1. AWARENESS OF ISO 9000 (2000) By C. Das Additional Director
ERTL(E),Calcutta

2. Quality Management System ISO 9000 (2000)
Cl no 4.0 : Quality Management System
Cl no 5.0 : Management responsibility
Cl no 6.0 : Resource management
Cl.no 7.0 : Product realization
Cl no 8.0 : Improvement

3. 6.0 Resource Management Provision of Resources 6.1 Human Resources 6.2
Infra-
structure
6.3
Work
Environment
6.4
Competence
Awareness
& Training

4. PROVISION OF RESOURCES (Cl no 6.1)
Timely determination & provision of resources needed to
Address customer satisfaction
Implementation of QMS processes
Improvement of QMS processes

5. HUMAN RESOURCES - 1 (Cl no 6.2)
Assign responsibilities to competent personnel
Determine competence on the basis of
Education
Training
Skill
Experience

6. HUMAN RESOURCES - 2 (Cl no 6.2)
Training, awareness & competency
Identify competency needs
Provide training to satisfy these needs
Evaluate effectiveness of training
Ensure awareness of relevance and importance of assigned activities and their role in achievement of quality objectives
Maintain record of education, experience, training and qualifications

7. Provide TRAINING as identified Measure EFFECTIVENESS of Training
Identification of Training needs
Provide TRAINING as identified
Re-training
Measure EFFECTIVENESS of Training

8. FACILITIES ( Cl no 6.3 ) Identify Provide Maintain This includes
Work space & associated facilities
Equipment, hardware & software
Support services
Facilities required to achieve
product conformity

9. WORK ENVIRONMENT( Cl no 6.4)
Identify & manage
the human and physical factors of work environment needed to achieve product conformity
Examples : - Safety rules & guidance
- Heat,Humidity,Light etc.
- Ergonomics etc.
- Creative work & social interaction

10. 7.0 Product Realization Planning of Product Realisation 7.1 Customer
Related
Processes
7.2
Design
and/or
Development
7.3
Purchasing
7.4
Production
& Service
Provision
7.5
Control of
Meas. &
Monitoring
device
7.6
Planning
Determination of
requirements
Process
Control
Input
Validation
Information
Review of
Requirement
Output
Identification &
Traceability
Verification
Review
Validation
Customer Property
Customer
Communication
Verification
Changes
Preservation

12. PRODUCT REALISATION The sequence of processes and subprocesses
required to achieve the product

14. Process Sub-Process OUTPUT Internal customer Activities INPUT External

15. Product Life Cycle CUSTOMER Customer feedback Product realization
Design Development
Process identification
CUSTOMER
Needs & Expectation
Process monitoring
Product Characteristics
Product conformity
Cont. Improvement
Product Specification
Product Delivery
Customer requirement

16. PROCESS REALIZATION To ensure product realization, attention to be given:
Desired output
Activities
Control measures
Equipment
Information
Process steps
Flows
Training needs
Methodologies
Other resources

17. PRODUCT REALISATION PLANNING ( Cl no 7.1)
Determine & Document Quality Plans
Quality objectives for product
Need to establish processes
Verification & validation required and acceptance criteria
Record that will establish conformity of product & process

18. Quality Plan The document that describes,
how the processes of QMS are applied to
a specific product, project or contract
is called
Quality Plan.

19. IDENTIFICATION OF CUSTOMER REQUIREMENTS (Cl no. 7.2.1)
Product requirements specified by customer
availability
delivery
support
Product requirements not specified by customer but necessary to meet intended use
Obligations related to products
Regulatory & legal requirements

20. SOURCE OF INFORMATION
Process or activities specified by customers/ other interested parties
Market research
Contract requirement
Competitor analysis
Bench marking
Process due to statutory/ regulatory reqm.

21. REVIEW OF PRODUCT REQUIREMENTS ( Cl no 7.2.2)
Review specified & additional requirements
Ensure
Product requirements are adequately defined
Document product requirements
Resolve any differences
Assess ability to meet defined requirement
Record results of review
In case of changes
Repeat review
Amend documentation &Communicate to relevant persons

22. REVIEW OF PRODUCT REQUIREMENTS ( Cl no 7.2.2)
Where the customer provides no documented
statement of requirement , the customer
requirements shall be confirmed by the
organization before acceptance
Note : Formal review may not be applicable for
Internet sale etc.

23. ORGANISATION MANAGEMENT Production Human Resources Finances Public
Advertising
Public
Relation
Marketing
DESIGN
& DEVELOPMENT
Production
Finances
Human Resources
Store
Delivery
Servicing

24. CUSTOMER COMMUNICATION (Cl no 7.2.3)
Identify & implement arrangements for communication with customer for
Product information
Enquiries
Contract (or order handling)
Amendments
Customer feedback, including complaints

25. DESIGN / DEVELOPMENT (Cl no 7.3)
Design and/or development planning
Design and/or development inputs
Design and/or development outputs
Design and/or development review
Design and/or development verification
Design and/or development validation
Control of design and/or development changes

26. DESIGN / DEVELOPMENT ( Cl no 7.3.1)
Plan and control design/development of the product.
Determine:
Stages of design/development processes
Review, verification and validation activities for each design/development stage
Define responsibilities and authorities for design/development activities.
Identify & manage interfaces
Update design planning output

27. DESIGN PLANNING ACTIVITIES
Activity Resp. Period Remarks
1.0 Conceptual
Design
2.0 Block Diagram design
3.0 Detail circuit diagram
design
Design review at various stages
5.0 Prototype testing / Design verification
6.0 Design validation

28. INTERNAL INTERFACE Conceptual Design Computation Design Group(s)
Other Design
Group(s)
Design Groups
Drawing Office
Design Co-ordinator
Design reviewers

29. EXTERNAL INTERFACE Sales Purchasing Design Manufacturing
Specialist Groups
Commission & Service
Development

30. DESIGN / DEVELOPMENT INPUTS ( Cl no 7.3.2 )
Define & documented
functional and performance requirements
applicable regulatory and legal requirements
information derived from previous similar designs
any other requirements essential for design/development.

31. DESIGN / DEVELOPMENT INPUTS (Contd...)
Review inputs for
Adequacy.
Completeness
Ambiguity
Conflicts
Resolve, if necessary

32. EXAMPLE OF DESIGN INPUTS
Customer Specification
Data Book
Statutory or regulatory standars
Company standars
Design codes
Design manual
Service reports

33. EXTERNAL INPUT Contractual requirements & interested party’s spec.
Customer or market place need and/or
expectation
Contractual requirements & interested
party’s spec.
Relevant statutory & regulatory reqmnt.
International/National standards

34. DESIGN / DEVELOPMENT OUTPUTS( Cl no 7.3.3 )
Document
Verify (against design inputs)
Approve prior to release
Outputs shall
meet input requirements
provide adequate information for production and service operations
contain or reference product acceptance criteria
define the characteristics of the product that are essential to its safe and proper use

35. EXAMPLE OF DESIGN OUTPUT
Detailed specifications
Layout drawing
Circuit diagrams
Manufacturing instructions
Material specifications
Special processes
Part lists
Operations / Service Manual

36. WHAT IS DESIGN REVIEW ? Definition :
A formal documented , comprehensive
and systematic examination of a design
requirements and capability of the
design to meet these requirements and
to identify problems and propose
solutions

37. WHAT IS DESIGN REVIEW ? A design Review is an engineering
management process : A formal ,
systematic study of a design :
Performance
Environment
Quality
Reliability & maintainability
Safety

38. DESIGN / DEVELOPMENT REVIEW (Cl no 7.3.4 )
Carry out systematic review
evaluate the ability to fulfil requirements
identify problems and propose follow-up actions
Involve representatives of functions concerned
Record results of the reviews and follow-up

39. DESIGN / DEVELOPMENT VERIFICATION( Cl no 7.3.5 )
Perform verification
Ensure compliance with inputs
Record results & follow-up actions

40. HOW DESIGN VERIFICATION CAN BE CONDUCTED ?
Review of the design documents
Conducting Qualification Tests
Alternative calculations
Comparing with old design

41. DESIGN / DEVELOPMENT VALIDATION( Cl no 7.3.6)
Validate product for intended use
Validation prior to delivery OR
Partial validation to the extend possible
Record results of validation and follow-up

42. DESIGN / DEVELOPMENT CHANGES( Cl no 7.3.7)
Identify
Document
Control
Evaluate effect on parts and delivered products
Verify
Validate
Approve.
Record results & follow-up actions
Operate configuration control

43. PURCHASING ( Cl no 7.4 ) Purchasing Control Purchasing Information
Verification of purchased product

44. PURCHASING( Cl no 7.4.1 ) Control purchasing processes
Evaluate and select suppliers
Define criteria for selection and periodic evaluation
Record results of evaluations and follow-up actions
Apply control to the extent required

45. PURCHASING INFORMATION( Cl no 7.4.2)
Purchasing documents shall include
Unique product identification
Requirements for approval or qualification of
product
procedures
processes
equipment
personnel
Quality Management System requirements
Ensure the adequate information prior to release

46. VERIFICATION OF PURCHASED PRODUCTS(Cl no 7.4.3)
Identify & implement necessary verifications
Specify need for verification at suppliers premises
Verification arrangements
Method of product release

47. Production and service operations(Cl no 7.5)
Operations control
Identification and traceability
Customer property
Preservation of product. Implementation of defined processes for release, delivery and applicable post-delivery activities

48. OPERATION CONTROL(Cl no 7.5.1)
Control production and service operations
Availability of information that specifies the characteristics of the product
Where necessary, the availability of work instructions
Use of suitable equipment for production and service operations
Availability and use of measuring and monitoring devices
Implementation of monitoring activities
Implementation of defined processes for release, delivery and applicable post-delivery activities

49. VALIDATION OF PROCESSESS(Cl no 7.5.2 )
Validate production and service processes
whose resulting output can not be verified by subsequent monitoring or measurement.

50. VALIDATION OF PROCESSESS(Cl no 7.5.2 )
Demonstrate process capability to achieve planned results
Define validation arrangements including
Qualification of processes
Qualification of equipment and personnel
Use of defined methodologies and procedures
Requirements for records
Re-validation

51. PROCESS VALIDATION Validation of Product Validation of Process
Qualification of Process, equipment , Personnel , Procedure & methods
Special attention to :
High Value Product
Where de in product will only be apparent in use
Which cannot be repeated
Where verification of the product not possible
When there is any change in the product characteristics arising out from any reason or feedback , subsequent change in process identified and revalidated .

52. IDENTIFICATION & TRACEABILITY(Cl no 7.5.3)
Identify product uniquely
Identify product status
Maintain traceability
Control & record unique identification
Note : It may be the part of configuration management

53. CUSTOMER PROPERTY(Cl no 7.5.4)
Exercise care & control
identify
verify
protect
maintain
Record & report to customer
loss
damages
other unsuitability

54. PRESERVATION OF PRODUCT( Cl no 7.5.5)
Preserve product conformity during internal processing & delivery
Maintain
identification
handling
packaging precautions
storage precautions
protect against abuses

55. CONTROL OF MEASURING & MONITORING DEVICES - 1(Cl no 7.6)
Assure product conformity through measurement & monitoring
Identify measurements to be made
Identify & control measuring and monitoring devices
Maintain measurement capability
Use ISO for guidance

56. CONTROL OF MEASURING & MONITORING DEVICES - 2(Cl no 7.6)
Control shall include
periodic calibration & adjustment
traceability to national standards
safeguarding against unauthorized adjustments
protection against damage/deterioration during handling, storage, maintenance & uses
recording results of calibration
in case of failure in calibration
validation of previous results
corrective actions

57. 8.0 Measurement , Analysis and Improvement
Monitoring
8.2
Control of
Non
Conformity
8.3
Analysis of
Data
8.4
Improvement
8.5
General
8.1
Continual
Improvement
Customer Satisfaction
Internal Audit
Corrective
Action
Measurement and Monitoring
of Processes
Preventive
Action
Measurement and Monitoring
of Product

58. MEASUREMENT, ANALYSIS & IMPROVEMENT ( Cl no 8.0 )
Plan
Measure & Monitor
Customer Satisfaction
Internal audit
Process
Product
Control Nonconforming Products
Analysis of Data
Improvement
Continual Improvement
corrective Actions
Preventive Actions

59. PLANNING ( Cl no 8.1 ) Identify need for measurement & monitoring
Assuring product conformity
Assuring process capability
Achieve improvement
Identify
Methodologies
Statistical Techniques
Define & document
Measurement & monitoring plans
Implement plans

60. Customer satisfaction(Cl no 8.2.1)
Use as performance indicator of Quality Management System
Determine customer satisfaction / dissatisfaction status
Determine methodology
Document
Implement

61. Source : Measurement of customer satisfaction
Customer complaints
Direct communication with customer
Questionnaire and surveys
Focus groups
Report from customer organization
Reports from various media
Sector studies

62. INTERNAL AUDITS - 1( Cl no 8.2.2)
Conduct periodic internal audits
Determine effective implementation & maintenance of QMS
Plan audit program considering
status
importance
results of previous audit
Use ISO10011 for guidance

63. INTERNAL AUDITS - 2(Cl no 8.2.2)
Define & document
Audit scope
Audit frequency
Audit methodology
Responsibilities for
conducting audit
ensuring independent
recording results
reporting to management
Ensure timely corrective actions
Verification of corrective actions
Reporting verification results

64. MEASUREMENT & MONITORING : PROCESSES (Cl no 8.2.3)
Apply suitable methods
Cover product realization processes
Confirm continuing ability of each process to meet customer requirements

65. MEASUREMENT & MONITORING:PRODUCTS (Cl no 8.2.4)
Product characteristics
Verify product requirements are met
Identify stages
Document acceptance criteria
Document method of verification
Document extent of verification
Document responsibility for verification
Document resources to be used
Record results
Establish compliance
Control further processing/release/delivery

66. CONTROL OF NONCONFORMITY( Cl no 8.3)
Hold further processing
Identify
Prevent unintended use
Correct
Re-verify after correction
If detected after delivery/use, take appropriate actions
If necessary, obtain concession

67. ANALYSIS OF DATA( Cl no 8.4)
Determine suitability & effectiveness of Quality Management System
Determine improvement opportunities
Collect & Analyse data
Use data generated by measurement / monitoring & other sources
Generate & use information on
Customer satisfaction/dissatisfaction
Conformance to requirements
Characteristics of product, processes
Trend of characteristics
Suppliers

68. IMPROVEMENT( Cl no 8.5.1 ) Continual improvement
Facilitate continual improvement
Identify, Plan & Manage continual improvement processes
Use
Quality policy Quality objectives
Audit results Analysis of data
Corrective actions Preventive actions
Management Review Other means

69. CORRECTIVE ACTIONS( Cl no 8.5.2)
Eliminate cause of nonconformity
Define & document procedure for
Identifying nonconformity
Determining cause of nonconformity
Evaluating actions needed to eliminate cause of nonconformity
Determination & implementation of corrective actions
Recording results of actions taken
Reviewing corrective action taken
Corrective actions shall be appropriate to the impact of problem

70. Source of information for CA
Customer complaints
Nonconformity reports
Internal audit reports
Output form management reviews
Output form Data analysis
Output form Satisfaction measurement
Relevant Quality Management System records
The Organization’s people
Process measurement
Result of self assessment

71. PREVENTIVE ACTIONS( Cl no 8.5.3)
Prevent occurrence of potential problem
Define & document procedure for
Identifying potential nonconformity
Determine their cause
Determine preventive actions
Record result of actions taken
Review effect of preventive action

72. Source of information for PA
Use of Risk analysis tools
Review of Customer needs & expectations
Market analysis
Management Review output
Output form Data analysis
Satisfaction measurement
Process measurement
Systems that consolidate sources of info from interested party

73. Source of information for PA (Cont.)
Relevant quality system management records
Lessons learned form past experience
Result of self assessment
Process that provide early warning of approaching out-of-control operating conditions

74. How to plan CONTINUAL Improvement ?
Setting of Objectives for people, project and
the organization
Benchmarking competitor performance &
best practice
Recognition and reward for achievement of
improvement
Suggestion scheme including timely reaction
by management

75. Indicators of Improvement Process
Effectiveness
Efficiency
External effect ( Statutory /Regulatory changes)
Potential weakness ( Lack of capability,consistency)
The opportunity to employ better methods
Control of plan & unplanned changes
Measurement of planned benefits

76. Sources of Information for improvement assessment
Validation data
Process yield data
Test data
Data from self assessment
Stated requirement and feedback from
interested parties
Experience of people in the organization
Financial data
Product performance data
Service delivery data

77. THANK YOU