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
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– 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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