Professional Documents
Culture Documents
The Quality
Auditing
[Training for Quality
Auditors]
2
Course Syllabus and Agenda
Definition:
A quality audit is a systematic, independent and
documented process of examining any activity of an
organization based on objective evidence, to determine
a. The extent to hich quality activities and related results
comply ith the planned arrangements
b. The extent to hich these arrangements have been
implemented effectively, and
c. hether these arrangements are suitable to achieve the
quality objectives.
!hat is an Audit"
5
#ompliance audit:
The process of chec!ing hether the organization has
implemented hat they have stated and hether the
people are doing, the documents had as!ed them to do.
!hat is an Audit" Continued#
7
"nternal audit:
"nternal audit acts as the organizations eyes and ears to
gather feedbac! for correction and improvement.
The purpose of internal audit is
1
to identify possible product2process improvements.
1
to identify deficiencies in products or in the plant2quality
management system.
$nternal Audit
9
$act finding
(nbiased
*onest
Tactful
Attentive
/atient
Arrogant
3egligent
7iased
8ague
7laming
"mpatient
"mpolite
15
+espect #onfidentiality.
;ou ill be in possession of sensitive or confidential
information : do not discuss it outside of the audit>.
Auditors Responsibilities
18
8erbal overload from the auditee may dilute the true response.
Audit /lanning
&election of Auditors
/re%audit "nformation
Planning and Preparation
23
Audit /lan
The audit plan is a formal document, hich covers every
area, process and department for the audit activity.
"t specifies :
6uality )anual
#ontents
Auditing Techniques
6uestioning Techniques
Try to remember names for use during the audit 9 /eople li!e to
have their names remembered.
:et your host !no that you are !eeping a record of all requests.
.eneral Techniques
,hat
,here
,hen
,ho
-pen questions :
The ansers to your open ended questions ill tell you if the
auditee understood the questions.
#losed questions :
Are the operators responsible for entering process data into the
recordB
The anser does not allo you to judge if the question as fully
understood 'or miss understood0 by the auditee.
Does not promote a dialog beteen the auditor and the auditee.
;ou must engage the auditee in order to realize the full benefits
of the audit.
7efore you forget here you ere and hat you observed.
Reporting Audits
54
&end the audit report and observations ith a cover letter or a cover
e%mail to the auditee.
=nsure that you include firm instructions for reporting corrective and
preventive actions bac! to you.
=nsure that you have self notification process that can tell you hen
someone is overdue for reporting corrective actions.