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
Module 9
Implementing Agency GMP Workshop Kuala Lumpur 14-16 Nov 2005 1
by Asean
CONTENT OF PRESENTATION
TABLE OF CONTENT
a. Introduction
 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
European Committee e. References Module 9
for Standardization
by Asean
INTRODUCTION
European Committee
for Standardization
Module 9
by Asean
OBJECTIVES
 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
Module 9
by Asean
DEFINITION
 “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
European Committee
for Standardization
Module 9
by Asean
ROLES OF IA
 As a powerful tool to measure the effectiveness

of quality management system
 Evaluates manufacturer’s compliance with GMP

in all aspects related production and quality
control
 Detects any shortcomings in the implementation

of GMP
 Recommend the necessary corrective and

preventive actions
European Committee
for Standardization
Module 9
by Asean
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
European Committee
for Standardization
Module 9
by Asean
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
Module 9
by Asean
BENEFITS OF IA
 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
Module 9
by Asean
KEY PRINCIPLES OF IA
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
European Committee
for Standardization
Module 9
by Asean
PRINCIPLE OF AN AUDITOR
 Ethical
 Professional
 Fair
European Committee
for Standardization
Module 9
by Asean
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
Module 9
by Asean
GUIDANCE FOR AUDITEE
When being audited:
• 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 you’re not sure
European Committee
for Standardization
Module 9
by Asean
MANAGING IA
European Committee
for Standardization
Module 9
by Asean
FLOW CHART OF IA
Authority for the audit
programme
Establishing
the internal audit program
obectives
responsibilitties Plan
resources
procedure and guidance
Implementing internal audit program competence and

scheduling audits evaluation of
evaluating auditors auditors Do
selecting audit team
Improving the audit directing audit activiries
Act Audit activities
programme maintaining records
Monitoring & reviewing

the internal audit program
monitoring & reviewing
Check
identifying needs for corrective
identifying needs for prevention actions
identifying opportunities for improvement
European Committee
for Standardization
Module 9
by Asean
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
Module 9
by Asean
IA
OBJECTIVES
PLANNING
The planning of IA consists of :
• Authority for administering the IA program
• Establishing IA program
 Objectives
 Responsibility
 Procedure and guidance
European Committee
for Standardization
Module 9
by Asean
IA IMPLEMENTATION
The implementation of IA program

consists of :
 Scheduling audit
 Implementation of audit program
 Audit record and report
European Committee
for Standardization
Module 9
by Asean
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.
European Committee
for Standardization
Module 9
by Asean
AUDITING ACTIVITIES
European Committee
for Standardization
Module 9
by Asean
OVERVIEW OF AUDIT ACTIVITES

Planning and scheduling audit
Conducting document review
Preparing for on-site activities
Conducting audit
Prepare audit report
Conducting follow-up
European Committee
for Standardization
Module 9
by Asean
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
(eg. audit checklists, sampling plans, forms for
recording information; questionnaires)
European Committee
for Standardization
Module 9
by Asean
AUDIT DOCUMENTATION
• 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
 official document to report the audit findings
European Committee
for Standardization
Module 9
by Asean
EXAMPLE OF AN AUDIT CHECKLIST
• General format for an audit checklist
European Committee
for Standardization
Module 9
by Asean
EXAMPLE OF AN AUDIT CHECKLIST

CHECKING LIST FOR GMP ASSESSMENT
Date : Location : Warehouse
Auditor : Auditee :
DESCRIPTION GMP.REF. PARAMETER AUDIT FINDING

Personnel 1.2.1 - Organization structure
5.1.2 - Personnel hygiene
2.1.5 - Training record
Storage area 10.1.1 - Design and layout of defined area
3.1 - Flow of personnel and goods
3.6 - Structure of the storage area, based
3.9 & 3.10 on GMP
3.12.2 - HVAC system
- Record of monitoring parameter
Sanitation 3.1 - Pest record program
- The map of bait
5.3 - The cleanliness of weighing
apparatus
Documentation 4.3 - Record of maintenance and
calibration of weighing apparatus
10.2.2.3 - The effectiveness of label system
10.2.2.1 - Inventory stock control
European Committee
for Standardization
Module 9
by Asean
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 trained to use the machine?
4. How often is the equipment being calibrated

and cleaned?
5. When is the last breakdown of the machine?

Are there any product being affected?
European Committee
for Standardization
Module 9
by Asean
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:

 Interviews with different personnel
 Carry out both horizontal and vertical audits.
Focus on safety and quality of product.
 Use “Trace-back” method
European Committee
for Standardization
Module 9
by Asean
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
Module 9
by Asean
ISOLATED VERSUS SYSTEMIC DEFICIENCY
NON CONFORMANCE DEFICIENCIES

ISOLATED SYSTEMIC
Latex gloves rip SOP contains an error
Wrong expiration date written on a Batch record is poorly written so

reagent bottle instruction can be confusing
Operator or lab technician spills a Area management does not reinforce

sample requirement to continually record
information properly
Pressing machine of eye shadow Preventive maintenance program does
burns out not include liquid filling machine motor
European Committee
for Standardization
Module 9
by Asean
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
Module 9
by Asean
AUDIT REPORT
 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
European Committee
for Standardization
Module 9
by Asean
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
Module 9
by Asean
AUDIT REPORT: AN EXAMPLE
No GMP.Ref Findings of IA Grading Location Auditee Auditor
1. 2.1.1 Production and QC Critical Human Abas Budi

departments are Resources
headed by the
same person
2. 4.3 Monitoring of Major or Warehouse Tuti May Lin
temperature in a Minor
warehouse
3 11.1 Inadequate control Major or Production Herman Ida

over sub-contractor Minor
European Committee
for Standardization
Module 9
by Asean
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 follow-up
audit and/or requesting for an updated SOP
European Committee
for Standardization
Module 9
by Asean
CONCLUSIONS
Nobody likes to be
audited………..
It is a means to have
continuous improvement
European Committee
for Standardization
Module 9
by Asean
RELATED HYPERLINK DOCUMENTS
 Trainer Manual of Internal Quality Audit
European Committee
for Standardization
Module 9
by Asean
REFERENCES
1. ASEAN Guidelines for Cosmetic GMP.
2. International standard ISO 9001:2002,
3. Guidelines for quality and/or environmental
management system auditing, 1st Edition, 2002
4. www.cityu.edu.hk, Internal Quality Audit
Scheme.
5. www.fineprint.com, Internal Audit Procedure
6. Stimson W.A., Internal Quality Auditing, Meeting
the challenge of ISO 9000:2000, Paton Press,
2001
7. WHO – EDM, Basic Principle of GMP: Self-
Inspection.
European Committee
for Standardization
Module 9

Interna Audit Module

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Project co-financed by

European Union Project co- financed

ASEAN GMP TRAINING MODULE

 To define the activities and requirements of IA

 To identify the roles and benefits of IA in a

 To learn how to plan, perform and monitor IA

 As a powerful tool to measure the effectiveness

 Evaluates manufacturer’s compliance with GMP

 Detects any shortcomings in the implementation

 Recommend the necessary corrective and

 Ensures quality in obtaining and responding to the

 Includes all written quality documents,

 Tells you the health of a quality system

GUIDANCE WHEN CONDUCTING AN AUDIT

• Auditing should be seen as a positive process not a

GUIDANCE FOR AUDITEE

When being audited:

Implementing internal audit program competence and

Monitoring & reviewing

Considerations should be given to the following:

The planning of IA consists of :

• Authority for administering the IA program

The implementation of IA program

• Implementation of audit program should be

OVERVIEW OF AUDIT ACTIVITES

Conducting document review

Preparing for on-site activities

Prepare audit report

• Conducting document review

EXAMPLE OF AN AUDIT CHECKLIST

• General format for an audit checklist

EXAMPLE OF AN AUDIT CHECKLIST

DESCRIPTION GMP.REF. PARAMETER AUDIT FINDING

Area audited : ______________________ Date: __________________

Question (QSR-GMP Reference) Response

1. Does the company have a work instruction to

4. How often is the equipment being calibrated

5. When is the last breakdown of the machine?

AUDITING ACTIVITIES (1)

 Good communication during the audit

 Roles of escort and observer

 Steps in conducting on site audit:

AUDITING ACTIVITIES (2)

 Either conformity or non-conformity

 Sort out isolated or systemic

ISOLATED VERSUS SYSTEMIC DEFICIENCY

NON CONFORMANCE DEFICIENCIES

Wrong expiration date written on a Batch record is poorly written so

Operator or lab technician spills a Area management does not reinforce

The audit finding can be classified into 2 groups:

 Various formats can be used depending on auditee

AUDIT REPORT: AN EXAMPLE

No GMP.Ref Findings of IA Grading Location Auditee Auditor

1. 2.1.1 Production and QC Critical Human Abas Budi

3 11.1 Inadequate control Major or Production Herman Ida

Follow-up and closing of loop:

RELATED HYPERLINK DOCUMENTS

 Trainer Manual of Internal Quality Audit

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Area audited : ____ Date: