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Barber process basedintegrating9001_14k_18k_final

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Barber process basedintegrating9001_14k_18k_final

  1. 2. Process Based Integration of ISO 9001:2000, ISO 14001, and OHSAS 18001 David Barber, General Manager Omnex Canada [email_address]
  2. 3. <ul><li> 2000 - 2004, Omnex, Inc. </li></ul><ul><li>3025 Boardwalk Suite 120 </li></ul><ul><li>Ann Arbor, MI 48108 </li></ul><ul><li>734-761-4940 </li></ul><ul><li>First Edition August 2004 </li></ul><ul><li>This publication is protected by Federal Copyright Law, with all rights reserved. No part of this publication may be reproduced, stored in a retrieval system, translated, transcribed, or transmitted, in any form, or by any means manual, electronic, electro-magnetic, mechanical, chemical, optical, or otherwise, without prior explicit written permission from Omnex, Inc. </li></ul>
  3. 4. Course Objectives <ul><li>To provide an overview of the requirements of: </li></ul><ul><ul><li>ISO9001:2000 </li></ul></ul><ul><ul><li>ISO14001:1996 </li></ul></ul><ul><ul><li>OHSAS 18001:1999 </li></ul></ul><ul><li>To provide a process-based approach to planning and implementation of an integrated Quality, Environmental and Health & Safety management system </li></ul><ul><li>Demonstrate the use of proven quality tools to enhance the integration process </li></ul>
  4. 5. Course Outline <ul><li>Rationale for Integration </li></ul><ul><li>Brief Comparison of the Standards </li></ul><ul><li>Understanding the Requirements and their Relationships </li></ul><ul><li>The Process Approach - Strategies for Integration </li></ul><ul><li>Tools Used for Integration </li></ul>
  5. 6. Integrated Management Systems A Rationale
  6. 7. Management System Principles <ul><li>Customer focused organization </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 management </li></ul><ul><li>Continual Improvement </li></ul><ul><li>Factual approach to decision making </li></ul><ul><li>Mutually beneficial supplier relationship </li></ul>
  7. 8. Management System Process Model
  8. 9. Rationale for Management Systems <ul><ul><li>ISO 9001:2000 </li></ul></ul><ul><ul><li>Customer Satisfaction & Competitive Advantage </li></ul></ul><ul><li>ISO 14001:1996 </li></ul><ul><ul><li>Eliminate or Minimize Environmental Impact </li></ul></ul><ul><li>OHSAS 18001:1999 </li></ul><ul><ul><li>Eliminate or Minimize Physical Harm or Damage </li></ul></ul>
  9. 10. Rationale for Integration <ul><li>Object of Each Standard is Reduction and Control of Variation in Processes Resulting in: </li></ul><ul><ul><li>Product Non-Conformity and Waste </li></ul></ul><ul><ul><li>Injuries, Deaths and Property Damage </li></ul></ul><ul><ul><li>Environmental Impact and/or contamination </li></ul></ul><ul><li>System approaches to Management, Improvement and Control are the Same </li></ul>
  10. 11. Benefits of Integration <ul><li>Focus </li></ul><ul><ul><li>Integration of organization’s overall goals and objectives </li></ul></ul><ul><li>Efficiency </li></ul><ul><ul><li>Integration of Management planning, realization & control processes </li></ul></ul><ul><li>Effectiveness </li></ul><ul><ul><li>Application of proven quality management tools to EMS and H&S </li></ul></ul>
  11. 12. Benefits of Integration <ul><li>Better Resource Management </li></ul><ul><ul><li>Improve Resource utilization </li></ul></ul><ul><ul><ul><li>People, Equipment, Facilities, Materials, Energy </li></ul></ul></ul><ul><ul><li>Reduce Time Required </li></ul></ul><ul><ul><ul><li>Minimal duplication of efforts </li></ul></ul></ul><ul><ul><li>Commonize Documentation </li></ul></ul><ul><ul><ul><li>Integration & Simplification of procedures and instructions </li></ul></ul></ul><ul><ul><li>Cost avoidance/savings </li></ul></ul><ul><ul><ul><li>Identification of cost reduction opportunities </li></ul></ul></ul><ul><ul><li>Employee empowerment </li></ul></ul><ul><ul><ul><li>Easier to understand, follow and use </li></ul></ul></ul>
  12. 13. Benefits of Integration <ul><li>Better Risk Management </li></ul><ul><ul><li>Reduction, Prevention and Control of </li></ul></ul><ul><ul><ul><li>Quality failures </li></ul></ul></ul><ul><ul><ul><li>Accidents, injuries, illness, deaths </li></ul></ul></ul><ul><ul><ul><li>Property & equipment damage or loss </li></ul></ul></ul><ul><ul><ul><li>Environmental incidents and accidents </li></ul></ul></ul><ul><ul><ul><li>Potential prosecution and fines </li></ul></ul></ul><ul><ul><ul><li>Damage to Public image </li></ul></ul></ul><ul><ul><ul><li>Loss of Employee morale </li></ul></ul></ul>
  13. 14. Benefits of Integration <ul><li>Competitive Edge </li></ul><ul><ul><li>International markets </li></ul></ul><ul><ul><ul><li>Level playing field </li></ul></ul></ul><ul><ul><ul><li>Customer & Industry and Governmental standards </li></ul></ul></ul><ul><ul><li>Financial Performance </li></ul></ul><ul><ul><li>Insurance opportunities </li></ul></ul><ul><ul><li>Due diligence </li></ul></ul>Reduced Costs and Improved Profitability
  14. 15. Brief Comparison of the Standards ISO 9001:2000 ISO 14001:1996 OHSAS 18001:1999
  15. 16. BMS Stakeholders <ul><li>ISO 9001:2000: Customers, Suppliers </li></ul><ul><li>EMS ISO14001: All interested parties </li></ul><ul><ul><li>Employees, Customers, Suppliers & contractors, public, regulatory authorities </li></ul></ul><ul><li>OHSAS 18001: Employees, contractors, visitors, regulatory authorities, trade/labor unions </li></ul>
  16. 17. Shared Focus ISO 9001
  17. 18. Shared Focus ISO 14001 & OHSAS 18001
  18. 19. Structure of the Three Standards <ul><li>Part of overall Business Management System (BMS) </li></ul><ul><li>All three standards, or systems follow the same management system process: </li></ul><ul><ul><li>Plan (System, Processes and Resources) </li></ul></ul><ul><ul><li>Do (Operate Processes) </li></ul></ul><ul><ul><li>Check (Monitor, Measure and Analyze) </li></ul></ul><ul><ul><li>Act (Continually Improve) </li></ul></ul>
  19. 20. Structure of Three Standards <ul><li>  </li></ul><ul><ul><li>Customer and product requirements (9001) </li></ul></ul><ul><ul><li>Environmental Aspects & Impacts (14001) </li></ul></ul><ul><ul><li>Job Hazards and Risk assessment (18001) </li></ul></ul><ul><ul><li>Continual improvement </li></ul></ul><ul><ul><li>Meet requirements (customer or legal/other) </li></ul></ul><ul><ul><li>Prevention (non-conforming product, pollution, accidents) </li></ul></ul><ul><ul><li>Reference to objectives </li></ul></ul>Planning (identify) Policy (all require)
  20. 21. Structure of Three Standards Emergency Response not directly addressed in 9001 <ul><ul><li>Management structure and resource allocation </li></ul></ul><ul><ul><li>Training and communication </li></ul></ul><ul><ul><li>Documentation and control of documents </li></ul></ul><ul><ul><li>Process & operational controls </li></ul></ul>Differences Similarities
  21. 22. Structure of Three Standards All share similar purpose and function in control, measurement & Improvement
  22. 23. Structure of Three Standards All share similar purpose and function, and in all cases inputs & outputs should be defined Focus on Actions to Improve Results
  23. 24. 3. Understanding the Requirements and their Relationships Clause by clause analysis
  24. 25. General Comments <ul><li>All three standards emphasize identification and compliance to regulatory and related requirements. </li></ul><ul><li>ISO 9001 (Clauses 6.3 & 6.4) requires the provision of ‘infrastructure’, including proper management of the ‘work environment’. </li></ul><ul><ul><li>This implies management of workplace health & safety, and control of environmental impacts. </li></ul></ul><ul><li>The scopes ISO 14001 & OHSAS 18001 overlap: </li></ul><ul><ul><li>ISO 14001 – ‘Environment’ includes Humans </li></ul></ul><ul><ul><li>OHSAS 18001 – ‘Hazard’ includes property damage & damage to workplace environment. </li></ul></ul>
  25. 26. Potential for Integration <ul><li>We will now review the requirements of ISO 9001 by clause… </li></ul><ul><li>and discuss/comment on the potential for integration of ISO14001 and OHSAS 18001 requirements within the Quality System structure. </li></ul><ul><ul><li>ISO9000:2000 requirements are in BLACK </li></ul></ul><ul><ul><li>ISO14001-96 requirements are in GREEN </li></ul></ul><ul><ul><li>OHSAS18000 requirements are in BLUE </li></ul></ul><ul><ul><ul><li>Note: The “checkmark” indicates comments regarding similarities and methods (best practices) for integration. </li></ul></ul></ul><ul><li>Note: Within the three standards various comparison tables are available. However, caution must be taken as not to fall into the cross-reference table method trap only. </li></ul>
  26. 27. ISO 9001- 4.0 Quality Management System <ul><li>Intent </li></ul><ul><ul><li>Describe the overall requirements of a QMS </li></ul></ul><ul><ul><ul><li>4.1 General Requirements </li></ul></ul></ul><ul><ul><ul><li>4.2 General Documentation Requirements </li></ul></ul></ul><ul><ul><li>Allows for some flexibility in extent of documentation </li></ul></ul>
  27. 28. ISO 9001 - 4.1 General Requirements <ul><li>ISO 9001 - 4.1 </li></ul><ul><li>Outlines the overall requirements for a QMS. The detailed requirements are contained in clauses 4.2, 5.0, 6.0, 7.0 and 8.0. </li></ul><ul><li>ISO14001 – 4.1 </li></ul><ul><li>Overall requirements for an EMS. Detailed requirements in clauses 4.2 through 4.6 </li></ul><ul><li>OHSAS 18001 – 4.1 </li></ul><ul><li>Overall requirements for an OH&HSMS. Detailed requirements in clauses 4.2 through 4.6 </li></ul>
  28. 29. ISO 9001- 4.2 Documentation Requirements ISO14001 and OHSAS 18001 do not specifically require a Manual, but all other requirements apply
  29. 30. ISO 9001 - 4.2.1 General Documentation Requirements <ul><li>Requirement for documented </li></ul><ul><ul><li>quality policy (5.3) and quality objectives (5.4.1) </li></ul></ul><ul><ul><li>A quality manual </li></ul></ul><ul><ul><li>Documented procedures </li></ul></ul><ul><ul><li>Documents needed for the effective planning, operation and control of processes </li></ul></ul><ul><ul><li>Records </li></ul></ul>
  30. 31. ISO 9001 - 4.2.2 Quality Manual <ul><li>QMS Manual to include </li></ul><ul><ul><li>the scope of the QMS, and exclusions (see 1.2 Application); </li></ul></ul><ul><ul><li>documented procedures established for the QMS, or reference to them; </li></ul></ul><ul><ul><li>description of the interaction between the processes of the QMS </li></ul></ul><ul><li>ISO 14001 & OHSAS 18001 </li></ul><ul><ul><li>Description of core elements of system & interaction (implies scope) </li></ul></ul><ul><ul><li>Direction to related documentation </li></ul></ul><ul><ul><li>Policy Manual not specifically required </li></ul></ul><ul><ul><li>Some Elements require documented procedures or specific records </li></ul></ul><ul><ul><li>OHSAS requires documentation to be kept to a minimum for effectiveness and efficiency </li></ul></ul><ul><ul><li>All elements can be integrated into one manual </li></ul></ul>
  31. 32. ISO 9001 - 4.2.3 Control of Documents <ul><li>Documented procedure </li></ul><ul><ul><li>Identification of required internal & external documents </li></ul></ul><ul><ul><li>Approval, distribution controls, review & update </li></ul></ul><ul><ul><li>Retention requirements </li></ul></ul><ul><li>ISO14001[4.4.5] & OHSAS 18001[4.4.5] </li></ul><ul><ul><li>Document control requirements are essentially identical. </li></ul></ul><ul><ul><li>Documents maintained for legal purposes, identified </li></ul></ul><ul><ul><li>All required documents can be controlled via one procedure or process . </li></ul></ul><ul><ul><li>An enterprise-wide quality information software system is the best approach </li></ul></ul>
  32. 33. ISO 9001 - 4.2.4 Control of Records <ul><li>Documented procedure </li></ul><ul><ul><li>identification, storage, protection, retrieval, retention time and disposition of records. </li></ul></ul><ul><ul><li>Records to be legible, readily identifiable and retrievable. </li></ul></ul><ul><li>ISO14001[4.5.3] & OHSAS 18001[4.5.3] </li></ul><ul><ul><li>Record control requirements are essentially identical. </li></ul></ul><ul><ul><li>All required records can be controlled via one procedure or process. </li></ul></ul><ul><ul><li>An enterprise-wide quality information software system is the best approach </li></ul></ul>
  33. 34. Procedures / Processes to be Merged <ul><li>Required Processes (Support Processes) </li></ul><ul><ul><li>Document Control* </li></ul></ul><ul><ul><li>Records* </li></ul></ul><ul><ul><li>Control of Nonconforming Product / Situations* </li></ul></ul><ul><ul><li>Corrective Action* </li></ul></ul><ul><ul><li>Preventive Action* </li></ul></ul><ul><ul><li>Internal Auditing* </li></ul></ul><ul><ul><li>Training & Competence </li></ul></ul><ul><ul><li>Management Review </li></ul></ul>*Organization shall have a documented procedure.
  34. 35. Procedures / Processes to Merged <ul><li>Possible Additional Procedures (Processes) </li></ul><ul><ul><li>Business Planning (BMS Control Plans) </li></ul></ul><ul><ul><li>Objectives setting & review </li></ul></ul><ul><ul><li>Quality Planning /Management Programs </li></ul></ul><ul><ul><li>Identification of customer, regulatory and other requirements </li></ul></ul><ul><ul><li>New Product / Process Development </li></ul></ul><ul><ul><li>Continual Improvement Process </li></ul></ul><ul><ul><li>Measuring, Monitoring, Analysis of Data </li></ul></ul><ul><ul><li>Equipment Maintenance, calibration and control </li></ul></ul><ul><ul><li>Contingency planning & Emergency preparedness & response </li></ul></ul>
  35. 36. ISO 9001- 5.1 Management Commitment <ul><li>Evidenced by </li></ul><ul><ul><li>Communicating importance of customer & legal requirements </li></ul></ul><ul><ul><li>Establish Quality Policy </li></ul></ul><ul><ul><li>Establish Quality Objectives </li></ul></ul><ul><ul><li>Conduct Management Reviews </li></ul></ul><ul><ul><li>Ensure adequate resources. </li></ul></ul><ul><li>ISO14001 & OHSAS 18001 </li></ul><ul><ul><li>Corresponding requirements in </li></ul></ul><ul><ul><ul><li>Element 4.2 – Policy </li></ul></ul></ul><ul><ul><ul><li>Elements 4.3.3 – Objectives </li></ul></ul></ul><ul><ul><ul><li>Element 4.4.1 – Structure & Responsibility </li></ul></ul></ul><ul><ul><li>Description of Management Responsibilities can be integrated for all three standards . </li></ul></ul>
  36. 37. ISO 9001- 5.2 Customer Focus <ul><li>Requirement to determine customer requirements </li></ul><ul><ul><li>Details outlined in Clause 7.1 & 7.2 of Product Realization </li></ul></ul><ul><ul><li>ISO14001 </li></ul></ul><ul><ul><ul><li>Corresponding requirements in </li></ul></ul></ul><ul><ul><li> Element 4.3.1 – Environmental Aspects </li></ul></ul><ul><ul><li> Element 4.3.2 – Legal & Other requirements </li></ul></ul><ul><ul><li>OHSAS 18001 </li></ul></ul><ul><ul><ul><li>Corresponding requirements in </li></ul></ul></ul><ul><ul><li>Element 4.3.1 – Hazard identification & risk assessment </li></ul></ul><ul><ul><li>Element 4.3.2 – Legal & Other requirements </li></ul></ul><ul><ul><li>Focus includes requirements of other stakeholders as well as those of customers. </li></ul></ul>
  37. 38. ISO 9001 – 5.3 Quality policy <ul><li>Requirement to develop & publish a Quality Policy </li></ul><ul><ul><li>ISO14001 & OHSAS 18001 </li></ul></ul><ul><ul><li>Corresponding requirements in Element 4.2 </li></ul></ul><ul><ul><ul><li>Similar requirements for approval, communication, availability & review. </li></ul></ul></ul><ul><ul><ul><li>Similar content requirements (improvement, meet requirements, prevent deficiencies, overall objectives) </li></ul></ul></ul><ul><ul><li>Decision to publish separate policies or a combined policy should be based on ease of understanding by key stakeholders (employees) </li></ul></ul>
  38. 39. ISO 9001- 5.4.1 Quality Objectives <ul><li>Requirement to develop & review Quality Objectives </li></ul><ul><ul><li>ISO14001 & OHSAS 18001 </li></ul></ul><ul><ul><li>Corresponding requirements in Element 4.3.3 </li></ul></ul><ul><ul><ul><li>Similar requirements for setting and reviewing objectives and measurable targets, considering established requirements and inputs . </li></ul></ul></ul><ul><ul><li>Process for setting objectives and measurable targets should be integrated. </li></ul></ul><ul><ul><li>Some objectives may be linked. E.g. Scrap reduction (quality), Material/equipment damage (safety) and Waste reduction (environmental) </li></ul></ul>
  39. 40. ISO 9001- 5.4.2 Quality Planning <ul><li>Requirement to plan QMS & maintain integrity of QMS as result of changes to system </li></ul><ul><ul><li>ISO14001 & OHSAS 18001 </li></ul></ul><ul><ul><li>Corresponding requirements in Element 4.3.4 Environmental & OH&S management programmes </li></ul></ul><ul><ul><li>Process for planning and maintaining integrity is similar for all three standards. </li></ul></ul><ul><ul><li>Plans, arrangements and management programmes relating to all three standards should be developed and reviewed comprehensively. </li></ul></ul>
  40. 41. ISO 9001- 5.5.1 Responsibility & Authority <ul><li>Requirement to define and communicate responsibilities and authorities at all levels </li></ul><ul><ul><li>ISO14001 & OHSAS 18001 </li></ul></ul><ul><ul><li>Corresponding requirements in Element 4.4.1 Structure & Responsibility </li></ul></ul><ul><ul><li>Overall organizational structure and means of documenting/communicating responsibilities should be carefully coordinated to cover all three standards. </li></ul></ul><ul><ul><li>Consider a responsibility matrix. </li></ul></ul><ul><ul><li>Include text and/or visual identifiers (symbols) within the same document for each of the three systems </li></ul></ul>
  41. 42. ISO 9001- 5.5.2 Management Representative <ul><li>Requirement to appoint a management representative </li></ul><ul><ul><li>ISO14001 & OHSAS 18001 </li></ul></ul><ul><li>Corresponding requirements in Element 4.4.1 Structure & Responsibility </li></ul><ul><li>Overall responsibilities are similar: “Implement, maintain and report”. </li></ul><ul><li>May or may not be the same individual. </li></ul><ul><li>Worker Representative (not necessarily related to implementation, reporting, etc.) required under OHSAS </li></ul>
  42. 43. ISO 9001- 5.5.3 Internal communication <ul><li>Requirement establish internal communication process </li></ul><ul><ul><li>ISO14001 </li></ul></ul><ul><ul><li>Corresponding requirements in Element 4.4.3 Communication </li></ul></ul><ul><ul><li>OHSAS 18001 </li></ul></ul><ul><ul><ul><li>Corresponding requirements in Element 4.4.3 Consultation & Communication </li></ul></ul></ul><ul><ul><li>Processes for communication from management to employees about requirements, results, etc. should be integrated. </li></ul></ul><ul><ul><li>Processes for capturing communications from employees (concerns, suggestions, etc.) should also be integrated and documented. </li></ul></ul>
  43. 44. ISO 9001- 5.6 Management Review <ul><li>Requirement establish a Management Review process </li></ul><ul><ul><li>Clauses 5.6.2 & 5.6.3 define both inputs and outputs for review process. </li></ul></ul><ul><ul><li>ISO14001 & OHSAS 18001 </li></ul></ul><ul><ul><li>Corresponding requirements in Element 4.6 Management Review </li></ul></ul><ul><ul><li>Management Review processes should be as integrated as possible, to enable more effective review of all relevant inputs, results, etc., and to enable more effective planning. </li></ul></ul><ul><ul><li>Top Management Reviews may derive from a series of low level meetings, but must be conducted by top management. </li></ul></ul>
  44. 45. ISO 9001- 6.1 Provision of resources <ul><li>Requirement determine and provide adequate resources to maintain and improve the system . </li></ul><ul><ul><li>ISO14001 & OHSAS 18001 </li></ul></ul><ul><ul><li>Corresponding requirements in Element 4.4.1 Structure & Responsibility </li></ul></ul><ul><ul><li>Resource planning, budgeting and allocation processes should be as integrated as possible. </li></ul></ul>
  45. 46. ISO 9001- 6.2 Competence, awareness & Training <ul><li>Requirement to determine training requirements, provide training, evaluate effectiveness and maintain records. </li></ul><ul><ul><li>ISO14001 & OHSAS 18001 </li></ul></ul><ul><ul><li>Corresponding requirements in Element 4.4.2 Training, Awareness & Competence. </li></ul></ul><ul><li>All training requirements for the three standards should be managed under one training system. </li></ul><ul><li>All competencies can be defined and managed under one system. </li></ul>
  46. 47. ISO 9001 – 6.3 Infrastructure requirements <ul><li>Requirement to provide and maintain buildings, workspace, utilities, equipment and support services. </li></ul><ul><ul><li>ISO14001 & OHSAS 18001 </li></ul></ul><ul><ul><li>Corresponding requirements in Element 4.4.1 Structure & Responsibility: provision of resources. Implies provision of infrastructure for fulfillment of the requirements of both standards. </li></ul></ul><ul><ul><li>Requirements under OHSAS (4.4.6) for process & equipment installation/design </li></ul></ul><ul><li>The organization’s planning and budgeting processes should cover the requirements of all three standards. </li></ul>
  47. 48. ISO 9001 – 6.4 Work environment <ul><li>Requirement to provide adequate work environment to satisfy the requirements. </li></ul><ul><ul><li>ISO14001 & OHSAS 18001 </li></ul></ul><ul><ul><li>Corresponding requirements in Element 4.4.1 Structure & Responsibility: provision of resources. Implies provision of suitable work environment. </li></ul></ul><ul><ul><li>OHSAS 18001 specifically addresses planning and control of work environment (health, safety, ergonomics, etc.) – overall intent of the Specification </li></ul></ul><ul><ul><li>The organization’s planning and budgeting processes should cover the requirements of all three standards. </li></ul></ul><ul><ul><li>Implementation of the OHSAS 18001 requirements will assist in identification of work environment issues and controls. </li></ul></ul>
  48. 49. ISO 9001 – 7.1 Planning of product realization <ul><li>Requirement to plan and develop processes (procedures, documents, etc.) for product realization, monitoring schemes (measurements, sampling) and records.Linked to Quality objectives. </li></ul><ul><ul><li>ISO14001 & OHSAS 18001 </li></ul></ul><ul><ul><li>Corresponding requirements in Elements 4.3.1 Aspect/ Hazard Identification, 4.4.6 Operational Controls, 4.5.1 Monitoring & Measurement, and Element 4.5.3 Records. </li></ul></ul><ul><ul><li>Operational controls for EMS and OH&S should be developed in concert with product realization processes to minimize duplication. </li></ul></ul><ul><ul><li>Operational controls for EMS and OH&S extend to all processes, not just product realization (e.g. building maintenance, cafeteria, landscaping, etc.) </li></ul></ul>
  49. 50. ISO 9001 – 7.2.1 Determination of product requirements <ul><li>Requirement to identify customer product specifications, and other related requirements, including regulatory requirements. </li></ul><ul><ul><li>ISO14001 & OHSAS 18001 </li></ul></ul><ul><ul><li>Corresponding requirements in Element 4.3.1 Environmental Aspects and impacts (Hazard identification, risk assessment and risk control) & Element 4.3.2 Legal and other requirements. </li></ul></ul><ul><ul><li>Includes applicable customer as well as other stakeholder requirements. </li></ul></ul><ul><ul><li>Process for identifying and maintaining the above requirements should be integrated. </li></ul></ul><ul><ul><li>The process planning section of this workshop provides a recommended method. </li></ul></ul>
  50. 51. ISO 9001 – 7.2.2 Review of Requirements Related to the Product <ul><li>Review process required to ensure product requirements are identified and current, including contract and order requirements. </li></ul><ul><li>ISO14001 & OHSAS 18001 </li></ul><ul><li>Corresponding requirements in Element 4.3.1 Environmental Aspects and impacts (Hazard identification, risk assessment and risk control) & Element 4.3.2 Legal and other requirements. </li></ul><ul><li>These require a process for ongoing review of aspects and risks as a result of changes in requirements, products or processes. </li></ul><ul><li>Review and update of processes should be integrated to ensure all applicable requirements are systematically identified. </li></ul>
  51. 52. ISO 9001 – 7.2.3 Customer Communication Requirements <ul><li>Process required to communicate with customers about product requirements, contract and order requirements, feedback & complaints. </li></ul><ul><li>ISO14001 & OHSAS 18001 </li></ul><ul><li>Corresponding requirements in Element 4.4.3 Communications (external) (Consultation & Communication) </li></ul><ul><li>Some potential for integration of processes, keeping in mind that the scope of communications under ISO14001& OHSAS 18001 is broader than customers . (Government, community & other interested parties) </li></ul>
  52. 53. ISO 9001 – 7.3 Design & Development <ul><li>Process consists of </li></ul><ul><ul><ul><li>Planning (7.3.1) Inputs (7.3.2) </li></ul></ul></ul><ul><ul><ul><li>Outputs (7.3.3) Review (7.3.4) </li></ul></ul></ul><ul><ul><ul><li>Verification (7.3.5) Validation (7.3.6) </li></ul></ul></ul><ul><ul><ul><li>Change control (7.3.7) </li></ul></ul></ul><ul><li>ISO14001 & OHSAS 18001 </li></ul><ul><li>Corresponding requirements in Element 4.4.6 Operational controls to control environmental impacts and OH&S risks (includes design of process, equipment and installations to account for human factors) . </li></ul><ul><li>Outputs from Aspects & Impacts (4.3.1), hazard identification & risk assessment (4.3.1) and identification of legal & other requirements (4.3.2) should be considered as inputs for design & development (7.3.2) . </li></ul><ul><li>Conversely Outputs from design & development should provide for reevaluation of Aspects & Impacts and hazards & risks. </li></ul>
  53. 54. ISO 9001 – 7.4 Purchasing <ul><li>Process consists of </li></ul><ul><ul><li>Purchasing Process (7.4.1) </li></ul></ul><ul><ul><li>Purchasing Information (7.4.2) </li></ul></ul><ul><ul><li>Verification of Purchased Product (7.4.3) </li></ul></ul><ul><li>ISO14001 & OHSAS 18001 </li></ul><ul><li>Corresponding requirements in Element 4.4.6(c) Operational controls – communication to, and control of, suppliers & contractors to control environmental impacts and OH&S risks of purchased products or services . </li></ul><ul><li>Also the purchasing function should provide an input link to Aspects & Impacts (4.3.1), hazard identification & risk assessment (4.3.1) and identification of legal & other requirements (4.3.2). </li></ul>
  54. 55. ISO 9001 – 7.5 Production & Service Provision <ul><li>Process consists of </li></ul><ul><ul><li>Planning, Development and Provision of Product/Service </li></ul></ul><ul><ul><li>Control (7.5.1) </li></ul></ul><ul><ul><li>Validation (7.5.2) </li></ul></ul><ul><ul><li>Identification & Traceability(7.5.3) </li></ul></ul><ul><ul><li>Customer Property (7.5.4) </li></ul></ul><ul><ul><li>Preservation of product (7.5.5) </li></ul></ul><ul><li>ISO14001 & OHSAS 18001 </li></ul><ul><li>Corresponding requirements in Element 4.4.6 Operational controls control environmental impacts and OH&S risks relating to production & service provision . </li></ul><ul><li>Also outputs from Aspects & Impacts (4.3.1), hazard identification & risk assessment (4.3.1) and identification of legal & other requirements (4.3.2) should be considered as inputs for Production & Service controls (7.5.1) . </li></ul>
  55. 56. ISO 9001 – 7.6 Control of Monitoring & Measuring Devices/Technologies <ul><li>Process consists of </li></ul><ul><ul><li>Processes for monitoring and sampling </li></ul></ul><ul><ul><li>Equipment calibration and safeguarding </li></ul></ul><ul><ul><li>Validation of measurement results </li></ul></ul><ul><li>ISO14001 & OHSAS 18001 </li></ul><ul><li>Corresponding requirements in Element 4.5.1 Monitoring & measurement (Performance measurement and monitoring) for </li></ul><ul><ul><li>monitoring of activities and processes </li></ul></ul><ul><ul><li>Equipment Calibration </li></ul></ul><ul><li>Monitoring and measurement processes may in some cases be common to all three systems. (e.g. a quality failure may also generate an environmental impact.) </li></ul><ul><li>Procedures for equipment calibration can be integrated . </li></ul>
  56. 57. ISO 9001 – 8.2.1 Customer Satisfaction Requirements <ul><li>Requirement to monitor customer perception of satisfaction </li></ul><ul><li>ISO14001 & OHSAS 18001 </li></ul><ul><li>No direct correspondence, although Element 4.4.3 – Communication (Consultation & Communication) provide a process for managing communications with internal & external stakeholders (complaints, concerns, etc.) </li></ul><ul><li>Some integration of processes for receiving and responding to relevant communications is possible, especially corrective and preventative action. </li></ul>
  57. 58. ISO 9001 – 8.2.2 Internal Audit Requirements <ul><li>Requirement to conduct internal audits at planned intervals—audit effectiveness in practice </li></ul><ul><li>ISO14001 & OHSAS 18001 </li></ul><ul><li>Corresponding requirements in Element 4.5.4 – EMS Audit (Audit) </li></ul><ul><li>Auditing methods, procedures and programs can be integrated. </li></ul><ul><li>Potential for cross-functional auditors (environmental & safety technical knowledge important) </li></ul>
  58. 59. ISO 9001 – 8.2.3 Monitoring & Measurement of Processes <ul><li>Requirement to monitor and measure QMS processes </li></ul><ul><li>ISO14001 & OHSAS 18001 </li></ul><ul><ul><li>Corresponding requirements in Element 4.5.1 – Monitoring & Measurement (Performance measurement & monitoring) </li></ul></ul><ul><li>Many of the processes involved would apply to all three standards. Planning of monitoring and measurement processes should be integrated. </li></ul><ul><ul><ul><li>Tracking of objectives & targets </li></ul></ul></ul><ul><ul><ul><li>Monitoring of critical activities & processes. </li></ul></ul></ul>
  59. 60. ISO 9001 – 8.2.4 Monitoring & Measurement of Product <ul><li>Requirement to monitor and measure characteristics of product towards conformity. </li></ul><ul><li>ISO14001 & OHSAS 18001 </li></ul><ul><li>Corresponding requirements in Element 4.5.1 – Monitoring & Measurement (Performance measurement & monitoring), applicable where product or service itself presents either regulatory, environmental or H & S characteristics. </li></ul><ul><li>Planning of monitoring and measurement processes should be integrated. </li></ul>
  60. 61. ISO 9001 – 8.3 Control of Nonconforming Product <ul><li>Requirement to identify and control nonconforming product. </li></ul><ul><ul><ul><li>Linked to 8.5.2 – Corrective Action & 8.5.3 – Preventative Action </li></ul></ul></ul><ul><li>ISO14001 & OHSAS 18001 </li></ul><ul><li>No direct correspondence, unless nonconforming product presents an environmental impact or an H & S hazard at the facility. </li></ul><ul><li>Element 4.5.2 – Nonconformance, corrective & preventative Action ( Accidents, incidents, nonconformances & corrective & preventative action) </li></ul><ul><li>The processes for handling and resolving nonconformities are similar, and can be integrated. </li></ul>
  61. 62. ISO 9001 – 8.4 Analysis of Data <ul><li>Requirement to collect and analyze data from monitoring and other sources to demonstrate effectiveness of QMS and identify opportunities for improvement. </li></ul><ul><li>ISO14001 & OHSAS 18001 </li></ul><ul><li>Corresponding requirements in Element 4.5.1 – Monitoring & Measurement (Performance measurement & monitoring) (monitor key characteristics of it’s operations) and 4.6 (necessary information is collected for management review) </li></ul><ul><li>The processes for analysis of data are implied in ISO14001 & OHSAS 18001. Adoption of QMS methodology would strengthen effectiveness of all three systems. </li></ul>
  62. 63. ISO 9001 – 8.5.1 Continual Improvement <ul><li>Requirement to continually improve the effectiveness of the QMS. </li></ul><ul><li>ISO14001 & OHSAS 18001 </li></ul><ul><li>Corresponding requirements in Elements 4.3.3 – Objectives and Targets (Objectives), and Element 4.3.4 – Environmental Management Programmes (OH&S Management Programmes) </li></ul><ul><li>The processes are similar for all three standards: </li></ul><ul><ul><li>Use of the policy, objectives, audit results, analysis of data, corrective and preventive actions and management review. </li></ul></ul>
  63. 64. ISO 9001 – 8.5.2 Corrective Action <ul><li>Requirement identify and correct nonconformities. </li></ul><ul><ul><ul><li>Links to Clause 8.5.3 – Preventative Action </li></ul></ul></ul><ul><li>ISO14001 & OHSAS 18001 </li></ul><ul><ul><li>Corresponding requirements in Element 4.5.2 – Nonconformance, corrective & preventative Action (Accidents, incidents, nonconformance’s & corrective & preventative action) </li></ul></ul><ul><li>The processes and methodology are similar for all three standards, and can be fully integrated. </li></ul><ul><li>Proper root cause analysis is essential. </li></ul><ul><li>OHSAS requirement to put proposed corrective actions through the risk assessment process. </li></ul>
  64. 65. ISO 9001 – 8.5.3 Preventive Action <ul><li>Requirement identify and prevent potential nonconformities. </li></ul><ul><ul><li>Links to Clause 8.5.2 – Corrective Action </li></ul></ul><ul><li>ISO14001 & OHSAS 18001 </li></ul><ul><li>Corresponding requirements in Element 4.5.2 – Nonconformance, corrective & preventative Action ( Accidents, incidents, nonconformance’s & corrective & preventative action) </li></ul><ul><li>The processes and methodology are similar for all three standards, and can be fully integrated. </li></ul><ul><li>Proper root cause analysis is essential. </li></ul><ul><li>OHSAS requirement to put proposed preventative actions through the risk assessment process. </li></ul>
  65. 66. Requirements Not Incorporated into ISO 9001:2000 <ul><li>2 Requirements found in ISO14001 & OHSAS 18001 and not covered by ISO 9000:2000 </li></ul><ul><li>4.4.7 – Emergency Preparedness & Response </li></ul><ul><ul><li>Identification of potential incidents and emergency situations, response plan, and investigation. </li></ul></ul><ul><li>4.5.1 – Monitoring (auditing) compliance to applicable regulations </li></ul><ul><li>Both requirements can still be integrated into the overall system. </li></ul>
  66. 67. Strategies for Integration The Process Approach
  67. 68. Establish the Processes
  68. 69. Where to Start – The Process Approach <ul><li>The first step is to structure your QMS using the ISO 9001:2000 process approach model </li></ul><ul><ul><li>Some organizations may already have completed this fundamental shift from the old element based QMS to the process based system </li></ul></ul><ul><ul><li>Breakdown department barriers </li></ul></ul><ul><ul><li>Identify and document your “Key Processes” </li></ul></ul><ul><ul><li>Understand there are different types of processes </li></ul></ul>
  69. 70. Different types of Processes <ul><li>OMNEX believes there are several types of processes </li></ul><ul><ul><li>Customer Oriented Processes (COPs) </li></ul></ul><ul><ul><ul><li>COP’s can be within the other types of processes as well </li></ul></ul></ul><ul><ul><li>Management Oriented Processes (MOPs) </li></ul></ul><ul><ul><li>Support Processes (SOPs) </li></ul></ul><ul><ul><li>Product Realization Process </li></ul></ul><ul><ul><li>System Processes </li></ul></ul><ul><li>Types (names & categories) of process will vary from one organization to another </li></ul>
  70. 71. Where to Start – The Process Approach <ul><li>Next, are all processes required by ISO 14001 and OHSAS 18001 effectively implemented? </li></ul><ul><li>Identify customer, legal, and regulatory inputs and outputs within the various processes. These are sometimes called “Customer Related Processes (COP’s)” </li></ul><ul><li>Analyze the processes: </li></ul><ul><ul><li>Define Process </li></ul></ul><ul><ul><li>Eliminate redundancies </li></ul></ul><ul><ul><li>Eliminate waste </li></ul></ul><ul><ul><li>Improve effectiveness & efficiency </li></ul></ul>
  71. 72. Process Characteristics <ul><li>A process can be identified by a series of unique, but consistent, characteristics. There are six characteristics of a process that are mandatory for effective quality management. </li></ul><ul><ul><li>A process owner exists </li></ul></ul><ul><ul><li>The process is defined </li></ul></ul><ul><ul><li>The process is documented </li></ul></ul><ul><ul><li>The linkages of the process are established </li></ul></ul><ul><ul><li>The process is monitored and improved </li></ul></ul><ul><ul><li>Records are maintained </li></ul></ul>
  72. 73. Reminder <ul><li>Note, not all process have a direct impact on the quality of the product or service you provide. </li></ul><ul><li>However they must be part of your integrated system. Some examples are: </li></ul><ul><ul><li>Building and property maintenance (internal and external), miscellaneous products, safety & fire systems (internal and external), disposal/recycling of non-production waste, biohazards, emergency response, disaster recovery, etc. </li></ul></ul>
  73. 74. Process Focus <ul><li>Sequence and Interaction of Processes </li></ul>Source: ISO 9000:2000 CD2
  74. 75. Process Focus Vs. Department Focus Processes, not Departments, Drive Performance
  75. 76. Sequence & Interaction of Processes – A Process Map Example
  76. 77. Detailed Integration <ul><li>Address the detailed requirement of all three standards </li></ul><ul><li>As the processes are established, analyzed, and improved, it is much easier to address all the requirements of all three standards </li></ul><ul><li>Review the detailed comparison in the previous sections </li></ul><ul><li>There are many tools to assist in understanding how to continuously analyze, monitor, measure, and improve these processes (following chapter) </li></ul><ul><li>ALL PROCESSES SHOULD BE IMPROVED </li></ul>
  77. 78. Defining Quality Policy and Objectives
  78. 79. Establishing Policy & Objectives <ul><li>All three standards require us to establish, implement, communicate, and continually improve through the use of Policies & Objective </li></ul><ul><li>We must: </li></ul><ul><ul><ul><li>Describe the need and process for defining a quality policy </li></ul></ul></ul><ul><ul><ul><li>Define the process for gathering and analyzing customer, regulator, legal and stakeholder needs and expectations </li></ul></ul></ul><ul><ul><ul><li>Identify a method for going from “expectations and needs” to objectives </li></ul></ul></ul>
  79. 80. ISO 9001 Quality Policy & Objectives 5.2 Customer Focus 5.3 Quality Policy 5.4.1 Quality Objectives 8.2.1 Customer Satisfaction
  80. 81. Links Between Customer Requirements and Processes Customer Requirements Quality/Business Objectives Quality/Business Planning Processes
  81. 82. Quality, Environmental and OHSAS Objectives & Measurables (example )
  82. 83. <ul><li>Who is the customer? </li></ul><ul><ul><li>Product and service purchasers </li></ul></ul><ul><ul><li>Product and service users </li></ul></ul><ul><ul><li>Financial stakeholders </li></ul></ul><ul><ul><li>Employees </li></ul></ul><ul><ul><li>Government </li></ul></ul><ul><li>What is a Requirement? </li></ul><ul><ul><li>Need or expectation of external entities </li></ul></ul><ul><ul><li>The key to stakeholder satisfaction </li></ul></ul><ul><ul><li>The focus of continual improvement activities </li></ul></ul>Determining Stakeholder Requirements Interested Parties Customer = Recipient of a product Example: Consumer, End User, Retailer, Beneficiary, Purchaser A customer can be internal or external to the organization
  83. 84. Rate Customer Requirements (Example) <ul><li>Rate the Requirements to establish priorities </li></ul><ul><ul><li>Rating criteria </li></ul></ul><ul><ul><ul><li>5 Crucial : may result in near term loss of business, shutdown, business failure, etc. </li></ul></ul></ul><ul><ul><ul><li>4 Very Important : may become a “5” in 18 months to 2 years </li></ul></ul></ul><ul><ul><ul><li>3 Important : not to be taken too lightly or to be ignored, but lower priority </li></ul></ul></ul><ul><ul><ul><li>2 Somewhat Important : be aware of these, particularly if they are easy to satisfy </li></ul></ul></ul><ul><ul><ul><li>1 Low Priority </li></ul></ul></ul><ul><li>Evaluate from the Customer’s Perspective </li></ul><ul><li>Seek Additional Information </li></ul><ul><li>A more detailed analysis may be done, chapter 5. </li></ul>
  84. 85. Objectives for All Areas of Performance <ul><li>Remember the differing focus and rationale of each of the three management standards: </li></ul><ul><li>QMS deals mainly with: </li></ul><ul><ul><li>Quality </li></ul></ul><ul><ul><li>Cost </li></ul></ul><ul><ul><li>Delivery </li></ul></ul><ul><ul><li>Some safety and controlled substances </li></ul></ul><ul><li>EMS deals with Environmental: </li></ul><ul><ul><li>Aspects </li></ul></ul><ul><ul><li>Impacts </li></ul></ul><ul><li>HSMS addresses accident, injury and health: </li></ul><ul><ul><li>Hazards </li></ul></ul><ul><ul><li>Risks </li></ul></ul>
  85. 86. Business Control Plan <ul><li>A simple method of gathering objective and deploying them throughout the organization in order to: </li></ul><ul><ul><li>Identify the source of the requirement or expectation </li></ul></ul><ul><ul><li>Link objectives (QMS, BMS, HSMS) to key processes </li></ul></ul><ul><ul><li>Indicated the importance of the objective </li></ul></ul><ul><ul><li>Establish responsible and authority (Empowerment) </li></ul></ul><ul><ul><li>Set goals & targets </li></ul></ul><ul><ul><li>Reporting frequency </li></ul></ul><ul><ul><li>Show relationships between Quality, Environmental, OH&S </li></ul></ul><ul><ul><li>Improve communication </li></ul></ul><ul><ul><li>Establish control methods </li></ul></ul><ul><ul><li>Indicate improvement actions </li></ul></ul>
  86. 87. Business Management System Control Plan (ADD EMS & HSMS)
  87. 88. The Shift to Empowerment <ul><li>In the quality field, the shift to empowerment is almost complete: </li></ul><ul><ul><li>Quality is everyone’s responsibility, and </li></ul></ul><ul><ul><li>The quality professional is there to provide technical assistance to the entire organization. </li></ul></ul><ul><li>This same empowerment shift must take place within the environmental & OHS field: </li></ul><ul><ul><li>Top Management must drive quality, environmental and OHS system (a true Business System). </li></ul></ul><ul><ul><li>All individuals must understand their role within this new integrated system and be given the authority to improve all areas of their processes. </li></ul></ul>
  88. 89. System Integration Tools & Methodologies
  89. 90. Process Planning Tools <ul><li>Now we must look at how we analysis and control our Production, Manufacturing, and/or Service processes in more detail. </li></ul><ul><ul><li>The value add process </li></ul></ul><ul><ul><li>What we get paid to do </li></ul></ul><ul><ul><li>Product Realization & core business </li></ul></ul><ul><li>Cross-functional teams are established for: </li></ul><ul><ul><li>New product/service development, and </li></ul></ul><ul><ul><li>On-going production/services </li></ul></ul>
  90. 91. Process Planning Tools <ul><li>Quality tools used mainly in manufacturing can now be used within the entire BMS </li></ul><ul><li>Tools of most use are: </li></ul><ul><ul><li>Fishbone Diagrams (Sources of Variation) </li></ul></ul><ul><ul><li>Process Flow Diagrams </li></ul></ul><ul><ul><li>Failure Mode & Effects Analysis </li></ul></ul><ul><ul><li>Control Plans </li></ul></ul><ul><li>These tools will integrate all three systems </li></ul>
  91. 92. Fishbone Diagram – Sources of Variation
  92. 93. Process Flow
  93. 94. PFMEA Conceptual Overview
  94. 95. Process Planning System Diagram
  95. 96. Example of a EMS Control Plan
  96. 97. Example of a HSMS Control Plan
  97. 98. Continual Improvement Process Control
  98. 99. Review <ul><li>Rationale for Integration </li></ul><ul><li>Brief Comparison of the Standards </li></ul><ul><li>Understanding the Requirements and their Relationships </li></ul><ul><li>The Process Approach - Strategies for Integration </li></ul><ul><li>Tools Used for Integration </li></ul>
  99. 100. Thank You !

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