Planning and Preparing Effective Quality Audit_MNAR.pdf

for improvement

1. 1
Planning and
Preparing
Effective
Quality Audits

2. 2
Learning Objectives
•Understand the principles of management
system auditing
•Describe how to conduct an effective internal
quality audit to ISO 9001:2015

3. 3
Principles of Management
System Auditing
1

4. 4
What is an Audit?
•A quality audit is a systematic, independent and
documented process of examining any activity
of an organization based on objective evidence
to determine:
a.The extent to which quality activities and related
results comply with the planned arrangements
b.The extent to which these arrangements have been
implemented effectively, and
c.Whether these arrangements are suitable to achieve
the quality objectives.
Principles of Management System Auditing

5. 5
What Are Audits Used For?
•Looking at the overall process
•Auditing conformity
•Auditing effectiveness
•Approving Suppliers / Subcontractors
•Assessing for Certification
•Investigating problems
•Way of improving
Principles of Management System Auditing

6. 6
Likely Effects on QMS of a Weak IQA
System
•Inadequate review of the Quality Management
System versus the requirements
•Conclusions not reliable basis for Top
Management to evaluate the effectiveness of
QMS implementation
•Diminished people’s full support to the Quality
Management System
Principles of Management System Auditing

7. 7
Important Terms and Definitions
•Audit -A systematic, independent and
documented process for obtaining audit
evidenceand evaluatingit objectively to
determine the extent to which audit criteria are
fulfilled
Principles of Management System Auditing

8. 8
Important Terms and Definitions
•Audit Criteria –Setof policies, proceduresor
requirementsused as a reference against which
audit evidence is compared
•Audit Evidence –Records, statements of fact
or other information, which are relevantto the
audit criteria and verifiable
Principles of Management System Auditing

9. 9
Important Terms and Definitions
•Audit findings –Resultsof the evaluation of the
collected audit evidence against audit criteria
•Audit conclusion –Outcomeof an audit
provided by an audit team after consideration of
the audit objectives and all audit findings
•Auditor–Personwith competence to conduct
an audit
Principles of Management System Auditing

10. 10
Important Terms and Definitions
•Audit Scope –extentand boundariesof an
audit; generally includes a description of the
physical locations, organizational units, activities
and processes, as well as the time period
covered
•Audit Program –set of one or more audits,
planned for a specific timeframe and directed
towards a specific purpose
Principles of Management System Auditing

11. 11
Important Terms and Definitions
•Audit Plan –description of the activitiesand
arrangementsfor an audit
•Auditee–organization being audited
•Audit client –organization or person requesting
an audit
•Competence –demonstrated personal
attributes and demonstrated abilityto apply
knowledge and skills
Principles of Management System Auditing

12. 12
Types of Quality Audits
•First party audit
Internal audit (by your
organization’s Quality
department)
•Second party audit
Your customer auditingyour
organization
•Third party audit
A certification body auditing
your organization
Principles of Management System Auditing

13. 13
7 Basic Steps for an Audit
1.Scheduling the audit
2.Planning the audit
3.Opening meeting
4.Conducting the audit
5.Reporting audit findings
6.Closing meeting
7.Post audit activities
Principles of Management System Auditing

14. 14
Executing the Internal Audit
Maintain control of the audit
Control audit time
Speak and ascertain from right people
Be professional
Be objective –look at the facts
Observe everything
Avoid hear-say
Be nosey, but polite
Principles of Management System Auditing

15. 15
Developing an Audit Checklist
•Familiarize with the Quality Manual, processes
and the associated documentation to be audited
•Make a list of possible questions
•List items to look for and observe
Important process stage
Records originated / maintained
Personnelinvolved
•Leave spaceto record observations
•Use only one sheet per process or project
Principles of Management System Auditing

16. 16
Audit Interviews
•Establish rapportwith
auditee
•Encourage freespeaking
•Ask open-ended
questions
•Closed questions
For logical conclusions
Leading questions
•Avoid repetitivequestions
•Observe body language
of the interviewee and
adapt question if needed
•Maintain eye contact
•Minimizenote-taking
during interview
•Restate your
understanding of their
response
Principles of Management System Auditing

17. 17
Recording Observations
•Personsinterviewed
•Location or area
observed
•Documentsexamined
•Records verified
•ISO clauses involved
•Process stage involved
•Compliances/Non-
compliances
•Reference of non-
compliance
•Notes on non-
conformances should be:
Simple
Crisp
Neatly worded
•Record aspect to be
followed up in next
assessment
Principles of Management System Auditing

18. 18
Non-conformances
•Issue Corrective Action Requests (CAR)
Ensure it is simple, crisp and neatly worded
Identify ownership
Identify the paragraph of the standard that has been
violated
State requirements of resolutions
Non-compliance should not be subjected to
INTERPRETATION
Principles of Management System Auditing

19. 19
CAR Response
•Must have specific details of implementation
Whatspecific action(s) willbe taken
Whowill be responsible
Whenwill it be completed
•Use SMART criteria
Specific
Measurable
Achievable
Realistic
Timely
Principles of Management System Auditing

20. 20
Report to Management
•Reports should be thoroughand specific
•Must be reviewedby management to be
effective
Principles of Management System Auditing

21. 21
Summary Report
•Audit team
•Dates of actual audits
•Department / Area / Activity
•Audit non-conformance reports
•Total number of non-conformances
System/process not defined
System/process not implemented
•Summary
Principles of Management System Auditing

22. 22
Five Principles of Auditing
1.Ethical conduct
2.Fair presentation
3.Due professional care
4.Independence
5.Evidence-based approach
Principles of Management System Auditing

23. 23
Five Principles of Auditing
1. Ethical Conduct : the foundation of
professionalism
Trust
Integrity
Confidentiality
Discretion
----These are essential to auditing---
Principles of Management System Auditing

24. 24
Five Principles of Auditing
2. Fair presentation : the obligation to report
truthfully and accurately
Audit reports, audit conclusions must reflect accurately
the audit activities
Significant obstacles encountered during the audit and
unresolved diverging opinions between the audit team
and the auditeeshould be reported
Principles of Management System Auditing

25. 25
Five Principles of Auditing
3. Due professional care : the application of
diligenceand judgmentin auditing
Auditors exercise care in accordance with the
importanceof the task they perform and the
confidenceplaced in them by the audit client and other
interested parties
Having the necessary competence/skillis an important
factor
Principles of Management System Auditing

26. 26
Five Principles of Auditing
4. Independence : the basis for impartiality of the
audit and objectivity of the audit conclusions
Auditors are independent of the activity being audited
and are freefrom bias and conflict of interest
Auditors maintain an objective state of mind
throughout the audit process to ensure that the audit
findings and conclusions will be based only on
objective evidence
Principles of Management System Auditing

27. 27
Five Principles of Auditing
5. Evidence-based approach : the rational
method for reaching reliable and reproducible
audit conclusions in a systematic audit process
The audit evidence is verifiable
The audit evidence is based on available information
during the audit
Appropriate use of sample related to the confidence
that can be placed to the audit conclusions
Principles of Management System Auditing

28. 28
Effective Internal Auditing
to ISO 9001:2015
2

29. 29
Contents
1.Managing the audit program
2.Planning the audit
3.Conducting the audit
4.Reporting the audit findings
5.Post-audit activities

30. 30
1.Managing the Internal Audit Program

31. 31
1. Authority for the Audit Program
•Granted by management
•Management Representative
Establish, implement, monitor, review and improve the
audit program
Identify the necessary resources and ensure they are
provided
Appointed by Top Management and is a member of
the organization’s management
Managing the Internal Audit

32. 32
Tips on Gaining Management Support
to the Audit Program
•Communicate the costof audit observations
•Explain the regulatory effects of nonconforming
processes
•Educate by stating or restating management’s
rolein the audit program
•Distribute audit reports to management
•Have a member of management participate in
an audit
Managing the Internal Audit

33. 33
2. Establishing the Audit Program
•Define audit program objectives–to direct planning and
conduct of audits
•Define the extentof audit program –influenced by the
size, nature and complexity of the organization
•Define audit program responsibilities–assigned to one
or more auditors who has general understanding of audit
principles and has management skills as well as
technical and business understanding relevant to
activities to be audited
•Determine and provide audit program resources
•Establish audit procedure(s)
Managing the Internal Audit

34. 34
3. Implementing the Audit Program
•Schedule the audits
•Evaluating auditors
•Selecting audit teams
•Directing audit activities
•Maintaining records
Managing the Internal Audit

35. 35
4. Monitoring and Reviewing the
Audit Program
•Monitoring and reviewing the program
•Identifying needs for corrective / preventive
action
•Identifying opportunities for improvement
Managing the Internal Audit

36. 36
5. Improving the Audit Program
•Continual improvement of the internal audit
program to improve effectiveness and efficiency
based on outcomesand recommendationsof
the audit review
Managing the Internal Audit

37. 37
2. Planning the Internal Audit

38. 38
Planning and Preparation
1.Audit Planning
2.Communicating the Audit Plan
3.Selection of Auditors
4.Preparing for Audit
5.Pre-audit Information
Planning the Internal Audit

39. 39
Audit Planning
•Audit Plan
The audit plan is a formal document, which covers
every area, process and department for the audit
activity
•It specifies :
The area, process or department to be audited
The frequency of the audit, preferably the month in
which the area, process or department will be audited
Planning the Internal Audit

40. 40
Audit Planning
•Full audit of the entire Quality System
How many auditors will be needed
How will the responsibilities be divided
Appoint a Lead Auditor to keep the audit focused
•Partial
Which department or processes
Which clause(s) of the standard
Planning the Internal Audit

41. 41
Audit Planning
•Schedule
The audit schedule is a document that gives details of
the area, process and department to be audited during
the scheduled audit.
It also specifies dates of audit, names of auditor and
corresponding auditeearea, process or department.
Planning the Internal Audit

42. 42
Audit Planning
•Timing
The best time to audit is when people are at their
busiest and tempted to take short cuts or make
mistakes
However convenience of the auditeeis essential and
their readinessand concurrence should be determined
before proceeding on an audit
Planning the Internal Audit

43. 43
Audit Planning
•Audit Frequency
Based on criticalityof area / process to be audited
Based on quality history of the area to be audited
Can be influenced by upcoming regulatory events (e.g., audits,
complaints/recall, follow-up, compliance etc.)
Do not agree to frequent requests for postponements or
cancellations
Emergency audits might be added to your schedule at short
notice. Do not over schedule yourself, otherwise emergencies will
destroy your carefully crafted schedule.
Facility / area upgrade / shutdownswill impact your schedule –
preview upcoming maintenance plans and work around them
Planning the Internal Audit

44. 44
Auditing Techniques
•Upstream
Starting with the final process and working backwards
to the beginning
•Downstream
Starting with the first process and following the flow
•Horizontal
Across similar processes
•Mixed
Combination of Up/Down stream and horizontal
Planning the Internal Audit

45. 45
Auditing Techniques
•Horizontal Auditing
Follows a process from goodsreceipt through to
finished product release and distribution
A good way to get a “feel” of the site and its problems
•Vertical auditing
Good to help identify the severity of a specificissue
Can be time consuming
You need to know when to stop
Focuses deeper and deeperinto a specific area,
product or problem
Planning the Internal Audit

46. 46
Communicate the Audit Plan
•Ensure that the schedule is communicatedto all
site personnel, especially those whose areas will
be audited
•Clearly list the areas / systems / products to be
audited and list specific datesfor each of the
audits
•Realistically establish and agree each audit’s
duration
•Adhere to the schedule –don’t risk losing
credibility by postponing audits
Planning the Internal Audit

47. 47
Selection of Auditors
•Based on educational qualification, industrial
experience, in-house / outside trainings and
technical knowledge of the individual
•People within the organization who have been
trained to conduct audits
•Important precaution to be taken is to ensure
that people do not audit their own area
•Auditors must treat audit as a fact finding
exerciseand so should do a professional job
Planning the Internal Audit

48. 48
Selection of Auditors
•Brief the auditor on the objectivesof the audit
•Define the limitsof the area to be audited
•Apprise auditor of any special requirements, e.g.
follow-up of corrective action, priority areas for
verification, etc.
Planning the Internal Audit

49. 49
Preparing for Audit
•Prepare and send detailed agenda, objective and scope
of the audit
•Know your standards
•Ensure that the auditeeis well aware of the standards
you will be using during the audit
•Prepare a detailed checklist
Checklists are methodical way of ensuring that all necessary
areas are audited and right questions asked
However, auditors should adopt a flexible approach and use their
own judgment to deviate, if necessary
Planning the Internal Audit

50. 50
Preparing the Checklist of Questions
•Check which elements of the Standard apply to the area
to be audited
•Check key requirements in the document
•Check for any problems which normally are known to
occur in the process to be audited
•If necessary, ask other people for advice
•Refer to other previous audit checklists/reports
•Sequence questions in a logical way and also to permit
Plan-Do-Check-Act approach to auditing
Planning the Internal Audit

51. 51
Internal Auditor Responsibilities
•Obtain and assess evidence in a fair manner
•Preserve his independence and integrity
•Be flexible to changing situations during the audit
•Interact with auditeesin a positive way
•Add value to auditee’sprocess or activities
•Perform the audit process fully and adhere to the audit
plan
•Arrive at acceptable conclusions based on audit findings
and objective evidence
•To stand his ground despite possible pressure of
contrary views
Planning the Internal Audit

52. 52
Auditor Planning for Each Audit
•Auditor reads and understands the QMS documentation
and business process
•Communication with the auditeeto confirm audit
schedule
•Preparation of the audit agenda and checklists (should
reflect Plan-Do-Check-Actapproach) **
•Auditor checks that his audit kit is complete (with audit
plan, previous audit reports, forms and note pads,
references, pens)
Planning the Internal Audit

53. 53
Pre-audit Information
•Activities performed by auditee
•Site master file
•Quality Manual
•Review the layouts
•Understand the process flow
•Previous nonconformity reports for verification of
effectiveness of corrective actions
Planning the Internal Audit

54. 54
3. Conducting the Internal Audit

55. 55
The Audit Agenda
•Opening Meeting
•Audit Proper
•Closing Meeting
Conducting the Internal Audit

56. 56
The Opening Meeting
•This is your first point of face-to-face contact with auditee
•Be punctualor you risk losing your credibility
•Each side introduces the attendees
Each auditor introduces him/her self
•Try to remember names for use during the audit –People like to
have their names remembered
•Re-confirm the agenda. Modify or change if agreed by both the
sides
•Site / departmental presentation. Make notesof important
information.
Conducting the Internal Audit

57. 57
The Opening Meeting
What to say during the opening meeting?
•Review / discuss the following Opening Meeting agenda
for the audit program, to include:
Objective and scope of audit and audit criteria
The schedule of events; other arrangements
Definitionof nonconformities, major and minor
How you will report the audit results
Confidentiality of audit data
Resolve any questions and items for clarification from the
auditees
Conducting the Internal Audit

58. 58
The Opening Meeting
•Who should attend the opening meeting?
Audit Team and Management Team to be audited
•Who should preside the opening meeting?
Chaired and managed by the Lead Auditor or Team
Leader
Conducting the Internal Audit

59. 59
The Site / Area Tour
•A very critical part of audit
•Respect dress codes of the areas to be visited
•Do not be afraid to ask to visit controlled areas
•Allow one auditor to speak at a time
•Talk to workers during site tour
•Ensure that you understand the answers
If not ask the same question again
Ask for clarification if required
Conducting the Internal Audit

60. 60
The Site / Area Tour
•Keep all senses open
Sight, smell, hearing, touch and taste
•Stay close to agreed plan of the tour
Try not to get distracted and lose time
Be willing to stop and focuson an area of non-
compliance
•Keep a record of documents requested during
tour
Request your host to make a copy of the documents to
support your findings and observations
Conducting the Internal Audit

61. 61
Audit Proper
•Interview the staff responsiblefor each task
•Obtain audit evidenceby:
Askingquestions: inquire about task details
Observing actual task: watch the task being done
Checking records: confirm if task done is consistent
with the documented procedure; cross check with
what records reveal
Follow the audit trail: sequenceof process steps
Conducting the Internal Audit

62. 62
Examples of open questions
•When are suppliers review performed?
•How is the inspection status identified on this
item?
•Where does the document come from?

63. 63
Examples of closed questions
•Do you have a work instruction for this
operation?
•Does this instrument require calibration?
•Is this die supplied by the customer?
---interrogation

64. 64
Examples of clarifying questions
•Tell me more about this operation?
•Please give me some examples?
•What do you mean by inspection line mismatch?
---auditor is not listening, stupid or time
consuming

65. 65
Audit Proper
•Compareand evaluate practice against the documented
QMS (Conforming? At variance?)
•Use checkliststo guide you in completing the audit
•Define nonconformitywhere lapses of the practice
against QMS documentation might be found
•Record objective evidence(s) of the NC
•Confirmwith the auditeethe presence of NC
•Point out observation(s) and area(s) for improvement
Conducting the Internal Audit

66. 66
Audit Using PDCA Approach
The IQA auditor may cover the following key
points:
1. What are the key objectives for the function/
process?
Are objectives,quantitative targets and programs defined?
Do they define desired outcomes of function?
Do they address customerrequirements?
Do they relate to the organization’s Quality Policy?
Do they relate to legal requirements, if any?
Conducting the Internal Audit

67. 67
Audit Using PDCA Approach
2. Are resources available and managed, as planned,
to achieve objectives?
Is there a process for defining and allocating
resources?
Are resource needs identified, adequate, accounted
for?
Does this include financial, specialized skills,
equipment, technology and the like?
Conducting the Internal Audit

68. 68
Audit Using PDCA Approach
3. Are key activities and methods for achieving
objectives identified, documented and controlled?
Are plans, procedures, formula, etc. documented?
Are process and operating criteria defined?
Are responsibilities and authorities defined?
Conducting the Internal Audit

69. 69
Audit Using PDCA Approach
4. What measuresare available to demonstrate
achievement of objectives, and what evidenceis
available to demonstrate continual improvement for
the function/process?
•Review and assess, among others:
Process capability, equipment reliability
Waste rates, variance vs. budget and other metrics
Legal compliance (findings should be backed up by data and
company records)
Performance monitoring and monitoring results; analyses
Actions taken for un-met objectives, product nonconformities,
significant process deviations.
Conducting the Internal Audit

70. 70
What Key Things to Look For and
Where?
•Task -work methods defined, efficiency
•People -training, skills, competence and motivation
•Equipment; Work Environment
Identification, capability, condition, safety, sanitation
•Documents / Records
Identification, issue, content, correctness and distribution
Retention, preservation, legibility, accessibility
Conducting the Internal Audit

71. 71
How to Handle Difficult Auditees
•Take a communication class on verbal and non-
verbal skills
•Get training on dealing with difficult people
•Understand cultural differences
•Explain to the auditeethe benefit or requirement
to the company
•Ask open-ended questions from checklist
•Stop an audit during difficult situations with
auditees
Conducting the Internal Audit

72. 72
The Daily Wrap-up (for multiple-day audits)
•Require / Request a daily wrap-up meeting
Include the audit escorts and day’s participants at a minimum
Do not categorize the issues (as major or minor) –more of the
same issues tomorrow may make the observation more severe
Discuss observations found during the day. Give the site a
chance to correct them or to provide more evidence to support
their defense.
Daily meetings promote understanding and prevent surprises at
the final wrap-up
Clarify any follow-ups for tomorrow and tomorrow’s agenda
The daily wrap-up provides clarity and keeps the auditee
engaged in the process
Conducting the Internal Audit

73. 73
4. Reporting the Audit Findings

74. 74
The Audit Reporting Cycle
•Discuss and agreeon findings
•Record findings
•Hold closing meeting
•Issue audit report
•Update records
•Agree to undertake follow-up audit, if needed
•Carry out and record results of Follow-up Audit
Reporting Internal Audit Findings

75. 75
Types of Audit Findings
•Positive findings
Good practice; conformities
•Negative findings
Nonconformities
•Observations
Opportunities for
improvements
Reporting Internal Audit Findings

76. 76
2 Types of Nonconformities
•Absence of, or failure to implement
and maintain, one or more of the
sub-clauses of ISO 9001
•Available objective evidence,
raises doubt as to the ability of the
organization to provide conforming
products
•A number of minor nonconformities
against one sub-clause of ISO
9001
Major Findings (Category 1)
Reporting Internal Audit Findings

77. 77
2 Types of Nonconformities
•Failure to meet one
requirement of a sub-clause
(e.g. 7.5.3.1)
•Single observed lapsein
implementing one requirement
of company QMS procedures
•No preventive or corrective
actions were taken
Minor Findings (Category 2)
Reporting Internal Audit Findings

78. 78

79. 79

80. 80

81. 81
The Closing Meeting
•Who should attend the opening meeting?
Audit Team and Management Team to be audited
•Who should preside the opening meeting?
Chaired and managed by the Lead Auditor or Team
Leader
Reporting Internal Audit Findings

82. 82
The Closing Meeting
•Thankthe auditeesfor their help and time
•Commend auditeesfor accomplishments
•List the positive findings that you saw or found during the
audit
•Report any nonconformity–invite the individual auditor to
report their respective findings
•Present the Major (Category 1) findings followed by Minor
(Category 2). Add the Observationsif there are not too many
findings in total.
•Present findings based on facts,and back the findings up with
information contained in the standards, if questioned
Reporting Internal Audit Findings

83. 83
The Closing Meeting
•Respond to questions openlyat end of the audit
•Be prepared to change your wordings or even observations
based upon facts presented by auditee(s)
•Report the overall conclusions and recommendations
•Invite comments from auditees
•Resolve any inquiries or concerns
•Obtain consensus from auditeeson nonconformity reports
•Establish date of submission to auditor of corrective action
•Reiterate confidentiality
Reporting Internal Audit Findings

84. 84
5. Post Audit Activities

85. 85
Reporting Audits
•Why do we write an audit report?
As a record of site/departmental deficiencies
To provide the Site Management Team with an
independent report of deficiencies identified
To create the formal environment necessary for an
active, periodic follow up
Post Audit Activities

86. 86
Reporting Audits
•How do we write an audit report?
Include positive points as well as deficiencies
(negative findings and observations) identified
Management must have a balanced overview of
conditions within the plant; therefore, provide them
information on areas of strength (best practices) and
areas requiring improvement
Post Audit Activities

87. 87
Reporting Audits
•When do you write an Audit Report?
As soon asyou possibly can after conclusion of the
audit
Before you beginyour next audit
Before you forgetwhere you were and what you
observed
Post Audit Activities

88. 88
Tips on Publishing Timely Audit Report
•Create a standardized audit report form that can be used by
all auditors. These audit reports can be “fill in the blank” so
that any observations or nonconformities observed can be
entered efficiently.
•As with audit preparation, schedule plenty of time to complete
the audit report. If the report is submitted more than a week
after the audit, the information is usually forgottenby the
auditee and doesn’t benefit the organization.
Post Audit Activities

89. 89
Interacting with Auditors –Do’s for
Auditees
•Be honest and open
•Recognize they may be experts
•Realize they may not be subject
matter experts
•Understand the purpose of the
meeting and review related records
prior to interviews
•Turn mobile phones to silent mode

90. 90
Interacting with Auditors –Do’s for
Auditees
•Listen carefully and understand each
question before answering. Be sure
responses are complete and accurate
•Respond only to the question asked–
keep answer simple and direct
•Weigh answers carefully, being
certain you have the facts to back
them up
•Limit comments to areas where you
have "first-hand" knowledge

91. 91
Interacting with Auditors –Don’ts
for Auditees
•Assume auditors are familiar with
your organization’s quality or
financial control system
•Challenge auditors
•Show more competence in the
standard being audited
•Argue internally
•Express unfairness
•Ask for solution
•Fix non-conformities on the spot

92. 92
Interacting with Auditors –Don’ts
for Auditees
•Speculate or answer hypothetical
questions
•Agree or disagree with opinions
•“Ramble" or provide irrelevant
information (such as office gossip)
•Get offended by WHY questions
•Sign anything on behalf of the
company

93. 93
Responding to the Audit Report
•Ask to reviewthe draft report
•Provide a management response, which should include:
Whether you agree or disagree with the finding
Corrective action plan
Target date for implementation
•Understand the audit follow-up process
•Consult with the Quality department or Controller’s office
prior to finalizing a response

94. 94