Audit
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An audit is a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled. This presentation illustrates: - The Audit definition - Possible reasons for auditing - Audit Types - How to conduct an audit 0- Audit preparation 0 Audit performance 0- Audit reporting 0- Audit follow up and closure - Auditor key skills * For business possibilities, feel free to contact me.
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Audit
- 2. M. Abogazia The audit definition •The on-site verification activity, such as inspection or examination, of a process or quality system, to ensure compliance to requirements. An audit can apply to an entire organization or might be specific to a function, process, or production step.
- 3. M. Abogazia The audit definition cont. •An audit is a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.
- 4. M. Abogazia
- 5. M. Abogazia Possible reasons to audit: •ensure compliance with ISO 9001:2008 •ensure compliance with organization requirements •ensure compliance with regulatory requirements •ensure the QMS is effectively implemented and maintained •look for opportunities for improvement •look for preventive action
- 6. M. Abogazia “Comply” V.S “confirm”
- 7. M. Abogazia Audit types: •Internal audits – first party. •Customer audits of suppliers – second party. •External independent audits – third party.
- 8. M. Abogazia Audit types: •Internal audits – first party oPerformance to the organization’s objectives oIdentification of problem areas! oFinding opportunities for improvement!
- 9. M. Abogazia Audit types: •Customer audits of suppliers – second party oConformance to customer requirements oCustomer’s special interest items
- 10. M. Abogazia Audit types: •External independent audits – third party oConformity to a specific standard
- 11. M. Abogazia The system The process The product The system audit is the largest and the most extensive audit which focus on the entire Quality Management System of the organization. A process audit usually concentrate on 1 or 2 specific process within an organization. A product process is a final assessment of final product (after final inspection) to ensure conformance to all requirements and “fitness for use” Audit types:
- 12. M. Abogazia How to conduct an audit?
- 13. M. Abogazia Audit preparation • Audit planning is a key factor to make it successful! Audit performance • The style of carrying out the audit defines how skillful the auditor is! Audit reporting • Audit has no meaning without communicating the audit result! Audit follow-up and closure • How to eliminate shortfalls effectively! The audit phases
- 14. M. Abogazia Define the purpose • Why the audit will be conducted? • -System maintenance? • -Improvement confirmation? • -Problem investigation? Define the scope • Where the audit will be conducted • -Which area? • -Which process? • -Which product? Identify requirements • What are the requirements should be achieved? • -Standards • -Procedures • -Manuals • -Forms Notify the auditee • What is going to be carried out? When? How? • -Audit notification • -Schedule • -Readiness confirmation Prepare checklists • Questions to be asked? • -Check list contents • -References Audit preparation
- 15. M. Abogazia Introducing audit • Meet the auditee! • -Review purpose and scope • -Review scheduleand guide Start the audit • Using checklist! • -Ask questions (Open question!) • -Gather information (interview right persons) • -Confirm facts! Identify nonconformities • What are the nonconformities you found? • -Clearfor auditee • -Nonconformity Evidence • -Get auditee agreement Closing the audit • Meet the auditee, again! • -Audit summary • -Highlight good points • -Summarize improvement points! Audit performance
- 16. M. Abogazia Audit report • Detailed reporting! • -Audit details(Date, purpose, scope, attendees, etc.) • -Good points summary • -Main findings (Majornonconformities, Minornonconformities, improvement points) CAR* issuance • CAR against nonconformities! • -Nonconformity reference • -Evidence of nonconformity • -Required actions • -Target date CAR log • CAR log contents • -List of nonconformities • -Target dates of closing and follow up • -Corrective and Preventive actions • -Actual date of closure Audit reporting *CAR = Corrective Action Request
- 17. M. Abogazia Re-audit • Confirm countermeasure • -Using CAR log target dates • -Verify countermeasure of nonconformities • -Field visit may be needed Countermeasure effectiveness • Is it sustainable? • -Action continuitycheck • -How to maintain! • -Verify understandingby main player • -CloseCAR! Status reporting • Closed CAR reporting to management! • -CAR Log again! • -Report to related manager (QMS officer!) • -File all Audit Records and keep retrievable • -Re-check in next audit! Audit follow up and closure
- 18. M. Abogazia Auditor key skills •Excellent communication skills! •Ability to put auditee at ease! •Ability to stay calm when working under pressure •Being objective –unbiased –facts only! •Ability to analyze what is said by auditee •Ability to link between audited process within scope!
- 19. M. Abogazia This presentation prepared and conducted by: Eng. Mohamed Abogazia
- 20. M. Abogazia References: • [1] Shewhart, Walter A. (1931). Economic Control of Quality of Manufactured Product. New York: D. Van Nostrand Company. ISBN 0-87389-076-0 • [2] Dr. Edwards Deming (2000). Out of the Crisis. MIT Press, Centre for Advanced Engineering Study. • [3] Mikel Harry and Richard Schroeder (2000). Six Sigma The Breakthrough Management Strategy Revolutionizing The World’s Top Corporation. • [4] James P Womack and Daniel T Jones (1996). Lean Thinking. Simon & Schuster. ISBN 0-684-81035-2 • [5] Taiichi Ohno (1988). Toyota Production System: Beyond Large-Scale Production, Productivity Press, ISBN 0-915299-14-3 • [6] Shigeo Shingo (1990). Modern Approaches to Manufacturing Improvement: The Shingo System. Productivity Press, ISBN 0- 915299-64-X • [7] Kaoru Ishikawa (1976). Guide to Quality Control. Asian Productivity Organization, UNIPUB. ISBN 92-833-1036-5