QUALITY SYSTEM PROCEDURE

Doc. Title : Internal Quality Audit Doc. No. : QSP03 Rev. No. : 0 Date : 01.03.2011

INTERNAL QUALITY AUDIT

01.03.2011
DATE OF ISSUE

0
REVISION

First Issue.
REVISION DESCRIPTION

Approved by Managing Director

: _____________________________

Prepared by Management Representative : _____________________________

Internal Quality Audit.

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QSP03

QUALITY SYSTEM PROCEDURE

Doc. Title : Internal Quality Audit Doc. No. : QSP03 Rev. No. : 0 Date : 01.03.2011

1.0

SCOPE:
The purpose of this procedure is to ensure that the Quality Management System is being operated correctly and effectively, by performing planned and documented checks, designed to ensure that, but not limited to: - the quality system documentation adequately defines the need of the business - the documented procedures and work instructions are practical, understood and implemented. - the training of employees is adequate to allow them to do their tasks. Also this procedure defines the way in which the company will perform internal quality auditing of the quality management system.

2.0

RESPONSIBILITIES: MANAGEMENT REPRESENTATIVE:

To prepare the annual internal quality audit schedule and the internal quality audit plan. Coordinate with the internal quality auditors to perform the audits timely and effectively. Chang es in the audit plan and schedules. Condu ct management review meetings. Prepar e the overall internal quality audit reports, which are to be presented for the management review meetings. Follow up with the department managers to close out the internal quality audit CARs.

INTERNAL QUALITY AUDITORS:

Prepar e the internal quality audit checklist for the relevant department they are going to audit. Condu ct the internal quality audits as per the schedule. Prepar e and issue the CARs for the non-conformities observed during the auditing. Carry out the follow-up audit to close out the CARs noticed during the auditing.

DEPARTMENT MANAGERS:
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QUALITY SYSTEM PROCEDURE

Doc. Title : Internal Quality Audit Doc. No. : QSP03 Rev. No. : 0 Date : 01.03.2011

Releas e the internal quality auditor working in his section as per the audit plan. Ensur e that the responsible person in his section shall be available at the time of auditing and to co-operate with the auditors for a smooth auditing. Also responsible to clear the CARs during the follow-up audit and implements the proposed corrective actions in their section.

3.0 A. 3.1

PROCEDURE: AUDIT PLANNING:

The MR shall prepare the annual internal quality audit schedule (QF03A) in the beginning of every year. The internal quality auditing shall be done at least twice in a year. The annual internal quality audit schedule shall indicate the planned month of auditing, the departments which are to be audited and also the criteria for auditing. As per the annual internal quality audit schedule, the internal quality audit plan (QF03B) is prepared by the MR. The internal quality audit plan shall indicate the audit criteria, departments which are to be audited, the date and time of audit, the name of auditor and the auditee. It shall also indicate the date of follow up audit also. The MR shall be responsible for any alterations in the annual internal quality audit schedule and the internal quality audit plan. The MR shall ensure that the internal quality auditors are impartial and that they are not auditing their own area of concern. The MR shall issue the internal quality audit plan to the respective department heads to release the internal quality auditors for performing the task. The MR is responsible for ensuring that the internal quality audit program takes place. He shall also be responsible for proposing training of internal quality auditors.

3.2

3.3

3.4
3.5

3.6 3.7

B. 3.8

AUDIT PREPARATION:
The internal quality auditor shall be responsible to prepare the internal quality audit check list, (QF03C) prior to the auditing
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Internal Quality Audit.

QUALITY SYSTEM PROCEDURE

Doc. Title : Internal Quality Audit Doc. No. : QSP03 Rev. No. : 0 Date : 01.03.2011

3.9

The internal quality auditor shall prepare himself for each audit as follows: - by reading through previous audit reports. - by familiarizing himself with the requirements of ISO 9001:2008 and the local standards (quality manual, procedures, process plans, and work instructions.) - by contacting the auditee and confirming the date and time of audit.

C.
3.10

CONDUCTING THE INTERNAL QUALITY AUDIT:

Prior to the commencement of the audit, the internal quality auditor shall advice the auditee on the objective, scope and methodology of the audit. During the auditing, the auditor will make use of the standard auditing techniques to collect objective information concerning the subject being audited and also will collect documentary evidence for conformity or nonconformity. He shall also keep the auditee informed as to the progress of the audit and any findings. In the event of non-compliance observed, the internal quality auditor may select further samples to verify the extent of compliance. If non-conformances are noticed, the internal quality auditor shall prepare a Corrective Action Request (CAR), (QF03D) highlighting the deviations and referring to the relevant documents based on the objective evidence obtained during the audit. The internal quality auditor shall bring the non-conformity to the notice of the concerned department manager and they shall agree upon the timely corrective actions. Two copies of the CAR shall be made. One copy to be handed over to the concerned auditee and the other with the MR. The CAR report shall be signed off by all parties concerned as being a true and accurate representation of the facts. The CAR report shall contain the following details: CAR Ref. No. Date of Audit. The Procedure and ISO clauses audited. Name of Auditor and Auditee. The Results of the Audit. Agreed Corrective Actions. Follow up Audit date (tentative). The concerned department manager shall be responsible to implement the corrective actions as planned and the MR shall be responsible to monitor the effectiveness of the implemented corrective actions.
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3.11

3.12

3.13

3.14

3.15

3.16

3.17

Internal Quality Audit.

QUALITY SYSTEM PROCEDURE

Doc. Title : Internal Quality Audit Doc. No. : QSP03 Rev. No. : 0 Date : 01.03.2011

3.18

The MR shall be responsible to carry out the follow-up audit with any of the internal quality auditor to verify the implementation and effectiveness of the corrective actions. Follow-up activities shall indicate the verification of the actions taken and the reporting of the verification results. Based on the results of the follow-up audit, the Management Representative for Quality shall consider as to whether the CAR shall be closed or not. The status of the CAR shall be maintained by the MR in a prescribed format. (QF03E). If the auditee persistently fails to carry out the assigned follow-up actions, the auditor must inform the MR, who will take steps to ensure that the follow up action takes place.

3.19

3.20

4.0

QUALITY FORMS Form Description 1. Annual internal quality audit schedule 2. Internal Quality Audit Plan 3. Internal Quality Audit Check List 4. Corrective Action Request 5. Internal Quality Audit Status Register Form No. QF03A QF03B QF03C QF03D QF03E

5.0

RECORDS
Quality Records 1. Annual Internal Quality Audit Schedule 2. Internal Quality Audit Plan 3. Corrective Action Requests 4. Internal Quality Audit Status Register Location M.R. Office M.R. Office M.R. Office M.R. Office Retention Period Two years Two years Two years Two years Disposition Authority M.R. M.R. M.R. M.R.

6.0

REFERENCES
Quality System Procedures for: a.) Control of Non-conforming product. b.)Corrective Actions.

Internal Quality Audit.

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QSP03