Procedure Outline
1. Internal Audit of Quality System
- Quality Manager (MM) arranges a plan for internal audit for 12 months period, each Division once in a year minimum.
- Time planning which is set up for each Division depends on priority with consideration of audit implementation urgency.
- Prior to audit, MM will determine auditor team which is consist of 2 people for each team, these people is enlisted in ISO internal auditor but not enlisted as a member of audited Division (independent). One of them appointed as a leader/ head of internal auditor team.
- One week prior to audit date, the appointed auditor should be contacted in order to prepare the audit. If one of auditor unable to do the audit, MM will replace with other auditor. Auditor reconfirms about audit execution to the Head of Division. If there is a change on audit time, the auditor will inform MM.
- If necessary, MM will monitor the audit execution and/or invite other personnel to be an observer.
2. Reporting the Internal Audit Result
- After the audit has been done, auditor prepares the finding of non-conformance by using Internal Audit Report Form and Corrective Action Requirement.
- In order to fill up non-conformance in a form, the auditor has to complete the available columns and describe an observed non-conformance based on 4 following requirements :
- Description of non conformance
- Objective evidence of non-conformance
- Non-conformance aspect/process
- Non-conformance in a specific document.
- Internal audit report signed by the head of auditor team prior delivery to the auditee (Head of Division) in order to make an agreement of non-conformance, and determination of corrective and preventive actions which have to conduct by intended Division.
- If necessary the MM will make some changes in the non-conformance description before the copy is produced, it can be redactional change, change in category, cancellation due to the lack of objective evidence, or the change of number due to its integration to the major non-conformance.
- As the agreement of audit result and corrective/preventive actions have not been reached yet, the head of internal auditor team has to stay responsible for the reporting status. An adequate report will deliver to MM for review and make copies for distribution.
- If audited Division implemented corrective and preventive actions before the designated time, the Division will inform the MM for verification. If the MM did not informed about the corrective and preventive action status, then MM will verify it on designated time.
- If corrective and preventive actions have not been done on designated time, the Head of Division, as the one in charge, have to make a written reason to explain why the actions cannot be done and arrange reschedule for verification. And if the verification time passed again without corrective and preventive actions, the MM will make a non-conformance for the same case.
- If necessary, MM can give some action or change suggestions for corrective and preventive actions which are proposed by the Head of Division, with some consideration based on quality system implementation.
- Audit report will be one of discussion material in Management Review Meeting.
- If there are any suggestion or correction demand from external auditor, the finding report and response will be proceed as internal audit procedure.