Subject :Internal Quality Audit Ref : QD26
1.0 Purpose
This document serves to ensure the compliance of procedures and planned activities as well as to determine the effectiveness of the quality system. 
2.0 Scope
Applicable to the Quality Management and any other Internal Quality Auditors responsible for conducting the audit as well as to the respective personnel accountable for the audited activity.
3.0 Attachment
Attachment MA/QD26/001 - Internal Quality Audit Schedule
Attachment MA/QD26/002 - Internal Quality Audit Checklist
Attachment MA/QD26/003 - Discrepancy/Variation Report
Attachment MA/QD26/004 - Auditee/Auditor Acknowledgment Form
4.0 Procedure
System Flow Responsibilities
& Authorities
Related Docs
& Forms
Notes
Appoint Internal Quality Auditors (IQA)
.

QM

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1
Conduct Internal Quality Audit
.
Internal Quality Auditor

Internal Quality Audit Checklist

2
Acknowledge Non-Conformances
.
Auditee/Internal Quality Auditor Auditee/Auditor Acknowledgment
3
Generate Discrepancy/Variation Report
.
Internal Quality Auditor

Discrepancy/Variation Report

4
Conduct Post Audit Review/Meeting DInternal Quality Auditor, Dept head/Section Head
.

Discrepancy/Variation Report

5
Initiate Corrective Action(s)
.
Dept/Section Head

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6
Conduct Verfication Audit
.
Internal Quality Auditor Discrepancy/Variation Report 7
Review/Close Audit Internal Quality Auditor

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8

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Highlights/Explanation
Note 1:

The Quality Management shall co-ordinate the Internal Quality Audit activities. He shall appoint two or more Internal Quality Auditors (depending on the areas of audit) form the company to assist in the audit.

The Internal Quality Audit shall be conducted at least once a year and this shall be recommended by the quality Management and approved by the Managing Director prior to the commencement of the audit.
.

Note 2:

The scope of the audit shall be conducted in the activities as reflected in the Internal Quality Audit Schedule (Attachment MA/QD26/001)

The Internal Quality Auditor shall conduct the audit to verify compliance of the various activities to the documented procedure as specified in the Quality Manual. As a guide, the Internal Quality Audit Checklist (Attachment MA/QD26/002) shall be used Audits are to be conducted in the presence of the person-in-charge of the area or activity.
.

Note 3:

Non-conformances on the part of the auditee and/or activity shall be recorded on the Auditee/Auditor Acknowledgment Form (Attachment MA/QD26/004) by the Internal Quality Auditor and this shall be acknowledged/signed by the auditee and Internal Quality Auditor.
.

Note 4:

Deficiencies in the audited activities shall be documented by the Internal Quality Auditors on a Discrepancy/Variation Report (Attachment MA/QD26/003).
.

Note 5

A post audit meeting shall be conducted by the Internal Quality Auditor together with the Quality Management and the respective Section/Department Head of the areas audited to explain discrepancies found and to discuss on the time required to take the necessary corrective action. A verification audit date shall also be agreed upon and should be within a period of one month - all these shall be recorded in the Discrepancy/Variation Report and be acknowledged/signed by the Internal Quality Auditor and Section/Department Head.

* A copy or copies of the Discrepancy/Variation Report(s) will be 
  extended to the Section/Department Head of the affected department 
  for their awareness and corrective actions.
.

Note 6 The affected department shall initiate corrective actions on the discrepancies and ensure that this is done within the given time i.e., 01 month.

* Should the affected department be unable to rectify the discrepancies 
  within the stipulated time, the Section/Department Head shall inform the 
  Internal Quality Auditor and QM and obtain a mutual agreement to 
  extend the deadline.

Note 7 The Internal Quality Auditor shall on the specified date of the Verification Audit, review the corrective actions taken on the discrepancies using the respective Discrepancy/Variation Report.
Note 8 Should the Internal Quality Auditor find the discrepancies rectified, he shall close the audit by recording the findings in the "Auditor's Comments" of the then arrange to have the completed audit report returned to the Quality Management for filing.

* Should the Internal Quality Auditor not find the discrepancies rectified, 
  he shall schedule and conduct further verification audits until all 
  discrepancies are satisfactorily resolved.
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General Remarks/Comments
Any changes to the documents in the quality manual as a result of the audit shall be done according to QD11 (Document Control).

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