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- 1. Saudi Arabian Quality Council Al-Khobar, Saudi Arabia NEW IDEAS AND FUNDAMENTALS OF QUALITY AUDITING Afaq Ahmed (afaq.ahmed@aramco.com) Quality Specialist Inspection Department, Saudi Aramco December 19, 2011 © Copyright 2011, Saudi Aramco. All rights reserved. No portion of this article may be reproduced, by any process or technique, without the express written consent of Saudi Aramco.
- 2. Road Map Definitions Quality Audit Fundamentals New Quality Audit Approach Process Components Case Study Quality Excellence Assessments Summary
- 3. Definitions Audit Systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled. (*) Assessment An estimate or determination of the significance, importance, or value of something. (**) Survey Audits conducted in support of supplier evaluation prior to a decision to purchase, the audit objectives may include an evaluation of the prospective supplier’s ability to meet contract or purchase requirements. * ** ISO 19011-2011 Performance based assessments, Wilson and Pearson
- 4. Quality Audit Fundamentals Conducting an Audit Planning Objective, scope and criteria Review of Quality Management System documents & records Review of previous audit reports Auditor’s assignment Schedule Working papers Execution Reporting Opening meeting Prepare Collecting objective evidence Approve Findings Conclusion Closing meeting Distribute
- 5. Quality Audit Fundamentals Auditor Competence Personal Behavior Ethical Courageous Diplomatic Tenacious Decisive Punctual Observant Knowledge and Skills Education, Training and Experience • Quality Management System (QMS) Standard • Development, implementation and continual improvement of QMS • Terminology (quality and industry specific) • Quality tools • Relevant industry work experience (processes and products) • Audit experience
- 6. Process Components Approach: A New Perspective on Quality Audits Current Practice: ISO Check List Are records established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system? Are personnel performing work affecting product quality competent on the basis of appropriate education, training, skills and experience?
- 7. Process Components Approach Audit is focused on essential components of a process: INPUT OUTPUT PROCESS CONTROL MEASURE
- 8. Process Components Approach How to do it in six steps? 1. Study Process 2. Identify Activities 3. Identify Process Components (I, O, M & C) & Elements 4. Identify Audit Items for each Element I = Input, O = Output, M = Measures and C = Control 5. Map Audit Items to an Audit Criteria 6.Identify Linkages
- 9. Case Study Audit of a Pressure Vessel’s Manufacturer
- 10. Case Study Step 1: Study Pressure Vessel Manufacturing Process Flow Chart Receiving Inspection Visual Inspection Pressure Test Cutting NDT Coating Rolling Dimensional Inspection Final Inspection Welding PWHT PWHT: Post Weld heat Treatment NDT: Nondestructive Testing
- 11. Case Study Step 2: Identify Activities to be Audited Flame Cutting Rolling Welding
- 12. Process Components Approach How to do it? 1. Study Process 2. Identify Activities 3. Identify Process Components (I, O, M & C) Elements 4. Identify Audit Items for each Element I = Input, O = Output, M = Measures and C = Control
- 13. Case Study Step 4: Identify Audit Items for each Element Rolling: Input: 1. Cut sheet 2. Identification & Traceability 3. Filled work order 4. Inspection record 5. Fabricator 6. Plate rolling machine 7. Specification Control: 1. Fabricator 2. Maintenance 3. Set-up Output: 1. Rolled shell 2. Identification & Traceability 3. Filled work order 4. Inspection record Rolling Measure: 1. Dimensions 2. Visual 3. Yield 4. Scrap
- 14. Case Study Step 4: Identify Audit Items for each Element Audit items for Rolling Input (I) and Measure (M) Elements: I and M Elements Audit item Fabricator Competency records of rolling machine operator Rolling Machine Rolling machine capacity Measurement Dimensional and visual inspection of rolled shell
- 15. Process Components Approach How to do it? 1. Study Process 2. Identify Activities 3. Identify Process Components (I, O, M & C) Elements 4. Identify Audit Items for each Element I = Input, O = Output, M = Measures and C = Control 5. Map Audit Items to an Audit Criteria
- 16. Case Study Step 5: Map Audit Items to an Audit Criteria ISO 9001 Clauses Mapped to Plate Rolling Input (I) and Measure (M) Audit Items I & M Audit Items ISO 9001 Clause Description Competency records of rolling machine operator 6.2.2e Competency records Use of suitable rolling machine 7.5.1c Use of suitable equipment Dimensional and visual inspection of rolled shell 8.2.4 Monitoring and measurement of product
- 17. Process Components Approach How to do it? 1. Study Process 2. Identify Activities 3. Identify Process Components (I, O, M & C) Elements 4. Identify Audit Items for each Element I = Input, O = Output, M = Measures and C = Control 5. Map Audit Items to an Audit Criteria 6. Identify linkages
- 18. Case Study Step 6: Identify Linkages to Supporting Activities, Functions and Facilities: Interact -ion Activity Function Facilities Audit Samples Flame cutting – Plate identification (heat #, job #, material) Drawing (title, # and rev #) Welding consumables details MTR: Material Test Report Linkage Question Receiving Inspection Are records of MTR and receiving inspection maintained? Engineering Is drawing used by the flame cutting operator of latest revision? Welding consumables store room Are welding consumables stored as per manufacturer recommendations? ISO 9001 Clause 4.2.4 4.2.3 7.5.5
- 19. Overview of Audit Items ISO 9001 Clause Description Audit Items 4.2.3a Control of documents Control of drawing and work instruction used by the flame cutting operator 6.1 Provision of resources Adequate number of welders 6.3b Infrastructure Preventive maintenance of rolling machine 7.4.3 Verification of purchased product Steel sheet receiving inspection 7.5.1c Production Rolling machine capability to roll the plate of required thickness 7.5.2c Validation WPS and PQR availability 7.6 Calibration Calibration of gauges used for inspection of rolled shell WPS: Welding Procedure Specification PQR: Procedure Qualification Record
- 20. Quality Excellence Assessments Quality Excellence Assessment Quality Audit to ISO 9001 Standard Criteria is flexible (Excellence Model) Criteria is rigid (standard) Objective is to measure performance Objective is to check conformance Report is based on best practices and Opportunities for improvements (OFI) Report is based on non-conformances All functions (e.g. IT and security) Only functions related to Quality Management System (Engineering, Purchasing) All Management Systems (e.g. financial, environmental) Only Quality Management System (QMS) Assessment is done in pairs i.e. business driver and it’s results ISO 9001 is not structured around business drivers and results Heavy emphasis on achievement of consistently good results over a long period of time and benchmarked against best in class ISO 9001 standard does not require benchmarking of results Assessment is used as a tool to improve performance to be “Best in Class” Audit purpose is to measure effective implementation of QMS
- 21. Summary Audit, Assessment and a Survey Fundamental activities of an Audit Auditor Competency New Perspective in Auditing (Process Approach) Provides a methodical approach to prepare for an audit Enhances audit findings, results and the audit program Minimizes potential risks associated with quality auditing Quality Excellence Assessments
- 22. Saudi Arabian Quality Council Al-Khobar, Saudi Arabia Thank You Afaq Ahmed (afaq.ahmed@aramco.com)