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ASEAN GMP TRAINING MODULE

INTERNAL AUDIT
Prepared by:
Lam Kok Seng - Singapore
Approved by:
ASEAN Cosmetics GMP Team
Endorsed by:
ASEAN Cosmetic Committee
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CONTENT OF PRESENTATION

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TABLE OF CONTENT

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a. I ntroduction
Objectives
Description of Internal Quality Audit
Scope of IQA
Benefit of IQA
The key principle of internal audit
The role of internal audit
Quality audit documentation
b. Managing the internal audit program
Process flow for the management of an audit program
Authority for internal audit program
Establishing the audit program
Audit program implementation
Monitoring and reviewing the audit program
c. Audit activities
Overview of audit activities
Initiating the audit
Conducting document review
Preparing for on-site audit activities
Conducting on-site audit activities
Preparing, approving, and distributing the internal audit report
Completing and conducting audit follow-up
d. Conclusion
e. References

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INTRODUCTION

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OBJECTIVES

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To define the activities and requirements of

IA

To identify the roles and benefits of IA in

a quality management system
To learn how to plan, perform and
monitor IA

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DEFINITION

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Internal Audit" is an independent

examination of a quality system
It measures the effectiveness of an
organisation's quality management system.
It is a documented and systematic tool
It should be done periodically by independent
and qualified people

Audit" itself is a checking system, NOT a

quality assessment

As a communication tool of management

policies. All personnel have to understand
and do their jobs well
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ROLES OF IA

As a powerful tool to measure the

effectiveness of quality management
system

Evaluates manufacturers compliance with

GMP in all aspects related production and
quality control

Detects any shortcomings in the

implementation of GMP

Recommend the necessary corrective and

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preventive actions

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SCOPE OF IA (1)

Ensures quality in design, approval,

monitoring and evaluation of products
should comply GMP requirements

Ensures quality in GMP 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
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SCOPE OF IA (2)

Includes all written quality documents,

instructions and records

Covering all elements of GMP including

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

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BENEFITS OF IA

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Tells you the health of a quality system

Identify the root of a problem and plan for

corrective and preventive actions with
timeline

Achieve better allocation of resources

Able to avoid potentially big problem

Learn what an auditors look for

Continuous improvement

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KEY PRINCIPLES OF IA

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Approaches towards IA:

Independent
Evidence-based approach
All activities related to IA should:
be reviewed by an independent party
be a self-appraisal system
have a sampling plan and tracking system
be open, constructive and effective
Strategies in conducting audit:
Ask with the basic audit questions about the
quality system in place
Start with what, why, how, who, where,
when
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PRINCIPLE OF AN AUDITOR

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Ethical
Professional
Fair

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GUIDANCE WHEN CONDUCTING AN AUDIT

Auditing should be seen as a positive process

not a fault finding

Audits need to be documented

Prior to the audit date, an auditor needs to

review the quality system documentation,
corrective and preventive actions, and past
audit findings and develop a checklist

During an audit, an auditor need to see

evidences that the processes are being done
in accordance to procedures and policies

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GUIDANCE FOR AUDITEE

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When being audited:

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Volunteer information
Report deficiencies and difficulties if you know
of any
Be honest, open and cooperative
Ensure that underlying causes are identified
Ask the auditor if youre not sure

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MANAGING IA

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FLOW CHART OF IA
Authority for the audit
programme

Establishing
the internal audit program
obectives
responsibilitties
resources
procedure and guidance

Act

Improving the audit

programme

Implementing internal audit program

scheduling audits
evaluating auditors
selecting audit team
directing audit activiries
maintaining records

Monitoring & reviewing

the internal audit program
monitoring & reviewing
identifying needs for corrective
identifying needs for prevention actions
identifying opportunities for improvement

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Plan

competence and
evaluation of
auditors

Do

Audit activities

Check

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RESOURCES FOR IA
Considerations should be given to the following:

Resources
Audit techniques
Processes to achieve and maintain the
competency of auditors and to improve their
performance
Competency and availability of auditor
Available time for auditing

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IA
OBJECTIVES
PLANNING

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The planning of IA consists of :

Authority for administering the IA
program
Establishing IA program

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Objectives
Responsibility
Procedure and guidance

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IA IMPLEMENTATION

The
implementation
program consists of :

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Scheduling audit
Implementation
of
program
Audit record and report

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of

IA

audit

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IA 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.
Auditing findings should be reported to
the management.

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AUDITING ACTIVITIES

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OVERVIEW OF AUDIT ACTIVITES

Planning and scheduling
audit
Conducting document
review
Preparing for on-site
activities
Conducting audit

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Prepare audit
report
Conducting followup
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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
Preparing for the on-site audit activities
effective
Preparing audit plan
Assigning work to the audit team
Preparing work documents
(eg. audit checklists, sampling plans,
forms for recording information;
questionnaires)

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AUDIT DOCUMENTATION

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Audit plan
should be sent to auditee prior to
audit activity
findings from the last audit should
be also mentioned
Audit note should include
an audit questionnaire
all records and comments during the
audit
Audit report is an
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EXAMPLE OF AN AUDIT
CHECKLIST

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General format for an audit checklist

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EXAMPLE OF AN AUDIT
CHECKLIST

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CHECKI NG LI ST FOR GMP ASSESSMENT

Date
Auditor
DESCRI PTI ON
Personnel

:
:

Location
Auditee

Storage area

GMP.REF.
1.2.1
5.1.2
2.1.5
10.1.1
3.1
3.6
3.9 & 3.10
3.12.2

Sanitation

3.1
5.3

Documentation

4.3
10.2.2.3
10.2.2.1

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PARAMETER
- Organization structure
- Personnel hygiene
- Training record
- Design and layout of defined area
- Flow of personnel and goods
- Structure of the storage area, based
on GMP
- HVAC system
- Record of monitoring parameter
- Pest record program
- The map of bait
- The cleanliness of weighing
apparatus
- Record of maintenance and
calibration of weighing apparatus
- The effectiveness of label system
- Inventory stock control

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: Warehouse
:
AUDI T FI NDI NG

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IA MONITORING
INTERNA: AUDIT QUESTIONAIRES
Area audited : ______________________

Date: __________________

Question (QSR-GMP Reference)

Response

1. Does the company have a work

instruction to operate the machine?
2. How is the machine being cleaned and
maintained?
3. Are personnel
machine?

trained

to

use

4.How often is the equipment

calibrated and cleaned?

the

being

5. When is the last breakdown of the

machine?
Are there any product being affected?
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AUDITING ACTIVITIES (1)

Conducting on-site audit activities

Conduct opening meeting

Good communication during the audit

Roles of escort and observer

Steps in conducting on site audit:

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Interviews with different personnel

Carry out both horizontal and vertical audits.
Focus on safety and quality of product.
Use Trace-back method

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AUDITING ACTIVITIES (2)

Generating audit findings

Either conformity or non-conformity
Sort out isolated or systemic
deficiencies
Isolated deficiency:
Tends to happen randomly; no meaningful
pattern; rarely happens

Systemic deficiency:
Could be connected to a particular process,
product, material, person or organisation;
shows pattern; happens more than once
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ISOLATED VERSUS SYSTEMIC DEFICIENCY

NON CONFORMANCE DEFICIENCIES
ISOLATED

SYSTEMIC

Latex gloves rip

SOP contains an error

Wrong expiration date written

on a reagent bottle

Batch record is poorly written so

instruction can be confusing

Operator or lab technician spills

a sample

Area management does not

reinforce requirement to
continually record information
properly
Preventive maintenance program

Pressing machine of eye

shadow burns out
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does not include liquid filling

machine motor

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AUDIT MONITORING
The audit finding can be classified into 2 groups:
1. Compliance :
a. Satisfactory /Adequate
b. Outstanding

2. Non-compliance :
a. Critical deficiency
b. Major deficiency
c. Minor deficiency

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AUDIT REPORT

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Objectives
Audit scope
Identification of audit team leader and
members
Date and place where the on-site
audit activities were conducted
Audit criteria and findings
Conclusions

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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
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AUDIT REPORT: AN EXAMPLE

No

GMP.Re
f

Findings of IA

Gradin
g

Location

1.

2.1.1

2.

Production and
QC departments
are headed by
the same person

Critical

Human
Abas
Resources

Budi

4.3

Monitoring of
temperature in a
warehouse

Major
or
Minor

Warehous
e

Tuti

May Lin

11.1

Inadequate
control over subcontractor

Major
or
Minor

Productio
n

Herman

Ida

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Auditee

Auditor

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CLOSURE
Follow-up and closing of loop:

Receive a satisfactory response from auditee

and their commitment to correct for any
deficiency

Ensures CAPA identify the root cause and they

are satisfactory, accomplished and
documented

Timeframe for CAPA is being followed

Verify and track CAPA by scheduling a followup audit and/orModule

requesting
for an updated SOP 34
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CONCLUSIONS

Nobody likes to be
audited..
It is a means to have
continuous
improvement
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RELATED HYPERLINK DOCUMENTS

European Committee
for Standardization
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Trainer Manual of Internal Quality Audit

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REFERENCES
1.
2.
3.
4.
5.
6.
7.
European Committee
for Standardization
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ASEAN Guidelines for Cosmetic GMP.

International standard ISO 9001:2002,
Guidelines for quality and/or environmental
management system auditing, 1st Edition,
2002
www.cityu.edu.hk, Internal Quality Audit
Scheme.
www.fineprint.com, Internal Audit
Procedure
Stimson W.A., Internal Quality Auditing,
Meeting the challenge of ISO 9000:2000,
Paton Press, 2001
WHO EDM, Basic Principle of GMP: SelfInspection.
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