Managing Effective Quality Audits by Operational Excellence Consulting

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The ISO 9001 standard is increasingly being adopted by many organizations world-wide. Whether you are conducting an internal quality audit in your organization or preparing for an external audit, it is important that the auditing process is thorough, systematic and effective. This powerpoint presentation will help you to:

1. Conduct a step by step internal quality audit to the ISO 9001:2008 standard;
2. Prepare you for an external audit; and
3. Conduct a supplier audit.

To download this complete presentation, please go to: http://www.oeconsulting.com.sg

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Managing Effective Quality Audits by Operational Excellence Consulting

  1. 1. © Operational Excellence Consulting. All rights reserved. © Operational Excellence Consulting. All rights reserved. Managing Effective Quality Audits
  2. 2. 2© Operational Excellence Consulting. All rights reserved. Learning Objectives By the end of the program, you will be able to: • Understand the principles of management system auditing • Describe how to conduct an effective internal quality audit to ISO 9001:2008 • Define how to prepare for an external audit • Explain how to conduct a supplier audit
  3. 3. 3© Operational Excellence Consulting. All rights reserved. Program Outline 1. Principles of management system auditing 2. Conducting effective internal quality audit to ISO 9001:2008 3. Preparing for external audits 4. Conducting supplier audits NOTE: As this is a PREVIEW, only selected slides are shown. To download the complete presentation, please visit: http://www.oeconsulting.com.sg
  4. 4. © Operational Excellence Consulting. All rights reserved. Principles of Management System Auditing 1
  5. 5. 5© Operational Excellence Consulting. All rights reserved. What is an Audit? • A quality audit is a systematic, independent and documented process of examining any activity of an organization based on objective evidence to determine: a. The extent to which quality activities and related results comply with the planned arrangements b. The extent to which these arrangements have been implemented effectively, and c. Whether these arrangements are suitable to achieve the quality objectives. Principles of Management SystemAuditing
  6. 6. 6© Operational Excellence Consulting. All rights reserved. What Are Audits Used For? • Looking at the overall process • Auditing conformity • Auditing effectiveness • Approving Suppliers / Subcontractors • Assessing for Certification • Investigating problems • Way of improving Principles of Management SystemAuditing
  7. 7. 7© Operational Excellence Consulting. All rights reserved. Likely Effects on QMS of a Weak IQA System • Inadequate review of the Quality Management System versus the requirements • Conclusions not reliable basis for Top Management to evaluate the effectiveness of QMS implementation • Diminished people’s full support to the Quality Management System Principles of Management SystemAuditing
  8. 8. 8© Operational Excellence Consulting. All rights reserved. Types of Quality Audits • First party audit  Internal audit (by your organization’s Quality department) • Second party audit  Your customer auditing your organization • Third party audit  A certification body auditing your organization Principles of Management SystemAuditing
  9. 9. 9© Operational Excellence Consulting. All rights reserved. Basic Steps for an Audit • Scheduling the audit • Planning the audit • Opening meeting • Conducting the audit • Reporting audit findings • Closing meeting • Post audit activities Principles of Management SystemAuditing
  10. 10. 10© Operational Excellence Consulting. All rights reserved. Five Principles of Auditing 1. Ethical conduct 2. Fair presentation 3. Due professional care 4. Independence 5. Evidence-based approach Principles of Management SystemAuditing
  11. 11. © Operational Excellence Consulting. All rights reserved. Effective Internal Auditing to ISO 9001:2008 2
  12. 12. 12© Operational Excellence Consulting. All rights reserved. Tips on Gaining Management Support to the Audit Program • Communicate the cost of audit observations • Explain the regulatory effects of nonconforming processes • Educate by stating or restating management’s role in the audit program • Distribute audit reports to management • Have a member of management participate in an audit Managing the Internal Audit
  13. 13. 13© Operational Excellence Consulting. All rights reserved. Planning and Preparation • Audit Planning • Communicating the Audit Plan • Selection of Auditors • Preparing for Audit • Pre-audit Information Planning the Internal Audit
  14. 14. 14© Operational Excellence Consulting. All rights reserved. The Audit Agenda • Opening Meeting • Audit Proper • Closing Meeting Conducting the Internal Audit
  15. 15. 15© Operational Excellence Consulting. All rights reserved. The Opening Meeting What to say during the opening meeting? • Review / discuss the following Opening Meeting agenda for the audit program, to include:  Objective and scope of audit and audit criteria  The schedule of events; other arrangements  Definition of nonconformities, major and minor  How you will report the audit results  Confidentiality of audit data  Resolve any questions and items for clarification from the auditees Conducting the Internal Audit
  16. 16. 16© Operational Excellence Consulting. All rights reserved. The Site / Area Tour • A very critical part of audit • Respect dress codes of the areas to be visited • Do not be afraid to ask to visit controlled areas • Allow one auditor to speak at a time • Talk to workers during site tour • Ensure that you understand the answers  If not ask the same question again  Ask for clarification if required Conducting the Internal Audit
  17. 17. 17© Operational Excellence Consulting. All rights reserved. Types of Audit Findings • Positive findings  Good practice; conformities • Negative findings  Nonconformities • Observations  Opportunities for improvements Reporting Internal Audit Findings
  18. 18. 18© Operational Excellence Consulting. All rights reserved. The Closing Meeting • Thank the auditees for their help and time • Commend auditees for accomplishments • List the positive findings that you saw or found during the audit • Report any nonconformity – invite the individual auditor to report their respective findings • Present the Major (Category 1) findings followed by Minor (Category 2). Add the Observations if there are not too many findings in total. • Present findings based on facts, and back the findings up with information contained in the standards, if questioned Reporting Internal Audit Findings
  19. 19. 19© Operational Excellence Consulting. All rights reserved. Post-Audit Actions • Audit reports submitted for management review • Reports include corrective/preventive actions, and Management Representative’s assessment of QMS effectiveness and efficiency, based on internal audit results • Continual improvement plans, based on internal audit results Post Audit Activities
  20. 20. © Operational Excellence Consulting. All rights reserved. How to Prepare for an External Audit 3
  21. 21. 21© Operational Excellence Consulting. All rights reserved. Planning for an External Audit • Planning for an external audit will take time and effort, but it will be worth the trouble • Taking the time to plan for an external audit will make the audit smoother, higher quality, less time consuming and less costly • Planning for the external audit involves determining what you want the auditor to focus on and choosing an auditor that meets your need and experience criteria
  22. 22. 22© Operational Excellence Consulting. All rights reserved. Define the Audit Requirements • Different types of entities will have different audit requirements • Government entities will likely need a different type of audit than corporations
  23. 23. 23© Operational Excellence Consulting. All rights reserved. Prior to the External Audit • Ensure all internal audits scheduled for the area to be audited have been completed and weaknesses (such as noncompliance with regulations/standards) have been corrected. • Review control activities and related documentation (reconciliations, records of call monitoring activities, test records, minutes of management review meetings, etc.) to ensure it is complete and filed logically. Do not create control documentation if it does not exist, as this is considered fraud.
  24. 24. 24© Operational Excellence Consulting. All rights reserved. Interacting with Auditors – Do’s for Auditees • Be honest and open • Recognize they may be experts • Realize they may not be subject matter experts • Understand the purpose of the meeting and review related records prior to interviews • Turn mobile phones to silent mode
  25. 25. 25© Operational Excellence Consulting. All rights reserved. Interacting with Auditors – Don’ts for Auditees • Assume auditors are familiar with your organization’s quality or financial control system • Challenge auditors • Show more competence in the standard being audited • Argue internally • Express unfairness • Ask for solution • Fix non-conformities on the spot
  26. 26. © Operational Excellence Consulting. All rights reserved. How to Conduct a Supplier Audit 4
  27. 27. 27© Operational Excellence Consulting. All rights reserved. Introduction to Supplier Quality Audit • For important purchases, ensuring acceptable supplier quality is critical • Performing a supplier quality audit is one step in ensuring the selection of a capable supplier • A supplier quality audit is more than just walking a supplier's shop floor and looking around (avoid behaving like “industrial tourists”)
  28. 28. 28© Operational Excellence Consulting. All rights reserved. Objectives of Supplier Quality Audit • Review the supplier’s management philosophies and practices • Review supplier’s total quality system • Address specific issues needing corrective action or to review technical and service capabilities of a supplier • Means to understand supplier capabilities and to drive supplier improvements as needed
  29. 29. 29© Operational Excellence Consulting. All rights reserved. Key Steps for Conducting a Supplier Quality Audit 1. Supplier audit planning and preparation 2. On-site supplier audit 3. Post audit activity
  30. 30. © Operational Excellence Consulting. All rights reserved. To download this presentation, please visit us at: www.oeconsulting.com.sg END OF PREVIEW

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