Ø
Select the “Non-Conformance Report” tab.
The multiline displays the following.
NCR # |
The identification number of
the non-conformation report. |
NC Description |
The name/description of the
non-conformation report. |
Ø
Enter the following.
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” and whose status is “Active” in the
“Maintain Quick Codes” activity. |
||
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” and whose status is “Active” in the
“Maintain Quick Codes” activity. |
||
NC Category |
Use the drop-down list box to
specify the category of the NC. |
|
|
NC User Status |
Use the drop-down list box to
specify the user status of the NC. |
|
|
The system displays the following.
NC Status |
The status of the NC. |
Ø
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 |
The system displays the following.
Severity |
The seriousness of the NC. |
Proposed Action |
The action planned for
resolution of the NC. |
Ø
Enter the following.
Action By Date |
The date by which the
proposed action to resolve the NC, must be complete. |
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. |
Ø
Enter the following.
Corrective Action |
Any remedial action proposed
to resolve the NC. |
Preventive Action |
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. |
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. |
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. |
Ø
Select the “Reference Details” tab.
The multiline displays the following.
Reference Element |
The reference factor. |
Reference # |
The identification number of
the reference document. |
Instructions |
Any procedural steps
pertinent to the reference. |
File Name |
The reference document
associated with the audit. |
Ø
Select the “View File” link to see the document associated
with the audit.