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![Internal Auditor Quiz
Answers for the ISO 9001:2000 Clause Quiz
The correct clauses for the ten requirements are:
1. Reviewing the system at planned intervals = 5.6.1 [also 8.2.2 regarding audits]
2. Identifying the status of product measurements = 7.5.3
3. Maintaining process equipment = 6.3 (b)
4. Handling, packaging, and storing products = 7.5.5
5. Preventing the "recurrence" of nonconformities = 8.5.2 (not 8.5.3)
6. Maintaining evidence of conformity of acceptance criteria = 8.2.4
7. Ensuring requirements are complete and unambiguous = 7.3.2 [implied by 7.2.2 (a)]
8. Identifying the control of outsourced processes = 4.1
9. Planning for design review, verification, and validation = 7.3.1 (b) [implied by 7.1]
10. Including a quality manual in the documentation = 4.2.1 (b)
How did you do on the quiz? Do you agree with these answers?
51Auditor Training rev 0 022009
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Uploaded byIsidro Sid Calayag
Practical auditing
This document provides an agenda for a training on practical auditing for internal quality auditors. It discusses key audit concepts like the PDCA cycle and process approach. It also covers important audit skills like interview techniques, note taking, report writing, and auditing difficult clauses. Common audit findings are presented along with tips for auditing undocumented processes and improving audit practices. The document concludes with an auditor code of ethics emphasizing integrity, objectivity, confidentiality and competence.
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Practical auditing
- 1. PRACTICAL AUDITING Continual ImprovementProgram for Internal Quality Auditors By Sid Calayag
- 2. Agenda • PDCA andProcess Approach • Interview/Question Technique • Notes, Check List & Cheat Sheet • Report Writing • Toughest ISO 9001:2000 Clauses • How to Audit Difficult Clauses • How to Audit Undocumented Process • Auditor’s Code of Ethics 2Auditor Training rev 0 022009
- 3. Warm-up Exercise The exercisewill be used to gauge your present knowledge must be completed in 10 minutes. Countdown starts now. . . 3Auditor Training rev 0 022009
- 4. 4 Process Based Approach MANAGEMENT RESPONSIBILITY RESOURCEMANAGEMENT MEASUREMENT, ANALYSIS & IMPROVEMENT PROCESSINPUT OUTPUT C U S T O M E R P DC A PRODUCT REALIZATION Satisfaction C U S T O M E R Requirements
- 5.
- 6. Interview and QuestionTechnique • Interview • Reason • Steps • Question Techniques • Closed-ended Question • Open-ended question • Show-me Question 6Auditor Training rev 0 022009
- 7. Interview Reason • Supplementsthe documented process • Determines the actual defined process • Principal way of obtaining information • Allows auditee to explain work practices • Ascertains understanding and commitment Auditor Training rev 0 022009 7
- 8. Interview Steps -1 •Interview persons at their workplace • Conduct interviews during normal hours • Put person at ease (lower anxiety level) • Explain your purpose (what you want) • Ask about their job (question; observe) • Verify responses (confirm understanding) Auditor Training rev 0 022009 8
- 9. Interview Steps -2 • Check the facts (use other sources) • Record evidence (notes on checklist) • Make tentative conclusion (no secrets) • Give opportunity to discuss other topics • Thank for their time and cooperation Auditor Training rev 0 022009 9
- 10. Summary on Interview •Remember, it is an interview, not an interrogation! • Investigate a claim; accept an admission. Auditor Training rev 0 022009 10
- 11. Questioning Techniques -1 • Ask question and then actively listen • Rely primarily on open-ended questions • Avoid closed question (except to confirm) • Ask for explanations and examples • Rephrase your question for clarification • Restate answer for your understanding • Keep neutral; don't disagree or interrupt Auditor Training rev 0 022009 11
- 12. Questioning Techniques -2 • Ask "suppose" or "what if" questions • Find basic flaws with simple questions • Ask the blunt question about quality • Nod in agreement to maintain dialog • Use silence for expanded responses • Observe unguarded facial expressions • Learn from remarks of nearby people Auditor Training rev 0 022009 12
- 13. Close and Open-endedQuestion • Open-ended question can be used in determining the actual process during the interview. • Close-ended question can be used to conclude the result of the interview. Auditor Training rev 0 022009 13 Sample
- 14. Summary on QuestioningTechniques • STOP TALKING - LISTEN Do not ask closed questions unless to conclude item Maintain a 20% talking : 80% listening ratio • USE THE SIX HONEST SERVING MEN “I keep six honest serving men They taught me all I knew Their names were WHAT and WHY and WHEN And HOW and WHERE and WHO” (The Elephant Child - Kipling) • SHOW ME
- 15. Notes, Check List& Cheat List • Taking Notes in an Audit • Check List • Cheat List 15Auditor Training rev 0 022009
- 16. Taking Notes inan Audit • One use of a checklist is as a repository for your notes • Take brief notes on what you have read, heard, and seen • Capture specific references • record what people are telling you about their practices • Some of your notes will be used immediately for your next line of questioning Auditor Training rev 0 022009 16
- 17. Check List Requirements forcheck list • Standard requirement • Customer requirement • Organizational requirement • Legal requirement Auditor Training rev 0 022009 17
- 18. Advantages on UsingCheck List Checklists, if developed and used properly: • Promote planning for the assigned audit • Ensure a consistent audit approach • Act as a sampling plan and time manager • Serve as a memory aid and confidence builder • Provide a repository for notes on evidence Auditor Training rev 0 022009 18
- 19. Drawback on UsingCheck List Drawback • May result in poor coverage. • Restrict interview questions • May cause the auditor to use an outdated tool if not updated according to the new standard Auditor Training rev 0 022009 19
- 20. Summary on CheckList • A checklist should guide auditors through the system flow from quality policy, to objectives, to processes, to measurements, to results, to actions, and eventually to continual improvement. • Auditors should use the checklist as a planning tool for their assignment and be willing to pursue other areas of investigation. Auditor Training rev 0 022009 20
- 21. Cheat Sheet • A"cheat sheet" is a concise set of notes used for quick reference • Job notes may not accurately describe the tasks, in conflict with written instructions, or unapproved by management. ISO 9001:2000, clause 4.2.3 states that "Documents required by the quality management system shall be controlled." So, if cheat sheets are needed by employees to carry out their activities, these would be viewed as documents that must be controlled. Auditor Training rev 0 022009 21
- 22. Report Writing • UseCPLANES as a reminder • C – Clause • P -- Procedure or Instruction • L -- Location • A – Activity • N – Nature of Deficiency • E – Evidence • S – Scale of Deficiency Auditor Training rev 0 022009 22
- 23. Writing Nonconformity Reports •Conformity, • Conformance, or • Compliance? 23Auditor Training rev 0 022009
- 24. Exercise No. 1 Howwell do you know the new ISO 9001:2000 standard? Can you identify the clauses for these requirements? 1. Reviewing the system at planned intervals 2. Identifying the status of product measurements 3. Maintaining process equipment 4. Handling, packaging, and storing products 5. Preventing the "recurrence" of nonconformities 6. Maintaining evidence of conformity of acceptance criteria 7. Ensuring requirements are complete and unambiguous 8. Identifying the control of outsourced processes 9. Planning for design review, verification, and validation 10. Including a quality manual in the documentation 24Auditor Training rev 0 022009 answer
- 25. Toughest Requirements • 4.1General Requirements • 5.1 Management Commitment • 5.4.1 Quality Objectives • 5.4.2 Quality Management System Planning (vs. 7.1 Planning of Product Realization) • 7.3.1 Design and Development Planning 25Auditor Training rev 0 022009
- 26. Toughest Requirements • 7.5.2Validation of Processes for Production and Service Provision • 8.2.1 Customer Satisfaction • 8.5.1 Continual Improvement • 8.5.3 Preventive Action 26Auditor Training rev 0 022009
- 27. Most Common AuditFindings * Internal Audit Findings • 1. Customer satisfaction data and assessment (8.2.1 . . . • 2. Documentation gaps (4.2.3 . . . • 3. Continual improvement process (8.5.1 . . . • 4. Objectives not measurable (5.4.1 . . . • 5. Collection and analysis of data (8.4 . . . • 6-7. Top management commitment and responsibility (5.4 . . . • 6-7. Record keeping gaps (4.2.4 . . . • 8-9. Competency requirements (6.2.2 . . . • 8-9. Effective control of processes (4.1 . . . * Ref. : <http://standardsgroup.asq.org/news/psi/IMS06-2002E-Implementing_ISO_9001-BD.pdf> 27Auditor Training rev 0 022009
- 28. Most Common AuditFindings * Registrar Audit Findings • 1. Documentation gaps • 2-3. Objectives not measurable • 2-3. Top management commitment and responsibility • 4. Continual improvement process • 5-6. Customer satisfaction data and assessment • 5-6. Effective control of processes • 7-8. Collection and analysis of data • 7-8. Record keeping gaps • 9. Competency requirements * Ref. : <http://standardsgroup.asq.org/news/psi/IMS06-2002E-Implementing_ISO_9001-BD.pdf> 28Auditor Training rev 0 022009
- 29. Comparison of Rankings AuditorTraining rev 0 022009 29 Internal Audit Findings • 1. Customer satisfaction data and assessment • 2. Documentation gaps • 3. Continual improvement process • 4. Objectives not measurable • 5. Collection and analysis of data • 6-7. Top management commitment and responsibility • 6-7. Record keeping gaps • 8-9. Competency requirements • 8-9. Effective control of processes Registrar Audit Findings • 1. Documentation gaps • 2-3. Objectives not measurable • 2-3. Top management commitment and responsibility • 4. Continual improvement process • 5-6. Customer satisfaction data and assessment • 5-6. Effective control of processes • 7-8. Collection and analysis of data • 7-8. Record keeping gaps • 9. Competency requirements
- 30. How to AuditDifficult Clauses 4.1 General Requirements Clause 4.1 covers the requirement for your organization to set up a quality management system and broadly defines the associated activities. These activities are described in greater detail in the remainder of the standard. And, when you audit these other clauses, you are in essence auditing clause 4.1. 30Auditor Training rev 0 022009
- 31. How to AuditISO 9001:2000, Clause 4.1 • By recognizing its linkages to the clauses in the remainder of the standard. • Audit those other areas well and you are in effect auditing clause 4.1. Auditor Training rev 0 022009 31
- 32. How to AuditDifficult Clauses 5.0 Management Responsibility • 5.1 Management Commitment • 5.4.1 Quality Objectives • 5.4.2 Quality Management System Planning (vs. 7.1 Planning of Product Realization) 32Auditor Training rev 0 022009
- 33. How to AuditDifficult Clauses 5.1 Management Commitment Look for evidence on how top managers ensure their commitment is well known throughout the organization and records that show how they are keeping their promise 33Auditor Training rev 0 022009
- 34. How to AuditDifficult Clauses 5.4.1 Quality Objective Are You Setting SMART Quality Objectives? • Is it specific? • Is it measurable • Is it achievable • Is it relevant • Is it timed? 34Auditor Training rev 0 022009
- 35. How to AuditDifficult Clauses 5.4.2 Quality Management System Planning (vs. 7.1 Planning of Product Realization) Organizations must decide how to monitor, measure, and analyze their processes, as well as, be ready to implement the actions necessary to achieve planned results and continually improve the processes. Even outsourced processes are included in the planning. Determine how this is done using process approach. 35Auditor Training rev 0 022009
- 36. How to AuditDifficult Clauses 7.0 Product Realization • 7.1 Planning of Product Realization • 7.3.1 Design and Development Planning • 7.5.2 Validation of Processes for Production and Service Provision Determine how the quality plan is developed. 36Auditor Training rev 0 022009
- 37. How to AuditDifficult Clauses 8.0 Measurement, analysis and Improvement • 8.2.1 Customer Satisfaction • 8.5.1 Continual Improvement • 8.5.3 Preventive Action 37Auditor Training rev 0 022009
- 38. Auditing Undocumented Process Auditinga Process that is Undocumented Refer to the guide provided to you separately Auditor Training rev 0 022009 38
- 39. Summary on AuditPractice Audits examine compliance from three perspectives: 1. Documents (or definitions) that indicate the process is adequate 2. Records that show the process is implemented (being practiced) 3. Results that prove the process is effective (objectives are met) By using the process approach in auditing, you will be able to gather all the evidence that you need in auditing for any clause that you may encounter in the field. Auditor Training rev 0 022009 39
- 40. EXERCISE No. 2 AuditorTraining rev 0 022009 40 The purpose of the exercise is to provide practice in assessing evidence in an objective manner..
- 41. Auditor Training rev0 022009 41 Workshop Mock-up audit of Engineering Department • 5.4.1 Quality Objectives • 7.3.1 Design and Development Planning
- 42. Tips on Auditing •Adjust your audit approach • Evaluate the effectiveness of the system • Remind auditors how to verify conformity • Know how to audit an undocumented process • Improve your current internal audit practices 42Auditor Training rev 0 022009
- 43. Auditor Conduct • Becritical • Be side-tracked • Argue • Swear • Be late • Be sarcastic • Compare • Pass opinions • Apportion blame AN AUDITOR SHOULD NOT
- 44. Code of Conductfor Auditors Purpose To communicate the integrity, objectivity, confidentiality, and competence expected of internal auditors, as well as, to provide a means for them to pledge their commitment to these principles. Auditor Training rev 0 022009 44
- 45. Code of Conductfor Auditors Integrity The integrity of internal auditors establishes trust and provides the basis for relying on their judgment. As an internal auditor, I pledge to: 1. Perform my work with honesty, accuracy, fairness, and responsibility. 2. Not engage in activities that might discredit the audit profession or my organization. Auditor Training rev 0 022009 45
- 46. Code of Conductfor Auditors Objectivity Internal auditors must be objective in gathering, evaluating, and communicating information about the activities being examined. They must make a balanced and impartial assessment of all the relevant facts and not be unduly influenced by their interests, or those of others, in making judgments. As an internal auditor, I pledge to: 3. Not join in any activity or relationship that may affect my unbiased assessment. 4. Not accept anything that may impair, or appear to impair, my judgment. 5. Disclose all the material facts to avoid any distortion of my audit report. Auditor Training rev 0 022009 46
- 47. Code of Conductfor Auditors Confidentiality Internal auditors must respect the value and ownership of the information they receive and not disclose it without the appropriate authority (unless obligated for legal or professional reasons). As an internal auditor, I pledge to: 6. Be prudent in the use and protection of the information acquired during my audit duties. 7. Not use the information for personal gain or in any way detrimental to the organization. Auditor Training rev 0 022009 47
- 48. Code of Conductfor Auditors Competence Internal auditors must apply their knowledge, skills, and experience in the performance of their assessment duties. As an internal auditor, I pledge to: 8. Engage only in audits where I possess the needed knowledge, skills, and experience. 9. Perform audits in accordance with the procedures and practices of my organizations. 10. Continually improve my proficiency and the quality and value of my audit services. 11. Assist other auditors under my supervision to develop their audit management skills. 12. Report any complaints regarding my performance and address them to avoid recurrence. Auditor Training rev 0 022009 48
- 49. Addendum • Exercise No.3 – take home exercise • ISO 9000 : 2005 – • ISO 9001: 2008 – • Sample Question for Top Management Auditor Training rev 0 022009 49
- 50. Exercise No. 3 Thisis an exercise to see how nonconformities are reported This is a take-home exercise. The answer shall be submitted later. 50Auditor Training rev 0 022009
- 51. Internal Auditor Quiz Answersfor the ISO 9001:2000 Clause Quiz The correct clauses for the ten requirements are: 1. Reviewing the system at planned intervals = 5.6.1 [also 8.2.2 regarding audits] 2. Identifying the status of product measurements = 7.5.3 3. Maintaining process equipment = 6.3 (b) 4. Handling, packaging, and storing products = 7.5.5 5. Preventing the "recurrence" of nonconformities = 8.5.2 (not 8.5.3) 6. Maintaining evidence of conformity of acceptance criteria = 8.2.4 7. Ensuring requirements are complete and unambiguous = 7.3.2 [implied by 7.2.2 (a)] 8. Identifying the control of outsourced processes = 4.1 9. Planning for design review, verification, and validation = 7.3.1 (b) [implied by 7.1] 10. Including a quality manual in the documentation = 4.2.1 (b) How did you do on the quiz? Do you agree with these answers? 51Auditor Training rev 0 022009 Back
- 52. ISO 9000:2005 • Itmakes no changes to the basic principles of quality management stated in ISO 9000:2000 • It is essentially a tidying-up exercise to ensure consistency within ISO Standards • It will probably have little, or no real impact on our quality system Auditor Training rev 0 022009 52
- 53. ISO 9001:2008 • ISO9001:2000 is due for an update in 2008. • It is currently at Draft International Standard (DIS) stage • Changes to the standard are very small • It will replace ISO 9001:2000 Auditor Training rev 0 022009 53
- 54. How to AuditDifficult Clauses 6.0 Resource Management • 6.1 Provision of Resources • 6.2 Human Resources • 6.3 Infrastructure • 6.4 Work Environment 54Auditor Training rev 0 022009 Process Approach Interview Question PDCA Note Check List Cheat Sheet
- 55. Sample Question forTop Management • How do you influence/oversee the quality policy? • What quality targets have been set for each department for this fiscal year? What about plant- wide targets? How did you influence these targets? What is your basis? • How do you ensure that the integrity of the quality management system is maintained when changes are implemented? (i.e., costdowns, new products, hirings/layoffs...) • How do you use our "Key Measurables" information to ensure continual improvement in quality? Auditor Training rev 0 022009 55
- 56. Sample Question forTop Management • How are your Objectives developed? • How do you use the Policy? • What does the System gain from Management Review? • Please provide an example of Improvement within the company. • "If you could do it, what one thing in the Management System would you improve?“ Auditor Training rev 0 022009 56
- 57. Sample Question forTop Management • How do you contribute to achieving your organization's objectives? • How are objectives determined? • How are employees trained on objectives? • How is progress against objectives communicated to the organization? • What processes and/or tools are in place to help achieve objectives? • Is there evidence of progress? Auditor Training rev 0 022009 57 Back