Interna Audit Module

Project co-financed by
European Union
Project co- financed

by Asean
ASEAN GMP TRAINING MODULE
INTERNAL AUDIT
Prepared by:
Lam Kok Seng - Singapore
Approved by:
ASEAN Cosmetics GMP Team
Endorsed by:
ASEAN Cosmetic Committee
European Committee
for Standardization
Implementing Agency
Module 9
European Union
CONTENT OF PRESENTATION

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TABLE OF CONTENT
European Committee
for Standardization
Implementing Agency
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
Module 9
European Union

by Asean
INTRODUCTION
European Committee
for Standardization
Implementing Agency
Module 9
European Union
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
European Committee
for Standardization
Implementing Agency
Module 9
European Union
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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European Committee
for Standardization
Implementing Agency
European Union
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
European Committee
for Standardization
Implementing Agency

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European Union
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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European Committee
for Standardization
Implementing Agency

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European Union
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
European Committee
for Standardization
Implementing Agency
Module 9

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European Union
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
European Committee
for Standardization
Implementing Agency
Module 9
European Union
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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European Committee
for Standardization
Implementing Agency
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PRINCIPLE OF AN AUDITOR

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Ethical
Professional
Fair
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for Standardization
Implementing Agency
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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
European Committee
for Standardization
Implementing Agency
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European Union
GUIDANCE FOR AUDITEE

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When being audited:
European Committee
for Standardization
Implementing Agency
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
European Committee
for Standardization
Implementing Agency
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European Union

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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
European Committee
for Standardization
Implementing Agency
Module 9
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
European Committee
for Standardization
Implementing Agency
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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
European Committee
for Standardization
Implementing Agency
Objectives
Responsibility
Procedure and guidance
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IA IMPLEMENTATION
The
implementation
program consists of :
European Committee
for Standardization
Implementing Agency
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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for Standardization
Implementing Agency
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AUDITING ACTIVITIES
European Committee
for Standardization
Implementing Agency
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OVERVIEW OF AUDIT ACTIVITES

Planning and scheduling
audit
Conducting document
review
Preparing for on-site
activities
Conducting audit
European Committee
for Standardization
Implementing Agency
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)
European Committee
for Standardization
Implementing Agency
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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
European Committee
for Standardization
Implementing Agency
official document to report the audit

findings Module 9
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EXAMPLE OF AN AUDIT
CHECKLIST

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General format for an audit checklist
European Committee
for Standardization
Implementing Agency
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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
European Committee
for Standardization
Implementing Agency
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?
European Committee
for Standardization
Implementing Agency
Module 9
26
European Union

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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:
European Committee
for Standardization
Implementing Agency
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
European Committee
for Standardization
Implementing Agency
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European Union

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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
European Committee
for Standardization
Implementing Agency
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
European Committee
for Standardization
Implementing Agency
Module 9
30
European Union

by Asean
AUDIT REPORT
European Committee
for Standardization
Implementing Agency
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
European Committee
for Standardization
Implementing Agency
Module 9
32
European Union

by Asean
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
European Committee
for Standardization
Implementing Agency
Module 9
Auditee
Auditor
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European Union

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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
9
European Committee
for Standardization
Implementing Agency
European Union

by Asean
CONCLUSIONS
Nobody likes to be
audited..
It is a means to have
continuous
improvement
European Committee
for Standardization
Implementing Agency
Module 9
35
European Union

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RELATED HYPERLINK DOCUMENTS
European Committee
for Standardization
Implementing Agency
Trainer Manual of Internal Quality Audit
Module 9
36
European Union
REFERENCES
1.
2.
3.
4.
5.
6.
7.
European Committee
for Standardization
Implementing Agency

by Asean
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.
37
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Project co-financed by

Project co- financed

ASEAN GMP TRAINING MODULE

Project co- financed

Project co- financed

Project co- financed

To define the activities and requirements of

To identify the roles and benefits of IA in

Project co- financed

Internal Audit" is an independent

Audit" itself is a checking system, NOT a

As a communication tool of management

As a powerful tool to measure the

Evaluates manufacturers compliance with

Detects any shortcomings in the

Recommend the necessary corrective and

Project co- financed

Ensures quality in design, approval,

Ensures quality in GMP implementation

Ensures quality in appointment,

Project co- financed

Includes all written quality documents,

Covering all elements of GMP including

Project co- financed

Project co- financed

Tells you the health of a quality system

Identify the root of a problem and plan for

Achieve better allocation of resources

Able to avoid potentially big problem

Learn what an auditors look for

Project co- financed

Approaches towards IA:

Project co- financed

Project co- financed

GUIDANCE WHEN CONDUCTING AN AUDIT

Auditing should be seen as a positive process

Audits need to be documented

Prior to the audit date, an auditor needs to

During an audit, an auditor need to see

GUIDANCE FOR AUDITEE

Project co- financed

When being audited:

Project co- financed

Project co- financed

Improving the audit

Implementing internal audit program

Monitoring & reviewing

Project co- financed

Project co- financed

The planning of IA consists of :

Project co- financed

Project co- financed

Implementation of audit program should

Project co- financed

Project co- financed

OVERVIEW OF AUDIT ACTIVITES

Project co- financed

Forming an audit team and assign roles and

Conducting document review

Project co- financed

official document to report the audit

Project co- financed

General format for an audit checklist