Audit

1. Internal Quality Audit

2. Course Objective
 To provide formal training to
prospective Internal Quality Auditors
in the principles and practices of
QMS auditing
 To provide general concepts of
Quality & requirement of standard
 To provide practice in the auditing
techniques used

3. Contents
 Quality Management System
 Quality Audit Concepts
 Auditing Principles & Techniques
 Audit Planning
 Audit Conduction
 Audit Reporting
 Corrective Action
 Audit Follow-up
 Audit Analysis
 Examination

4. 5. MANAGEMENT RESPONSIBILITY
When developing, implementing & managing the
Quality management system, top management
must consider the 8 Quality Management
principles outlined earlier.
5.1 Management Commitment
Top Management must provide
evidence of commitment by:
• Communicating to the organization the
importance of meeting customer requirements
• Establishing Quality Policy
• Ensuring that the Quality Objectives are
established
• Conducting Management Review Meetings
• Ensuring the availability of resources

5. 5.2 Customer Focus
Top Management must ensure that the
customer requirements are determined and
met with the aim of enhancing customer
satisfaction
WHAT ARE CUSTOMER REQUIREMENTS ?
• Stated requirements
• Implied requirements
• Statutory and regulatory requirements
• Organizational requirements

6. CUSTOMER SATISFACTION
WHAT IS CUSTOMER SATISFACTION?
Perception of the customer, as to whether
the organization has met customer
requirements
ISO 9001:1994 Used the term "Quality
Assurance”
ISO 9001:2000 Aims to “enhance
customer satisfaction”, in addition to
Quality Assurance

7. 5.3 Quality Policy
The Quality Policy should
• Be appropriate to the purpose of the
organization; Include a commitment to
comply with the requirements and
continuously improve the effectiveness
of the Quality Management System
• Provide a framework for establishing
and reviewing quality objectives

8. Quality Policy
Quality policy should
• be communicated and understood
within the organization
• be reviewed for continuing suitability
Normally the Quality Policy should be
reviewed in the Management Review
Meetings.

9. 5.4.1 Quality Objectives
Quality Objectives should be
• Established at relevant functions
and levels
• Measurable
• Consistent with the Quality Policy
DEPARTMENTAL OBJECTIVES
In some organizations
Departmental quality objectives are
prepared to be in line with the
company objectives, which are in line
with the company policy

10. 5.6 Management Review
Management Reviews should be platforms
for exchange of new ideas, with open
discussions.
• Carried out at Planned intervals. Frequency
to be determined by needs of the
organization.
• To assess opportunity for improvement and
the need for change in the system
• Review of Quality Policy
• Review of Quality Objectives
• Records of M.R.M. to be maintained

11. 5.6.2 Management Review Inputs
• Process performance & product conformity
(Rejections)
• Status of Corrective & Preventive Actions
• Follow up of previous M.R.M.
• Recommendations for improvement
• Changes to the QMS
• Results of Audits
• Customer feedback

12. 5.6.3 Management Review Outputs
• Improvement in the effectiveness of
QMS
• Improvement in meeting customers
requirements
• Resource needs

13. 8.2.1 Customer Satisfaction
The organization is required to monitor
customer perception as to whether the
organization has met customers
requirement.
This information may be obtained from
• Customer complaints
• Direct communication with customers
• Questionnaires and surveys
• Subcontracted collection and analysis of
data
• Media reports
• Sector and Industry studies

14. 8.2.2 Internal Audit
WHAT IS INTERNAL AUDIT
Internal audit is a tool to evaluate the
maintenance and effectiveness of the
quality management system.
Internal Audit is carried out by suitably
qualified members of the Organization, at
planned intervals.
Auditors do not audit their own area of
activity.
Internal Audit is usually carried out against
documented Procedures and Quality Manual
of the organization

15. 8.2.2 Internal Audit
Internal Audits are conducted to confirm
that Quality management system is
effectively implemented & maintained.
• Requirements of the International
standard are met.
• To find out opportunity for improvement.
• To find out the strengths & weaknesses of
the QMS.
• Findings of Internal Audits are discussed
in Management Review Meetings

16. 8.2.3 Monitoring and Measurement
of Processes
Measurement of Process performance
could cover the following areas:
• Capability
• Reaction Time
• Cycle time or throughput
• Waste reduction
• Yield

17. 8.4 Analysis of Data
• The organization must decide on what
data it needs to collect and analyze, so
that the evaluation can provide information on
areas where continual improvement is possible.
Analysis of data can provide information relating to
• Customer satisfaction
• Conformity to product requirements
• Opportunities for Preventive action
• Suppliers

18. 8.5 Improvement
8.5.1 Continual Improvement
Continual improvement is a recurring
activity to increase the ability to fulfill
requirements.
ISO 9001 provides several avenues for
continually improving the performance of
its processes, such as:
• Stated requirements and Customer
feedback
• Financial data
• Product and service delivery data
• Process yield data

19. Performance Improvement
• “If you do what you have always done,
you will get what you have always
gotten”
• “If we want to change a result, we
have to change the process that
produces the result”

20. PROCESS MONITORING MATRIX.
Sl. FUNCTION
/ PROCESS
OWNER
PROCESS
REQUIRED FOR
MONITORING
MON
ITOR
MONITORING
PARAMETERS
FRE
Q.
1.
Works Head
Control of
nonconforming
product.
O.H. Cost of rework /
scrap.
Mon
thly.
2. Handling customer
complaints.
O.H. Total number of cu.
complaints and their
status.
Mon
thly.
3. Control of
production
processes.
O.H. Number of
schedules not
completed in time.
Mon
thly.
4. F.H. (Q.A.) Monitoring &
measurement of
product.
O.H. Status of Internal
complaint register.
Mon
thly.

21. PROCESS MONITORING MATRIX.
5. F.H.
(Stores)
Preservation of product. O.H. Number of
complaints on
packing and
delivery.
Quarte
rly.
6. F.H.
(Maint.)
Maintenance of
Machines.
O.H. Break-down
hours.
Month
ly.
7. F.H. (Per.) Training. O.H. Training man-
hours.
Quarte
rly.
8. F.H. (Mktg) Customer Satisfaction. O.H. Average of
rating by
customer
Twice
in a
year.
9. F.H.
(Purchase)
Purchasing. O.H. Number of
delayed items.
Month
ly.

22. Quality Audit
Systematic, independent and documented
process for obtaining audit evidence and
evaluating it objectively to determine the
extent to which audit criteria are fulfilled.

23. Objectives of Quality Audit
 Determine compliance of the QMS
 Determine suitability & effectiveness
of the QMS in achieving specified
quality objectives
 Provide confidence to customer &
management
 Offers an opportunity to improve the
QMS

24. Quality Audit
A systematic examination of the quality system
 Intent
 Implementation
 Effectiveness

25. Evidence of Intent
 Quality Policy & Objectives
 Responsibilities and Authorities
 QMS Documentation
 Resource Allocation

26. Evidence of Implementation
 Records
 Activities
 Interviews
 Products
 Understanding

27. Evidence of Effectiveness
 Records/Results
 Measurements
 Milestones
 Management Review
 Internal Quality Audit
 Customer Feedback
 Timely Corrective & Preventive Action
 Document Control

28. Quality Auditing Misconceptions
 It cannot replace product
inspection activities.
 It cannot be used as a means to
accept or reject products.
 It cannot be a substitute for
an effective quality system.
QMS audit assesses the degree to which a QMS
complies with specified requirements.

29. Why conduct Quality Audits ?
 To verify compliance with QMS Standard
 To provide information to the management
about the health of QMS
 To find & resolve nonconformance before
Certification body or customer finds them
 Improvement via problem identification
 Improvement via sharing good practices
 Improve quality awareness

30. Types of Quality Audit
 Internal Quality Audit
 First Party Quality Audit
 External Quality Audit
 Second Party Quality Audit
 Third Party Quality Audit
 Other Types of Quality Audits
 System Audit
 Process Audit
 Product / Project Audit

31. Role of Auditor
Audit Type Primary Focus Represents Advice ?
First Party QMS Management Yes
Second Party Contract Organization Depends
Third Party ISO 9001 All No

32. Audit Features
Quality audits are formalized, regular,
systematic checks of the quality system.
 Trained & independent personnel
 Random sample checks
 Objective criteria

33. Requirement of ISO 9001:2000
Internal quality audit is a mandatory requirement of
ISO 9001:2000 QMS standard,
Clause 8.2.2
 Documented Procedure
 Audit Criteria, Scope, Frequency & Method
 Audit Conduct – independent
 Reporting Results
 Eliminate nonconformities & their causes
 Follow-up Activities
It is mandatory to report feedback of Internal Audits
for Management Review

34. Quality Audit Cycle
◊ Quality Audit Planning
◊ Quality Audit Conduct
◊ Quality Audit Reporting
◊ Quality Audit Corrective Actions
◊ Quality Audit Follow-up

35. Quality Audit Planning
 Normally done by MR
 Quality Audit Schedule
 Selection of Auditors
 Selecting Information Sources
 Checklist Preparation

36. Quality Audit Planning
Quality Audit Schedule
 Frequency of Internal Quality Audits
 Importance of activity
 Status of implementation
 Contractual requirement
 Scope of Audit
 Areas / Activities / Processes / Projects / Products
 Reference Standard & Scheme
 Location / Site
 Audit Programme
 Dates & Timings
 Areas & Activities
 Auditors & Auditee

37. Quality Audit Planning
Quality Audit Schedule
Month of the year
Area/Activity Jan. Feb. Mar. Apr. May June Jul. Aug. Sept. Oct. Nov. Dec
.
Production
Procurement
Q.A.
Training
Design
Marketing
M.R.
 Audit
Conducted
 Audit Scheduled
 Corrective Action Taken

38. Quality Audit Planning
Quality Audit Programme
Audit No.: Date:
Date Time Area/
Activity
Auditor(s) Auditee(s) ISO 9001 Clauses

39. Quality Audit Planning
Selection of Auditors
 Trained
 Independent
 Knowledgeable
 Communication skill
 Tactful Dealing
 Objective
 Impartial
 Flexibility
 Integrity

40. Quality Audit Planning
Selecting Information Sources
 Quality System Documentation
 Records of past audits
 Corrective and Preventive
Action
 Problem areas

41. Quality Audit Planning
Checklist Preparation
An important tool for auditor
 Helps in selecting well balanced & representative
samples
 Keeps the auditor on track / time management
 Ensures that areas/activities are not missed
 Allows a smooth changeover to another auditor
Types of checklists
 Criteria Checklist
 Audit Checklist

42. Quality Audit Planning
Checklist Preparation
Area/Activity : Production Auditor:
Reference Documents : Date:
Doc.
Ref.
Look At Look For Sample
Size
Remarks
Sec. 7 Process Control Sheet PCS records available &
controlled
2-4
Sec. 7 Calibration records Traceability to National or
International standards
2-4
Sec. 7 Product Suitable identification marks
during various stages of
realization.
2-4
Sec. 7 Purchase order i) Completeness of Purchasing
information.
ii) Approval for release
2-4
Sec. 7 Test Report Test Report prepared. Any
problems & action taken.
2-4

43. Quality Audit Conduct
 Opening Meeting (Optional in Internal Audit)
 Collect Information
 Auditing Techniques
 Questioning Techniques
 Review Findings
 Closing Meeting (Optional in Internal Audit)

44. Quality Audit Conduct
Opening Meeting
 Introduction
 Explain Audit purpose & scope
 Agreement on audit programme

45. Quality Audit Conduct
Collecting Information
 Conduct physical audit
 Record Observations
 Use Checklist
 Examine Documents & Records
 Discussion with personnel
 Observe surroundings
 Examine resources & facilities

46. Quality Audit Conduct
Auditing Techniques
 Vertical Audit
Audit the complete development cycle
e.g., Audit of a project
 Horizontal Audit
Audit of particular activity across the organization
e.g., Audit of Test Planning, Design Review etc.
across different projects

47. Quality Audit Conduct
Questioning Techniques
 Approach
Open Question
Unit Concept
(What/Why/When/Where/Who/How & Show)
 Close Ended (Who does …….)
Please show me………
 Hypothetical Question
 Dumb Question
 Inverse Question
 Comparison Question
 Silent Question

48. Quality Audit Conduct
Auditee Reactions
 Authority
 Antagonism
 Hostility
 Volunteered Information
 Internal Conflicts
 Deception
 Stress
 Diversionary Tactics
 Long lunch & other breaks
 Detours between interviews
 Introducing other interesting topics
 Searching for document, records etc.

49. Quality Audit Conduct
 Interviewing is the main tools
 Listen to the auditee
 Look at the evidence
 Make sure you are asking the right person
 Watch out for auditee reactions
 Handle diversionary tactics carefully

50. Quality Audit Conduct
Closing Meeting
 Review Findings
 Highlight strong points
 Identify & Grade non-conformances
 Agree non-conformances
 Present Summary of findings

51. Quality Audit Reporting
o Audit Observations
o Non-conformance Report
o Summary Report

52. Quality Audit Reporting
Non-conformance or Discrepancy
An observed condition or evidence that
 Specified requirement is violated
 Situation adverse to quality
A Non-conformance should indicate
the exact observation of the fact
 Where the discrepancy was found
 What was observed
 Who was there – indicate designation
 Why the facts constitute discrepancy
 Sufficient reference to allow traceability
Indicate appropriate clause of ISO 9001 Standard

53. Objective Evidence
A factual evidence which exists & can be verified
 Based on actual observation of the fact
 Not based on opinion or preference
 Not influenced by emotion / prejudice
Relevance
Records
Accuracy Documents Existence
Statements
Observations
Significance
Documents
Records
Statements
Observations

54. Audit Reporting
Non-Conformance Statement
Why – The requirement(s) (if not obvious)
HOWEVER
Where –
What – The facts to negate the requirements
Who –
When –
ISO 9001 Clause – select the most appropriate
Phrases to avoid:
 It seams that ….
 Generally speaking ….
 The company has failed to ….
 There is no commitment
 Mr. XYX said …

55. Non-Conformance Statements
 Calibration plan indicates that the equipment PRT104,
used in the assembly area , was due for calibration for
the last one month. No evidence of calibration available
for the above said equipment. Procedure QSP 24 for
maintenance of equipment requires timely calibration
of all equipment as per plan. ISO 9001:2000
requirement also confirms the same.
 The drawing DRG/0789 for component C issued by the
design deptt to Inspection deptt for inspecting incoming
component C had unauthorized hand made amendment
with pencil.
The document control procedure QSP 21 requires
changes to be re-approved by authorized person.

56. Non-Conformance Statements
 Supplier M/s Supriya Products have been rated as C in the
monthly rating consistently for the past 6 months, inspite of
regular reminders sent every month, asking him to improve the
performance.
Controls exercised on supplier have not been changed over a
period of 6 months though the requirement as per procedure QSP
28 is to base the type and extent of control exercised on the
supplier on past experience, where applicable.
 As per the Corrective action plan (CAPA 31) dated 17.12.2002, it
was decided to impart training to the paint shop operators as
defects at that stage were attributed mainly to the operators, skill.
In spite of the training imparted on 24.12.2002, defects till date
are still attributed to operator's skill only in the defect report
(FMT 031)
Corrective action, thus taken, is not effective to ensure that non
conformities do not reoccur. Procedure QSP 07 requires controls
to be applied to ensure that corrective actions taken ensure that
non conformities do not re occur.

57. Quality Audit Reporting
Grading of Non-Conformance
Opportunities for improvement
 Major
 Absence or total breakdown of system requirement
 Significant failure to comply with specified requirement
 Minor
 Single observed isolated lapse of a system requirement
 A minor problem having negligible effect on quality &
warranting attention
A number of minor non-conformances could result in
the system failure and would be considered as major
non-conformance

58. Corrective Action
Initiate action on the non-conformances
Examine the discrepancy & evidences
Analyze the cause of discrepancy
Establish the root cause of discrepancy
Suggest the action
Implement the action
Check the effectiveness of the action taken

59. Corrective Action
 Correction - Fix the problem
 Where it was found
 On other products under development
 Corrective Action - Stop it happening again
 Change procedure, Give training / education
 Including other projects, departments etc.
 Preventive Action - Stop it happening in the first
place
 Monitoring and Measurement

60. Corrective Action
Determination of Corrective Action
Immediate Action
 Correct the instance
 Consider what it may impact
Long Term Action
 Analyze and address root cause
 Changes to process / procedure
 Training / Education

61. Corrective Action
Non-conformances details:
Although there have been 6 instances of virus
contamination over the last six months, all
of which have been known to the management, no policy
nor preventive measures have been taken.
 Immediate Action
 Virus checking of all existing software.
 Long Term Action
 New procedure for virus checking of all software.
 Training in virus checking to all staff
 Review of management corrective action procedure to
determine why action was not taken timely.

62. Follow-up Audit
Verify the effectiveness of corrective action
 Resolution of the problem
 Implementation of solution
 Evaluation of effectiveness
 Re-audit to confirm the
implementation

63. Quality Audit Guidelines
 Be prepared
 Use objective criteria
 Focus on problems, not on people
 Improved communication
 Be emphatic
 Be courteous

64. Effectiveness of Quality System
Sources of Information
 Internal Quality Audit Results
 Management Review Reports
 Measurements
 Internal Rejections
 Customer Complaints
 Corrective & Preventive Action Reports
Trends are more informative

65. Analysis of Non-Conformances
 Number of NCs in different departments
 Number of NCs element wise
 Number of NCs in comparison with last audit
 Number of NCs in order of importance of activity
 Number of uncleared NCs.

66. Management Review Reporting
 Summary of Audit findings
 Statistics of Non-conformances
 Area of concern/weakness
 Effectiveness of the QMS

67. Categories of Non-Conformances
• Tendency to write long NC
Enthusiastic auditor
• Shifting focus
NC start & end part are incoherent
• Opinion expression
Auditor trying to show his knowledge
Forcing views on auditee (Directives)
• Preconceived NC
Biasing
• Doubtful NC
Auditor not sure of NC

68. Categories of Non-Conformances
• Vague NC
NC not supported with objective evidence
• Repeated NC
Similar NC raised in different areas/activities
• Trivial NC
Insignificant NC having no impact on quality
• Wrong Clause Identification
Not paying proper attention

69. Thank you