Project co-financed by European Union Project co- financed

by Asean

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Module 9Module 9GMP Workshop Kuala Lumpur 14-16 GMP Workshop Kuala Lumpur 14-16

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Prepared by:Lam Kok Seng - Singapore

Approved by:ASEAN Cosmetics GMP Team

Endorsed by:ASEAN Cosmetic Committee

ASEAN GMP TRAINING MODULE

INTERNAL AUDITINTERNAL AUDIT

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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

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INTRODUCTION

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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

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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

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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

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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

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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

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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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

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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

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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

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MANAGING IA

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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

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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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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.

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AUDITING ACTIVITIES

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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

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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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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

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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

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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:

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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

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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

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.