1. 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

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 2 CONTENT OF PRESENTATION

3. 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

4. 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

5. 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 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

6. 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

7. 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

8. 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) l Includes all written quality documents, instructions and records l Covering all elements of GMP including results of previous internal quality audit and any corrective and preventive actions (CAPA) taken

9. 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

10. 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

11. 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

12. 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 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

13. 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

14. 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

15. 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

16. 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

17. 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

18. 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 program consists of : IA IMPLEMENTATION Scheduling audit Implementation of audit program Audit record and report

19. 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.

20. 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

21. 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

22. 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

23. 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

24. 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

25. 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 25 EXAMPLE OF AN AUDIT CHECKLIST

26. 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 calibrated and cleaned? 5. When is the last breakdown of the machine? Are there any product being affected? IA MONITORING

27. 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:

28. 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)

29. 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 ISOLATEDSYSTEMIC Latex gloves ripSOP 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

30. 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 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

31. 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

32. 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 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

33. 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 NoGMP.RefFindings of IAGradingLocationAuditeeAuditor 1.2.1.1Production and QC departments are headed by the same person CriticalHuman Resources AbasBudi 2.4.3Monitoring of temperature in a warehouse Major or Minor WarehouseTutiMay Lin 311.1Inadequate control over sub-contractor Major or Minor ProductionHermanIda AUDIT REPORT: AN EXAMPLE

34. 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 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

35. 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

36. 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 Trainer Manual of Internal Quality Audit

37. 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, 2002 4.www.cityu.edu.hk, Internal Quality Audit Scheme.www.cityu.edu.hk 5.www.fineprint.com, Internal Audit Procedurewww.fineprint.com 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.