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Prepared by: Lam Kok Seng - Singapore Approved by: ASEAN Cosmetics GMP Team Endorsed by:

ASEAN GMP TRAINING MODULE INTERNAL AUDIT. Prepared by: Lam Kok Seng - Singapore Approved by: ASEAN Cosmetics GMP Team Endorsed by: ASEAN Cosmetic Committee. CONTENT OF PRESENTATION. INTRODUCTION. OBJECTIVES. To define the activities and requirements of IA.

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Prepared by: Lam Kok Seng - Singapore Approved by: ASEAN Cosmetics GMP Team Endorsed by:

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  1. ASEAN GMP TRAINING MODULE INTERNAL AUDIT Prepared by: Lam Kok Seng - Singapore Approved by: ASEAN Cosmetics GMP Team Endorsed by: ASEAN Cosmetic Committee Module 9 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  2. CONTENT OF PRESENTATION Module 9 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  3. INTRODUCTION Module 9 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  4. 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 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 checkingsystem, NOTa quality assessment • As a communication tool ofmanagement policies. All personnel have to understand and do their jobs well 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 Module 9 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  7. 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 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 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 Module 9 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  10. 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 Module 9 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  11. PRINCIPLE OF AN AUDITOR • Ethical • Professional • Fair 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 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 Module 9 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  14. MANAGING IA Module 9 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  15. FLOW CHART OF IA 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 Module 9 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  17. IA PLANNING OBJECTIVES The planning of IA consists of : • Authority for administering the IA program • Establishing IA program • Objectives • Responsibility • Procedure and guidance Module 9 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  18. IA IMPLEMENTATION The implementation of IA program consists of : • Scheduling audit • Implementation of audit program • Audit record and report Module 9 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  19. 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. Module 9 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  20. AUDITING ACTIVITIES Module 9 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  21. OVERVIEW OF AUDIT ACTIVITES Planning and scheduling audit Conducting document review Preparing for on-site activities Conducting audit Prepare audit report Conducting follow-up Module 9 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  22. AUDIT ACTIVITIES • 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) Module 9 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  23. 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 Module 9 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  24. EXAMPLE OF AN AUDIT CHECKLIST • General format for an audit checklist Module 9 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  25. EXAMPLE OF AN AUDIT CHECKLIST 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 Module 9 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  27. 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 Module 9 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  28. 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 Module 9 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  29. 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 ISOLATED VERSUS SYSTEMIC DEFICIENCY Module 9 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  30. AUDIT MONITORING The audit finding can be classified into 2 groups: • Compliance : • Satisfactory/Adequate • Outstanding • Non-compliance : • Critical deficiency • Major deficiency • Minor deficiency Module 9 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  31. 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 Module 9 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  32. 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 Module 9 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  33. AUDIT REPORT: AN EXAMPLE 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 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 Module 9 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  36. RELATED HYPERLINK DOCUMENTS • Trainer Manual of Internal Quality Audit Module 9 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  37. REFERENCES • ASEAN Guidelines for Cosmetic GMP. • International standard ISO 9001:2002, • Guidelines for quality and/or environmental management system auditing, 1st Edition, 2002 • www.cityu.edu.hk, Internal Quality Audit Scheme. • www.fineprint.com, Internal Audit Procedure • Stimson W.A., Internal Quality Auditing, Meeting the challenge of ISO 9000:2000, Paton Press, 2001 • WHO – EDM, Basic Principle of GMP: Self-Inspection. Module 9 GMP Workshop Kuala Lumpur 14-16 Nov 2005

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