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
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
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
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
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)
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
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