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.