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312 Part IV: Quality Assurance
examples of discrepancies. Examples of effective or noteworthy accomplishments,
such as effective components of the quality system or innovative processes that
prevent mistakes, are documented in the working papers as well the final audit
report to encourage further implementation. Examples of discrepancies such as
inadequate instructions, training, and/or noncompliance with customer specifications
are documented in the working papers as well the final audit report to initiate
corrective action.
When the need for corrective action is identified during an audit, a corrective
action request (CAR) is generated. A CAR is a document that identifies a discrepant
condition(s), the source or standard giving rise to the discrepant condition, when
and who discovered the discrepant condition, who is responsible for addressing
the discrepant condition, the allowable time frame for corrective action, and so
on. The primary intent of the CAR is to trigger action eliminating, or reducing the
negative effects of, the condition. Ultimately, the CAR is intended to be the vehicle
that drives process improvement. From this perspective, the CARs directly impact
customer satisfaction. So important are CARs, they are normally cited in the audit
report with a required action to verify that the CAR was acted on and actually
resulted in one or more process improvements.
Audit Reporting and Follow-Up
Part IV.C.3
A final report is submitted to the client indicating the facts of the audit and conclusions
regarding the ability of the subject system, element, process, or product
to achieve quality objectives. Proper planning and execution of the audit facilitates
the preparation of this report and provides data to support its conclusions.
The lead auditor is responsible for the accuracy of the report and the validity of its
conclusions. The report should be submitted to the client, who in turn is responsible
for providing a copy to the auditee.
The audit final report should include, at a minimum, the following:
1. Type of audit conducted
2. Objectives of audit
3. Identification of involved parties: auditor, auditee, and third party
4. Audit team members
5. Critical nonconformities (CARs) and other observations (effective or
noteworthy accomplishments)
6. Audit standards and reference documents used
7. Determination of proper corrective action(s)
8. Duration of audit
9. Audit report distribution and date
10. Audit results and recommendations
11. Audit-related records