② Items that require corrective actions should be reported to the head of department to be audited
so that corrective actions can be taken before the end meeting of the audit. When corrective
actions are not taken for an item, this item automatically becomes a pointed out item.
(3) Items to be pointed out
① Problems and significant changes according to requirements by quality/envirment management system.
② Nonconforming products against quality requirements
③ Auditors should prepare for an audit checklist reflecting requirement of quality management
system for a smooth audit process.
(4) Meeting after audit
① After audit, the audit team should have a meeting with the audited department and inform
the results of audit and items pointed out. Both parties resolve different opinions.
② Auditors should take minutes of the meeting and circulate the minutes to the attendees.
Attendess should sign and date in the minutes.
4) Reporting of audit results
(1) A head of quality control should prepare results of audit that includes items pointed out
within 7 days and report the results to the management representative.
(2) When corrective actions need to be taken or a significant problem is pointed out, a head
of quality control should record these in the results of audit and report the results to the
department audited.
(3) The audit team automatically disbands after reporting the results of audit to the management
representative.
5) Follow-up actions
(1) A head of quality control evaluates a reply to the audit results, makes sure if corrective actions
are taken by checking documents or by re-auditing, and controls corrective and preventive actions.
(2) When correcitve actions are verified to be taken, a head of quality control prepares the results
of corrective and preventive actions, and gets approval for the results from the management
representative, which closes the items for corrective actions.
(3) When a reply to the results of the audit or the results of corrective actions are not satisfying,
a head of quality control prepares another request with enhanced corrective actions and sends
the request to the department audited.
(4) Re-audit after corrective actions does not require the plan for annual audit and audit checklist,
but it could be carried out in a same way as the original audit. The results of re-audit should be
reported to the management representative.
(5) A head of quality control reports the results of audit to the management representative as
management review data.
6) Audit for production process
(1) A head of quality control makes plans for audit for representative products and product lines
twice a year.
(2) Production process audit should be carried out according to the audit plans, and the results
should be recorded.
(3) The audit procedure for production process follows that for quality/ environment management system.