03 internal quality audit qsp03

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QUALITY SYSTEM PROCEDUREDoc. Title : Internal QualityAudit

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Doc. No. : QSP03 Date : 01.03.2011

INTERNAL QUALITY AUDIT

01.03.2011 0 First Issue.DATE OF ISSUE REVISION REVISION DESCRIPTION

Approved by Managing Director : _____________________________

Prepared by Management Representative : _____________________________

Internal Quality Audit. of 5 QSP03




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Doc. No. : QSP03 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 anddocumented 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 internalquality auditing of the quality management system.

2.0 RESPONSIBILITIES:

MANAGEMENT REPRESENTATIVE:

Toprepare the annual internal quality audit schedule and the internal qualityaudit plan.

Co-ordinate with the internal quality auditors to perform the audits timely andeffectively.

Changes in the audit plan and schedules.

Condu

ct management review meetings. Prepare the overall internal quality audit reports, which are to be presented forthe management review meetings.

Followup with the department managers to close out the internal quality auditCAR’s.

INTERNAL QUALITY AUDITORS:

Prepare the internal quality audit checklist for the relevant department they aregoing to audit.

Conduct the internal quality audits as per the schedule.

Prepare and issue the CAR’s for the non-conformities observed during theauditing.

Carryout the follow-up audit to close out the CAR’s noticed during the auditing.

DEPARTMENT MANAGERS:





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Release 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.

Alsoresponsible to clear the CAR’s during the follow-up audit and implementsthe proposed corrective actions in their section.

3.0 PROCEDURE:

A. AUDIT PLANNING:

3.1 The MR shall prepare the annual internal quality audit schedule (QF03A) in thebeginning of every year. The internal quality auditing shall be done at leasttwice in a year.

3.2 The annual internal quality audit schedule shall indicate the planned month of auditing, the departments which are to be audited and also the criteria forauditing.

3.3 As per the annual internal quality audit schedule, the internal quality audit

plan (QF03B) is prepared by the MR. The internal quality audit plan shallindicate the audit criteria, departments which are to be audited, the date andtime of audit, the name of auditor and the auditee. It shall also indicate thedate of follow up audit also.

3.4 The MR shall be responsible for any alterations in the annual internal qualityaudit schedule and the internal quality audit plan.

3.5 The MR shall ensure that the internal quality auditors are impartial and thatthey are not auditing their own area of concern.

3.6 The MR shall issue the internal quality audit plan to the respective departmentheads to release the internal quality auditors for performing the task.

3.7 The MR is responsible for ensuring that the internal quality audit programtakes place. He shall also be responsible for proposing training of internalquality auditors.

B. AUDIT PREPARATION:

3.8 The internal quality auditor shall be responsible to prepare the internal qualityaudit check list, (QF03C) prior to the auditing





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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 thelocal standards (quality manual, procedures, process plans, and workinstructions.)

- by contacting the auditee and confirming the date and time of audit.

C. CONDUCTING THE INTERNAL QUALITY AUDIT:

3.10 Prior to the commencement of the audit, the internal quality auditor shalladvice the auditee on the objective, scope and methodology of the audit.

3.11 During the auditing, the auditor will make use of the standard auditingtechniques to collect objective information concerning the subject being

audited and also will collect documentary evidence for conformity or non-conformity. He shall also keep the auditee informed as to the progress of theaudit and any findings.

3.12 In the event of non-compliance observed, the internal quality auditor mayselect further samples to verify the extent of compliance.

3.13 If non-conformances are noticed, the internal quality auditor shall prepare aCorrective Action Request (CAR), (QF03D) highlighting the deviations andreferring to the relevant documents based on the objective evidence obtainedduring the audit.

3.14 The internal quality auditor shall bring the non-conformity to the notice of theconcerned department manager and they shall agree upon the timelycorrective actions.

3.15 Two copies of the CAR shall be made. One copy to be handed over to theconcerned auditee and the other with the MR. The CAR report shall be signedoff by all parties concerned as being a true and accurate representation of thefacts.

3.16 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).

3.17 The concerned department manager shall be responsible to implement thecorrective actions as planned and the MR shall be responsible to monitor theeffectiveness of the implemented corrective actions.





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3.18 The MR shall be responsible to carry out the follow-up audit with any of theinternal quality auditor to verify the implementation and effectiveness of thecorrective actions. Follow-up activities shall indicate the verification of the

actions taken and the reporting of the verification results.

3.19 Based on the results of the follow-up audit, the Management Representativefor Quality shall consider as to whether the CAR shall be closed or not. Thestatus of the CAR shall be maintained by the MR in a prescribed format.(QF03E).

3.20 If the auditee persistently fails to carry out the assigned follow-up actions, theauditor must inform the MR, who will take steps to ensure that the follow upaction takes place.

4.0 QUALITY FORMS

Form Description Form No.1. Annual internal quality audit schedule QF03A2. Internal Quality Audit Plan QF03B3. Internal Quality Audit Check List QF03C4. Corrective Action Request QF03D5. Internal Quality Audit Status Register QF03E

5.0 RECORDS

Quality Records LocationRetention

PeriodDispositionAuthority

1. Annual Internal Quality AuditSchedule

M.R. Office Two years M.R.

2. Internal Quality Audit Plan M.R. Office Two years M.R.3. Corrective Action Requests M.R. Office Two years M.R.4. Internal Quality Audit StatusRegister

M.R. Office Two years M.R.

6.0 REFERENCES

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


03 internal quality audit qsp03

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