Recording Final Non-Conformance report for NCs                           

Recording Quality Audit Findings

Unified Glossary

Basics of using a typical web page

Prerequisites

Using online help

The “Final NC Report” tab page appears

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 system generates the following.

Line #

A system generated number indicating the line number of the entry in the multiline.

NCR #

The identification number of the NC report.

NC Description

The name / description of the NC. Mandatory.

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.

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.

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.

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.

The system generates the following:

NC Status

The status of the NC, which could be “Pending Deferral”, “Acceptance Pending” or “Actioned”.

Action

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

  • “Pending Action”, to indicate CAPA is not complete.

  • “Cancel”, to indicate to cancel the NC.

Severity

Use the drop-down list box to specify the severity of the NC. The system displays quick codes defined under the Quick Code Category “Severity” and 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.

Ref. Procedure

The procedures followed or used as reference for recording NCs.

Risk Index

 A numeric value to Numeric value to quantify the risk caused by the NC.

Objective Evidence

A qualitative or quantitative information, records or statements which can be verified as evidence for recording the NC.

Proposed Action Auditor

The corrective action proposed by the auditor against the NC.

Action By Date

The date by which corrective action must be complete.

Ensure that the date entered int his field is earlier than the current system date.

When no value is specified in the “Standard Duration for Corrective Action (Days)” field in the “Set Options” activity of the current business component, data entry int his field is mandatory if the following conditions are true in the multiline:

1. A value is specified in the “NCR #” column.

Responsible Person for CAPA

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

Ensure that the number entered in this field:

  • Is a valid and active employee number as defined in the “Employee Personal Information” business component.

  • Is mapped to the user name as on the current date.

Note that if no value is specified in this field, the system retrieves the value from the “Audit Execution / Personnel Details” tab page. However, if no value is specified the “Responsible Person for CAPA” field in the “Audit Execution / Personnel Details”  tab p age, the system defaults the value of the “Primary Auditee” given in the Audit Execution/Personnel Details” tab.

Help facility available

Observation Type

Use the drop-down list box to specify the observation type of the NC. The system displays quick codes defined under the Quick Code Category “Observation Type” and 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.

Root Cause

Use the drop-down list box to specify the root cause of the NC. The system displays the root causes defined  with “Active” status in the “Maintain Root Cause Codes” activity.

Date entry in this field is mandatory if the following conditions are true:

  • The parameter “Editing of root cause Info during CAPA recording” in the Set Options activity of the current business component is set as “Not Allowed”

  • The parameter “Root Cause Mandatory” is set as “Both” or “Only in Findings”.

Ensure that the value selected in this field is a valid root cause in “active” status.

Contributing Factor

Use the drop-down list box to specify the contributing factor for the of the NC. The system displays the root causes defined  with “Active” status in the “Maintain Root Cause Codes” activity.

Ensure that the value selected in this field is a valid root cause in “active” status.

Root Cause Analysis

 An analytical view / 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.

Ensure that the value selected in this field is a human factor which is in “active” status.

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.

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.

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.

File Name

The document associated with the NC.

Help facility available

Auditor Remarks

Any comments / additional information from the auditor.

The system generates the following.

Ques ID

A user defined identification number for the questionnaire.

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

The system updates the Audit Status  in the Audit Report Details group box as “Findings Recorded”.

To proceed

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Prerequisite

1. An Audit Report must have been created

2. The Audit Status in the “Audit Report Details” group box must be other than "Findings Confirmed", "Pending Action", "Pending Closure", or "Closed"

Note: The system does not allow addition of new rows in the multiline if the Audit Report is Checklist Based.

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