AUDIT PROCESS

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 Quality
Degree to which a set of inherent 
characteristics fulfils a need or
expectation that is stated, generally
. implied or obligatory
ISO 9000:2000 
Definition 2.2.11 

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 Quality audit

 Systematic, independent and

documented process for obtaining
evidence and evaluating it objectively
to determine the extent to which audit
criteria are fulfilled.
 ISO 9000:2000

 Definition 2.9.1

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 Audit criteria
–
– Set of policies, procedures or
requirements against which collected
audit evidence is compared.
– Ex: Customer requirements,
Documented quality system, Company
standards, ISO 9001:2000
– ISO 9000:2000
– Definition 2.9.4

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 ISO 19011:2001 m
Scope

 It is applicable to all organizations

implementing, maintaining or auditing a
quality and/or environmental
management system and thus having
a need to conduct and manage internal
and/or external management system
audits.
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 Quality system audit types

 1st Party - WE auditing our own

system (Internal)
 2nd Party - WE auditing our supplier

(External)
 3rd Party - WE being audited by a

registration body, (TUV) (External)

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 Audit objectives
 Objectives for an audit might be any of the following:
 a) determining the extent of conformity of the auditee's
management system to specified requirements.
 b) evaluating the capability of the management system to
ensure compliance with legislative requirements
 c) evaluating the effectiveness of the implemented
management system in meeting specified objectives
 d) identifying areas of potential improvement of the
management system

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 Auditing benefits

* Verifying compliance


 *Providing information for management

 review
 * Increasing quality awareness


 *Reducing risk of product/service failures

 Identifying improvement opportunities
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 Auditors
responsibilities

* Complying with company requirements

* Assist with preparing audit schedule
* Carrying out the audit
* Record and report the findings
* Carry out follow-up audit
* Maintain independence and confidentiality
* Maintain audit records

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 Auditor attributes

 Open mindedness
 Tenacity
 Diplomacy
 Decisiveness
 Observant
 Self-reliance
 Perceptiveness
 Integrity
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 Auditing Process

 Six phases of a structured audit:

 - audit scheduling
 - Preparation
 - conducting the audit
 - reporting the results
 recording proposed corrective action and
timescales
 -following up actions

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 Audit planning

*The organization shall plan the

audit programme taking into
account the status and importance
of the activities and areas to be
audited as well as the results of
previous audits (ISO 9001:2000
Clause 8.2.2)

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 Audit planning
 Departments Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov
Dec
 Principals offi p p A p
A
 Agricultural Coll. P
 City college p A A
 Eastlands college p
A
 Technical college A p A
 Purchasing A p A
p
 Kitchen A A p
 Chem. Laboratory A
p
 Documents/records A A
p
 Auditing A A
p
 Food store A
p
 Key: P = Audits scheduled on the basis of IMPORTANCE only
 A = Additional audits taking into account the STATUS and
 IMPORTANCE.


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 Planning decisions

 frequency
 timing
 scope
 objectives
 auditors

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 Preparing for the audit

 An audit plan needs to be prepared which

 includes as appropriate:
 a) audit objectives and scope
 b) audit criteria and reference documents
 c) areas and /or activities to be audited and the
agreed dates of the audit(s)
 d) identification of any processes to be audited
 e) audit duration
 f) the need for guides and their responsibilities
 g) audit method 21
 Audit documents

* audit procedures
* nonconformity report forms
* audit summary report forms
* corrective action schedule
* checklists

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 Checklist benefits

 Maintains clear audit objectives

 Evidence of planning
 Maintains audit pace and continuity
 Reduces risk of auditor bias
 Manages auditor workload
 Records sample of activities in the audit

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 Audit method

• Vertical (Upstream/ downstream)

* Horizontal

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 Conducting the audit
 Opening meeting
 Collecting and verifying information
 Record audit findings
 Keep auditee informed
 Prepare reports
 Report audit findings

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 Questions

 The six "friends" of an auditor: The auditors

seventh "friend"
 What?
 Show me (please)
 Why?
 Where?
 When?
 How.?
 Who?

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 Classifying

 Major nonconformity might be

defined as:
 A nonconformity of such severity that its

existence would indicate that a

nonconforming product or service could be
released to the customer or, where the
requirements of an appropriate clause of
ISO 9001:2000 has not been adequately
addressed.
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 Classifying

 Minor nonconformity might be defined

as:
 A situation where there is a likelihood

that nonconforming product or service

will occur, or where the benefits of ISO
9001-.2000 are not being realised,
because of the absence of, or lack of
adherence to a procedure.
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 Report meeting

 Summarise findings
 Review nonconformities
 Agree commitment for corrective
actions
 Agree timescales

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 Follow-up options

 Verification at location of audit

findings
 Review of documentation

 Verification at next audit

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