Professional Documents
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ISO 9001:2000
9001:2000
QUALITY
QUALITY MANAGEMENT
MANAGEMENT SYSTEM
SYSTEM
INTERNAL
INTERNAL AUDIT
AUDIT
1
What is Quality ??
Fitness for use
Fitness for use
Conformance to requirements
Conformance to requirements
Accuracy
Accuracy
Perfection
Perfection
Zero Defect
Zero Defect
Adequacy
Adequacy
Cost Effectiveness
Cost Effectiveness
2
Quality
Customers’ expectations of quality are not the same for
Customers’ expectations of quality are not the same for
different classes of products or services.
different classes of products or services.
Best-in-Class Quality
Best-in-class
Best-in-classquality
qualitymeans
meansbeing
beingthe
thebest
bestproduct
productoror
service
serviceinina aparticular
particularclass
classofofproducts
productsororservices.
services.
World-Class Company
3
ISO International
InternationalOrganization
Organizationfor
forStandardization
Standardization
Founded
Foundedinin1946
1946ininGeneva
Geneva, ,Switzerland
Switzerland
ISO
ISOisisaanon-governmental
non-governmentalorganization
organizationthat
thatforms
formsaabridge
bridgebetween
between
the
thepublic
publicand
andprivate
privatesectors.
sectors.
World's
World'slargest
largestdeveloper
developerand
andpublisher
publisherof
ofInternational
InternationalStandards.
Standards.
ISO
ISOisiscomposed
composedof
ofmore
morethan
than90
90members
memberscountries
countries
"ISO",
"ISO",derived
derivedfrom
fromthe
theGreek.
Greek.ISO,
ISO,meaning
meaning"equal".
"equal".Whatever
Whateverthe
the
country,
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whateverthe
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theshort
shortform
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notfor
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ISO 9001:2000
ISO
ISO --International
InternationalOrganization
Organizationfor
forStandardization
Standardization
9001
9001 --Number
Numberassigned
assignedby
byISO
ISO
4
? 5
OBJECTIVES OF ISO 9000:2000 requirements
EXPECTED PLANNED
QUALITY QUALITY
by the Customer by the Company
PERCEIVED PRODUCED
QUALITY QUALITY
by the Customer by the Company
6
The 8 principles of QMS …
• Customer focus
• Customer focus
• Leadership
• Leadership
• Involvement of people
• Involvement of people
• Process approach
• Process approach
• System approach to management
• System approach to management
• Continual improvement
• Continual improvement
• Decisions based on facts
• Decisions based on facts
• Relationship with suppliers mutually beneficiary
• Relationship with suppliers mutually beneficiary
7
The 8 principles of QMS …
Customer Focus
Organizations Determine
Determine customer
customer needs
needs
&& expectations
expectations
Depends on
Customers .
Requirements
Requirements
Customer
Customer satisfaction
satisfaction
Principle 1
8
The 8 principles of QMS …
Leadership
Leaders
Leaders must
must set
set the
the direction
direction of
of the
the
organization
organization
Leaders
Leaders must
must create
create and
and maintain
maintain internal
internal
environment
environment that
that encourages
encourages people
people toto
achieve
achieve the
the organization’s
organization’s objectives
objectives
Principle 2
10
The 8 principles of QMS …
11
The 8 principles of QMS …
Involvement of people
Must
Must encourage
encourage the
the involvement
involvement of
of people
people at
at
all
all level
level
Must
Must help
help people
people to
to develop
develop and
and use
use their
their
abilities
abilities
Principle 3
12
The 8 principles of QMS …
13
The 8 principles of QMS …
Process Approach
Control
AA desired
desired result
result is
is more
more efficiently
efficiently achieved
achieved when
when
resources
resources and
and activities
activities are
are managed
managed as as aa process
process
Principle 4
14
The 8 principles of QMS …
Process A Process C
Process B Process D
Input
Output
Control
15
The 8 principles of QMS …
16
The 8 principles of QMS …
Principle 5
17
The 8 principles of QMS …
18
The 8 principles of QMS …
Continual Improvement
Customer Focus
Deming’s
Deming’s
wheel
wheel PLAN DO
(P.D.C.A.)
(P.D.C.A.)
CHECK Continual
ACT Improvement
ISO
Principle 6 9000
20
The 8 principles of QMS …
Principle 7
21
The 8 principles of QMS …
22
The 8 principles of QMS …
An
Anorganization
organizationand
andits
itssuppliers
suppliersare
areinterdependent
interdependentandandaa
mutually
mutuallybeneficial
beneficialrelationship
relationshipenhances
enhancesthe
the ability
ability of of
both
bothtotocreate
createvalue
value
Principle 8
23
The 8 principles of QMS …
24
ISO 9000:2000 Family
25
ISO 9000:2000 Support Documents
26
The ISO 9000:2000 requirements
Five Operating Elements
4- QUALITY MANAGEMENT SYSTEMS
(QMS, documentation requirements)
5- MANAGEMENT RESPONSIBILITY
(Management commitment, Customer focus, Quality Policy, Planning,
Responsibility, Authority and Communication, Management Review)
6- RESOURCE MANAGEMENT
(Provision of Resources, Human Resources, Infrastructure, Work
Environment)
7- PRODUCT REALIZATION
(Planning, Customer Related Processes, Design and Development),
Purchasing, Service Provision, Control of Measuring Devices)
8- MEASUREMENT, ANALYSIS AND IMPROVEMENT
(Monitoring and Measurement, Control of Non-conforming Product,
Analysis of Data, Improvement)
27
The ISO 9000:2000 requirements
Continual improvement of the
Quality Management System
Management
Responsibility
Satisfaction
CUSTOMERS
CUSTOMERS
Measurement,
Resource
Analysis and
Management
Improvement
Requirements
Product /
Input Output Product
Service
Data Data Service
Realization
28
QUALITY MANAGEMENT SYSTEM
29
QUALITY MANAGEMENT SYSTEM
30
QUALITY MANAGEMENT SYSTEM
31
QUALITY MANAGEMENT SYSTEM
32
QUALITY MANAGEMENT SYSTEM
4.2.1 General
Basis of Auditing ( Auditor may look for )
Availability of
Availability of
•• Statements of Quality Policy and Objectives
Statements of Quality Policy and Objectives
•• Quality Manual
Quality Manual
•• Availability of Documented Procedure
Availability of Documented Procedure
4.2.3 Control of Documents
4.2.3 Control of Documents
4.2.4 Control of records
4.2.4 Control of records
8.2.2 Internal Audit
8.2.2 Internal Audit
8.3 Control of Nonconforming products
8.3 Control of Nonconforming products
8.5.2 Corrective Action
8.5.2 Corrective Action
8.5.3 Preventive Action
8.5.3 Preventive Action
33
QUALITY MANAGEMENT SYSTEM
34
QUALITY MANAGEMENT SYSTEM
36
QUALITY MANAGEMENT SYSTEM
37
MANAGEMENT RESPONSIBILITY
5 . Management Responsibility
5.1 Management 5.5 Responsibility , authority
commitment and communication
5.5.1 Responsibility , authority
5.2 Customer focus
5.5.2 Management
representative
5.3 Quality policy 5.5.3 Internal communication
5.4 Planning
5.6 Management review
5.4.1 Quality objectives
5.6.1General
5.4.2 QMS planning
5.6.2 Review input
5.6.3 Review output
38
MANAGEMENT RESPONSIBILITY
39
MANAGEMENT RESPONSIBILITY
••Market analysis
Market analysis
40
MANAGEMENT RESPONSIBILITY
43
MANAGEMENT RESPONSIBILITY
••Organizational chart
Organizational chart
44
MANAGEMENT RESPONSIBILITY
Ensuring that processes needed for the QMS are established , implemented and
maintained
Note : Responsibility may include liaison with external parties in relation to QMS
45
MANAGEMENT RESPONSIBILITY
46
MANAGEMENT RESPONSIBILITY
47
MANAGEMENT RESPONSIBILITY
Audit results
Customer feedback
Process performance & product conformity
Status of preventive and corrective actions
Follow up actions from earlier reviews
Changes that could affect the QMS
Recommendation for improvement
48
MANAGEMENT RESPONSIBILITY
49
QUALITY MANAGEMENT SYSTEM
50
RESOURCE MANAGEMENT
6. RESOURCE MANAGEMENT
6.1 Provision of resource
6.2 Human resource
6.2.1 General
6.2.2 Competence , awareness and training
6.3 Infrastructure
6.4 Work environment
51
RESOURCE MANAGEMENT
Staffing schedules
Staffing schedules
52
RESOURCE MANAGEMENT
53
RESOURCE MANAGEMENT
Competence needed
Competence needed
Skill gap analysis
Skill gap analysis
Identification of training needs
Identification of training needs
Provision of training
Provision of training
Evaluation of training effectiveness
Evaluation of training effectiveness
JobJobdescriptions
descriptions
Relatedrecords
Related
records
Employee’s awareness about relevance and importance of their work
Employee’s awareness about relevance and importance of their work
Analyses of labor turnover or staff absenteeism
Analyses of labor turnover or staff absenteeism
55
RESOURCE MANAGEMENT
6.3 Infrastructure
The organization shall Identify ,provide & maintain the infrastructure needed
to achieve product conformity .
Infrastructure includes as applicable
Trends of maintenance
Trends of maintenance
Equipment Performance
Equipment Performance 56
RESOURCE MANAGEMENT
Physical factors
• Heat • Noise • Vibration • Cleanliness
•Light • Pollution • Air flow •Hygiene
7 Product Realization
7.4 Purchasing
58
PRODUCT REALIZATION
Examples
Production Control plan
Project Plan
59
PRODUCT REALIZATION
Orders
Orders
Documentation of amendments
Documentation of amendments
Product information
Enquiries , contracts or order handling , including
amendments
Customer feedback , including customer complaints
Contracts
Contracts
Acknowledgement of order
Acknowledgement of order
63
PRODUCT REALIZATION
64
PRODUCT REALIZATION
65
PRODUCT REALIZATION
66
PRODUCT REALIZATION
67
PRODUCT REALIZATION
68
PRODUCT REALIZATION
69
PRODUCT REALIZATION
70
PRODUCT REALIZATION
Quality
Drawing
Plans
Quality Plans
Design input records
D&D
Design input records
review records
D&D
D&D review records
verification records
Test
D&D verification records
records
D&D
Test records
validation records
Validation
D&D validation records
approval
Validation approval
Design change requests
New
Design change requests
revision status
History
New revision status
of changes
History of changes
71
PRODUCT REALIZATION
7.4 Purchasing
72
PRODUCT REALIZATION
7.4 Purchasing
7.4.1 Purchasing process
Ensure that purchased product meets requirements
Evaluate and selects suppliers based on their ability to
supply conforming product
Establish criteria for selection , evaluation and re-
evaluation of suppliers
Results of evaluation and any necessary actions must be
recorded
73
PRODUCT REALIZATION
7.4 Purchasing
7.4.2 Purchasing information
Purchasing information must describe the product to be
purchased including where appropriate :
* requirements for approval of product , procedures
processes and equipment
* requirements for qualification of personnel
* quality management system requirements
74
PRODUCT REALIZATION
7.4 Purchasing
Basis of Auditing ( Auditor may look for )
Purchase specification
Purchase specification
Evidence of supplier evaluation
Evidence of supplier evaluation
List of approved suppliers
List of approved suppliers
Evaluation Criteria
Evaluation Criteria
Purchase order – clarity in terms of commercial and technical
Purchase order – clarity in terms of commercial and technical
Quality assurance agreements
Quality assurance agreements
Order approval documents
Order approval documents
75
PRODUCT REALIZATION
7.4 Purchasing
7.4.3 Verification of Purchased product
Establish & implement inspection or other activities
needed to ensure purchased product conformity
Acceptance criteria
Acceptance criteria
77
PRODUCT REALIZATION
The organization shall plan and carry out production & service
provision under controlled conditions . Controlled conditions
include as applicable:
78
PRODUCT REALIZATION
Maintenance schedule
Maintenance schedule
Service Contracts
Service Contracts
Spare parts management
Spare parts management
Identification of Special process
Identification of Special process
Availability of validation specification
Availability of validation specification
80
PRODUCT REALIZATION
Routing tag
Routing tag
segregation slips
segregation slips
81
PRODUCT REALIZATION
82
PRODUCT REALIZATION
Inventory list
Inventory list
Dispatch methods
Dispatch methods
83
PRODUCT REALIZATION
Identification of Equipments
Identification of Equipments
Acceptance Criteria
Acceptance Criteria
Calibration instruction
Calibration instruction
84
PRODUCT REALIZATION
Acceptance Criteria
Acceptance Criteria
Calibration instruction
Calibration instruction
85
MEASUREMENT , ANALYSIS AND IMPROVEMENT
87
MEASUREMENT , ANALYSIS AND IMPROVEMENT
88
MEASUREMENT , ANALYSIS AND IMPROVEMENT
89
MEASUREMENT , ANALYSIS AND IMPROVEMENT
90
MEASUREMENT , ANALYSIS AND IMPROVEMENT
Statistical Techniques
Statistical Techniques
92
MEASUREMENT , ANALYSIS AND IMPROVEMENT
93
MEASUREMENT , ANALYSIS AND IMPROVEMENT
94
MEASUREMENT , ANALYSIS AND IMPROVEMENT
95
MEASUREMENT , ANALYSIS AND IMPROVEMENT
96
MEASUREMENT , ANALYSIS AND IMPROVEMENT
97
MEASUREMENT , ANALYSIS AND IMPROVEMENT
98
MEASUREMENT , ANALYSIS AND IMPROVEMENT
SPC
Benchmarking
Quality Circles
Risk Assessment
Teamwork for Quality
Quality Function Deployment
99
MEASUREMENT , ANALYSIS AND IMPROVEMENT
100
MEASUREMENT , ANALYSIS AND IMPROVEMENT
101
MEASUREMENT , ANALYSIS AND IMPROVEMENT
102
MEASUREMENT , ANALYSIS AND IMPROVEMENT
103
QMS DOCUMENTATION
104
QMS DOCUMENTATION
Quality Manual
Quality Manual: Document specifying the QMS of an
organization
Documented Procedure
Documented Procedure : Specified way to carry out an activity
or process
Record
Record : Document stating result achieved or providing
evidence of activities performance
105
QMS DOCUMENTATION
Document
Document : Information and its supporting medium
Documentation can be in any format or medium
Document provides guidelines
Information Medium
- Procedure Paper
- Specification Electronic
- Drawing Photographic
- Standard Magnetic
Examples Examples
- Procedure for production - Production Report
planning - Inspection Results
- Drawing
- Part Quality Standard
- Work Instruction for
Printing
107
QMS DOCUMENTATION
WHY
Define WHAT will be
Stated Once done
Policy ,
Manual
WHO
WHEN
Procedures
WHERE
HOW Work Instructions
Or
Practices
Evidence
Records
Or
Proof
Documentation Pyramid
108
INTERNAL AUDIT
INTERNAL AUDIT
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INTERNAL AUDIT
INTERNAL AUDIT
110
INTERNAL AUDIT
What is Audit
111
INTERNAL AUDIT
Audit Definition
Audit :
Systematic , documented verification process
of objectively obtaining and evaluating
evidence to determine whether specified
activities , events , conditions , management
systems or information about these matters
conform with audit criteria , and
communicating these results of this process
to the client
Audit Evidence :
A statement of facts or other information relevant
to audit criteria
- based on actual observation
- uninfluenced by emotion
- stated or documented
- verifiable 112
INTERNAL AUDIT
Definitions
Auditee :
Organization to be audited
Auditor :
A person qualified to perform audits
Lead Auditor :
A person qualified to manage and perform audits
Audit Scope :
Audit scope provides the extend and boundaries of
the audit
113
INTERNAL AUDIT
Audit criteria
Audit Criteria :
Policies , practices , procedures or requirements
against which the auditor compares the collected
evidence about the subject matter
114
INTERNAL AUDIT
Audit Objectives
Objectives of the audit are
115
INTERNAL AUDIT
116
INTERNAL AUDIT
117
INTERNAL AUDIT
118
INTERNAL AUDIT
Audit Process
Audits are expensive
Audits must be well managed
Audits must not be carried out by surprise
Always agree mutually convenient dates well in
advance
119
INTERNAL AUDIT
Audit Process
Audit Plan Preparation
Conduct Audit
Report preparation
120
INTERNAL AUDIT
Audit Checklist
Audit checklists are used during the audit to collect the
information / evidence / notes
Benefits
To assist memory
Maintains continuity during the audit
To ensure depth & continuity of the audit
Help in time management
Part of audit report
121
INTERNAL AUDIT
Time Management
Fact Finding
Audit Reporting
122
INTERNAL AUDIT
Time Management
123
INTERNAL AUDIT
Fact Finding
Collect Evidence
124
INTERNAL AUDIT
Fact Finding
- Observations
- Reading
- Communication
- Interviews
- Listening
- Use of check lists
125
INTERNAL AUDIT
126
INTERNAL AUDIT
Communication Skills
How do we communicate ?
- Verbal
- Using Body Language
- Through Facial Expressions
- Using different styles and sounds
127
INTERNAL AUDIT
Physical Factors
Environment Factors
Intellectual Factors
Emotional Factors
128
INTERNAL AUDIT
129
INTERNAL AUDIT
Communication barriers
130
INTERNAL AUDIT
Communication - Interviewing
Hold interviews only during normal working
hours
Put the auditee at ease
Communicate the objective of the interview
Show an interest in what THEY do
Always start with open ended questions
Verify the facts and records is as finding
Avoid arguments
Explain your observations
Thank the auditee for participation and
opportunity for auditing
131
INTERNAL AUDIT
132
INTERNAL AUDIT
133
INTERNAL AUDIT
135
INTERNAL AUDIT
136
INTERNAL AUDIT
Argumentative Inflexible
Opinionated Lazy
Over conclusive Impractical
Inconsistent Know it all
Inconsiderate Indecisive
Untrained Uncommunicative
Accepts things at Unprofessional
face value
137
INTERNAL AUDIT
Auditor’s Qualities
Auditor must be a good listener . Listen and Listen
with full attention
Listen without your own judgment and conclusion
Do not start teaching
Active listening always assist auditee to give more
information
Generate questions from what auditee says – this
possible only when auditor listens carefully
Auditors should be situation manager
138
INTERNAL AUDIT
Sampling
No time to check everything
Select representative sample
No sampling calculation
Sample should represent all activities
Should be on random basis
Spot checking
Take permission before asking / taking samples
139
INTERNAL AUDIT
Observations
Keep observing the physical evidence
Example –Equipment in Production Area
-What is used for ?
-Need it to be calibrated ?
-Was it calibrated ?
-Is there a record ?
-What is the reading ?
-Is the reading within the acceptable range ?
-Identification ?
-Status with respect to measurement ?
-Storage location and condition
140
INTERNAL AUDIT
Reporting and audit conclusion
Definition
Requirements
- Need or expectation that is stated , generally implied
or obligatory
Conformity
- Fulfillments of a requirement
Non Conformity
- Non fulfillment of a requirement
Defect
- No fulfillment of a requirement related to intended use
Corrective Action
- Action to eliminate the cause of a detected non
conformity
141
INTERNAL AUDIT
Non conformity
Non Conformity
- Non fulfillment of a requirement
142
INTERNAL AUDIT
143
INTERNAL AUDIT
144
INTERNAL AUDIT
145
INTERNAL AUDIT
Timely Reporting
Report without delay
Don’t leave writing report till late
Time never becomes available
Prepare NCR’s on the spot
Timely reporting adds value
146
INTERNAL AUDIT
147
G.M.Pens International Pvt Ltd
Non conformance
Signature of Auditee Signature of Auditor
Agreed corrective action Responsibility
Details
Corrective action
Preventive action
Responsibility Target Date
Verification of Corrective Action ( Follow up Audit)
details
Verification Audit
Signature of Auditee Signature of Auditor( followup audit)
Verified Corrective Actions is Effective / Not Effective
Details
NCR Closed Yes / No
Report Status
To be discussed in management review Yes / No
148
Signature
INTERNAL AUDIT
Situation 1
The auditor enters the manufacturing area & identifies lots of filled
polythene bags kept.
149
INTERNAL AUDIT
Situation 2
new source.
150
INTERNAL AUDIT
Situation 3
151
INTERNAL AUDIT
Situation 4
152
INTERNAL AUDIT
Thank You
153