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  • A QUALITY MANAGEMENT SYSTEM The Structure for Implementing World Class Quality Management Principles
  • Cairo Iso 2000

    1. 1. ISO 9000:2000
    2. 2. ISO 9000:1994 Specified Quality System Requirements Twenty Quality System Elements 1. Management Responsibility 2. Quality System 3. Contract Review 4. Design Control 5. Document & Data Control 6. Purchasing 7. Control Of Customer Supplied Product 8. Product Identification & Traceability 9. Process Control 10. Inspection & Testing 11. Control Of Inspection, Measuring, & Test Equipment 12. Inspection And Test Status 13. Control Of Nonconforming Product 14. Corrective And Preventive Action 15. Handling, Storage, Packaging, Preservation, & Delivery 16. Control Of Quality Records 17. Internal Quality Audits 18. Training 19. Servicing 20. Statistical Techniques ISO 9001 - All 20 Elements; ISO 9002 - No Design Control; ISO 9003 - No Design Control, Purchasing, Process Control Or Servicing
    3. 3. ISO 9001: 2000 Specified Quality System Requirements A Process Approach - Four Specific Areas <ul><li>Management Responsibility </li></ul><ul><li>Resource Management </li></ul><ul><li>Product Realization </li></ul><ul><li>Measurement Analysis, Improvement </li></ul>All ISO 9000:1994 Requirements Addressed New: Continual Improvement Customer Satisfaction Customer Requirements
    4. 4. THE EIGHT QUALITY MANAGEMENT PRINCIPLES <ul><li>Customer Focus </li></ul><ul><li>Leadership </li></ul><ul><li>Involvement Of People </li></ul><ul><li>Process Approach </li></ul><ul><li>System Approach To </li></ul><ul><li>Management </li></ul><ul><li>Continual Improvement </li></ul><ul><li>Factual Approach To Decision </li></ul><ul><li>Making </li></ul><ul><li>Mutually Beneficial Supplier </li></ul><ul><li>Relationships </li></ul>
    5. 5. THE PROCESS MODEL IS THE BASIS FOR THE STANDARD Continual Improvement Of The Quality Management System Management Responsibility Resource Management Product Realization Measurement Analysis, Improvement Customer Customer Satisfaction Requirements Product Value Added Activities Information Flow
    6. 6. QUALITY MANAGEMENT SYSTEM
    7. 7. GENERAL REQUIREMENTS (Paragraph 4.1) <ul><li>Identify Processes </li></ul><ul><li>Determine Sequence & Interaction </li></ul><ul><li>Determine Criteria & Methods </li></ul><ul><li>Resources & Information </li></ul><ul><li>Monitor, Measure, & Analyze </li></ul><ul><li>Implement Actions </li></ul><ul><li>Continual Improvement </li></ul>
    8. 8. DOCUMENTATION REQUIREMENTS (Paragraph 4.2) Quality Policy & Objectives Quality Manual Documented Procedures Essential Documents Quality Records
    9. 9. THE QUALITY MANUAL Scope Justification For Exclusions Documented Procedures Or Reference Describe Interactions
    10. 10. DOCUMENTATION REQUIREMENTS <ul><li>A Procedure To: </li></ul><ul><li>Approve Documents </li></ul><ul><li>Review, Update, And Re-Approve </li></ul><ul><li>Identify Changes & Revision Status </li></ul><ul><li>Relevant Versions Available </li></ul><ul><li>Legible And Identifiable </li></ul><ul><li>External Origin Controlled </li></ul><ul><li>Unintended Use Of Obsolete Documents </li></ul><ul><li>Identify Retained Obsolete Documents </li></ul>
    11. 11. CONTROL OF QUALITY RECORDS <ul><li>Evidence Of Conformity And Effectiveness </li></ul><ul><li>Legible, Readily Identifiable And Retrievable </li></ul><ul><li>A Documented Procedure </li></ul><ul><li>Identification </li></ul><ul><li>Legibility </li></ul><ul><li>Storage </li></ul><ul><li>Retrieval </li></ul><ul><li>Protection </li></ul><ul><li>Retention Time </li></ul><ul><li>Disposition </li></ul>
    12. 12. MANAGEMENT RESPONSIBILITY
    13. 13. MANAGEMENT RESPONSIBILITY Paragraph 5.1 - Management Commitment Evidence Of Commitment Communication Establish Quality Policy Establish Quality Objectives Management Reviews Available Resources
    14. 14. MANAGEMENT RESPONSIBILITY Paragraph 5.2 - Customer Focus <ul><li>Customer Needs And Expectations </li></ul><ul><li>Determined </li></ul><ul><li>Fulfilled </li></ul>The Aim Is To Achieve Customer Satisfaction
    15. 15. MANAGEMENT RESPONSIBILITY Paragraph 5.3 - Quality Policy <ul><li>Appropriate </li></ul><ul><li>Commitment To Meet Requirements </li></ul><ul><li>Continual Improvement </li></ul><ul><li>Framework For Establishing & Reviewing </li></ul><ul><li>Quality Objectives </li></ul><ul><li>Communicated & Understood </li></ul><ul><li>Reviewed For Continuing Suitability </li></ul>
    16. 16. PLANNING Paragraph 5.4.1 - Quality Objectives <ul><li>Quality Objectives </li></ul><ul><li>Relevant Functions & Levels </li></ul><ul><li>Measurable and Consistent </li></ul><ul><li>QMS Planning </li></ul><ul><li>Meet Requirements & Objectives </li></ul><ul><li>Maintain QMS Integrity </li></ul>
    17. 17. RESPONSIBILITY, AUTHORITY AND COMMUNICATION (Paragraph 5.5) <ul><li>Responsibilites, Authorities & Interrlationships </li></ul><ul><li>Are Defined & Communicated </li></ul><ul><li>Appoint A Management Representative </li></ul><ul><li>Ensure Processes Needed Are Established </li></ul><ul><li>Report On Performance Of QMS </li></ul><ul><li>Ensures Promotion Of Awareness </li></ul><ul><li>Appropriate Communication Processes </li></ul><ul><li>Within Organization </li></ul><ul><li>Effectiveness Of The QMS </li></ul>
    18. 18. MANAGEMENT REVIEW Paragraph 5.6 - General <ul><li>At Planned Intervals </li></ul><ul><li>Must Include </li></ul><ul><li>Evaluate Need For QMS Improvement </li></ul><ul><li>Evaluate Need For QMS Changes </li></ul><ul><li>Records Must Be Maintained </li></ul>
    19. 19. MANAGEMENT REVIEW INPUTS & OUTPUTS <ul><li>Inputs Include </li></ul><ul><li>Audit Results </li></ul><ul><li>Customer Feedback </li></ul><ul><li>Process Performance </li></ul><ul><li>Corrective & Preventive Action Status </li></ul><ul><li>Follow-up Of Previous Actions </li></ul><ul><li>Recommendations </li></ul><ul><li>Output </li></ul><ul><li>Improvement Of The QMS </li></ul><ul><li>Product Improvement </li></ul><ul><li>Resource Needs </li></ul>
    20. 20. RESOURCE MANAGEMENT
    21. 21. PROVISION OF RESOURCES (Paragraph 6.1) The Organization Must Determine & Provide Resources Needed: To Implement & Maintain The QMS To Continually Improve Effectiveness To Address Customer Satisfaction
    22. 22. HUMAN RESOURCES Paragraph 6.2.1 - General <ul><li>Competent Personnel </li></ul><ul><li>Education </li></ul><ul><li>Skills </li></ul><ul><li>Experience </li></ul>
    23. 23. RESOURCE MANAGEMENT Paragraph 6.2.2 Competence, Awareness & Training <ul><li>Identify Competency Needs </li></ul><ul><li>Provide Training </li></ul><ul><li>Evaluate Effectiveness </li></ul><ul><li>Personnel Know Relevance & Importance </li></ul><ul><li>Personnel Know Contribution </li></ul><ul><li>Maintain Records </li></ul>
    24. 24. RESOURCE MANAGEMENT Paragraph 6.3 - Infrastructure <ul><li>To Achieve Conformity </li></ul><ul><li>Identify, </li></ul><ul><li>Provide </li></ul><ul><li>Maintain </li></ul><ul><li>For Example: </li></ul><ul><li>Buildings, Workspace & Utilities </li></ul><ul><li>Process Equipment </li></ul><ul><li>Supporting Services </li></ul>
    25. 25. Determine & Manage Conditions Achieve Conformity To Requirements RESOURCE MANAGEMENT Paragraph 6.4 - Work Environment
    26. 26. PRODUCT REALIZATION
    27. 27. PRODUCT REALIZATION Paragraph 7.1- Planning of Product Realization <ul><li>Plan & Develop Consistent Processes </li></ul><ul><li>Plan As Appropriate </li></ul><ul><li>Product Quality Objectives & Requirements </li></ul><ul><li>Product Specific Processes, Documentation & Resources </li></ul><ul><li>Verification And Validation Monitoring </li></ul><ul><li>Records </li></ul><ul><li>Output Must Be Suitable </li></ul>
    28. 28. CUSTOMER-RELATED PROCESSES Paragraph 7.2.1 Determination of Requirements Related to The Product <ul><li>Customer Requirements Specified </li></ul><ul><li>Requirements Not Specified By Customer </li></ul><ul><li>Statutory & Regulatory Requirements </li></ul><ul><li>Additional Requirements </li></ul>
    29. 29. CUSTOMER-RELATED PROCESSES Paragraph 7.2.2 -Review Of Product Requirements <ul><li>Prior To Commitment </li></ul><ul><li>Requirements Defined </li></ul><ul><li>Differences Must Be Resolved </li></ul><ul><li>Ability To Meet Requirements </li></ul><ul><li>Records Maintained </li></ul><ul><li>Requirements Confirmed </li></ul><ul><li>Changes - Amendments, & Personnel Advised </li></ul>
    30. 30. CUSTOMER-RELATED PROCESSES Paragraph 7.2.3 - Customer Communication <ul><li>Product Information </li></ul><ul><li>Inquiries, Contracts Or Order </li></ul><ul><li>Handling (Including Amendments) </li></ul><ul><li>Customer Feedback </li></ul>
    31. 31. DESIGN AND DEVELOPMENT Paragraph 7.3.1 - Design &/or Devlopment Planning <ul><li>Plan & Control </li></ul><ul><li>Stages Of Design Process </li></ul><ul><li>Review Of Each Stage </li></ul><ul><li>Verification & Validation - Each Stage </li></ul><ul><li>Responsibilities & Authorities </li></ul><ul><li>Interfaces Must Be Managed </li></ul><ul><li>Output Must Be Updated </li></ul>
    32. 32. DESIGN AND DEVELOPMENT Paragraph 7.3.2 - Design &Development Inputs <ul><li>Must Be Defined & Records Maintained </li></ul><ul><li>Function & Performance </li></ul><ul><li>Statutory & Regulatory </li></ul><ul><li>Previous Designs </li></ul><ul><li>Any Other Requirements </li></ul><ul><li>Reviewed For Adequacy </li></ul><ul><li>Complete , Unambiguous & </li></ul><ul><li>Not In Conflict </li></ul>
    33. 33. DESIGN AND DEVELOPMENT Paragraph 7.3.3 - Design & Development Outputs Enables Verification Against Inputs Approved Prior To Release Meet Input Requirements Provide Appropriate Information Product Acceptance Criteria Essential Product Characteristics
    34. 34. DESIGN AND DEVELOPMENT Paragraph 7.3.4 - Design & Development Review <ul><li>At Suitable Stages </li></ul><ul><li>Systematic Review </li></ul><ul><li>Evaluate Ability To Fulfill Requirements </li></ul><ul><li>Identify Problems </li></ul><ul><li>Include Representatives Of Functions Concerned </li></ul><ul><li>Record Results And Necessary Actions </li></ul>
    35. 35. DESIGN AND DEVELOPMENT Paragraph 7.3.5 - Design & Development Verification Output Meets Input Requirements Record Results And Follow-up Actions
    36. 36. DESIGN AND DEVELOPMENT Paragraph 7.3.6 - Design & Development Validation Confirm Product Is Capable If Practical - Prior To Delivery Or Implementation Record Results And Necessary Actions
    37. 37. DESIGN AND DEVELOPMENT Paragraph 7.3.7 Control of Design & Development Changes Changes Identified & Records Maintained Must Be Reviewed, Verified & Validated As Appropriate Approved Prior To Implementation Include Evaluation Of Effect Record Results Of Review & Necessary Actions
    38. 38. PURCHASING Paragraph 7.4.1: The Purchasing Process <ul><li>Conforms To Requirements </li></ul><ul><li>Control Dependent Upon Effect On Processes & Product </li></ul><ul><li>Evaluate & Select Suppliers - Ability To Supply Product </li></ul><ul><li>Define Criteria - Selection , Evaluation & Re-evaluation </li></ul><ul><li>Record Results Of Evaluations & Resultant Actions </li></ul>
    39. 39. PURCHASING Paragraph 7.4.2: Purchasing Information <ul><li>Describe Product To Be Purchased </li></ul><ul><li>Requirements For Approval </li></ul><ul><li>Personnel Qualification Requirements </li></ul><ul><li>Quality Management Requirements </li></ul><ul><li>Ensure Adequacy Of Requirements Prior </li></ul><ul><li>To Communication To Supplier </li></ul>
    40. 40. PURCHASING Paragraph 7.4.3 Verification of Purchased Product <ul><li>Ensure Purchased Product Meets </li></ul><ul><li>Specified Purchase Requirements </li></ul><ul><li>Verification On Supplier’s Premises? </li></ul><ul><li>State Requirements </li></ul><ul><li>Methods Of Product Release </li></ul>
    41. 41. PRODUCTION & SERVICE PROVISION Paragraph 7.5.1 - Control of Production & Service Controlled Conditions <ul><li>Availability Of Info </li></ul><ul><li>Work Instructions </li></ul><ul><li>Suitable Equipment </li></ul><ul><li>Measuring & Monitoring Devices </li></ul><ul><li>Monitoring & Measurement Implementation </li></ul><ul><li>Release, Delivery & Post Delivery Activities </li></ul>
    42. 42. PRODUCTION & SERVICE PROVISION Paragraph 7.5.2 Validation Of Processes For Production And Service <ul><li>Output Not Verified </li></ul><ul><li>Deficiencies Apparent Later </li></ul><ul><li>Demonstrate Ability </li></ul><ul><li>Establish Arrangements (As Appropriate) </li></ul><ul><li>Defined Criteria </li></ul><ul><li>Approval Of Equipment & Personnel </li></ul><ul><li>Use Of Specific Methods & Procedures </li></ul><ul><li>Requirements For Records </li></ul>
    43. 43. PRODUCTION & SERVICE PROVISION Paragraph 7.5.3 - Identification & Traceability <ul><li>Identify by Suitable Means </li></ul><ul><li>Product Status - Monitoring & </li></ul><ul><li>Measurement Requirements </li></ul><ul><li>Traceability Requirement </li></ul><ul><li>Control </li></ul><ul><li>Record Unique Identification </li></ul>
    44. 44. PRODUCTION & SERVICE PROVISION Paragraph 7.5.4 Customer Property <ul><li>Exercise Care </li></ul><ul><li>Identify, Verify, Protect & Safeguard </li></ul><ul><li>Record & Report </li></ul><ul><li>Lost, </li></ul><ul><li>Damaged </li></ul><ul><li>Unsuitable Property </li></ul>
    45. 45. PRODUCTION & SERVICE PROVISION Paragraph 7.5.4 Preservation Of Product Preserve Conformity Identification, Handling, Packaging Storage & Protection Preservation - Product Components
    46. 46. PRODUCTION & SERVICE PROVISION Control of Measuring & Monitoring Devices <ul><li>Identify Devices </li></ul><ul><li>Establish Processes </li></ul><ul><li>Ensure Measurement Capability </li></ul><ul><li>Where Applicable </li></ul><ul><li>Calibrated or Verified </li></ul><ul><li>Adjusted Where & When Necessary </li></ul><ul><li>Identify Calibration Status </li></ul><ul><li>Safeguard </li></ul><ul><li>Protected From Damage </li></ul><ul><li>Out of Calibration -Validate Previous Results </li></ul><ul><li>Maintain Records </li></ul><ul><li>Validate Software </li></ul>
    47. 47. MEASUREMENT, ANALYSIS AND IMPROVEMENT
    48. 48. MEASUREMENT ANALYSIS & IMPROVEMENT Paragraph 8.1 General <ul><li>Plan And Implement </li></ul><ul><li>Demonstrate Conformity </li></ul><ul><li>Ensure Conformity Of QMS </li></ul><ul><li>Continually Improve QMS Effectiveness </li></ul><ul><li>Determination Of Applicable Methods </li></ul>
    49. 49. MONITORING AND MEASUREMENT Paragraph 8.2.1 Customer Satisfaction Monitor Customer Perceptions Measurement of These Perceptions - Effectiveness Of QMS Methods of Obtaining & Using Must Be Determined
    50. 50. MONITORING AND MEASUREMENT Paragraph 8.2.2 Internal Audit <ul><li>Planned Intervals </li></ul><ul><li>Conformity to Plans </li></ul><ul><li>Conformity to Requirements </li></ul><ul><li>Implemented and Maintained </li></ul><ul><li>Processes Status & Importance </li></ul><ul><li>Define Criteria , Scope & Frequency </li></ul><ul><li>Objectivity & Impartiality </li></ul><ul><li>Documented Procedure </li></ul><ul><li>Actions Taken Without Delay </li></ul><ul><li>Follow-up Include Corrective Action Verification </li></ul>
    51. 51. MONITORING AND MEASUREMENT Paragraph 8.2.3 Monitoring & Measurement of Processes Apply Suitable Methods For Monitoring & Measurement Of QMS Process Confirm Ability Of Processes - Planned Results Results Not Achieved - Corrective Action Must Be Taken
    52. 52. MONITORING AND MEASUREMENT Paragraph 8.2.4 Monitoring & Measurement of Product Monitor & Measure Characteristics Of Product Taken At Appropriate Stages Evidence Of Conformity Records - Authority Responsible For Release No Product Release & Service Until All Activities Completed
    53. 53. CONTROL OF NONCONFORMING PRODUCT (Paragraph 8.3) <ul><li>Identify & Control </li></ul><ul><li>Documented Procedure </li></ul><ul><li>Control </li></ul><ul><li>Responsibilities & Authorities </li></ul><ul><li>Deal With nonconforming Product </li></ul><ul><li>Take Actions </li></ul><ul><li>Authorize Use, Release or Acceptance </li></ul><ul><li>Preclude Original Use </li></ul><ul><li>Records Maintained </li></ul><ul><li>Reverification </li></ul><ul><li>After Delivery - Take Appropriate Action </li></ul>
    54. 54. ANALYSIS OF DATA (Paragraph 8.4) <ul><li>Collect & Analyze </li></ul><ul><li>Demonstrate QMS Suitability & Effectiveness </li></ul><ul><li>Continual Improvement Indications </li></ul><ul><li>Measuring & Monitoring Activities </li></ul><ul><li>& Other Sources </li></ul><ul><li>Provide Information On </li></ul><ul><li>Customer Satisfaction </li></ul><ul><li>Conformance To Requirements </li></ul><ul><li>Characteristics & Trends Of Products & Processes </li></ul><ul><li>Opportunities For Preventive Action </li></ul><ul><li>Suppliers </li></ul>
    55. 55. IMPROVEMENT Paragraph 8.5.1 Continual Improvement <ul><li>Continually Improve Effectiveness Of QMS </li></ul><ul><li>Quality Policy </li></ul><ul><li>Objectives </li></ul><ul><li>Audit Results </li></ul><ul><li>Analysis Of Data </li></ul><ul><li>Corrective & Preventive Action </li></ul><ul><li>Management Review </li></ul>
    56. 56. IMPROVEMENT Paragraph 8.5.2 Corrective Action <ul><li>Eliminate Cause </li></ul><ul><li>Prevent Recurrence </li></ul><ul><li>Appropriate </li></ul><ul><li>Documented Procedure </li></ul><ul><li>Identifying Non-conformances </li></ul><ul><li>Determining Causes </li></ul><ul><li>Evaluating Need For Preventive Actions </li></ul><ul><li>Determining & Implementing Corrective Action </li></ul><ul><li>Recording Results </li></ul><ul><li>Reviewing Corrective Action </li></ul>
    57. 57. IMPROVEMENT Paragraph 8.5.3 Preventive Action <ul><li>Identify Preventive Action to Eliminate Potential </li></ul><ul><li>Non-conformities </li></ul><ul><li>Prevent Occurrence </li></ul><ul><li>Appropriate </li></ul><ul><li>Documented Procedure </li></ul><ul><li>Identifying Potential Problems </li></ul><ul><li>Identifying Need for Action </li></ul><ul><li>Determining & Implementing Action Needed </li></ul><ul><li>Recording Results of Action Taken </li></ul><ul><li>Review of Preventive Action Taken </li></ul>
    58. 58. THE PROCESS CENTERED ENTERPRISE (or the end of the organization chart) Tight Job Definition and Narrow Focus Close Supervision Ignorance of the Big Picture Incongruent Goals Information Attenuation Lack of Ownership, Accountability, Responsibility Alienation, Boredom, Discontent Life in the Functional Organization:
    59. 59. THE PROCESS CENTERED ENTERPRISE Everyone Knows the Organization’s Processes Everyone Knows where he or she fits in Everyone Knows who’s responsible for the Processes Everyone Knows what the Customers Need Everyone Knows the Real Enemy Everyone is Measured on Processes Everyone's Head is Turned 90 Degrees Recognizing a Process Centered Organization:
    60. 60. THE PROCESS CENTERED ENTERPRISE The Process Payoff: Order Cycle - Standard Order Cycle - Premium Order Cycle - Custom Production Cycle Submittal Cycle Inventory Turns Sales 30-40 days 10-13 days 40-50 days 8-15 days 3-5 weeks 8 $108M 10 days 1-5 days 23 days <3 days 5 minutes 20 $159M Functional Process
    61. 61. THE PROCESS CENTERED ENTERPRISE Identify Processes Document and Standardize Processes Rewrite Job Descriptions Realign Measurement and Reward Systems Redefine Management/Leadership Roles Reorganize Around Processes Reshape Language, Culture, and Customs How Do We Get There?
    62. 62. THE PROCESS CENTERED ENTERPRISE <ul><li>Leader </li></ul><ul><ul><li>Creating a Common Vision </li></ul></ul><ul><ul><li>Deploying Holistic Measurement and Reward </li></ul></ul><ul><li>Process Sponsor </li></ul><ul><ul><li>Process Advocate </li></ul></ul><ul><ul><li>Process Guidance </li></ul></ul><ul><li>Process Owner </li></ul><ul><ul><li>Process Design/Redesign </li></ul></ul><ul><ul><li>Process Measurement </li></ul></ul>Roles and Responsibilities:
    63. 63. THE PROCESS CENTERED ENTERPRISE Introducing the Process Owner: “ A process owner is someone who spends their time thinking about work and processes. My job is linking tasks into one body of work and then looking at the complete process and making sure that it all works together” Charles Dunagan Process Owner Customer Order and Inquiry Fulfillment Shell Chemical Co,
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