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 |
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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 |
--- |
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 |
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 |
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, |
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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