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AWARENESS OF ISO 9000 (2000)

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 : Management responsibility Cl no 6.0 : Resource management Cl.no 7.0 : Product realization

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AWARENESS OF ISO 9000 (2000)

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

  12. Process Sub-Process Activities OUTPUT Internal customer INPUT External Customer External Customer

  13. 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

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

  15. 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

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

  17. 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

  18. 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.

  19. 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

  20. 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.

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

  22. 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

  23. 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

  24. 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

  25. 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

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

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

  28. 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.

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

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

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

  32. 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

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

  34. 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

  35. 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

  36. 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

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

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

  39. 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

  40. 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

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

  42. 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

  43. 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

  44. 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

  45. 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

  46. 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

  47. 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.

  48. 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

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