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AWARENESS OF ISO 9000 (2000)

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AWARENESS OF ISO 9000 (2000) By C. Das Additional Director ERTL(E),Calcutta Quality Management System ISO 9000 (2000) Cl no 4.0 : Quality Management System Cl no 5.0 ... – PowerPoint PPT presentation

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Title: AWARENESS OF ISO 9000 (2000)


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

2
Quality Management SystemISO 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

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
11
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12
PRODUCT REALISATION
  • The sequence
  • of
  • processes and subprocesses
  • required to achieve the product

13
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14
Process
Sub-Process Activities
OUTPUT
Internal customer
INPUT
External Customer
External Customer
15
Product Life Cycle
Customer feedback
  • Product realization
  • Design Development
  • Process identification

CUSTOMER
Needs Expectation
Process monitoring
Product Characteristics
Cont. Improvement
Product conformity
Product Specification
Product Delivery
Customer requirement
16
PROCESS REALIZATIONTo 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
Advertising
Public Relation
Marketing
DESIGN DEVELOPMENT
Production
Finances
Human Resources
Store
Servicing
Delivery
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
  • 4.0 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
  • Customer or market place need and/or
  • expectation
  • Contractual requirements interested
  • partys 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 10012 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
Measurement 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 MONITORINGPRODUCTS (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 Organizations 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
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