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Project co-financed by European Union Project co- financed
by Asean
European Committee for StandardizationImplementing Agency
Module 9Module 9GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
Nov 2005Nov 20051
Prepared by:Lam Kok Seng - Singapore
Approved by:ASEAN Cosmetics GMP Team
Endorsed by:ASEAN Cosmetic Committee
ASEAN GMP TRAINING MODULE
INTERNAL AUDITINTERNAL AUDIT
Project co-financed by European Union Project co- financed
by Asean
European Committee for StandardizationImplementing Agency
Module 9Module 9GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
Nov 2005Nov 20052
CONTENT OF PRESENTATIONTABLE 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 e. References
Project co-financed by European Union Project co- financed
by Asean
European Committee for StandardizationImplementing Agency
Module 9Module 9GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
Nov 2005Nov 20053
INTRODUCTION
Project co-financed by European Union Project co- financed
by Asean
European Committee for StandardizationImplementing Agency
Module 9Module 9GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
Nov 2005Nov 20054
OBJECTIVES
To learn how to plan, perform and monitor IA
To define the activities and requirements of IA
To identify the roles and benefits of IA in a quality management system
Project co-financed by European Union Project co- financed
by Asean
European Committee for StandardizationImplementing Agency
Module 9Module 9GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
Nov 2005Nov 20055
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
Project co-financed by European Union Project co- financed
by Asean
European Committee for StandardizationImplementing Agency
Module 9Module 9GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
Nov 2005Nov 20056
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
Project co-financed by European Union Project co- financed
by Asean
European Committee for StandardizationImplementing Agency
Module 9Module 9GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
Nov 2005Nov 20057
SCOPE OF IA (1)
Ensures quality in obtaining and responding to the feedbacks from customers, consumers, employers, employees, government authority and other relevant institutions
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
Project co-financed by European Union Project co- financed
by Asean
European Committee for StandardizationImplementing Agency
Module 9Module 9GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
Nov 2005Nov 20058
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
Project co-financed by European Union Project co- financed
by Asean
European Committee for StandardizationImplementing Agency
Module 9Module 9GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
Nov 2005Nov 20059
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
Project co-financed by European Union Project co- financed
by Asean
European Committee for StandardizationImplementing Agency
Module 9Module 9GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
Nov 2005Nov 200510
Strategies in conducting audit:• Ask with the basic audit questions about the
quality system in place• Start with what, why, how, who, where,
when
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
Project co-financed by European Union Project co- financed
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European Committee for StandardizationImplementing Agency
Module 9Module 9GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
Nov 2005Nov 200511
PRINCIPLE OF AN AUDITOR
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
Project co-financed by European Union Project co- financed
by Asean
European Committee for StandardizationImplementing Agency
Module 9Module 9GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
Nov 2005Nov 200513
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
Project co-financed by European Union Project co- financed
by Asean
European Committee for StandardizationImplementing Agency
Module 9Module 9GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
Nov 2005Nov 200514
MANAGING IA
Project co-financed by European Union Project co- financed
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European Committee for StandardizationImplementing Agency
Module 9Module 9GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
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FLOW CHART OF IA
Improving the audit programme
competence and evaluation of
auditors
Authority for the audit programme
Audit activitiesAct
Plan
Check
Implementing internal audit programscheduling auditsevaluating auditors
selecting audit teamdirecting audit activiries
maintaining records
Establishingthe internal audit program
obectivesresponsibilitties
resourcesprocedure and guidance
Monitoring & reviewingthe internal audit program
monitoring & reviewingidentifying needs for corrective
identifying needs for prevention actionsidentifying opportunities for improvement
Do
Project co-financed by European Union Project co- financed
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European Committee for StandardizationImplementing Agency
Module 9Module 9GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
Nov 2005Nov 200516
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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The planning of IA consists of :
IA PLANNING
• Establishing IA program
Objectives Responsibility Procedure and guidance
• Authority for administering the IA program
OBJECTIVES
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The implementation of IA program consists of :
IA IMPLEMENTATION
Scheduling audit Implementation of audit
program Audit record and report
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• 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.
IA MONITORING
• Auditing findings should be reported to the management.
Project co-financed by European Union Project co- financed
by Asean
European Committee for StandardizationImplementing Agency
Module 9Module 9GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
Nov 2005Nov 200520
AUDITING ACTIVITIES
Project co-financed by European Union Project co- financed
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European Committee for StandardizationImplementing Agency
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OVERVIEW OF AUDIT ACTIVITES
Planning and scheduling audit
Conducting document review
Conducting audit
Prepare audit report
Conducting follow-up
Preparing for on-site activities
Project co-financed by European Union Project co- financed
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• Forming an audit team and assign roles and responsibility and agreed on the scope
• Conducting document review
• Preparing for the on-site audit activities
Review documents (SOPs, audit findings, corrective action/preventive action, etc.), check the integrity of the quality system and various controls are effective Preparing audit plan
Assigning work to the audit team Preparing work documents
(eg. audit checklists, sampling plans, forms for recording information; questionnaires)
AUDIT ACTIVITIES
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European Committee for StandardizationImplementing Agency
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AUDIT DOCUMENTATION
• Audit report is an
official document to report the audit findings
• 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 questionnaireall records and comments during the
audit
Project co-financed by European Union Project co- financed
by Asean
European Committee for StandardizationImplementing Agency
Module 9Module 9GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16
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EXAMPLE OF AN AUDIT CHECKLIST
• General format for an audit checklist
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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
5.1.2 2.1.5
- Organization structure - Personnel hygiene - Training record
Storage area 10.1.1 3.1 3.6 3.9 & 3.10 3.12.2
- 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
Sanitation 3.1 5.3
- Pest record program - The map of bait - The cleanliness of weighing
apparatus
Documentation 4.3 10.2.2.3 10.2.2.1
- Record of maintenance and calibration of weighing apparatus
- The effectiveness of label system - Inventory stock control
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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?
IA MONITORING
Project co-financed by European Union Project co- financed
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European Committee for StandardizationImplementing Agency
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AUDITING ACTIVITIES (1)
• Conducting on-site audit activities
Interviews with different personnel Carry out both horizontal and vertical audits.
Focus on safety and quality of product. Use “Trace-back” method
Conduct opening meeting
Good communication during the audit
Roles of escort and observer
Steps in conducting on site audit:
Project co-financed by European Union Project co- financed
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European Committee for StandardizationImplementing Agency
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• 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
AUDITING ACTIVITIES (2)
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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 properlyPressing machine of eye
shadow burns outPreventive maintenance program does not include liquid filling machine motor
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The audit finding can be classified into 2 groups:
1. Compliance :a. Satisfactory /Adequateb. Outstanding
2. Non-compliance :a. Critical deficiencyb. Major deficiencyc. Minor deficiency
AUDIT MONITORING
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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
AUDIT REPORT
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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
AUDIT REPORT
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No GMP.Ref
Findings of IA Grading
Location Auditee Auditor
1. 2.1.1 Production and QC departments are headed by the same person
Critical Human Resources
Abas Budi
2. 4.3 Monitoring of temperature in a warehouse
Major or Minor
Warehouse
Tuti May Lin
3 11.1 Inadequate control over sub-contractor
Major or Minor
Production
Herman Ida
AUDIT REPORT: AN EXAMPLE
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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 follow-up audit and/or requesting for an updated SOP
Project co-financed by European Union Project co- financed
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CONCLUSIONS
Nobody likes to be audited………..
It is a means to have continuous improvement
Project co-financed by European Union Project co- financed
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European Committee for StandardizationImplementing Agency
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RELATED HYPERLINK DOCUMENTS
Trainer Manual of Internal Quality Audit
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REFERENCES1. 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.