PROCEDURE FOR “INTERNAL AUDITS
Purpose:
The purpose This procedure is to implement a system for planned internal audits to verify compliance of the QMS activities and related result with the planned arrangement and to determine effectiveness of the QMS and identify opportunities for improvement.
Scope:
This procedure is applicable to all activities of the QMS and requirements of the international standards in the company.
Responsibility:
QUALITY MANAGER is responsible for implementation of this procedure.
Procedure:
Audit are designed for one or more of the following purposes
(a). To determine conformity or nonconformity of the activities to the specified requirement and elements of the International Standard / QMS.
(b). To determine effectiveness of the implemented QMS in achieving the specified quality policy and quality objectives.
(c). To verify compliance of QMS activities and related result with the planned arrangements, documented QMS.
Internal Audits are conducted at least once in six months.
Audit planning and schedule
QUALITY MANAGER makes annual plan for internal audit in the beginning of the year.
Based on the annual plan, QUALITY MANAGER prepares audit schedule based on the status and importance of the activity. He appoints the auditors for each area to be audited. Each audit team is required to audit all applicable elements of the quality system in the assigned department / function for audit.
QUALITY MANAGER informs the audit schedule to all auditors and the auditees.
Audit is conducted by the trained personal, independent of those having direct responsibility for the area / activity to be audited, wherever applicable & practical.
Executing the audit
During audit the auditor covers entire scope of the audit or as advised by the
QUALITY MANAGER
Before starting audit the auditor properly prepares a checklist wherever required for convenience in audit, to save wastage of time during audit and to follow a professional approach.
QUALITY MANAGER conducts an opening meeting among the auditors and audit heads to ensure availability of the resources and facilities required to conduct the audit.
Evidences are collected through interview, examination of document and observations of activities & condition in the concerned area / function.
Clues indicating nonconformity are noted, if they seem significant even through not covered by the checklist, and are investigated.
Information collected through interview is verified obtaining the same information from other independent sources like physical observation, measurements and records.
All audit finding are documented at the end of audit, audit team and auditees head reviews the entire finding to identify the actual nonconformity. Audit findings are documented on the non-conforming report.
All the audit finding and nonconformity are acknowledged by the auditees or auditee’s head.
Audit Report
Audit report is prepared for identified nonconformity on Non conformity report for its accuracy and completeness and submitted to the auditees.
Audit Completion
Audit is completed on submission of the audit report to the auditees.
Corrective action and follow-up:
Auditor is responsible only for identification of the nonconformity.
Auditees dept. is responsible to determine and initiate corrective action required to correct the nonconformity or its cause and for closure of the raised non-conformity report.
Corrective action and its follow-up are completed within a time period, agreed by the auditor and auditees dept. If required, QUALITY MANAGER is also consulted in this regard.
On the agreed completion date or earliest possible, auditor goes to the auditees dept. and verifies the satisfaction & effective implementation of the corrective action taken.
Auditor records his comments regarding verification of the corrective action taken. On satisfaction he signs and closes the nonconformity.
QUALITY MANAGER includes the audit report with details of the corrective actions taken in the agenda of the next management review meeting.
AUDIT CRITERIA:
The findings of the audit are categorized under three categories:
A). Observation/OFI (Opportunity for improvement)-which may result into non-conformity at the later stage if not addressed today.
B). Minor N C – All N C to be treated as major. Immediately take all the necessary step to resolve the problem
C). Major N C – Immediately bring it in attention of Higher Management. Take all the necessary step to resolve the problem