An audit is a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled. This presentation illustrates: - The Audit definition - Possible reasons for auditing - Audit Types - How to conduct an audit 0- Audit preparation 0 Audit performance 0- Audit reporting 0- Audit follow up and closure - Auditor key skills * For business possibilities, feel free to contact me.

1. Audit
MOHAMED ABOGAZIA
SEP 2017

2. M. Abogazia
The audit definition
•The on-site verification activity, such as inspection or
examination, of a process or quality system, to ensure
compliance to requirements. An audit can apply to an entire
organization or might be specific to a function, process, or
production step.

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The audit definition cont.
•An audit is a systematic, independent and documented
process for obtaining audit evidence and evaluating it
objectively to determine the extent to which audit criteria
are fulfilled.

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Possible reasons to audit:
•ensure compliance with ISO 9001:2008
•ensure compliance with organization requirements
•ensure compliance with regulatory requirements
•ensure the QMS is effectively implemented and maintained
•look for opportunities for improvement
•look for preventive action

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“Comply” V.S “confirm”

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Audit types:
•Internal audits – first party.
•Customer audits of suppliers – second party.
•External independent audits – third party.

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Audit types:
•Internal audits – first party
oPerformance to the organization’s objectives
oIdentification of problem areas!
oFinding opportunities for improvement!

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Audit types:
•Customer audits of suppliers – second party
oConformance to customer requirements
oCustomer’s special interest items

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Audit types:
•External independent audits – third party
oConformity to a specific standard

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The system
The process
The
product
The system audit is the largest and the most
extensive audit which focus on the entire
Quality Management System of the
organization.
A process audit usually concentrate on 1 or 2
specific process within an organization.
A product process is a final assessment of final
product (after final inspection) to ensure
conformance to all requirements and “fitness
for use”
Audit types:

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How to conduct an audit?

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Audit
preparation
• Audit planning
is a key factor
to make it
successful!
Audit
performance
• The style of
carrying out
the audit
defines how
skillful the
auditor is!
Audit
reporting
• Audit has no
meaning
without
communicating
the audit
result!
Audit
follow-up
and closure
• How to
eliminate
shortfalls
effectively!
The audit phases

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Define the
purpose
• Why the audit
will be
conducted?
• -System
maintenance?
• -Improvement
confirmation?
• -Problem
investigation?
Define the
scope
• Where the
audit will be
conducted
• -Which area?
• -Which
process?
• -Which
product?
Identify
requirements
• What are the
requirements
should be
achieved?
• -Standards
• -Procedures
• -Manuals
• -Forms
Notify the
auditee
• What is going
to be carried
out? When?
How?
• -Audit
notification
• -Schedule
• -Readiness
confirmation
Prepare
checklists
• Questions to
be asked?
• -Check list
contents
• -References
Audit preparation

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Introducing
audit
• Meet the
auditee!
• -Review purpose
and scope
• -Review
scheduleand
guide
Start the
audit
• Using checklist!
• -Ask questions
(Open question!)
• -Gather
information
(interview right
persons)
• -Confirm facts!
Identify
nonconformities
• What are the
nonconformities
you found?
• -Clearfor auditee
• -Nonconformity
Evidence
• -Get auditee
agreement
Closing the
audit
• Meet the auditee,
again!
• -Audit summary
• -Highlight good
points
• -Summarize
improvement
points!
Audit performance

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Audit report
• Detailed reporting!
• -Audit details(Date,
purpose, scope,
attendees, etc.)
• -Good points summary
• -Main findings
(Majornonconformities,
Minornonconformities,
improvement points)
CAR* issuance
• CAR against
nonconformities!
• -Nonconformity reference
• -Evidence of nonconformity
• -Required actions
• -Target date
CAR log
• CAR log contents
• -List of nonconformities
• -Target dates of closing and
follow up
• -Corrective and Preventive
actions
• -Actual date of closure
Audit reporting
*CAR = Corrective Action Request

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Re-audit
• Confirm
countermeasure
• -Using CAR log target
dates
• -Verify
countermeasure of
nonconformities
• -Field visit may be
needed
Countermeasure
effectiveness
• Is it sustainable?
• -Action continuitycheck
• -How to maintain!
• -Verify understandingby
main player
• -CloseCAR!
Status
reporting
• Closed CAR reporting to
management!
• -CAR Log again!
• -Report to related manager
(QMS officer!)
• -File all Audit Records and
keep retrievable
• -Re-check in next audit!
Audit follow up and closure

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Auditor key skills
•Excellent communication skills!
•Ability to put auditee at ease!
•Ability to stay calm when working under pressure
•Being objective –unbiased –facts only!
•Ability to analyze what is said by auditee
•Ability to link between audited process within scope!

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This presentation prepared and
conducted by:
Eng. Mohamed Abogazia

20. M. Abogazia
References:
• [1] Shewhart, Walter A. (1931). Economic Control of Quality of Manufactured Product. New York: D. Van Nostrand Company.
ISBN 0-87389-076-0
• [2] Dr. Edwards Deming (2000). Out of the Crisis. MIT Press, Centre for Advanced Engineering Study.
• [3] Mikel Harry and Richard Schroeder (2000). Six Sigma The Breakthrough Management Strategy Revolutionizing The World’s
Top Corporation.
• [4] James P Womack and Daniel T Jones (1996). Lean Thinking. Simon & Schuster. ISBN 0-684-81035-2
• [5] Taiichi Ohno (1988). Toyota Production System: Beyond Large-Scale Production, Productivity Press, ISBN 0-915299-14-3
• [6] Shigeo Shingo (1990). Modern Approaches to Manufacturing Improvement: The Shingo System. Productivity Press, ISBN 0-
915299-64-X
• [7] Kaoru Ishikawa (1976). Guide to Quality Control. Asian Productivity Organization, UNIPUB. ISBN 92-833-1036-5