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  1. Preparing for Quality System Certification U.S. Senator Byron Dorgan’s Aerospace & Defense Manufactures Roundtable

  2. Discussion Topics • Quality system development • Certification process • ISO 9001 myths and misconceptions • ISO 9001 interpretation of requirements

  3. Quality System Development • Establish unity of purpose throughout the organization • What are we try to achieve with ISO 9001? • How do we want to improve our business performance? • Eight Quality Management Principles (ISO 9000:2000) • Customer focus • Leadership • Involvement of people • Process approach • Systems approach to management • Continual improvement • Factual approach decision making • Mutually beneficial supplier relationships

  4. Quality System Development • Prepare a project plan to manage implementation • Establish scope for the quality management system • “Design and manufacture of fluid power controls” • Establish quality policy • Identify processes required to satisfy the scope • Customer orientated • Product realization processes • Support processes • Management processes • Start defining process details, resources and implementation actions (See 4.1 General requirements) • Monitor, measure and analyze process performance • Set initial quality objectives, plans and communication • Monitor the project progress at the management level

  5. Quality Systems Development • Tips for developing your quality system • Establish awareness that the QMS is the foundation for managing the business • No single business related activity should exist outside of the scope of the system • Include the management staff in the initial development of the system • Include the internal auditors in the system development • Work according to a project plan • Identify information technology (IT) needs up front

  6. Quality Systems Development • Tips for developing your quality system • Keep the documentation light, easy to use and to the point. • Use mix of text and graphical formats • Use simple systems to control the documentation • A picture says a thousand words

  7. Quality Systems Development • Build “working engines” before building documentation • Engines are vital and essential work processes that make the ISO 9001 system work • Management processes • Information collection and analysis processes • Supplier management processes • Improvement processes (C/A, P/A, auditing) • Employee development processes

  8. Quality Systems Development Establish a culture for planning and execution of improvement actions Plan Quality Improvement Act Do Check Quality Policy Plan Productivity Improvement Act Do Check

  9. Quality Systems Development • Critically examine legacy documentation • May not contain vital information • See ISO 9001:2000 4.1 General requirements • May not be user friendly • May cause challenges for internal auditors • Don’t be afraid to start over!

  10. Quality System Development (ISO 9001:2000) ISO 9001:2000 promotes the PDCA methodology for processes (See ISO 9001:2000 page VI) PLAN:establish the objectives and processes necessary to deliver results in accordance with customer requirements and organizational policies Plan DO: implement the processes Act Do CHECK: monitor and measure processes and product against policies, objectives and requirements Check ACT: take actions to continually improve process performance.

  11. Quality System Development • The Process Approach • ISO 9001:2000 promotes the adoption of a process approach to manage the organization. (see ISO 9001:2000 page V) • Provides a focus on inputs, process, and outputs • Enables a systems view by looking at the interconnection and interaction of individual processes • Processes are planned, resourced, implemented and validated/verified. Input Process Output

  12. Quality System Development The Process Approach • 4.1 General requirements • The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard • The organization shall; • Identify the processes needed for the QMS and their application • Determine the sequence and interaction of these processes • Determine criteria and methods needed to ensure both the operation and control of processes are effective • Ensure the availability of resources and information as necessary • Monitor, measure and analyze these processes • Implement actions necessary to achieve planned results and continual improvement of these processes

  13. ISO 9001 Myths and Misconceptions • Documentation efforts will cripple my company! • Quality manual • Quality policy and objectives • Six required procedures • Other documents needed by the organization • The organization is responsible to determine the level of documentation required • Document format and media is company choice

  14. ISO 9001 Myths and Misconceptions • ISO 9001 will require us to change the way we manage our business! • ISO 9001 provides a framework • Management determines the methods and manner of operations • Helps management to mitigate risks • Based on Plan-Do-Check-Act cycle

  15. ISO 9001 Myths and Misconceptions • We’ll spend all of our time filling out records! • Twenty (20) record categories • Records are determined by the organization • Used as “collectors” for process performance information • Channels information into analysis processes • Enables management to make improvements

  16. ISO 9001 Myths and Misconceptions • We’ll I have to hire more employees to manage the system? • The ISO 9001 requires management to provide resources necessary to achieve customer satisfaction • Resources are a business case decision • The resources are an investment in achieving the organization’s goals and customer satisfaction

  17. Certification Process • Selection of a registrar • Initial visit and document review • Pre-audit • Registration audit • Post audit corrective actions • Verification of actions • Certificate released, registered in public listing • Surveillance auditing begins at appropriate intervals

  18. What is ISO 9001:2000? • ISO 9001:2000 is a quality management system • Interconnected and interdependent processes • Provides a systematic approach to delivering products or services meeting customer requirements • Enables continuous improvement in achieving defined objectives

  19. Overview of ISO 9001:2000 ISO 9001:2000 is focused on processes Product realization processes Support processes Customer orientated processes Management processes

  20. Overview of ISO 9001:2000 • Product Realization Processes • Design, purchasing, manufacturing, maintenance, packaging, warehousing. • Customer Orientated Processes • Sales, marketing, contracting, after sales support, invoicing, managing complaints, product literature • Support Processes • Training, Calibration, document control, records • Management Processes (PDCA) • Strategic planning, management review, internal audits

  21. ISO 9001:2000 Overview • ISO 9001:2000 is contained in three primary documents • ISO 9000:2000 Quality management systems – Fundamentals and vocabulary • ISO 9001:2000 Quality management systems – Requirements • ISO 9004:2000 Quality management systems – Guidelines for performance improvements • A few guidance documents

  22. ISO 9001:2000 Requirements • ISO 9001:2000 contains five (5) main clauses defining the requirements • 4 Quality management system • 5 Management responsibilities • 6 Resource management • 7 Product realization • 8 Measurement, analysis and improvement

  23. ISO 9001:2000Balancing the Equation + = A B C 6.2 Human Resources 7 Product Realization 8 Measurement, Analysis and Improvement + 5.4.1 Quality Objectives = 6.3 Infrastructure + 8.2.1 Customer Satisfaction = + 6.4 Work Environment

  24. 4 Quality Management System The Core Requirement • 4.1 General requirements • The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard • The organization shall; • Identify the processes needed for the QMS and their application • Determine the sequence and interaction of these processes • Determine criteria and methods needed to ensure both the operation and control of processes are effective • Ensure the availability of resources and information as necessary • Monitor, measure and analyze these processes • Implement actions necessary to achieve planned results and continual improvement of these processes

  25. 4 Quality Management System • 4.2 Documentation requirements • The quality management system documentation shall include; • Documented statements of quality policy and quality objectives • A quality manual • Documented procedures required by this International Standard • Documents needed by the organization to ensure the effective planning, operation and control of its processes, and • Records required by this International Standard (see 4.2.4)

  26. 4 Quality Management System • 4.2.1 General (Cont.) • Note 1: The term “documented procedure” means that the procedure is established, documented, implemented and maintained. • Note 2: The extent of the quality management system documentation can differ from one organization to another due to; • The size of the organization and type of activities • The complexity of processes and their interactions • The competence of personnel • Note 3: The documentation can be in any medium

  27. 4 Quality Management System • 4.2.2 Quality Manual • The organization shall establish and maintain a quality manual that includes; • The scope of the quality management system, including details of and justification for any exclusions (see 1.2) • The documented procedures established for the quality management system, or reference to them, and • A description of the interaction between the processes of the quality management system (see handout)

  28. 4 Quality Management System • 4.2.3 Control of documents • Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4 • A documented procedure shall be established to define controls • To approve documents for adequacy prior to issue • To review and update as necessary and re-approve documents • To ensure that changes and the current revision status of document are identified • To ensure that relevant versions of applicable documents are available at points of use • To ensure that documents remain legible and readily identifiable • To ensure that documents of external origin are identified and their distribution controlled • To prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.

  29. 4 Quality Management System • 4.2.4 Control of records • Records shall be established and maintained to provide evidence of • Conformity to requirements • Effective operation of the quality system • Records shall remain • Legible • Ready retrievable • Documented procedure must be established to define; • Identification, storage, protection, retrieval, retention time and disposition

  30. 4 Quality Management System • Key points; • Document control enables creation and revision, must not curtail change. • Record control prevents loss of company information

  31. 4 Quality Management System Documented procedures =6 Quality records categories =20

  32. 4 Quality Management System • Alternatives to documented procedures • Competent employees - having defined education, skills and experience • Employee training - trained for specific tasks • Process controls – calibrated monitoring and measuring equipment, mistake proofing • Verification and validation – product evaluations that separate good products from bad

  33. 4 Quality Management System • “Picture if you will….” • A process operated by employees meeting defined competence requirements, specifically trained to do tasks as expected, using process controls that allow adjustment and correction to defined parameters, with product verification. …and no document procedures.”

  34. 5 Management Responsibility • 5.1 Management commitment • Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by; • Communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements • Establishing the quality policy • Ensuring that quality objectives are established • Conducting management reviews and • Ensuring the availability of resources

  35. 5 Management Responsibility • 5.2 Customer focus • Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1)

  36. 5 Management Responsibility • 5.3 Quality policy • Top management shall ensure that the quality policy • Is appropriate to the purpose of the organization • Includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system • Provides a framework for establishing and reviewing quality objectives • Is communicated and understood within the organization • Is reviewed for continuing suitablity

  37. 5 Management Responsibility • 5.4 Planning • 5.4.1 Quality (business) Objectives • Top management shall ensure that quality objectives, including those needed to meet requirements for product (see 7.1 a) are established at relevant functions and levels within the organization. • The quality objectives shall be measurable and consistent with the quality policy.

  38. 5 Management Responsibility 5.4.2 Organizations must plan on how to meet objectives Plan Quality Improvement Act Do Check Quality Policy Plan Productivity Improvement Act Do Check

  39. 5 Management Responsibility 5.4.1 Quality objectives established at relevant functions and levels with the organization.

  40. 5 Management Responsibility • 5.4 Planning • 5.4.2 Quality management system planning • Top management shall ensure that • The planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives, and • The integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

  41. 5 Management Responsibility • A simplified view of the components of planning; • Objectives (results expected) • Quality management processes affected or required • Resources • Measurement • Continual improvement

  42. 5 Management Responsibility Plan Quality Management Systems Approach • Determine customer needs and expectations • Establish quality policies and objectives • Determine (and implement) required processes and responsibilities • Determine and provide necessary resources • Establish measurement methods for each process • Apply measurements to check effectiveness and efficiency • Determine means of preventing nonconformances and elimination of their causes • Establish and apply a process for continual improvement Do Check Act

  43. 5 Management Responsibility Business Strategy • Planning considerations; • Objectives for the strategy • QMS processes required • Resources required • Measurement and analysis • Improvement opportunities Plan Act Do Check Leadership!

  44. 5 Management Responsibility • The “Shall plan” requirements found in clauses; • 5.4.2 Quality Management System Planning • 7.1.1 Planning of Product Realization • 7.3.1 Design and Development Planning • 8.1 Plan for Measurement and Monitoring Activities • 8.5.1 Planning for Continual Improvement

  45. 5 Management Responsibility • Considering the planning requirements, then what are plans? • Quality manual, quality objectives, procedures, work instructions, and information documents contain the output of most planning requirements. • Project specific examples; • Design project plans • Continuous improvement projects • Corrective and preventive actions • Employee work plans (e.g. MBO)

  46. 5 Management Responsibility • 5.5 Responsibility, authority and communication • 5.5.1 Responsibility and authority • Top management shall ensure that responsibilities and authorities are defined and communicated within the organization.

  47. 5 Management Responsibility • 5.5 Responsibility, authority and communication • 5.5.2 Management representative • Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes; • Ensuring that processes needed for the quality management system are established, implemented and maintained; • Reporting to top management on the performance of the quality management system and need for improvement, and • Ensuring the promotion of awareness of customer requirements throughout the organization

  48. 5 Management Responsibility 5.5 Responsibility, authority and communication 5.5.3 Internal communication • Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system.

  49. 5 Management Responsibility • 5.6 Management review • 5.6.1 General • Top management shall review the organization’s quality management system, at planned intervals to ensure it’s continuing suitability, adequacy and effectiveness. • This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. • Records from management reviews shall be maintained (see 4.2.4)

  50. 5 Management Responsibility • 5.6 Management review • 5.6.2 Review input • The input to management review shall include; • Results of audits • Customer feedback • Process performance and product conformity • Status of preventive and corrective actions • Follow-up action from previous management reviews • Changes that could affect the quality management system • Recommendations for improvement