPA Rejected" if “Report Conformance” selected as the “Action”.

2. The NC Status is "Pending", "Deferred", or "CAPA Rejected” if “Request Extension” is selected as the “Action”.

The system displays the following.

Severity

The seriousness of the NC.

Enter the following field in the multiline:

NC User Status

Use the drop-down list box to specify the NC user status. The system displays quick codes defined under the Quick Code Category “NC User Status” whose status is “Active” in the “Maintain Quick Codes” activity.

Action By Date

The date by which the proposed action to resolve the NC, must be complete.

Note that the date in this field can be modified only if the NC Status is “Pending” or “Proposal Rejected”.

The system displays the following.

Responsible Person For CAPA

The employee code of the person in charge of corrective and preventive action to resolve the NC.

Enter the following.

Corrective Action Performed	Any remedial action proposed to resolve the NC.
Preventive Action Performed	Any action propose to prevent the NC.
Root Cause	Use the drop-down list box to specify the root cause of the NC. The system displays root causes whose status is “Active” defined in the “Maintain Root Cause Codes” activity. Ensure the following: Data selection in this field is mandatory if the following conditions are true: 1. If the parameter “Root Cause Mandatory” is set as “Only in CAPA”, and / or 2. If the parameter “Root Cause Info during CAPA Recording” is set as “Allowed” in the set options activity of the current business component 3. If “Report Conformance” or “Close” is selected in the “Action” field for the modified rows in the multiline. The data in this field cannot be modified: 1. If the parameter “Root Cause Mandatory” is selected as “Only in Findings” and / or If the parameter “Editing of Root Cause Info during CAPA Recording” is set as “Not Allowed” in the set options activity of the current business component.
Contributing Factor	Use the drop-down list box to specify the contributing factor of the NC. The system displays root causes whose status is “Active” defined in the “Maintain Root Cause Codes” activity.

The system displays the following.

Return Comments

The Processing Comments recorded in the “Process Non-Conformities/Reports” page.

Enter the following fields in the multiline:

Root Cause Analysis	An analytical vie/breakdown of the root cause.
Human Factor	Use the drop-down list box to specify the human factor responsible for the NC. The system displays quick codes defined under the Quick Code Category “Human Factor” and whose status is “Active” in the “Maintain Quick Codes” activity.
Causal Category	Use the drop-down list box to specify the causal category of the NC. The system displays quick codes defined under the Quick Code Category “Causal Category” and whose status is “Active” in the “Maintain Quick Codes” activity.
Impact Analysis	An analytical view of the effect of the NC on the audit/audit entity.
Impact Analysis Ref.	Any document or reference that supports the impact analysis.
CAPA Approver #	The employee code of the CAPA approver, (Alphanumeric, 15).Help facility available
File Name	The document that contains the NC report. Help facility available
Auditee Remarks	The remarks of the auditee.

The system 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.
Mandatory?	Indicates whether the given question is mandatory to be responded while auditing which could be “Yes” or “No”.
Question Type	The type of question in the checklist.
Question Category	The category to which the question belongs
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.
Ques ID	A user defined identification number for the questionnaire.

Select the “View File” hyperlink to view the selected file.

To proceed, carryout the following:

Select the “Summary of Observations” tab to record response details and actions on observations.

Select the “Reference Details” tab to record details of references.