Chapter 3: Conducting an audit

Duration: 14:05 Hours (445 minutes)

Primary Objective:
After completing this chapter participants will be able to conduct an internal audit activity.
Enabling Objectives:
At the end of this chapter, participants will be able to:

 Initiate an audit
 Prepare for audit activity
 Review documents during an audit
 Conduct an audit activity
 Prepare and distribute audit report
 Complete an audit
 Conduct audit follow-up

Summary of activities

S. Activity Method of delivery Time Slide

N Number

1 Initiate an audit Reflection 20 min 1- 8

Lecture

2 Prepare for audit activity Interactive presentation and 45 min 9 - 16

discussion
Lecture

3 Review of documents during an audit Interactive presentation and 100 min 17 - 36

discussion
Lecture

4 Conduct an audit activity Interactive presentation and 110 min 37 - 54

discussion
Lecture

5 Prepare and distribute audit report Think/Pair/Share 15 min 55 – 58

Lecture

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6 Complete an audit One minute paper 10 min 59-61
Lecture

7 Conduct audit follow up Interactive presentation and 5min 62

discussion
Lecture

8 Chapter summary Lecture 5 min 63

Moke Laboratory audit and report Field Practice 540 min 64

presentation (Field Practice)
Report preparation
Interactive presentation
Evaluation by instructors

Resources needed:

● Flip chart and markers

● LCD projector and laptop

● Internet connection

● Participant Manual

● ISO 19011 standard

● SLIPTA Checklist

● Field activity evaluation checklist

● Vehicle for field practice

Advance preparation:

 Prepare blank flip chart and of different color markers for each group
 Read the Facilitator Guide, Participant Manual, the PowerPoint Presentation, Standards and
Checklist
 Ensure one Participant manual is provided for each participant
 Prepare 2 SLIPTA Checklist for Field visit
 Prepare evaluation checklist for practical field audit

Learning activities

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S. Topic Time Activities
No. (Min)

1 Initiate an audit 20
● Introduce yourself to the participants (your name, profession
 Reflection and organization) displaying slide 1. (If necessary
 Lecture
● Introduce the title of the chapter slide 2.

● Review the chapter objectives by displaying slide 3.

● Show the chapter outline of the presentation on slide 4.

● Display slide 5

o Ask the participants reflection questions

o Give them 5 minutes for reflection of three questions.
o Debrief the activity (see answer key of activity 3.1)

● Display slide 6-7 and explain the importance of establishing

contact with auditee.

● Display slide 8 and explain the determination of audit

feasibility.

2 Prepare for audit 45

● Display slide 9, and
activity

 Interactive o Create five groups on the topic provided

presentation o let them to discuss and present.
and discussion o Time: 30 minutes (10 minute for discussion and
 Lecture preparation,4 minutes for each group presentation)
o Debrief the activity (see answer key of activity 3.2)

● Display slide 10 and explain the importance of document

review

● Display slide 11 and explain types of documents to be

reviewed and factors to be considered during review.

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 ● Display slide 12, and explain the factors that team leaders
should consider to adopt during risk-based approach
planning.

● Display slide 13 and explain the scale and content of audit

planning, explain about that audit planning should address.

● Display slide 14 and explain considerations in audit planning

● Display slide 15 and explain how the team leader assign

team members responsibilities.

● Display slide 16 and discuss the documented information for

the audit to be prepared.

3 Review of documents
● Display slide 17
during an audit

 Interactive o Group the participants into five members.

presentation o Provided document (Document control SOP)
and discussion o Instruct to review the provided SOP against ISO
 Lecture 15189 version 2022 clause number 8.3
o Assist them on the reviewing process
o let them to present the findings of the review.
o Time: 60 minutes (35 minutes for discussion and 5
minutes for each group presentation)
o Debrief the activity (see answer key of activity 3.3)
 Display slide 18 and define what the document is.
 Display slide 19 and explain the five stages life cycle of
document.
 Display slide 20 and explain the document creation stage.
 Display slide 21 and explain the document review stage.
 Display slide 22, explain the document approval stage.
 Display slide 23, explain the document updating stage.
 Display slide 24, explain the document publishing stage.
 Display slide 25, discuss about the document review during
an audit.
 Display slide 26, explain benefits of document review.
 Display slide 27-30, explain how to conduct document

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 review.
 Display slide 31-35, explain the five tips(notes) used for
guiding document reviews.
 Display slide 36, explain things to be indicated during
document review report.

4 Conduct an audit 100  Display slide 37,

activity o Form two large groups and instruct to discuss all steps of
conducting an audit activity.
 Interactive o Let them summarize and present the discussion points.
presentation and
o Time:40 minutes (20 minutes for discussion and 10
discussion
 Lecture minutes for each group presentation).
o Debrief the activity (see answer key of activity 3.4)
 Display slide 38-40, Explain about roles and responsibilities
of guides and observers.
 Display slide 41, explain the purpose of opening meeting
 Display slide 42-43, explain points to be considered during
opening meeting.
 Display slide 44-45, explain communication activities during
an audit.
 Display slide 46, explain the audit method determination
factors such as objectives, scope and criteria, duration and
location.
 Display slide 47, explain the purpose of review of the
documented information.
 Display slide 48, Explain the process of collecting and
verifying information.
 Display slide 49, Brief methods of collecting information.
 Display slide 50,
Create 5 groups. Provide one annex for each group. Oreder
them to discuss, summarize and present.
Time:35 minutes (10 minutes for discussion and 5 minutes for
each group presentation).
 Display slide 51, explain what should be included in audit
findings.
 Display slide 52, explain preparations for closing meeting.
 Display slide 53, explain the contents of audit conclusion.
 Display slide 54, explain the participants of closing meeting

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 during conducting closing meeting.
 Display slide 55, list what to be explained during conducting
the closing meeting.

5 Prepare and distribute 110  Display slide 56,

audit report o Pair the participants to thin and share their ideas about
elements included in audit report and to whom they
 Think/Pair/
distribute report findings.
Share
o Time: 5 minutes.
 Lecture
o Debrief the activity (see answer key of activity 3.5)
 Display slide 57-58, explain how to prepare audit report.
 Display slide 59, Explain points to be considered during
distributing audit report.

6 Complete an audit 15 o Display slide 60,

o Distribute stick notes for all participants and let them
 One minute
to answer the question below:
paper
o when do you think the audit is completed?
 Lecture
o Can you disclose audit report? Explain why?
o Time: 5 minutes.
o Debrief the activity (see answer key of activity 3.6)
 Display slide 61, explain when we say audit is completed.

7 Conduct audit follow 10  Display slide 62, explain the effectiveness of an audit out
up come like correction. Corrective action and opportunity for
improvement.
 Interactive
presentation
and discussion
 Lecture

8 Chapter summary 5  Display slide 63, summarize the chapter linking with the
PDCA cycle.
 Lecture

Moke Laboratory 540  Display slide 64,

audit and report o Form two large group for an audit.
presentation (Field o Assign one instructor for each group.
Practice) o The facilitator will provide the materials like checklist
 Field Practice for each group and avail vehicle for transportation to
 Report

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 preparation assigned health facility.
 Interactive o The instructors will orient overall field audit activity
presentation (checklist utilization, evidence gathering, how to
 Evaluation by manage the challenges in the field work, and how to
instructors summarize actual audit findings)
o Instructors will explain the evaluation criteria for their
audit performance.

Answer key:

Activity 3.1 Self Reflection

Answer

1. The audit team leader should ensure that contact is made with auditee to:
 Confirm communication channels
 Confirm the authority to conduct the audit
 Provide relevant information on the audit scope, criteria and methods
 Request access to relevant information for planning purposes
 Determine applicable statutory and regulatory requirements
2. The audit team leader should ensure that contact is made with auditee to:
 Confirm communication channels
 Confirm the authority to conduct the audit
 Provide relevant information on the audit scope, criteria and methods
 Request access to relevant information for planning purposes
 Determine applicable statutory and regulatory requirements
3.Consideration for initiating an audit:
 Establishing contact with audit
 Determining feasibility of audit

Activity 3.2 Group discussion

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Answer

1. Review documented information is important to:

Gather information
 On the auditee’s operations
 Preparation of audit activities
 applicable audit work documents
Establish an overview
 To determine documented information for possible conformity
 To detect possible areas of concern

2. Risk-based approach to planning

 The audit team leader should adopt risk-based approach to planning
 The audit team leader should consider:
 The composition of the audit team and its overall competence
 The appropriate sampling techniques
 Opportunities to improve the effectiveness and efficiency of the audit
 The risks to achieve the audit objectives created by ineffective audit planning and
performing the audit.
3. Audit planning details
The scale and content of audit planning can differ (initial and subsequent audits or internal and
external audits)
Audit planning should address
 Audit objectives, scope, criteria and Methods
 Locations (physical and virtual), dates, duration of audit activities
 The allocation of appropriate resources
 The roles and responsibilities of the audit team members
4. The audit team leader, in consultation with the audit team should assign to each team
member responsibility for
 Auditing specific processes
 Activities and functions or locations
 Authority for decision-making
Such assignments should take into account competence of auditors, effective use of
resources, roles and responsibilities of auditors, auditors-in-training and technical experts
5. The documented information for the audit can include but is not limited to:
 Physical or digital checklists
 Audit sampling details

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  Audio visual information
Documented information prepared for, and resulting from, the audit should be retained
Documented information created during the audit process involving confidential should be
suitably safeguarded

Activity 3.3 Group discussion

Answer
The document control SOP lacks the following when evaluated against the provided standards:
 Effective date
 Organization name
 Document number
 No logo

Activity 3.4A Group discussion

Answer

Nine steps of conducting an audit:

 Assigning Roles and Responsibilities of Guides and Observers

 Conducting opening meeting
 Communicating during audit
 Audit information availability and access
 Reviewing documented information while conducting audit
 Collecting and verifying information
 Generating audit findings
 Determining audit conclusions
 Conducting closing meeting

Activity 3.4B Group discussion

Answer
1. The auditors should consider whether the information provides sufficient objective
evidence to demonstrate that requirements are being met, such as being:
 Complete (all expected content is contained in the documented information);
 Correct (the content conforms to other reliable sources such as standards and
regulations);
 Consistent (the documented information is consistent in itself and with related
documents);
 Current (the content is up to date).

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 2. Audit sampling typically involves the following steps:
 Establishing the objectives of sampling;
 Selecting the extent and composition of the population to be sampled;
 Selecting a sampling method;
 Determining the sample size to be taken;
 Conducting the sampling activity;
 Compiling, evaluating, reporting and documenting results.
Judgement-based sampling: Judgement-based sampling relies on the competence and
experience of the audit team
Statistical sampling: If the decision is made to use statistical sampling, the sampling plan
should be based on the audit objectives and what is known about the characteristics of
overall population from which the samples are to be taken.

Activity 3.5 Think/Pair/Share

Answer
The audit report should provide a complete, accurate, concise and clear record of the audit and
should include:

 Audit objectives, criteria, audit scope and the processes audited

 Identification of the audit client, audit team and auditee’s participants
 Dates and locations where the audit activities were conducted
 Audit findings and related evidence
 Audit conclusions

The audit report should distribute to the relevant interested parties.

Activity 3.6 One-minute paper

Answer
The audit is completed when planned audit activity have been carried out.
Unless required by law, the audit team and the individual(s) managing the audit program should
not disclose any information.
If disclosure of the contents of an audit document is required, the audit client and auditee should
be informed as soon as possible.

Activity 3.8 Mock Laboratory audit (Field practice)

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Answer
The performance of the field visit auditing is evaluated using Field visit evaluation checklist.

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