Internal Audit Training Course

Prepared by: QA Compliance

Friday, June 7 1
, 2024
Course Outline
Course title: Internal Auditor Training
 Part I
 Audit: An introduction
 Part II
 Managing an audit
 Part III
 Audit Activities

Friday, June 7, 2024

Course Objectives
 To define the activities and requirements of Internal Audit.
 To identify the roles and benefits of Internal Audit in a quality management
system.
 To learn how to plan, perform and monitor Internal Audit.
 To provide factual, unfiltered information to manage the quality system.
 To help minimizing potential risk.

Friday, June 7, 2024

 PART I
Audit: An Introduction

Friday, June 7 4
, 2024
 5

Friday, June 7, 2024

Definition

 ‘Internal Audit’ is an independent examination of a Quality System.

 It measures the effectiveness of an organization's Quality
Management System.
 Helps an organization accomplish its objective by bringing a
systematic approach to evaluate and improve effectiveness of risk
management, control and governance process.
 It is a documented and systematic tool. (i.e. audit schedule, audit
plan, reporting, follow up)
 It should be done periodically by independent and qualified people.
 As a communication tool of management policies. All personnel have
to understand and do their jobs. (i.e. access QMS, outcome of
discrepancies highlighted). 6

Friday, June 7, 2024

Roles / Purpose of Internal Audit

Measure the Evaluate

effectiveness of compliance with
Quality GMP/ISO in all
Management aspects of the
System established system

Internal Audit Roles / Purpose

Detect any
shortcomings (NC) Recommend the
in the necessary
implementation of Corrective and
GMP/QMS. Preventive Actions.

Friday, June 7, 2024

Scope of Internal Audit
Ensures quality in design, approval, monitoring and
evaluation of products should comply with cGMP/ ISO
requirements.

Ensures quality in cGMP/ ISO implementation and its

strategies.

Ensures quality in appointment, development and

performance of staff and key personnel.

Ensures quality in obtaining and responding to the feedbacks

from customers, consumers, employers, employees,
government authority and other relevant institutions.
8

Friday, June 7, 2024

Scope of Internal Audit (cont’d)
Includes all written quality documents, instructions and
records.

Covering all elements of cGMP/ISO including results of

previous internal quality audit and any corrective and
preventive actions (CAPA ) taken.

Friday, June 7, 2024

Benefits of Internal Audit (audit outcome)
Identify the root of
the problem and
plan for CAPA with
timeline Achieve better
Tells you the health
allocation of
of a quality system
resources

Benefits
Able to avoid
Continuous
potentially big
improvement
problem

Learn what an
auditors look for

10

Friday, June 7, 2024

 Problem

Cause,
needs to be
identified

It is not ease to identify a problem to its origin by looking at the problem surface ---
Use Root Cause Analysis Tools to find actual root cause 11
Key Principles (Outline) of an Internal Audit
Approaches Activities Strategies

Should be reviewed by Ask with the basic audit

Independent. questions about the quality
independent party.
system in place.
Should have sampling plan Start with WHAT, WHY, HOW,
Evidence-based approach.
and tracking system. WHO, WHERE, WHEN.

Should be open,
constructive and effective.

12

Friday, June 7, 2024

Internal Audits
Focus on compliance to the organization’s documented quality
management system.

Auditors will compare what is Are employees aware of trained

being done to the documented on and following the
policies, procedures and other standards/guidelines
relevant standards/guidelines documentation and
documentation. requirements?

Is the process done according

to the policies / plan?

13

Friday, June 7, 2024

Types of Audits
In addition to internal audits there are 2nd and 3rd party audits. Each type of
audit differs in purpose and focus.

External Audits/ 3rd Party Audits: an audit by an independent organization with

no stake in the management system. E.g. NPRA Audit, GDPMD Audit, ISO Audit

Customer Audits/ 2nd Party Audits: an outside company that conducts an audit
but has a relationship with the organization. e.g. Servier Audit

Internal Audits/ 1st Party Audits: employees or contractors for an organization

auditing for the organization.

14

Friday, June 7, 2024

Types of Internal Audits
System Audit: An assessment to determine whether or not the company’s
QMS meets the requirements of the GMP/ISO standard.
- Compare SOP to Regulations, Standards, Guidelines
- Verify system is documented

Compliance Audit: An assessment to determine whether or not you are

following your policies, procedure and work instructions as documented.
-Usually assess
• BMR & related forms
• Manufacturing logs
• QC test results
• Calibration status
• Training Programs
• Decision making against the specification – complaint, deviations, OOS, reprocess

15

Friday, June 7, 2024

 Referenced
Regulatory
Standards

Verify System
System Audit
versus
Standard Operating
Compliance Audit Procedures

Verify Compliance

Practices and
Records
Friday, June 7 16
, 2024
Focus of Internal Audit (as per ISO 9001)

Friday, June 7 17
, 2024
 1) Open Minded
Principles / Attributes of An Auditor
2) Avoid bias
3) Punctual
4) Precise
5) Self-Disciplined
6) Diplomatic
7) Keep to the objective
8) Always refer Professional
to the standard when
explaining
9) Listen and Observe
10)Always verify through records
11)Listen, Enquire and observe – SHOW ME!!
12)Stick to the facts
13)Refer to standards
Ethical14)Seek objective evidence of compliance or
PRINCIPLE Fair
non-compliance

1) Honest and Impartial 1) Nit-Picking is Avoided

2) Adhere to any agreed programme 2) Good points are taken into
3) Keep objective in Mind account (High-lighted)
4) Avoid argument 3) Auditee is given the benefit of
5) Comment against standard doubt when necessary
18

Friday, June 7, 2024

 Principles / Attributes of An Auditor
Integrity – Honest, Adhere to any agreed
PRINCIPLE Truthful, programme, Punctual,
Responsibility Self-disciplined
Impartial -
Unbiased, Fair Objectivity & Evidence Always verify
based approach - Seek through records
Keep Objective in objective evidence
Mind Diplomatic
Listen, Enquire and
Precise, observe and comply Observe – Show
with any applicable legal Me!! Avoid Argument
requirements 19

Friday, June 7, 2024

Internal Auditor
 Internal auditors are responsible for verifying the effective
implementation of the quality management system.
 Internal auditors must be trained on internal audit SOP and
attend this training course.
 Auditors:
 Find objective evidence that the system is
implemented and effective.
 Identify non-conformances:
 Where the system is not implemented or operating
as planned.
 Where the system does not meet requirements of
the standard.
20

Friday, June 7, 2024

Guidance When Conducting An Audit
Auditing shall focus on
identifying flaws/gaps of
processes and systems (+ve Audits need to be
positive process) rather documented
than finding faults on
individual.

Prior to the audit date, an

auditor needs to review the During an audit, an
quality system auditor need to see
documentation, corrective evidences that the
and preventive actions and processes are being done
past audit findings and in accordance to
Do not skip this step –
develop a skill. taking time to prepare procedures and policies.
and organize make you
much more effective 21

during audit.
Friday, June 7, 2024
 PART II
MANAGING INTERNAL AUDIT

Friday, June 7 22
, 2024
Plan-DO-Check-Act (PDCA)
 Plan: establish the objectives of the system and its
processes, and the resources needed to deliver results
in accordance with customers’ requirements and the
organization’s policies, and identify and address
risks and opportunities;
 Do: implement what was planned;
 Check: monitor and (where applicable) measure
processes and the resulting products and services
against policies, objectives, requirements and planned
activities, and report the results;
 Act: take actions to improve performance, as
necessary. 23

Friday, June 7, 2024

Plan-DO-Check-Act (cont’d)
Example: ISO 9001:2015 mapped for PDCA cycle

24

Friday, June 7, 2024

Flow Chart of Internal Audit
Authority for the
audit program

Establishing the internal audit program

 Objective
 Responsibilities Plan
 Resources
 Procedure and Guidance

Implementing internal audit program

 Scheduling audits
 Selecting audit team Audit activities
Improving the audit
program
 Directing audit activities Do
Act  Maintaining records
 Evaluating Auditors Performance Competence and
evaluation of auditors

Monitoring & reviewing the internal

audit program
 Monitoring & reviewing
 Identifying needs for corrective
actions Check
 Identifying needs for preventive
actions
 Identifying opportunities for
improvement
25

Friday, June 7, 2024

Resources for Internal Audit
Considerations should be given to the following:

Audit techniques

Available time for auditing

Competency and availability of

auditor

Processes to achieve and maintain the

competency of auditors and to improve their
performance
26

Friday, June 7, 2024

Planning of Internal Audit
 Establishing the Internal Audit program.

 Objectives

 Responsibility

 Procedure and guidance

Note: Refer SOP A/5/024

27

Friday, June 7, 2024

Internal Audit Monitoring
 Implementation of audit program should be monitored at
appropriate intervals and reviewed to assess whether its
objectives have been met and identified opportunities for
improvement.
 Audit findings should be reported to the management.

28

Friday, June 7, 2024

 PART III
Audit Activities

Friday, June 7 29
, 2024
Overview of Audit Activities
Planning and scheduling audits

Conducting document review

Preparing for on-site activities

Conducting on-site audit

Prepare audit report

Conducting follow-up

30

Friday, June 7, 2024

Audit Process

QUESTION

OBSERVE VERIFY
Friday, June 7 31
, 2024
Audit Activities
 Forming an audit team and assign roles and responsibility and agreed on the
scope.
 Conducting document review
• Review documents (SOPs, audit findings, corrective
action / preventive action etc.), check the integrity of
the quality system and various controls are effective.
 Preparing for the on-site audit activities
• Preparing audit plan.
• Assigning work to the audit team.
• Preparing work documents (e.g. audit checklists,
sampling plans, forms for recording information;
questionnaires.

32

Friday, June 7, 2024

Audit Documentation
 Should be sent to auditee prior to audit activity.
Audit Plan  Findings from the last audit should be also mentioned.

Audit Note  All records and comments during the audit.

Audit Report  Official document to report the audit findings.

33

Friday, June 7, 2024

Performing the Audit
After the opening meeting start the
audit:

Using your checklists and An effective audit will depend on

procedures as references, go out your ability to put people at ease
to observe the process and talk to and encourage open honest
people in the department. communication.

You are looking for evidence that

the Quality Management System is
working effectively.

34

Friday, June 7, 2024

Performing An Audit (cont’d)
Check documents and records. Take good notes.

Ask questions. Be specific on what is

reviewed and what is
found.
Observe processes and compare them
with documented procedures and work
The information you write
instructions.
down will be used to
identify non-conformances
and to assist the
Investigate any differences.
department in finding and
understanding what you
observed.
Follow audit trails, be curious.

35

Friday, June 7, 2024

Key Auditor Attributes

Communication Use local

Skills terminology
Objective
Reword
questions when
Tactful needed
Ability to
listen
Curious

Persistent
Flexible

36

Friday, June 7, 2024

Auditor Important Elements
Not everyone can be a good auditor – Training and Experience:
need more practice, exposure and reading • Standards, regulation, auditing
techniques and audit management skills

Good Communication and Interpersonal

Skills (Ability to listen, Use local Understanding of the business
terminology, Reword question when operating structure:
needed, Clear) • Inputs / Outputs of various systems
• Interactions of departments
• Rotation throughout various job
Interviewing Skills: functions upon hire (even with prior
• Intelligent and pertinent questions experience)
• Listen attentively

Analytical Skills:
• Ability to assimilate data and determine
how it relates to the audit criteria
• Analyze information and report results

37

Friday, June 7, 2024

Lead Auditor/ Team Leader
Lead Auditors should have additional knowledge and skills in audit
leadership to facilitate the efficient and effective conduct of the audit.
An audit team leader should be able to:

 Plan the audit and make effective use of resources during the audit.
 Represent the audit team in communications with the auditee.
 Organize, direct and motivate the audit team members.
 Mentor and provide guidance to auditor team members.
 Lead the audit team to reach the audit conclusions.
 Prevent to resolve conflicts.
 Lead the preparation of audit report.

38

Friday, June 7, 2024

Techniques There should not be
surprises at the closing
THE AUDITEE MAY BE meeting when you present
your findings.
STRESSED

Smile,
relax Make sure the auditee
understands what you
see as the non-
AUDITEE
Point out good things conformances.
that you see

Point out non –

conformances as you
Summarize with go
‘Everything looks AUDITORS
good here’ when you
can
Keep people informed of
what you are finding

Use open ended questions,

they provide more Ask for clarification or
information. (What, Where, more information if you
do not understand.
39

Why, Who, When, How)

Friday, June 7, 2024
Auditing Activities
Conducting on-site audit activities

 Conduct opening meeting.

 Good communication during the audit.
 Steps in conducting on site audit.
 Interviews with different personnel.
 Carry out both horizontal and vertical audits. Focus on
safety and quality of product.
 Use ‘Trace-back’ method.

Horizontal audit: When you audit

Vertical audit: When you audit the
one process across many
process used by the departments.
departments in the organization. 40

Friday, June 7, 2024

Auditing Activities (cont’d)
Generating audit findings

 Either conformity or non-conformity.

 Sort out isolated or systemic deficiencies.

Systemic deficiency:
Could be connected to a
particular process,
product, material, person
Isolated deficiency: or organization; shows
Tends to happen randomly; pattern; happens more
no meaningful pattern; than once.
rarely happens

41

Friday, June 7, 2024

Isolated versus Systemic Deficiency
Deficiencies

Systemic

Isolated

 SOP contains an error.

 Wrong expiration date written on a  Batch record is poorly written some
reagent bottle. instruction can be confusing.
 Operator or lab technician spills a  Area management does not reinforce
sample. requirement to continually record
information properly.

42

Friday, June 7, 2024

Audit Monitoring
The audit finding can be classified into 2 groups:

Compliance
• Satisfactory /Adequate
• Outstanding

Non-Conformance

• Critical deficiency Classification may varies

• Major deficiency according to respective
standards/guidelines
• Minor deficiency
43

Friday, June 7, 2024

Observation / Opportunity for Improvement (OFI)

A situation or condition of a management system that

may be weak, redundant, overly complex or in some other
manner, may be in the opinion of the auditor offer an
opportunity for an organization to improve its current status.
These OFIs do not require any action on the part of the
organization, however the organization should give them
serious consideration in view of the auditor’s knowledge and
exposure to similar systems.
An OFI may be an improvement system or could present
future problems.

44

Friday, June 7, 2024

Documenting the Audit
 Once you complete your audit, you will prepare an audit report and document
any non-conformances.
 The report will also include:
 General information
 Documents reviewed
 Persons interviewed
 General summary and assessment of how the system is performing

 When your documentation is completed you will be ready to hold your closing
meeting. The lead auditor will lead the meeting:
 Thank the group for their cooperation
 Remind them that this is an evaluation of the processes not the people

45

Friday, June 7, 2024

The Closing Meeting Summarize the findings

 The lead auditor will

lead the meeting:
 Thank the group
Review each of the non-
for their conformances, allow
cooperation questions and discuss the
 Remind them that finding to make sure that
Highlight areas that are working well. the group understands the
this is an
non-conformances and
evaluation of the provide suitable solution.
processes not the
people
Discuss any corrective actions that
you followed up on that were not
found to be effective.

Have the group sign the report

and46 record of attendance.

Friday, June 7, 2024

Audit Report
Identification of
audit team
Objectives
leader and
members
Audit scope
Conclusions

Date and place

audit activities
were conducted Audit criteria
and findings

47

Friday, June 7, 2024

Audit Report
 Various formats can be used depending on auditee (vendors, management or
auditee)

 Usually include name and location of auditee, date of audit, audit plan,
audit observations, classification of non-compliances, recommendations or
expectations.

 Should write against a standard.

 Focus on deficient conditions and not people.

 Include any positive observations.

 Keep the audit report simple and clear.

48

Friday, June 7, 2024

Audit Findings: An Example

49

Friday, June 7, 2024

Closure
Follow-up and closing of loop:
 Receive a satisfactory response from auditees and their
commitment to correct for any deficiency.
 Ensures CAPA identify the root cause and they are
satisfactory, accomplished and documented.
 Timeframe for CAPA closure is being monitored and followed.
 Verify and track CAPA effectiveness by follow-up audit OR
next scheduled audit.

50

Friday, June 7, 2024

Summary
 Internal Audits are one of the most important pieces of the
quality management system.
 Implementing an effective system will help ensure an
effective quality management and successful certification
audits.
 Training of the auditors is the key to having an effective
internal audit program.

51

Friday, June 7, 2024

 52

Friday, June 7, 2024