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Transcript of Interna audit module
Project co-financed by
European Union Project co- financed
by Asean
European Committee
for Standardization
Implementing Agency
Module 9
GMP Workshop Kuala Lumpur 14-16 Nov 2005 1
Prepared by:Lam Kok Seng - Singapore
Approved by:ASEAN Cosmetics GMP Team
Endorsed by:ASEAN Cosmetic Committee
ASEAN GMP TRAINING MODULE
INTERNAL AUDIT
Project co-financed by
European Union Project co- financed
by Asean
European Committee
for Standardization
Implementing Agency
Module 9
GMP Workshop Kuala Lumpur 14-16 Nov 2005 2
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 Standardization
Implementing Agency
Module 9
GMP Workshop Kuala Lumpur 14-16 Nov 2005 3
INTRODUCTION
Project co-financed by
European Union Project co- financed
by Asean
European Committee
for Standardization
Implementing Agency
Module 9
GMP Workshop Kuala Lumpur 14-16 Nov 2005 4
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 Standardization
Implementing Agency
Module 9
GMP Workshop Kuala Lumpur 14-16 Nov 2005 5
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 andqualified 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 Standardization
Implementing Agency
Module 9
GMP Workshop Kuala Lumpur 14-16 Nov 2005 6
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 Standardization
Implementing Agency
Module 9
GMP Workshop Kuala Lumpur 14-16 Nov 2005 7
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 Standardization
Implementing Agency
Module 9
GMP Workshop Kuala Lumpur 14-16 Nov 2005 8
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 Standardization
Implementing Agency
Module 9
GMP Workshop Kuala Lumpur 14-16 Nov 2005 9
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 Standardization
Implementing Agency
Module 9
GMP Workshop Kuala Lumpur 14-16 Nov 2005 10
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
by Asean
European Committee
for Standardization
Implementing Agency
Module 9
GMP Workshop Kuala Lumpur 14-16 Nov 2005 11
PRINCIPLE OF AN AUDITOR
Ethical
Professional
Fair
Project co-financed by
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by Asean
European Committee
for Standardization
Implementing Agency
Module 9
GMP Workshop Kuala Lumpur 14-16 Nov 2005 12
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 Standardization
Implementing Agency
Module 9
GMP Workshop Kuala Lumpur 14-16 Nov 2005 13
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 Standardization
Implementing Agency
Module 9
GMP Workshop Kuala Lumpur 14-16 Nov 2005 14
MANAGING IA
Project co-financed by
European Union Project co- financed
by Asean
European Committee
for Standardization
Implementing Agency
Module 9
GMP Workshop Kuala Lumpur 14-16 Nov 2005 15
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 program
scheduling audits
evaluating auditors
selecting audit team
directing audit activiries
maintaining records
Establishing
the internal audit program
obectives
responsibilitties
resources
procedure and guidance
Monitoring & reviewing
the internal audit program
monitoring & reviewing
identifying needs for corrective
identifying needs for prevention actions
identifying opportunities for improvement
Do
Project co-financed by
European Union Project co- financed
by Asean
European Committee
for Standardization
Implementing Agency
Module 9
GMP Workshop Kuala Lumpur 14-16 Nov 2005 16
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
Project co-financed by
European Union Project co- financed
by Asean
European Committee
for Standardization
Implementing Agency
Module 9
GMP Workshop Kuala Lumpur 14-16 Nov 2005 17
The planning of IA consists of :
IA PLANNING
• Establishing IA program
Objectives Responsibility Procedure and guidance
• Authority for administering the IA program
OBJECTIVES
Project co-financed by
European Union Project co- financed
by Asean
European Committee
for Standardization
Implementing Agency
Module 9
GMP Workshop Kuala Lumpur 14-16 Nov 2005 18
The implementation of IA programconsists of :
IA IMPLEMENTATION
Scheduling audit Implementation of audit program Audit record and report
Project co-financed by
European Union Project co- financed
by Asean
European Committee
for Standardization
Implementing Agency
Module 9
GMP Workshop Kuala Lumpur 14-16 Nov 2005 19
• 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 Standardization
Implementing Agency
Module 9
GMP Workshop Kuala Lumpur 14-16 Nov 2005 20
AUDITING ACTIVITIES
Project co-financed by
European Union Project co- financed
by Asean
European Committee
for Standardization
Implementing Agency
Module 9
GMP Workshop Kuala Lumpur 14-16 Nov 2005 21
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
by Asean
European Committee
for Standardization
Implementing Agency
Module 9
GMP Workshop Kuala Lumpur 14-16 Nov 2005 22
• 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
Project co-financed by
European Union Project co- financed
by Asean
European Committee
for Standardization
Implementing Agency
Module 9
GMP Workshop Kuala Lumpur 14-16 Nov 2005 23
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 questionnaire all records and comments during the audit
Project co-financed by
European Union Project co- financed
by Asean
European Committee
for Standardization
Implementing Agency
Module 9
GMP Workshop Kuala Lumpur 14-16 Nov 2005 24
EXAMPLE OF AN AUDIT CHECKLIST
• General format for an audit checklist
Project co-financed by
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by Asean
European Committee
for Standardization
Implementing Agency
Module 9
GMP Workshop Kuala Lumpur 14-16 Nov 2005 25
EXAMPLE OF AN AUDIT CHECKLISTCHECKING 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
Project co-financed by
European Union Project co- financed
by Asean
European Committee
for Standardization
Implementing Agency
Module 9
GMP Workshop Kuala Lumpur 14-16 Nov 2005 26
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 calibratedand 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
by Asean
European Committee
for Standardization
Implementing Agency
Module 9
GMP Workshop Kuala Lumpur 14-16 Nov 2005 27
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
by Asean
European Committee
for Standardization
Implementing Agency
Module 9
GMP Workshop Kuala Lumpur 14-16 Nov 2005 28
• 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)
Project co-financed by
European Union Project co- financed
by Asean
European Committee
for Standardization
Implementing Agency
Module 9
GMP Workshop Kuala Lumpur 14-16 Nov 2005 29
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
Pressing machine of eye shadow burns out
Preventive maintenance program does not include liquid filling machine motor
Project co-financed by
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by Asean
European Committee
for Standardization
Implementing Agency
Module 9
GMP Workshop Kuala Lumpur 14-16 Nov 2005 30
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
AUDIT MONITORING
Project co-financed by
European Union Project co- financed
by Asean
European Committee
for Standardization
Implementing Agency
Module 9
GMP Workshop Kuala Lumpur 14-16 Nov 2005 31
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
Project co-financed by
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by Asean
European Committee
for Standardization
Implementing Agency
Module 9
GMP Workshop Kuala Lumpur 14-16 Nov 2005 32
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
Project co-financed by
European Union Project co- financed
by Asean
European Committee
for Standardization
Implementing Agency
Module 9
GMP Workshop Kuala Lumpur 14-16 Nov 2005 33
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
Project co-financed by
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by Asean
European Committee
for Standardization
Implementing Agency
Module 9
GMP Workshop Kuala Lumpur 14-16 Nov 2005 34
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
by Asean
European Committee
for Standardization
Implementing Agency
Module 9
GMP Workshop Kuala Lumpur 14-16 Nov 2005 35
CONCLUSIONS
Nobody likes to be audited………..
It is a means to have continuous improvement
Project co-financed by
European Union Project co- financed
by Asean
European Committee
for Standardization
Implementing Agency
Module 9
GMP Workshop Kuala Lumpur 14-16 Nov 2005 36
RELATED HYPERLINK DOCUMENTS
Trainer Manual of Internal Quality Audit
Project co-financed by
European Union Project co- financed
by Asean
European Committee
for Standardization
Implementing Agency
Module 9
GMP Workshop Kuala Lumpur 14-16 Nov 2005 37
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, 20024. www.cityu.edu.hk, Internal Quality Audit Scheme.5. www.fineprint.com, Internal Audit Procedure6. 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.