Sixth lecture

Audit reports
 Audit report

An audit report is a record that shows the

actual status of what was discovered as a
.result of the audit process
 Contents of the audit report

Details of the .summary

.audit process .Opening session
.the goal .Closing session
.Term .Non-matches
.Audit team Workers request
.Audit plan .correction
 Preparations for the report

.The chief auditor prepares the report

The chief auditor reviews and approves
.the report
The report is sent along with a request to
take appropriate action within a specified
.period of time
distribution

.The audited institution

.The auditing party
 Confidentiality

The audit report must not be

distributed without written approval
from both the auditor’s
management and the audited
.entity’s management
 Response to the report

The auditor must respond to the

report by recording the proposed
corrective action within 14 days of
.being notified
 Record the audit report

One of the responsibilities of the

quality manager that requires an
appropriate administrative system to
.record the audit trail and its report
Conduct correction and follow-up

Corrective action and follow-up

 Corrective action

:ISO 8402 defines corrective action as

It is the measure taken to eliminate “

the causes of a non-conformity,
defect, or any undesirable situation
with the aim of preventing its
”.reoccurrence
 Preventive measures

The ISO 8402 standard defines

:preventive measures as

It is the measure taken to avoid “

the causes of the occurrence of an
expected non-conformity, defect,
or any undesirable situation with
 Corrective action

Corrective action must be taken

:if

External audit process (second party, third

party)
Internal audit
.Management audit
.Product non-conformity
.Customer complaints
 Request corrective action
A corrective action request has the following
:characteristics

.Reference number
.Details about the relevant department or activity
.Reference specification
.Details of non-conformity
.Proposed corrective action
The name of the person/department concerned
with the procedure and the expected date of its
 Stages of corrective action
Close it when active
Non-conformity detection

Determine the extent of nonc

Follow-up

Development
Quick fix

erify correction procedures Report and

implement Know the root causes of the pr
corrective
actions
 the responsibility

.Managers' responsibilities
Responsibilities of the audit team
.leader
 Current response

An immediate response is necessary

.to correct the non-conformity

The auditor must verify, with

objective evidence, the
effectiveness of the corrective
.action in the long term
Determine the extent of the
problem
.There is a canceled document
The presence of a test device that is
not included in the calibration
.control system
Purchasing materials from a supplier
 Investigate root causes

:The root causes are

Failure to dispose of a canceled
.document
Failure to define some types of
.testing devices
Lack of appropriate qualifications
.and competence
Failure to identify factors affecting
 Investigate root causes

Root causes are difficult to

:implement

Lack of knowledge, understanding, or

commitment from some members of
.management or employees
Lack of resources, personnel,
 Long-term corrective action

Determining the real root causes of

the problem is not easy, but it is
necessary to avoid the problem
.from recurring
 Verify effectiveness

Follow-up of the corrective action is

necessary to ensure its
.effectiveness
 Follow-up and closure

Verification must be through

.records
Evaluating new or amended
.regulations
Conduct another audit of the
activity in question after the date
.specified for closing the procedure
 Follow-up and closure

Important questions to take into

:consideration

What type and amount (sample size) of

information is required to perform
?appropriate verification
How much time is allowed to test the
corrective action to find sufficient evidence
?of its effectiveness
Follow up on corrective action

Records

Proposed corrective action

 Follow up on corrective action

Follow the application

escalation
Follow up on corrective action

Verification
 Preventive measures

Preventive measures fall within the scope

of attention of internal auditors, and as
soon as the necessity of preventive
action appears, a mechanism must be in
place to follow it up in the same way as
.in corrective action