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What is the CORRECTIVE ACTION FOLLOW-UP ?

The auditee is responsible for determining and initiating corrective action needed to correct a nonconformity or to correct the cause of nonconformity.

The auditor is only responsible for identifying the nonconformity.

Corrective action and subsequent follow-up audits should be completed within a time period agreed to by the client and the auditee in consultation with the auditing organization.

Note: The auditing organization should keep the client informed of the status of corrective action activities and follow-up audits. After verification of corrective action implementation, the auditing organization may prepare a follow-up report and distribute it in a manner similar to the original audit report.

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34. What are the AUDIT OBSERVATIONS ?
35. What it mean by the CLOSING MEETING with AUDITEE ?
36. What are AUDIT DOCUMENTS ?

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What are AUDIT DOCUMENTS ?

01. Audit Report Preparation :

The audit report is prepared under the direction of the lead auditor, who is responsible for its accuracy and completeness.

02. Report Content :

The audit report should faithfully reflect both the tone and content of the audit. It should be dated and signed by the lead auditor. It should contain the following items, as applicable :

A) The Scope and Objectives of the audit;

B) Details of the audit plan, the identification of audit team members and auditee's representatives, audit dates, and identification of the specific organization audited.

C) Identification of the reference documents against which the audit was conducted (Quality System Standard, Auditee's Quality Manual, etc.)

D) Observations of nonconformities.

E) Audit team's judgment of the extent of the auditee's compliance with the applicable quality system standard and related documentation.

F) The system's ability to achieve defined quality objectives.

G) The audit report distribution list.

A function-wise and clause-wise summary of noncompliances may be presented in the form of a NC Matrix.

Any communication made between the time of the closing meeting and the issue of the report should be by the lead auditor.

03. Report Distribution :

The audit report should be sent to the client by the lead auditor. It is the client's responsibility to provide the auditee's senior management with a copy of the audit report. Any additional distribution should be determined in consultation with the auditee. Audit reports containing confidential or proprietary information shall be suitably safeguarded by the auditing organization and the client.

The audit report should be issued as soon as possible. If it cannot be issued within an agreed time period, the reason for delay should be given to both the client and the auditee and a revised issue date established.

The audit is completed upon submission of the audit report to the client.

04. Record Retention :

Audit documents should be retained by agreement between the client, the auditing organization and the auditee, and in accordance with any regulatory requirements.

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What it mean by the CLOSING MEETING with AUDITEE ?

At the end of the audit, prior to preparing the audit report, the audit team should hold a meeting with the auditee's senior management and those responsible for the functions concerned. The main purpose of this meeting is to present audit observations to the senior management in such a manner so as to ensure that they clearly understand the results of the audit.

The lead auditor should present observations, taking into account their perceived significance.

The lead auditor should present the audit team's conclusions regarding the quality system's effectiveness in ensuring that quality objectives will be met.

Records of the closing meeting should be kept.

If requested, the auditor may also make recommendations to the auditee for improvements to the quality system. Recommendations are not binding on the auditee. It is up to the auditee to determine the extent, the way and means of actions to improve the quality system.

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What are the AUDIT OBSERVATIONS ?

All audit observations should be documented. After all activities have been audited, the audit team should review all of their observations to determine which are to be reported as nonconformities. The audit team should then ensure that these are documented in a clear, concise manner and are supported by evidence. Nonconformities should be identified in terms of the specific requirements of the standard or other related documents against which the audit has been conducted. Observations should be reviewed by the lead auditor with the responsible auditee manager. All observations of nonconformities should be acknowledged by the auditee management.

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Monday, May 21, 2007

What is the CORRECTIVE ACTION FOLLOW-UP ?

What are AUDIT DOCUMENTS ?

What it mean by the CLOSING MEETING with AUDITEE ?

What are the AUDIT OBSERVATIONS ?