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3 Types of audits
Product audit An examination of a particular product or
service (hardware, processed material, software) to evaluate
whether it conforms to requirements (that is, specifications,
performance standards, and customer requirements).
Process audit A verification that processes are working
within established limits. It evaluates an operation or method
against predetermined instructions or standards to measure
conformance to these standards and the effectiveness of the
instructions. Such an audit may:
Check conformance to defined requirements such as time,
accuracy, temperature, pressure, composition,
responsiveness, amperage, and component mixture.
Examine the resources (equipment, materials, people)
applied to transform the inputs into outputs, the
environment, the methods (procedures, instructions)
followed, and the measures collected to determine process
performance.
Check the adequacy and effectiveness of the process
controls established by procedures, work instructions,
flowcharts, and training and process specifications.
System audit An audit conducted on a management system.
It can be described as a documented activity performed to
verify, by examination and evaluation of objective evidence,
that applicable elements of the system are appropriate and
effective and have been developed, documented, and
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Purposes of audits
An auditor may specialize in types of audits based on the audit
purpose, such as to verify compliance, conformance, or
performance. Some audits have special administrative purposes
such as auditing documents, risk, or performance or following up
on completed corrective actions.
Certification
Companies in certain high-risk categoriessuch as toys, pressure
vessels, elevators, gas appliances, and electrical and medical devices
wanting to do business in Europe must comply with Conformit
Europenne Mark (CE Mark) requirements. One way for
organizations to comply is to have their management system
certified by a third-party audit organization to management system
requirement criteria (such as ISO 9001).
Customers may suggest or require that their suppliers conform to
ISO 9001, ISO 14001, or safety criteria, and federal regulations and
requirements may also apply. A third-party audit normally results
in the issuance of a certificate stating that the auditee organization
management system complies with the requirements of a pertinent
standard or regulation.
Third-party audits for system certification should be performed by
organizations that have been evaluated and accredited by an
established accreditation board, such as the ANSI-ASQ National
Accreditation Board (ANAB).
Performance versus compliance/conformance audits
Various authors use the following terms to describe an audit
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4 Phases of an audit
1. Audit preparation Audit preparation consists of
everything that is done in advance by interested parties, such as
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the auditor, the lead auditor, the client, and the audit program
manager, to ensure that the audit complies with the clients
objective. The preparation stage of an audit begins with the
decision to conduct the audit. Preparation ends when the audit
itself begins.
2. Audit performance The performance phase of an audit is
often called the fieldwork. It is the data-gathering portion of
the audit and covers the time period from arrival at the audit
location up to the exit meeting. It consists of activities including
on-site audit management, meeting with the auditee,
understanding the process and system controls and verifying
that these controls work, communicating among team
members, and communicating with the auditee.
3. Audit reporting The purpose of the audit report is to
communicate the results of the investigation. The report should
provide correct and clear data that will be effective as a
management aid in addressing important organizational issues.
The audit process may end when the report is issued by the lead
auditor or after follow-up actions are completed.
4. Audit follow-up and closure According to ISO 19011,
clause 6.6, The audit is completed when all the planned audit
activities have been carried out, or otherwise agreed with the
audit client. Clause 6.7 of ISO 19011 continues by stating that
verification of follow-up actions may be part of a subsequent
audit.
Note: Requests for correcting nonconformities or findings are very
common. Corrective action is action taken to eliminate the causes of
an existing nonconformity, defect, or other undesirable situation in
order to prevent recurrence (reactive). Corrective action is about
eliminating the causes of problems and not just following a series of
problem-solving steps. Preventive action is action taken to
eliminate the causes of a potential nonconformity, defect, or other
undesirable situation in order to prevent occurrence (proactive).
Excerpted from The ASQ Auditing Handbook, J.P. Russell, editor,
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