barber process basedintegrating9001_14k_18k_final

Process Based Integration of ISO 9001:2000, ISO 14001,

and OHSAS 18001

David Barber, General ManagerOmnex Canada

[email protected]

R1 08.04 © Omnex, Inc.

2000 - 2004, Omnex, Inc.3025 Boardwalk Suite 120

Ann Arbor, MI 48108734-761-4940

First EditionAugust 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

1. Rationale for Integration

2. Brief Comparison of the Standards

3. Understanding the Requirements and their Relationships

4. The Process Approach - Strategies for Integration

5. 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 9001:2000Customer Satisfaction & Competitive

Advantage

ISO 14001:1996Eliminate or Minimize Environmental Impact

OHSAS 18001:1999Eliminate 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



• 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



• 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



• 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

Inputs/resources Organization Outputs Interested parties

equipmentsupplies

human resources

information resources

technology resources

natural resources

energy

financial resources

others

confidence

offered products

risks and effects onpeopleand environmentwastes, emissions

financial results

effects on employees

information

others

customers, society, owners

customers

customers, owners

society, customers, owners

owners, members/employees, suppliers

members/employees,ownerscustomers, society, owners

ISO 9001focus


equipmentsupplies

human resources



natural resources

energy

financial resources

others

confidence

offered products


financial results


information

others


customers

customers, owners




ISO 9001focus

ISO 9001


Shared Focus


equipmentsupplies

human resources



natural resources

energy

financial resources

others

confidence

offered products


financial results


information

others


customers

customers, owners




OHSAS18001focus


equipmentsupplies

human resources



natural resources

energy

financial resources

others

confidence

offered products


financial results


information

others


customers

customers, owners




OHSAS18001focus

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

Policy (all require) Planning (identify)

• Continual improvement

• Meet requirements (customer or legal/other)

• Prevention (non-conforming product, pollution, accidents)

• Reference to objectives

• Customer and product requirements (9001)

• Environmental Aspects & Impacts (14001)

• Job Hazards and Risk assessment (18001)

Plan 4.2 Environmental Policy 4.2 OH&S Policy 5.3 Quality Policy

4.3.1 Environmental Aspects 4.3.1 Hazard identification & Risk assessment & control

4.3.2 Legal and Other Requirements

4.3.2 Legal and Other Requirements

4.3.3 Objectives and Targets 4.3.3 Objectives 5.4.1 Quality Objectives

4.3.4 Environmental Management Programs

4.3.4 OH&S Management Programs

5.4.2

8.5.1

Quality Management System PlanningContinual Improvement

14001 18001

5.27.2.17.2.2

Customer FocusDetermination of requirements related to productReview of requirements related to product

9001


Structure of Three StandardsDo 4.4.1 Structure and Responsibility 4.4.1 Structure and Responsibility 5

6Management ResponsibilityResource Management

4.4.2 Training, Awareness, and Competence

4.4.2 Training, Awareness, and Competence

6.22 Competence, awareness & training

4.4.3 Communications 4.4.3 Consultation & Communication

5.5.37.2.3

Internal communicationCustomer communication

4.4.4 EMS Documentation 4.4.4 Documentation 4.2 Documentation requirements4.4.5 Document and Data Control 4.4.5 Document and Data Control 4.2.3 Control of documents4.4.6 Operational Control 4.4.6 Operational Control 7.1

7.27.37.47.5

Planning product realizationCustomer-related processesDesign & developmentPurchasingProduction & service provision

4.4.7 Emergency Preparedness and Response

4.4.7 Emergency Preparedness and Response

8.3 Control of nonconforming product

14001 18001 9001

Similarities Differences

• Management structure and resource allocation

• Training and communication

• Documentation and control of documents

• Process & operational controls

Emergency Response not directly addressed in 9001



Check 4.5.1 Monitoring and Measurement 4.5.1 Performance Measurement & Monitoring

8.28.47.6

Monitoring & MeasurementAnalysis of dataControl of monitoring & measuring devices

4.5.2 Nonconformance and Corrective and Preventive Action

4.5.2 Accidents, Incidents, Nonconformance and Corrective and Preventive Action

8.38.5.28.5.3

Control of nonconforming productCorrective actionPreventative action

4.5.3 Records 4.5.3 Records & Record Management

4.2.4 Control of records

4.5.4 EMS Audit 4.5.4 Audit 8.2.2 Internal audit

14001 18001 9001

All share similar purpose and function in control, measurement &

Improvement



Act 4.6 Management Review 4.6 Management Review 5.6 Management Review14001 18001 9001

All share similar purpose and function, and in all cases inputs & outputs

should be defined

Focus on Actions to Improve Results


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 4.6OHSAS 18001 – 4.1• Overall requirements for an OH&HSMS.

Detailed requirements in clauses 4.2 through 4.6


ISO 9001- 4.2 Documentation Requirements

4.2.2 QualityManual

4.2.2 QualityManual

4.2.3 Control ofDocuments

4.2.3 Control ofDocuments

4.2.4 Control ofRecords

4.2.4 Control ofRecords

Quality ManualQuality Manual

List ControlledDocuments

List ControlledDocuments

ControlledDocuments

ControlledDocuments

List of RecordsList of Records

Records(in good

condition)

Records(in good

condition)

4.2DocumentationRequirements

4.2DocumentationRequirements

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, identifiedAll 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)1. Document Control*

2. Records*

3. Control of Nonconforming Product / Situations*

4. Corrective Action*

5. Preventive Action*

6. Internal Auditing*

7. Training & Competence

8. Management Review

*Organization shall have a documented procedure.


Procedures / Processes to Merged

Possible Additional Procedures (Processes)1. Business Planning (BMS Control Plans)2. Objectives setting & review3. Quality Planning/Management Programs4. Identification of customer, regulatory and other

requirements5. New Product / Process Development6. Continual Improvement Process7. Measuring, Monitoring, Analysis of Data8. Equipment Maintenance, calibration and control 9. 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 assessmentElement 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

& CommunicationProcesses 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 18001Corresponding 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 shouldbe 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 18001Corresponding 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 18001Corresponding 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 ofPlanning (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 18001Corresponding 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 18001Corresponding 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 18001Corresponding 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 18001Corresponding 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 SatisfactionRequirements

• Requirement to monitor customer perception of satisfaction

• ISO14001 & OHSAS 18001No 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 18001Corresponding 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 18001Corresponding 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 & targetsMonitoring 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 18001Corresponding 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 18001No 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 18001Corresponding 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 18001Corresponding 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 18001Corresponding 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 18001Corresponding 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 AOutput A/Control B

PROCESS B PROCESS COutput B

Input C

Mechanism B

Output C

Control C


Process Focus Vs. Department Focus

AccountingHumanResources

OperationsPurchasing Sales

Top Management

Result Measurables

Process Variation Outputs

Process A

Processes, not Departments, Drive Performance


CleaningMarketing StampingDesign Finishing Packaging Shipping

Maintenance CompliancePurchasing Training

InternalAuditing

Corrective /Preventive

Action

QualityPlanning

ManagementReview

CustomerSatisfaction

QualityObjectives

DocumentControl

DataControl

Support Processes

Realization Processes

QMS Processes

CleaningMarketing StampingDesign Finishing Packaging Shipping

Maintenance CompliancePurchasing Training

InternalAuditing

Corrective /Preventive

Action

QualityPlanning

ManagementReview

CustomerSatisfaction

QualityObjectives

DocumentControl

DataControl

Support Processes

Realization Processes

QMS Processes

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


Customers

Customers

Managementresponsibility

Measurement,analysis andimprovement

Resourcemanagement

Requirements

Satisfaction

ProductProductrealization

Input Output

Continual improvement of thequality management system

Key

Value-adding activities

Information flow

Figure 1 - Model of a process-based quality management system

© ISO 2000

5.2 Customer Focus5.3 Quality Policy5.4.1 Quality Objectives

8.2.1 Customer Satisfaction

ISO 9001 Quality Policy & Objectives


Customer Requirements

Quality/Business Objectives

Quality/Business Planning

Processes

Customer Requirements

Quality/Business Objectives

Quality/Business Planning

Processes

Links Between Customer Requirements and 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

Interested Parties

Customer = Recipient of a product

Example: Consumer, End User, Retailer, Beneficiary, Purchaser

A customer can be internal or external to the organization

Determining Stakeholder Requirements


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 years3 Important: not to be taken too lightly or to be ignored, but

lower priority2 Somewhat Important: be aware of these, particularly if they

are easy to satisfy1 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

VariationInput

Equipment

Machine

Material Holding

Fixture

Tooling

Materials

Metallurgy

Chemistry

Dimensions

Ergonomics

PreventiveMaintenance

Set-up

Methods &Systems

MeasurementSystems

Instructions

Cleanliness

Humidity

Environment

AmbientTemperature

Lighting

OperationVariation

Teamwork

People

Training/Knowledge

Communications

Teamwork l Continual Improvement

Continual Improvement Loop


Process Flow

Process Flow Diagram

11

05

10A

20-1 20-2

50

40

30-1 30-2 30-3

10B

35


PFMEA Conceptual OverviewPart/

Process/Purpose

CurrentControl

CurrentControl

CurrentControl

CauseEffectsProcessFailure

Cause

CurrentControl

RecommendedAction

RecommendedAction

RecommendedAction

RecommendedAction

CurrentControl

CurrentControl

CurrentControl

CauseEffectsProcessFailure

Cause

CurrentControl

RecommendedAction

RecommendedAction

RecommendedAction

RecommendedAction

Risk

Risk

Risk

Risk

Risk

Risk

Risk

RiskPCIDChar


Process Planning System Diagram

ProcessFlow

Requirements(ex: specifications,

designperformancespecification,

protoype requirementProcess parameters,Sources of variation,

Design matrixCustomer prints and/or CAD transmissions

In-process printsPlant layout

Problem reports andlogs

System and/or designFMEA

Process FMEA from asimilar product or

processContract review and

feasibilitySpecial product and

processcharacteristics matrix)

Associate PCswith Operational Steps

ProcessFMEA

IdentifyProcess

Characteristics(sources/causes

of variation)

8-D

Action Plan

IdentifyRoot Cause

ControlPlan

WorkInstructions

ISO/TS 16949Procedures

Identify Product Characteristics

OP10

OP20

OP30

Implement ControlStrategy

ImplementProcess

Improvements

SPC

Verify and Validate


Example of a EMS Control PlanEMS Control Plan

Control Plan Number: Key Contact/Phone: Date (original): Date (Revised):

Location/Department: Core Team: Other Approval/Date (IF Required):

Process Name/Activity

Characterics/AspectsRegulatory

CharacteristicsClass*

Methods

Objective/Target

EvaluationMeasurement

Technique

SampleSize Freq.

ControlMethod

ReactionPlan

*R - RegulatoryS - SignificantM - Medium

FumesMelting aluminum

Storm drain pollution

RReduce

emissions by25%

Airsampling

StandardOnceper

month

Monitorsamples

Chagefilters

Macine cast parts R Zeropollution

Watersampling

Sixsamples

Onceper

month

Monitorsamples

Adjusttreatment

EMS Control PlanControl Plan Number: Key Contact/Phone: Date (original): Date (Revised):


Process Name/Activity

Characterics/AspectsRegulatory

CharacteristicsClass*

Methods

Objective/Target

EvaluationMeasurement

Technique

SampleSize Freq.

ControlMethod

ReactionPlan

*R - RegulatoryS - SignificantM - Medium

FumesMelting aluminum

Storm drain pollution

RReduce

emissions by25%

Airsampling

StandardOnceper

month

Monitorsamples

Chagefilters

Macine cast parts R Zeropollution

Watersampling

Sixsamples

Onceper

month

Monitorsamples

Adjusttreatment


Example of a HSMS Control Plan

OH&SMS Control PlanControl Plan Number: Key Contact/Phone: Date (original): Date (Revised):


Process/Activity/Condition

Characterics/HazardRegulatoryCharacter-

istics Class*

Methods

Objective/Target Evaluation

Measure-ment

Technique

Sample

Size Freq.ControlMethod

ReactionPlan

*R - RegulatoryI - Intolerable RiskT - Tolerable

ArcWelding I Zero Eyeinjuries

Incidents AllOn-

goingCurtainGoggles

Treat-ment

OH&SMS Control PlanControl Plan Number: Key Contact/Phone: Date (original): Date (Revised):


Process/Activity/Condition

Characterics/HazardRegulatoryCharacter-

istics Class*

Methods

Objective/Target Evaluation

Measure-ment

Technique

Sample

Size Freq.ControlMethod

ReactionPlan

*R - RegulatoryI - Intolerable RiskT - Tolerable

ArcWelding I Zero Eyeinjuries

Incidents AllOn-

goingCurtainGoggles

Treat-ment


Activities, Products or

Services

Legal and other requirements Environmental Policy Operation

and business requirements. Views of Interested Parties

Identify Environmental Aspects (4.3.1)

OP10

Associate Environmental Aspects with Activities, Products or Services (Inputs and Outputs)

EMS FMEA

Action Plan

Identify Significant Aspects and Inpacts

Implement and Define: Objectives &

Targets EMP's Operational

Controls EPR's

Control Plan

Implement Operational

Controls and EP&R

Work Instructions

EMSProcedures

Monitoring and Measuring

Nonconformance & Corrective Preventive

Action

QOS

OP20

OP30

Continual Improvement

(EMP's)

Environmental Performance Measuables

---------Systemic Causation

Process Control

Continual Improvement


Review

1. Rationale for Integration

2. Brief Comparison of the Standards


4. The Process Approach - Strategies for Integration

5. Tools Used for Integration


Thank You Thank You !!

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