This document provides an overview of internal quality auditing techniques and common ISO 9001 requirements. It discusses using a process approach and PDCA cycle in audits. Interview skills like questioning techniques and taking notes are covered. Creating checklists and potential issues with "cheat sheets" are also summarized. The document reviews writing audit reports and addressing nonconformities. It identifies some of the toughest ISO 9001 clauses to audit and the most common nonconformities found in internal and registrar audits.

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
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3. Process Based Approach
MANAGEMENT
RESPONSIBILITY
C C
U U
RESOURCE MANAGEMENT
S S
T T
PRODUCT REALIZATION
O O
Requirements INPUT
PROCESS OUTPUT
M A P
M
C D
E E
R MEASUREMENT, ANALYSIS & R
IMPROVEMENT Satisfaction
4

4. THE PDCA CYCLE
VERIFY
PLAN
ACT DO
EVALUATE IMPLEMENT
CHECK
STUDY
VALIDATE

5. Interview and Question Technique
• Interview
• Reason
• Steps
• Question Techniques
• Closed-ended Question
• Open-ended question
• Show-me Question
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6. 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
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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)
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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
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9. Summary on Interview
• Remember, it is an interview, not
an interrogation!
• Investigate a claim; accept an
admission.
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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
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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
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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.
Sample
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13. 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

14. Notes, Check List & Cheat List
• Taking Notes in an Audit
• Check List
• Cheat List
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15. 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
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16. 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
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17. 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
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18. 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.
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19. 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.
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20. 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
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21. Writing Nonconformity Reports
• Conformity,
• Conformance, or
• Compliance?
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22. 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
answer
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23. 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
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24. 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
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25. 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>
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26. 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>
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27. Comparison of Rankings
Internal Audit Findings Registrar Audit Findings
• 1. Customer satisfaction data and • 1. Documentation gaps
assessment
• 2-3. Objectives not measurable
• 2. Documentation gaps
• 2-3. Top management commitment
• 3. Continual improvement process and responsibility
• 4. Objectives not measurable • 4. Continual improvement process
• 5. Collection and analysis of data • 5-6. Customer satisfaction data and
assessment
• 6-7. Top management commitment and
responsibility • 5-6. Effective control of processes
• 6-7. Record keeping gaps • 7-8. Collection and analysis of data
• 8-9. Competency requirements • 7-8. Record keeping gaps
• 8-9. Effective control of processes • 9. Competency requirements
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28. 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.
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29. 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.
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30. 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
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31. 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?
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32. 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.
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33. 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.
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34. 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
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35. Auditing Undocumented Process
Auditing a Process that is Undocumented
Refer to the guide provided to you
separately
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36. 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.
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37. EXERCISE No. 2
The purpose of the exercise is to provide
practice in assessing evidence in an objective
manner..
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38. Workshop
Mock-up audit of Engineering Department
• 5.4.1 Quality Objectives
• 7.3.1 Design and Development Planning
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39. Auditor Conduct
AN AUDITOR SHOULD NOT
• Be critical • Be sarcastic
• Be side-tracked • Compare
• Argue • Pass opinions
• Swear • Apportion blame
• Be late

40. 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.
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41. 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.
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42. 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.
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43. 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.
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44. 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.
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45. Addendum
• Exercise No. 3 – take home exercise
• ISO 9000 : 2005 –
• ISO 9001: 2008 –
• Sample Question for Top Management
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46. 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.
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47. 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
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48. 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
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