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Quality System Basics Section 1

Quality System Basics Section 1. ISO Survey ( As of December 2007). At least 9,51,486 ISO 9001:2000 certificates had been issued in 175 countries and economies Out of the top ten countries China ranks first with 2,10,773 certificates Italy, Japan and Spain follow

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Quality System Basics Section 1

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  1. Quality System Basics Section 1

  2. ISO Survey(As of December 2007) • At least 9,51,486 ISO 9001:2000 certificates had been issued in 175 countries and economies • Out of the top ten countries China ranks first with 2,10,773 certificates • Italy, Japan and Spain follow • India ranks fifth with 46,091 certificates • Followed by Germany, U.S.A., U.K., France and Netherlands with 18,922 certificates

  3. The DEMING PDCA Cycle

  4. Schematic Representation of Process Approach Top Management Process outputs inputs A B C Customers Customers REALISATION PROCESSES Support Processes • Top management processes - planning, allocation of resources, management review, etc. • Realization processes - customer related processes, design and development, product realization, etc. • Support processes - training, maintenance, etc.

  5. Model of Process based Quality Management System Continual Improvement of the quality management system R E Q U I R E M E N T S 4 S A T I S F A C T I O N Management Responsibility C U S T O M E R C U S T O M E R 5 Measurement, Analysis & Improvement Resource Management 6 8 7 Product Realization Product

  6. Application of PDCA Cycle • The ultimate aim of any management system is continual improvement of its performance • To achieve this, Deming’s PDCA cycle of improvement is interwoven in the structure ISO-9001:2008 as illustrated in the next slide • Plan – Do – Check - Act PLAN D0 CHECK

  7. PDCA Cycle applied to ISO 9001:2008 clause 4.1 ACT Implementation of improvement ( Clause 4.1f ) PLAN Identification of sequence, interaction criteria & methods ( Clause 4.1 a,b,c ) CHECK Monitoring, Measurement & Analysis ( Clause 4.1e) DO Implementation of the planning ( Clause 4.1.d)

  8. Deploying Quality Improvement Process Continual improvement process of Quality Management System can be deployed throughout the organization by undertaking PDCA activities at various levels

  9. Department/Section Heads PLAN • Establish procedures and instruction for departmental activities • Define responsibilities • Establish objectives • Plan resources including training of personnel • Establish communication channel for instructions and feed-back

  10. Department / Section Heads DO • Allocate clear responsibilities • Provide resources and support • Coordinate and harmonize activities • Resolve problems

  11. Department/Section Heads CHECK • How is my department doing? • Are processes under control? • What are my employees telling me? • Are we meeting customer requirements? • Am I meeting my objectives? • What are the key problems in my area? • How can we improve?

  12. Department / Section Heads ACT • Systematic problem-solving (based on importance, risks involved etc) • Develop action plans • Concentrate on improvement (incremental or “breakthrough” improvements) • Review existing procedures, and need for new procedures

  13. Quality Systems and Standards Development Section 2

  14. Quality Misconceptions • Quality means expense • Quality Systems are expensive nice to haves • Good Quality is high specification • Quality Control about testing and checking • Quality is the responsibility of the Quality Department • Quality comes from Inspection

  15. Prevention vs. Detection • Inspection was once considered the normal means of attaining quality • Inspection has been proved to be expensive as it is always performed after the problem has occurred • Inspection does not always find all the faults and there is a risk that faulty items can be received by the customer • As there is always a delay between the problem happening and the inspection it means that many more faulty items can be produced at cost

  16. Prevention vs. Detection …contd. • Quality planning is carried out to plan exactly how consistent quality can be achieved • Quality planning is less expensive as it involves a few peoples’ time and does not tie up the production line equipment and staff or waste materials • Controlling suppliers and getting them to ensure the quality of the supplies is cheaper and more reliable than inspection • Training of staff in understanding the processes they operate and control is more efficient than employing inspectors

  17. Control of Processes We control processes by controlling the inputs into the processes rather than inspecting the outputs • People – By training or qualification • Materials – Control of suppliers and specification • Methods – By procedures & standards • Machines – By maintenance systems • Environment – By organisation and care

  18. Process Approach • Process – Set of interrelated or interacting activities which transforms inputs to outputs • Product ( Service ) – Result of a process • Outputs of one process may be inputs into another process • Control the inputs to ensure outputs meet requirements • Analyse and review for continual Improvement

  19. 8 Principles of Quality • Customer Focus • Leadership • Involvement of People • Process Approach • System Approach to Management • Continual Improvement • Factual Approach to Decision Making • Mutually Beneficial Supplier Relations

  20. 1. Customer Focus • Understand current and future customer needs and expectations • Plan to meet customer requirements and exceed expectations • Clause 5.2 requires that Top Management shall ensure that requirements are determined and are met to enhance customer satisfaction

  21. 2. Leadership • Leaders establish unity of purpose and direction of the organisation • Leaders shall create and maintain the internal environment in which people can become fully involved in achieving the organisation’s objectives

  22. 3. Involvement of People • People at all levels are the essence of an organisation and their full involvement enables their abilities to be used for the organisation's benefit

  23. 4. Process Approach • A desired result is achieved more efficiently when activities and related resources are managed as a process • People, Machines, Methods, Materials and Environment are the classic inputs • Consistent inputs produce consistent outputs

  24. 5. System Approach to Management • Identifying, understanding and managing interrelated processes as a system contributes to the organisation’s effectiveness and efficiency in achieving its objectives • Outputs of one process are often inputs into the next process • Materials and information flow through systems, the smoother the flow, the greater the efficiency

  25. 6. Continual Improvement • Continual improvement of the organisation’s overall performance should be a permanent objective of the organization • This shall be planned and managed throughout the whole organization • No one and no system is ever perfect • There is always room for improvement

  26. 7. Factual Approach to Decisions • Effective decisions are based on the analysis of data and information • Methods and measures planned • Data needs to be gathered factually, independently and without bias • Information needs to be communicated in a usable format to decision makers

  27. 8. Mutually Beneficial Supplier Relationships • An organisation and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value

  28. The Quality Approach • Prevention should take place before the problems arise • It is cheaper and more effective to run preventive systems than to run inspection based systems • Preventive measures include planning activities carefully analyzing inputs and outputs, training, writing and implementing procedures, and auditing the activities

  29. History of Quality Standards • US Military Standards • AQAP Standards • Motor Industry Standards • BS 5750 : 1979 • ISO 10000 series • ISO 9000 : 1987 Series of Standards • ISO 9000 : 1994 • ISO 9000 : 2000 • ISO 9000 : 2008

  30. Standards and Guidelines • Standards regulate requirements that shall be met – ISO 9001 • Standards can be used to harmonise requirements or terms – ISO 9000 • Guidelines Documents – ISO 9004, ISO19011 Complement the Standards

  31. Standards Development • National, European and International Standards are produced on a consensus basis by committees and sub committees • ISO TC 176 is responsible for quality management and quality assurance standards • The ISO 9000 series are designed for international standardization of quality, environmental and health and safety management system standards • Standards are reviewed for possible change every 6 years and the ISO 9000 – 2000 standards will continue to be reviewed and further developed

  32. ISO 9000 Series Quality Management Systems Standards • ISO 9000:2005 –Fundamentals and vocabulary • ISO 9001:2008 – Requirements • ISO 9004:2000 – Guidelines for performance improvements • ISO 19011:2002 – Guidelines for Quality and /or Environmental Management systems Auditing

  33. ISO 9000 : 2005Fundamentals and Vocabulary • Explains the Quality Management System approach • Eight Quality Management Principles • Quality Policy and Objectives • Processes and responsibilities • Measurement methods and application • Means to prevent nonconformities • Applying process for continual improvement • Definitions

  34. ISO 9001 : 2008 Quality Management Systems - Requirements • Specifies requirements for a QMS where an organization needs to demonstrate its ability to provide products/services that fulfill customer and regulatory requirements • Requirements are generic and applicable to all products/services in all sectors of business

  35. ISO 9004 : 2000 Guidelines for performance improvements • Provides guidance that consider both the effectiveness and efficiency of the Quality Management System • Aimed at improvement of performance and satisfaction of customers and interested parties • Used with ISO 9001 as a consistent pair of standards

  36. ISO 19011:2002Guidelines For Quality and /or Environmental Management Systems Auditing • Principles of Auditing • Managing an Audit Programme • Audit Activities • Competence and Evaluation of Auditors

  37. ISO 9000 : 2005 Definitions • Quality – Degree to which a set of inherent characteristics fulfils requirements • Quality Management – Coordinated activities to direct and control an organization with regard to quality • Quality Management System – Management system to control and direct an organization with regard to quality • Quality Policy – Overall intentions and direction of an organization related to quality as formally expressed by top management

  38. ISO 9000 : 2005 Definitions … contd 2 • Quality Control – part of quality management focused on fulfilling quality requirements • Quality Assurance – part of quality management focused on providing confidence that quality requirements will be fulfilled • Quality Improvement – part of quality management focused on increasing the ability to fulfill quality requirements • Supplier – Organization or person that provides a product • Customer – Organization or person that receives a product

  39. ISO 9000 : 2005 Definitions ..cont 3 • Audit - Systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled • Audit Criteria – Set of policies, procedures or requirements • Audit Evidence – Records, statements of fact or other information which are relevant to the audit criteria and verifiable • Audit Findings – Results of the evaluation of the collected audit evidence against audit criteria

  40. Permissible Exclusions • ISO 9001 Clause 1.2 Application • Permissible reductions of scope limited to exclusions related to clause 7 - Product Realization and that such exclusions do not affect the organization’s ability, or responsibility, to provide product that meets customer and applicable regulatory requirements • Exclusion shall be stated in the quality manual

  41. ISO 9001 Clause 7 Product Realization • Planning of product realization • Customer related processes/communications • Design and Development • Purchasing • Control of production and service provision, Validation of Processes, Identification and traceability, Customer property, Preservation of product • Control of monitoring and measuring equipment

  42. Statement of Scope • Scope of application should relate to the management of the organization, the site or sites, the activities covered and the standard used stating exclusions • Conformity to the ISO 9001: 2008 standard cannot be claimed if exclusions are other than those in clause 7

  43. The Benefits of ISO-9000 1. Organisation focus on "how they do business". Each procedure and work instruction must be documented and thus, becomes the springboard for Continuous Improvement. 2. Documented processes - basis for repetition - help eliminate variation within the process - efficiency improves - cost of quality is reduced. 3. With the development of solid Corrective and Preventative measures, permanent, company-wide solutions to quality problems are found.

  44. The Benefits of ISO-9000 ….2 4. Employee morale is increased as they are asked to take control of their processes and document their work processes.5. Customer satisfaction and customer loyalty grows. Company transforms from a reactive organization to a pro-active, preventative organization. It becomes a company people want to do business with.6. Reduced problems resulting from increased employee participation, involvement, awareness and systematic employee training.

  45. The Benefits of ISO-9000 ….3 7. Better products and services result from Continuous Improvement processes.8. Fosters the understanding that quality, in and of itself, is not limited to a quality department but is everyone's responsibility.9. Improved profit levels result as productivity improves and rework costs are reduced.10. Improved communications both internally and externally which improves quality, efficiency, on time delivery and customer/supplier relations.

  46. Customer Quality Perceptions – Kano Model Delight Delighted Performance Needs Absent Needs Fully Implemented Basic Customer Satisfaction Disgusted Product Function

  47. Key Elements of Quality Management Systems Section 3

  48. Role of Management • Demonstrate Commitment • Policy and Objectives • Motivation and environment • Customer focus • Provision of resources • Monitoring and review • Decisions and improvement actions

  49. Quality Policy • Appropriate to the Organization’s purpose • Commitment to meet requirements and to continual improvement • Provides framework for setting objectives • Communicated and understood at appropriate levels • Reviewed for continuing suitability • Shall be controlled

  50. Quality Policy ITI is committed to provide Competitive & Reliable Products, Solutions and Services ITI will achieve this through: • Sound Quality Management Systems • Empowered Human Resources • Innovation Continual Improvement, Mutual Respect and Customer Delight will be our guiding philosophy Date: 05/05/2007 (PRITAM SINGH) Bangalore Chairman & Managing Director

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