0.

1E– Audit Management

 Session Plan

Format: Student led learning session with debates, participation and & open discussion
Objectives: Understand the importance of managing the audit in line with ISO 19011
Understand the various stages of the audit and their function

Understand the importance of effective planning and preparations for the

audit including the necessity of precise determination of audit scope

Understand the purpose and benefits of pre-audit contacts and their

typical forms

Understand the process and system approach to an audit and in particular

the importance of understanding the structure of the quality management
system, its processes, their sequence and interaction for planning and
performance of an audit.

Understand the requirements of ISO /IEC 17021 on auditing practices.

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Audit management

Audits MUST be well managed

to deliver good VALUE.
►The audit team leader has the overall responsibility for
the audit. Audit team members to assist the team
leader (for details on responsibilities see Chapter 15)
► Good audit management requires good:

 Planning and Preparation

 Communications (Client, Auditees and Auditors)

 Accurate and Objective Fact Finding

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Parties involved in an audit

Auditee
Auditee Provides
Providesaccess,
access,data,
data,
Organisation
Organisation information
information

Determines
Determinesobjectives,
objectives,
AuditClient
Audit Client
scope,
scope,criteria
criteria

1st.,2nd.,
2nd.,3rd
3rdParty
Party Auditor
AuditorTeam
Team
1st., (includes Audit
Auditing (includesauditors,
auditors, Audit
Auditing technical performance
Organisation technical expertsand
experts and performance
Organisation auditors in-training)
auditors in-training)

Audit
Auditreport
report
LeadAuditor
Lead Auditor

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Types of Audits

3 Types of Audits
First Party Audit
• Self-audit (Client, auditor and auditees are
Internal)

Second Party Audit

• Audit by an interested body (like a customer)

Third Party Audit

• Audit by independent body
(certification/registration body)

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The different phases of an audit

Time
6.2
6.2 Initiating
Initiating the
the audit
audit

6.3
6.3 Document
Document review
review ?

6.3
6.3 Preparing
Preparing for
for on-site
on-site activities
activities

?
6.4
6.4 Conducting
Conducting On
On site
site audit
audit
6.5
6.5 Audit
Audit reporting
reporting ?
6.6
6.6 Completing
Completing thethe audit
audit
?
6.7
6.7 Audit
Audit Follow-up
Follow-up
Reference:ISO19011 Section 6

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 Applicable audit methods Reference:ISO19011

Extent of involvement Location of the auditor Location of the auditor

between the auditor
and the auditee On-site Remote

Human - Conducting interviews. Via interactive

interaction - Completing checklists and communication means:
questionnaires with auditee — conducting interviews;
participation. — completing checklists
- Conducting document and
review with auditee questionnaires;
participation. — conducting document
- Sampling. review with auditee
participation.

No human - Conducting document - Conducting document

interaction review (e.g. records, data review (e.g. records, data
analysis). analysis).
- Observation of work - Observing work performed
performed. via surveillance means,
- Conducting on-site visit. considering social and
- Completing checklists. legal requirements.
- Sampling (e.g. products). - Analysing data.

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Audit management

Initiating the Audit

► Define audit objectives, scope and criteria
 Check the brief from the client and validate with auditee.
► Determine feasibility of the audit
 Is information and estimates of time and resources adequate?
► Select the audit team
 Need competence to fulfill audit objectives.
► Establish initial contact with the auditee
 What do they do?
 How big are they?
 Complexity of operations
 Degree of readiness
Ref: ISO 19011-6.2

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Audit management

Initiating the Audit

Audit Criteria Audit Scope
Reference against which
Extent and boundaries of the
conformity is determined
audit including:
►Standard
Locations
►Contractual Specification Organisational units

►QMS Documentation Activities and processes

covered
►QMS Planning

►Legislation or other
requirements Team Composition ?
Ref: ISO 19011-6.2 & ISO 17021

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Audit management

Managing Impartiality
What is impartiality….?

What is conflict of Interest..?

How do you think Auditors can be ‘insulated’ from

possible conflict of interest..?

Ref: ISO 19011-6.2 & ISO 17021

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Audit management

Conducting Stage 1 audit

► Adequacy of Documentation

► Assess readiness for full systems audit (I.e Stage 2 Audit)

► Focus on planning for Stage 2 (implementation) audit

► Establish personal contact and rapport with auditee

► Validates scope, purpose, methods

► Gather additional information

► Identify potential problems

Preparing for Stage 2 audit

 What preparations are required for a stage 2 audit?

 Can Stage 2 audit be done offsite? Ref: ISO /IEC 17021 & ISO 19011

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Audit management

Determination of person-days
Effective Number Audit Duration Audit Duration
of personnel
(Stage 1 + Stage2) – (Stage 1 + Stage2) –
No of Days – for No of Days – for
QMS EMS
(For Medium Complexity
Organisation)

1-5 1.5 2.5

6-10 2.0 3.0
11-15 2.5 3.5
16-25 3.0 4.5
26-45 4.0 5.5
46-65 5.0 6.0

Ref: IAF guideliens- MD5

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Audit management

Audit Plan Working Documents

► Scope 
Checklists
► Criteria 
Forms
► Dates & duration 
Standard
► Audit team 
Guidelines
► Detailed timetable

► Matrix plan

► Audit team requirements

► Remember to cover shifts

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Audit management

Notify the auditee and audit team

 Audit plan
 Timetable
 Matrix plan
 What else ?

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Audit management

Conducting on-site Audit Activities

►Team exercise :
 What are good meeting practices?
 Each team to make a list.

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Audit management

Conducting on-site Audit Activities

►Conducting the opening meeting

►Communication during the audit

►Collecting and verifying information

►Preparing audit conclusions

►Conducting the closing meeting

Ref:ISO 19011-6.4 & ISO/IEC 17021

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Audit management

Conducting On-site Audit Activities

Meetings, Communications and Field Visits

Opening and Closing meetings are formal

communications.

Wash-up meetings report ongoing status,

findings and progress.

Team liaison meetings help coordinate and

focus the audit team.

Regular feedback to auditees provides

ongoing communication
(see chapter “performing the audit “of this course).

Ref:ISO 19011-6.4

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Audit management

Opening meeting agenda:

►Introduce the team ►Grading of NCR’s

►Reason, scope & criteria ►Confirm staff aware &

available
►Review audit plan and
methods ►Confirm logistics

►Explain about sampling ►Confirm guides

►Confidentiality ►Safety requirements

►Method of reporting ►Questions

Ref:ISO 19011-6..4.2

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Audit management

Team Liaison Meetings:

►To ensure smooth and effective progress of the audit

►To ensure audit scope is covered

►To review non-conformances

►To collate the findings

Intermediate & final wash-up meetings

 With MR and other managers

 To review the audit findings
 To discuss non-conformances
 To agree corrective actions
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Audit management

Closing Meeting Agenda

►Thank the auditee and ►Disclaimer
reintroduce the team
►Overall summary
►Recap reason, scope & criteria
►Questions & answers
►Review audit plan and methods
►Corrective actions & time-
►Report the observations, scale
positive & negative
►Recommendation

►Follow-up

Ref:ISO 19011-6.4.9

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Audit management

Follow-up action Documentary Evidence

 At agreed time • Records

 Review of documentary • Training certificates

evidence • Amended procedures
 Re-audit on the site • Photographs
 Only review of corrective • Videos
actions
 Don’t start it all over again

•What if they are late?

Ref: ISO 19011-6.7

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