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PRACTICAL AUDITING
Continual Improvement Program
for Internal Quality Auditors
By Sid Calayag
Agenda
• PDCA and Process 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
Warm-up Exercise
The exercise will be used to gauge your
present knowledge must be completed in
10 minutes.
Countdown starts now. . .
3Auditor Training rev 0 022009
4
Process Based Approach
MANAGEMENT
RESPONSIBILITY
RESOURCE MANAGEMENT
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
THE PDCA CYCLE
PLAN
CHECK
STUDY
DO
IMPLEMENT
VERIFY
ACT
EVALUATE
VALIDATE
Interview and Question Technique
• Interview
• Reason
• Steps
• Question Techniques
• Closed-ended Question
• Open-ended question
• Show-me Question
6Auditor Training rev 0 022009
Interview Reason
• Supplements the 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
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
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
Summary on Interview
• Remember, it is an interview, not
an interrogation!
• Investigate a claim; accept an
admission.
Auditor Training rev 0 022009 10
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
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
Close and Open-ended Question
• 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
Summary on Questioning Techniques
• 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
Notes, Check List & Cheat List
• Taking Notes in an Audit
• Check List
• Cheat List
15Auditor Training rev 0 022009
Taking Notes in an 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
Check List
Requirements for check list
• Standard requirement
• Customer requirement
• Organizational requirement
• Legal requirement
Auditor Training rev 0 022009 17
Advantages on Using Check 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
Drawback on Using Check 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
Summary on Check List
• 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
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
Report Writing
• Use CPLANES 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
Writing Nonconformity Reports
• Conformity,
• Conformance, or
• Compliance?
23Auditor Training rev 0 022009
Exercise No. 1
How well 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
Toughest Requirements
• 4.1 General 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
Toughest Requirements
• 7.5.2 Validation 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
Most Common Audit Findings
* 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
Most Common Audit Findings
* 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
Comparison of Rankings
Auditor Training 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
How to Audit Difficult 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
How to Audit ISO 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
How to Audit Difficult 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
How to Audit Difficult 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
How to Audit Difficult 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
How to Audit Difficult 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
How to Audit Difficult 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
How to Audit Difficult 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
Auditing Undocumented Process
Auditing a Process that is Undocumented
Refer to the guide provided to you
separately
Auditor Training rev 0 022009 38
Summary on Audit Practice
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
EXERCISE No. 2
Auditor Training rev 0 022009 40
The purpose of the exercise is to provide
practice in assessing evidence in an objective
manner..
Auditor Training rev 0 022009 41
Workshop
Mock-up audit of Engineering Department
• 5.4.1 Quality Objectives
• 7.3.1 Design and Development Planning
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
Auditor Conduct
• Be critical
• Be side-tracked
• Argue
• Swear
• Be late
• Be sarcastic
• Compare
• Pass opinions
• Apportion blame
AN AUDITOR SHOULD NOT
Code of Conduct for 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
Code of Conduct for 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
Code of Conduct for 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
Code of Conduct for 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
Code of Conduct for 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
Addendum
• Exercise No. 3 – take home exercise
• ISO 9000 : 2005 –
• ISO 9001: 2008 –
• Sample Question for Top Management
Auditor Training rev 0 022009 49
Exercise No. 3
This is 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
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
Back
ISO 9000:2005
• It makes 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
ISO 9001:2008
• ISO 9001:2000 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
How to Audit Difficult 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
Sample Question for Top 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
Sample Question for Top 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
Sample Question for Top 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

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Practical auditing

  • 1. PRACTICAL AUDITING Continual Improvement Program for Internal Quality Auditors By Sid Calayag
  • 2. Agenda • PDCA and Process 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 exercise will 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 RESOURCE MANAGEMENT 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
  • 6. Interview and Question Technique • Interview • Reason • Steps • Question Techniques • Closed-ended Question • Open-ended question • Show-me Question 6Auditor Training rev 0 022009
  • 7. Interview Reason • Supplements the 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-ended Question • 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 Questioning Techniques • 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 in an 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 for check list • Standard requirement • Customer requirement • Organizational requirement • Legal requirement Auditor Training rev 0 022009 17
  • 18. Advantages on Using Check 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 Using Check 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 Check List • 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 • Use CPLANES 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 How well 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 • 4.1 General 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 • 7.5.2 Validation 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 Audit Findings * 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 Audit Findings * 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 Auditor Training 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 Audit Difficult 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 Audit ISO 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 Audit Difficult 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 Audit Difficult 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 Audit Difficult 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 Audit Difficult 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 Audit Difficult 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 Audit Difficult 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 Auditing a Process that is Undocumented Refer to the guide provided to you separately Auditor Training rev 0 022009 38
  • 39. Summary on Audit Practice 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 Auditor Training rev 0 022009 40 The purpose of the exercise is to provide practice in assessing evidence in an objective manner..
  • 41. Auditor Training rev 0 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 • Be critical • Be side-tracked • Argue • Swear • Be late • Be sarcastic • Compare • Pass opinions • Apportion blame AN AUDITOR SHOULD NOT
  • 44. Code of Conduct for 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 Conduct for 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 Conduct for 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 Conduct for 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 Conduct for 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 This is 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 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 Back
  • 52. ISO 9000:2005 • It makes 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 • ISO 9001:2000 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 Audit Difficult 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 for Top 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 for Top 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 for Top 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