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

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

Editor's Notes