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Quality Management System Implementation
Omnex Introduction <ul><li>Consulting and Client Site Training in Quality and Management Systems Development and Implement...
Omnex Introduction <ul><li>Capabilities </li></ul><ul><ul><li>Recognized Worldwide Experts in ISO 9000 & 14000, QS-9000 an...
Omnex Approach
Omnex Approach <ul><li>Conduct Discovery Analysis and Develop Plan </li></ul><ul><li>Establish Cross Functional Team & Obj...
Strategic Value of Omnex Approach <ul><li>Easy to Implement </li></ul><ul><li>Easy to Understand and Use </li></ul><ul><li...
Conduct Discovery Analysis <ul><ul><li>Understand existing systems </li></ul></ul><ul><ul><li>Understand existing processe...
Need for Cross Functional Team, Objectives, Process Definition
Quality Management System Strategy
ISO 9001:2000 <ul><li>Defines a business using a Process Model  </li></ul><ul><li>Requirements organized in five categorie...
ISO 9001:2000 Process Model Product realization Input Product/ Service (and/or service) Requirements Resource management M...
New Requirements in ISO 9001:2000 <ul><li>Voice of the Customer-Expectations & Requirments </li></ul><ul><li>Quantifiable ...
ISO 9001:2000 Business Plan
Understand Primary Business Processes <ul><li>Product and Service Realization </li></ul><ul><ul><li>Marketing </li></ul></...
Utilize Flow Charts for Documentation
Define Key Business Process Controls <ul><li>Identify Performance Characteristics (Values) </li></ul><ul><li>Conduct a Bus...
Employ Dynamic Process Control
Implementation Process
Organizing for ISO 9000 Implementation <ul><li>Management Team </li></ul><ul><ul><li>Develops Operating System in Manageme...
Implementation Structure Example
Implementation Steps <ul><li>Conduct Discovery Analysis </li></ul><ul><li>Develop Implementation Plan </li></ul><ul><ul><l...
Implementation Steps <ul><li>Form Key Process Teams </li></ul><ul><li>Train teams in methodologies for business processes ...
Implementation Steps <ul><li>Train Internal Audit Teams </li></ul><ul><li>Establish Management Review Process </li></ul><u...
Effective Management Review Process <ul><li>Meet Regularly </li></ul><ul><li>Maintain Discipline </li></ul><ul><li>Drive S...
Benefits of Omnex Approach <ul><li>Defined and Shared Responsibilities  </li></ul><ul><li>Documents Your Business Processe...
Typical Obstacles and Solutions <ul><li>Lack of Management Commitment </li></ul><ul><li>No Defined Plan </li></ul><ul><li>...
Need for Top Management Commitment <ul><li>If top management is not involved: </li></ul><ul><ul><li>There will be document...
Role of Omnex Consultants <ul><li>Provide Objective Voice </li></ul><ul><li>Contribute Technical Expertise </li></ul><ul><...
Global Presence & Alliances <ul><li>Omnex, Inc. </li></ul><ul><ul><li>Training Development & Publishing </li></ul></ul><ul...
Recent Domestic Clients <ul><li>Corrigan Moving Systems </li></ul><ul><li>Defiance Engineering & Testing </li></ul><ul><li...
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  1. 1. Quality Management System Implementation
  2. 2. Omnex Introduction <ul><li>Consulting and Client Site Training in Quality and Management Systems Development and Implementation: </li></ul><ul><ul><ul><li>ISO 9001:2000 Quality Management systems </li></ul></ul></ul><ul><ul><ul><li>ISO/QS 9000; ISO/TS 16949 (Automotive) </li></ul></ul></ul><ul><ul><ul><li>ISO 14000 Environmental Management Systems </li></ul></ul></ul><ul><ul><ul><li>QOS/BOS/Balanced Scorecard </li></ul></ul></ul><ul><ul><ul><li>Product and Service Development and Introduction </li></ul></ul></ul><ul><ul><ul><li>Business Process Re-Engineering </li></ul></ul></ul><ul><ul><ul><li>Productivity & Performance Enhancement </li></ul></ul></ul><ul><ul><ul><li>IT Systems/Business Process Integration </li></ul></ul></ul>
  3. 3. Omnex Introduction <ul><li>Capabilities </li></ul><ul><ul><li>Recognized Worldwide Experts in ISO 9000 & 14000, QS-9000 and QOS </li></ul></ul><ul><ul><li>Effective Strategic Business Approach to Implementations </li></ul></ul><ul><ul><li>Specialized Client Site Training </li></ul></ul><ul><ul><li>Performance Improvement systems and methodologies </li></ul></ul><ul><ul><li>International Resources with Multi-language and Global Service Delivery Capabilities </li></ul></ul><ul><li>Bias Toward Action </li></ul>
  4. 4. Omnex Approach
  5. 5. Omnex Approach <ul><li>Conduct Discovery Analysis and Develop Plan </li></ul><ul><li>Establish Cross Functional Team & Objectives </li></ul><ul><li>Assist in Selecting Registrar, Plan Registration Process </li></ul><ul><li>Create an Operating System </li></ul><ul><li>Define and Document Key Business Processes </li></ul><ul><li>Define and Document Key Business Process Controls </li></ul><ul><li>Establish Effective Data Management </li></ul><ul><li>Initiate Effective Management Review </li></ul><ul><li>Drive Continuous Improvement </li></ul>
  6. 6. Strategic Value of Omnex Approach <ul><li>Easy to Implement </li></ul><ul><li>Easy to Understand and Use </li></ul><ul><li>Easy to Maintain </li></ul><ul><li>Maximize Value, Minimize Paperwork </li></ul><ul><li>Supports Analysis for Continuous Improvement </li></ul>
  7. 7. Conduct Discovery Analysis <ul><ul><li>Understand existing systems </li></ul></ul><ul><ul><li>Understand existing processes and activities </li></ul></ul><ul><ul><li>Understand functional organizational structure </li></ul></ul><ul><ul><li>Map to system objectives </li></ul></ul><ul><ul><li>Align with current system and ISO 9001:2000 </li></ul></ul><ul><li>Develop Implementation Plan </li></ul>
  8. 8. Need for Cross Functional Team, Objectives, Process Definition
  9. 9. Quality Management System Strategy
  10. 10. ISO 9001:2000 <ul><li>Defines a business using a Process Model </li></ul><ul><li>Requirements organized in five categories </li></ul><ul><ul><li>Quality Management System Requirements </li></ul></ul><ul><ul><li>Management Responsibility </li></ul></ul><ul><ul><li>Resource Management </li></ul></ul><ul><ul><li>Process Management </li></ul></ul><ul><ul><li>Measurement, Analysis and Improvement </li></ul></ul><ul><li>Changes </li></ul><ul><ul><li>More business-based terminology and process model </li></ul></ul><ul><ul><li>Definition of “Quality”: Requirements focus on “Customer Satisfaction,” not “conformance to specification” </li></ul></ul><ul><ul><li>Formally mandates continuous improvement </li></ul></ul><ul><ul><li>Expanded emphasis on management responsibility and resource assurance </li></ul></ul>
  11. 11. ISO 9001:2000 Process Model Product realization Input Product/ Service (and/or service) Requirements Resource management Measurement, analysis, improvement Management responsibility Customer Customer Satisfaction QUALITY MANAGEMENT SYSTEM CONTINUAL IMPROVEMENT Output Quality Management System
  12. 12. New Requirements in ISO 9001:2000 <ul><li>Voice of the Customer-Expectations & Requirments </li></ul><ul><li>Quantifiable Objectives </li></ul><ul><li>Internal Communications </li></ul><ul><li>Infrastructure </li></ul><ul><li>Work Environment </li></ul><ul><li>Customer Communications </li></ul><ul><li>Measurement and Monitoring </li></ul><ul><li>Customer Satisfaction </li></ul><ul><li>Continual Improvement </li></ul>
  13. 13. ISO 9001:2000 Business Plan
  14. 14. Understand Primary Business Processes <ul><li>Product and Service Realization </li></ul><ul><ul><li>Marketing </li></ul></ul><ul><ul><li>Sales </li></ul></ul><ul><ul><li>Purchasing </li></ul></ul><ul><ul><li>Design </li></ul></ul><ul><ul><li>Production/Distribution </li></ul></ul><ul><ul><li>Delivery </li></ul></ul><ul><li>Planning </li></ul><ul><ul><li>Quality Planning </li></ul></ul><ul><ul><li>Analysis of Data </li></ul></ul><ul><ul><li>Improvement </li></ul></ul><ul><li>Management </li></ul><ul><ul><li>Strategic Planning </li></ul></ul><ul><ul><li>Resource Planning </li></ul></ul><ul><ul><li>Performance Monitoring </li></ul></ul><ul><li>Measurement(Accounting) </li></ul><ul><ul><li>Documentation </li></ul></ul><ul><ul><li>Analysis </li></ul></ul><ul><ul><li>Maintain Records </li></ul></ul><ul><li>Human Resources </li></ul><ul><ul><li>Staffing </li></ul></ul><ul><ul><li>Training </li></ul></ul>
  15. 15. Utilize Flow Charts for Documentation
  16. 16. Define Key Business Process Controls <ul><li>Identify Performance Characteristics (Values) </li></ul><ul><li>Conduct a Business Process Analysis (FMEA) </li></ul><ul><li>Develop an Improvement Plan </li></ul><ul><li>Implement a Control Plan </li></ul><ul><li>Generate Data for Continuous Improvement </li></ul>
  17. 17. Employ Dynamic Process Control
  18. 18. Implementation Process
  19. 19. Organizing for ISO 9000 Implementation <ul><li>Management Team </li></ul><ul><ul><li>Develops Operating System in Management Responsibility </li></ul></ul><ul><ul><li>Develops & Deploys Policy and Objectives </li></ul></ul><ul><ul><li>Conducts Management Review </li></ul></ul><ul><li>Steering Committee </li></ul><ul><ul><li>Lead by Management Representative </li></ul></ul><ul><ul><li>Cross functional </li></ul></ul><ul><ul><li>Appoint by virtue of authority, position and expertise </li></ul></ul><ul><ul><li>Champions for process teams </li></ul></ul><ul><li>Process Teams </li></ul><ul><ul><li>Cross functional </li></ul></ul><ul><ul><li>Subject matter & process experts </li></ul></ul><ul><ul><li>Develop all documentation </li></ul></ul>
  20. 20. Implementation Structure Example
  21. 21. Implementation Steps <ul><li>Conduct Discovery Analysis </li></ul><ul><li>Develop Implementation Plan </li></ul><ul><ul><li>Timing </li></ul></ul><ul><ul><li>Roles and Responsibilities </li></ul></ul><ul><ul><li>Status Assessment & Program Management </li></ul></ul><ul><ul><li>Identify key indicators for improvement </li></ul></ul><ul><li>Form Steering Committee(s) </li></ul><ul><li>Train and Orient Committee(s) </li></ul><ul><li>Select & Orient Registrar </li></ul>
  22. 22. Implementation Steps <ul><li>Form Key Process Teams </li></ul><ul><li>Train teams in methodologies for business processes </li></ul><ul><li>Implement Approaches and methodologies </li></ul><ul><li>Map and Document Key Processes </li></ul><ul><li>Form Process Level Teams </li></ul><ul><li>Map and Document Processes and Activities </li></ul><ul><li>Develop Level III Documentation </li></ul><ul><li>Implement Procedures, Work & Process Instructions </li></ul>
  23. 23. Implementation Steps <ul><li>Train Internal Audit Teams </li></ul><ul><li>Establish Management Review Process </li></ul><ul><li>Conduct Internal Audits concurrently with Implementation Process </li></ul><ul><li>Establish Corrective & Preventive Action </li></ul><ul><li>Conduct Pre-Audit Finishing Process </li></ul><ul><li>Registration Audit </li></ul>
  24. 24. Effective Management Review Process <ul><li>Meet Regularly </li></ul><ul><li>Maintain Discipline </li></ul><ul><li>Drive System Implementation Process </li></ul><ul><li>Focus on Strategically Critical Continuous Improvement </li></ul><ul><li>Utilize Data </li></ul><ul><ul><li>Achieve and Maintain Shared Level of Understanding </li></ul></ul><ul><ul><li>Support Effective Decision Making </li></ul></ul><ul><li>Take Action </li></ul>
  25. 25. Benefits of Omnex Approach <ul><li>Defined and Shared Responsibilities </li></ul><ul><li>Documents Your Business Processes </li></ul><ul><li>Easier to Implement and Maintain </li></ul><ul><li>Drives Performance Improvement </li></ul><ul><li>Focuses on Value </li></ul><ul><li>Relevant and Sustainable </li></ul>
  26. 26. Typical Obstacles and Solutions <ul><li>Lack of Management Commitment </li></ul><ul><li>No Defined Plan </li></ul><ul><li>NVA Documentation/ Frequent Rewrites </li></ul><ul><li>Lack of Understanding of Requirements </li></ul><ul><li>Organization by Elements </li></ul><ul><li>Address Early with Defined Objectives (Relevance) </li></ul><ul><li>Plan Your Work, Work Your Plan </li></ul><ul><li>Facilitate Documentation </li></ul><ul><li>Training </li></ul><ul><li>Organization by Key Processes & Activities </li></ul>
  27. 27. Need for Top Management Commitment <ul><li>If top management is not involved: </li></ul><ul><ul><li>There will be documents which do not reflect actual practices </li></ul></ul><ul><ul><li>Managers will give only “lip service” to policy and its implementation—system will lack relevance </li></ul></ul><ul><ul><li>ISO will be seen as a “paperwork monster” (generating enormous costs without benefit) that lessens value </li></ul></ul><ul><ul><li>There will be a lack of clear, quantifiable improvement </li></ul></ul>
  28. 28. Role of Omnex Consultants <ul><li>Provide Objective Voice </li></ul><ul><li>Contribute Technical Expertise </li></ul><ul><li>Maintain Focus and Discipline </li></ul><ul><li>Expand the Vision of the Organization </li></ul><ul><li>Provide Perspective from Other Successful Efforts </li></ul><ul><li>Analyze and Identify Opportunities with Credibility </li></ul><ul><li>Provide Disciplined Program Management </li></ul><ul><li>Provide Dedicated Resources </li></ul>
  29. 29. Global Presence & Alliances <ul><li>Omnex, Inc. </li></ul><ul><ul><li>Training Development & Publishing </li></ul></ul><ul><ul><li>Software Development </li></ul></ul><ul><ul><ul><li>AQuA ® </li></ul></ul></ul><ul><ul><ul><li>BOSs ® </li></ul></ul></ul><ul><li>AQSR, International </li></ul><ul><li>International Offices </li></ul><ul><ul><li>Brazil </li></ul></ul><ul><ul><li>Canada </li></ul></ul><ul><ul><li>Germany (J-V) </li></ul></ul><ul><ul><li>Mexico </li></ul></ul><ul><ul><li>India </li></ul></ul><ul><ul><li>Peoples Republic of China </li></ul></ul><ul><ul><li>Taiwan </li></ul></ul><ul><ul><li>Thailand </li></ul></ul><ul><ul><li>Venezuela </li></ul></ul>
  30. 30. Recent Domestic Clients <ul><li>Corrigan Moving Systems </li></ul><ul><li>Defiance Engineering & Testing </li></ul><ul><li>Delphi Automotive </li></ul><ul><li>EASi-Meg Engineering </li></ul><ul><li>Engineering Technology </li></ul><ul><li>Ford Customer Service Division </li></ul><ul><li>Ford Human Resources Service Center </li></ul><ul><li>Ford Warranty Specialists </li></ul><ul><li>General Motors Information Systems and Services </li></ul><ul><li>Giffels Arch. & Engr. </li></ul><ul><li>Hendrickson International </li></ul><ul><li>Lucent Technologies </li></ul><ul><li>Mobil Oil </li></ul><ul><li>Petro Canada </li></ul><ul><li>Siebe Automotive NA </li></ul><ul><li>Teleflex </li></ul><ul><li>Visteon </li></ul>

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