QP-04 Internal Audit

Doc. No. : QP-04 Rev.
No : 00
INTERNAL AUDIT
Eff. Date : Page No : 1 of 5
REVISION HISTORY
Rev. Detail of Revision Date

00 Initial Release
APPROVALS
PREPARED BY REVIEWED & APPROVED BY
Signature : Signature :
Name Name
Designation Designation
Date Date
1.0 PURPOSE
To ensure the Quality Management System is effectively implemented.
Doc. No. : QP-04 Rev. No : 00
INTERNAL AUDIT
2.0 SCOPE
This procedure covers internal audit carried out at all functions.
3.0 REFERENCE
Quality Manual QM-01
Management Review QP-03
Corrective Action QP-07
4.0 DEFINITION /ABBREVIATION

QMR - Quality Management Representative
CAR - Corrective Action Report
5.0 PROCEDURE OUTLINE
Responsibility Activity Interface
QMR Prepare Internal Audit Yearly Audit

Yearly Schedule Schedule
Appoint auditor & prepare Memo/Audit Plan

QMR
Audit Plan
Auditor Prepare Audit Checklist Audit Checklist
Auditor Auditing Audit Checklist
Auditor Prepare Audit Report & Audit Report/

CAR CAR
Responsibility Activity Interface
Prepare Audit Report & Audit Report /

QMR
CAR CAR
Responsible person Investigate root cause and Audit Report /

determine CAR
correction/corrective action
INTERNAL AUDIT
Implement
correction/corrective action
Verify effectiveness of
Auditor corrective action Audit Report/
CAR
No
Effective?
Yes
Closed the CAR

QMR Management Review
Procedure
Compile and submit to
Management Review
6.0 PROCEDURE DETAILS

6.1 Audit Planning
6.1.1 All activities within the scope of the Quality Management System is
subjected to an audit frequency of once a year, based on the Yearly Audit
Schedule prepared and maintained by the QMR.
6.1.2 The Yearly Audit Schedule is prepared as based on the status and
importance of the area/functions to be audited as well as the results of
previous audits.
6.1.3 Before the audit, QMR shall assign Auditor to audit the areas/functions
concerned & prepared the Audit Plan.
INTERNAL AUDIT
6.1.4 QMR shall ensure all the auditors are trained (have gone through
Awareness Training and Internal Audit Course) and independent of the
area/functions to be audited. If possible, preferably the selected internal
auditors have some practical auditing experiences.
6.1.5 The Audit Plan shall be communicated to auditors and all department head
or respective personnel in advance prior to the audit.
6.2 Auditing & Reporting

6.2.1 The Auditors shall prepare Audit Checklist on the area/functions to be
audited.
6.2.2 On the day of audit, the Auditors shall conduct an opening meeting (if
required) to explain the audit scope & the audit schedule to the auditees.
6.2.3 The Auditors shall carry out the audit by interviewing the relevant people,
examine the records and check against the documents and ISO 9001
standard. Sampling methodology should be used to capture objective
evidence.
6.2.4 The auditors shall take notes of all observations or findings during the audit
process and record in Audit Checklist.
6.2.5 Where nonconformity is detected during the audit, the auditor shall raise
Corrective Action Request (CAR) after discussion and clarification with
the auditee and prepare the Audit Report.
6.2.6 The auditor may issue an observation note on any observed minor non-
compliance after discussion and clarification with the auditee.
6.2.7 QMR shall review the Audit Report and CAR before passing to the
responsible person for corrective action.
6.2.8 QMR shall determine dateline to reply the CAR.
6.2.9 The responsible person shall investigate the root cause of the
nonconformities and determine correction and corrective action to prevent
recurrence.
6.2.10 The responsible person shall implement the corrective action taken as well
as CAR.
INTERNAL AUDIT
6.2.11 Where any corrective action leads to the update/changes of Quality

Management System, it shall be carried out according to the Control of
Document procedure.
6.3 Verification
6.3.1 The QMR/Auditor shall verify the effectiveness of the corrective action
and record the result in CAR.
6.3.2 The auditor shall close the CAR if the correction/corrective action is
effective or satisfactory. Otherwise, the Auditor shall carry out for the 2 nd
review within the agreed dated.
6.3.3 The auditor shall raise another CAR & Audit Report if the result of the 2 nd
review is not effective or satisfactory. The QMR shall address the matter
to the D and seek resolution.
6.3.4 QMR shall compile the results of the audits and present in the Management
Review Meeting. Refer to Management Review Procedure.

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Doc. No. : QP-04 Rev.

Rev. Detail of Revision Date

PREPARED BY REVIEWED & APPROVED BY

4.0 DEFINITION /ABBREVIATION

5.0 PROCEDURE OUTLINE

Responsibility Activity Interface

QMR Prepare Internal Audit Yearly Audit

Appoint auditor & prepare Memo/Audit Plan

Auditor Prepare Audit Checklist Audit Checklist

Auditor Auditing Audit Checklist

Auditor Prepare Audit Report & Audit Report/

Prepare Audit Report & Audit Report /

Responsible person Investigate root cause and Audit Report /

Closed the CAR

6.0 PROCEDURE DETAILS

6.2 Auditing & Reporting

6.2.11 Where any corrective action leads to the update/changes of Quality

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