Procedure MQC/SP/012 Internal Auditing

1        Purpose & Scope

1.1     This procedure facilitates planning and implementation of internal quality audits to verify that the quality activities and their results comply with the quality systems established in the Organization.

1.2       This procedure covers internal quality audits of all functions covered under the quality systems implemented in the Organization.

2        Responsibility & Authority

2.1     MR is overall responsible for implementation of internal quality audits.

2.2       Designated lead auditors and auditors are responsible for carrying out internal quality audits and for submission of audit reports.

2.3       Concerned HODs are responsible for taking appropriate corrective actions based on the nonconformities observed during the internal quality audit.

2.4       MR and concerned lead auditors are authorized to clear the nonconformity’s raised during the Audit.

3        Procedure

3.1            Internal quality audits are carried out for all functions and departments at least once in a year. MR prepares the internal quality audit plan for the year and based on the same, releases the audit schedule for conducting the internal quality audits at least one week before the audit and circulates the same to all concerned.  The schedule also identifies and the lead auditors and the team members for carrying out the audit. The frequency for the audit may be increased depending on the status and importance of the activity. The scope of audit includes all the activities of the department / function covered under the quality management systems.

3.2            In case there is significant change in Organization’s policy that affects the quality system, additional internal quality audits are carried out to verify their implementation and effectiveness.

3.3            Trained personnel who do not have direct responsibility for the activity being audited carry out internal quality audits.

3.4            Based in the scope and objectives of the audit, the lead auditor collects the working documents for recording the observations and reporting the results.   Wherever appropriate he prepares a checklist to facilitate effective performance of the audit.

3.5            While conducting the audit evidences are collected through interviews and/or examination of documents and observation of the activities being performed.

3.6            In case any nonconformity is observed, the same are documented in FM 112.

3.7            NCRs are identified in terms of the specific requirements of the standard and uniquely identified by assigning them a number.

3.8            NCRs are brought to the notice of auditee who acknowledges the same and indicates the reasons for the nonconformance, proposed corrective actions and the time schedule for implementing the same.

3.9            The auditee implements the corrective actions to eliminate the causes of the nonconformities observed during the audit and may offer the same for verification

3.10         If corrective actions were completed before submission of the audit report, the auditor, lead auditor/MR are authorized to clear the nonconformities based on verification and acceptance of the corrective actions taken by the auditee.

3.11         After submission of the audit report, the corrective actions are verified by MR or any person nominated by him for clearing the nonconformity reports.

3.12       Consolidated results of Internal Quality Audits, the corrective actions and their implementation and effectiveness are reviewed by the management during the management review meetings.

4                 References

 

 

5      Records

S.No.

Name of Record

Location

Retention Period

1 Audit Plan

MR

3 Years

2 Audit Results

MR

3 Years

 

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