Integrated Management Systems: QMS, EMS, OHSMS, FSMS including Aerospace, Service, Semiconductor/Electronics, Automotive, and Food

By Chad Kymal, Gregory Gruska and R. Dan Reid

Updated to the latest standard changes including ISO 9001:2015, ISO 14001:2015, and ISO 45001.

Includes guidance on integrating Corporate Responsibility and Sustainability.

Organizations today are implementing stand-alone systems for their Quality Management Systems (ISO 9001, ISO/TS 16949, or AS9100), Environmental Management System (ISO 14001), Occupational Health & Safety (ISO 18001), and Food Safety Management Systems (FSSC 22000). Stand-alone systems refer to the use of isolated document management structures resulting in the duplication of processes within one site for each of the management standards-QMS, EMS, OHSAS, and FSMS. In other words, the stand-alone systems duplicate training processes, document control, and internal audit processes for each standard within the company. While the confusion and lack of efficiency resulting from this decision may not be readily apparent to the uninitiated, this book will show the reader that there is a tremendous loss of value associated with stand-alone management systems within an organization.

This book expands the understanding of an integrated management system (IMS) globally. It not only saves money, but more importantly it contributes to the maintenance and efficiency of business processes and conformance standards such as ISO 9001, AS9100, ISO/TS 16949, ISO 14001, OHSAS 18001 / ISO 45001, FSSC 22000, or other GFSI
Standards.

• Language: English
• Publisher: ASQ Quality Press
• Release date: Mar 23, 2015
• ISBN: 9781953079763

Chad Kymal

Chad Kymal is the CTO and founder of Omnex Inc., an international consulting and training organization headquartered in the United States. After graduatingfrom the General Motors Institute, Chad spent a number of years working at General Motors and KPMG before founding Omnex Inc. in 1986. Over the course of Chad’s successful career, he has served on the Malcolm Baldrige Board of Examiners and has received numerous quality achievement awards, including the Quality Professional of the Year award by the American Society for Quality (ASQ) Automotive Division in 2005. In addition to his bachelor’s degree from GMI, Chad holds both a master’s degree in industrial and operations engineering from the University of Michigan and an MBA from the University of Michigan. Chad both developed and teaches auditor training for ISO 9001, ISO 14001,and OHSAS 18001/ISO 45001, as well as an Integrated Management Systems Lead Auditor training course where all three standards are combined in a single audit. Chad is the founder of AQSR, a global registrar that routinely provided integrated audits in QMS, EMS, and OHSMS. Chad is the author of four books and more than 100 papers including severalon integrated management systems.

Book preview

Integrated

Management Systems

QMS, EMS, OHSMS, FSMS including Aerospace, Service, Semiconductor/Electronics, Automotive, and Food

Updated to the latest standard changes including

ISO 9001:2015, ISO 14001:2015, and ISO 45001:2016

Includes guidance on integrating Corporate Responsibility and Sustainability

Chad Kymal, Gregory Gruska, and R. Dan Reid

ASQ Quality Press

Milwaukee, Wisconsin

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© 2015 by ASQ.

All rights reserved. Published 2015.

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Library of Congress Cataloging-in-Publication Data

Kymal, Chad.

Integrated management systems: QMS, EMS, OHSMS, FSMS including aerospace, service, semiconductor/elecrtronics, automotive, and food / by Chad Kymal,

Gregory Gruska, and R. Dan Reid.

   pages cm

ISBN 978-0-87389-894-2 (hardcover: alk. paper)

1. Quality control—Management. 2. Quality control—Standards. 3. Management information systems. I. Gruska, Gregory F., 1943- II. Reid, R. Dan (Robert Dan), 1949-

III. Title.

TS156.K96 2014

658.5’620218—dc23

                                          2014040874

No part of this book may be reproduced in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of the publisher.

Publisher: Lynelle Korte

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List of Figures and Tables

Figure 0.1

No integration or standardization

Figure 1.1

No integration or standardization

Table 1.1

Process integration matrix example (single site)

Figure 1.2

Three pillars of an integrated management system

Table 1.2

Integrated risk matrix example (single site)

Table 1.3

Integrated audit process example (single site)

Table 1.4

Single site process integration risk matrix

Figure 2.1

Stand-alone systems in an enterprise vs. enterprise integration

Table 2.1

Enterprise process score

Table 2.2

Standardized enterprise risk matrix example

Table 2.3

Standardized enterprise audits

Table 2.4

Enterprise process score

Table 2.5

Standardized enterprise risk

Table 2.6

Standardized enterprise audit of three sites

Figure 3.1

No integration or standardization

Figure 3.2

Stand-alone system (one site)

Figure 3.3

Process map example

Table 3.1

Management review topics matrix

Table 3.2

Process integration matrix

Figure 3.4

BMS control plan

Figure 3.5

Controls–risk evaluation relationship

Table 3A.1

Operational review meeting minimum agenda requirements

Figure 3A.1

Business planning and review flow chart

Table 3A.2

Strategic plan timetable example

Table 3A.3

Strategic plan table of contents example

Figure 4.1

Managing risk in EMS and OHS

Figure 4.2

Current controls

Figure 4.3

Sample column headings for risk assessment

Table 4.1

Severity table standardization

Table 4.2

Occurrence table standardization

Table 4.3

Standardization of detection tables

Figure 4.4

HACCP critical controls chart

Figure 4.5

FMEA-inspired HACCP sheets

Figure 4.6

Enterprise risk example

Table 5.1

Integrated audit schedule

Figure 5.1

Audit form example (Omnex)

Figure 5.2

Audit form example (ABC Corp)

Table 5.2

Integrated audit checklist for the training process

Figure 5.3

Integrated audit trails

Figure 5.4

Risk audit trail

Figure 5.5

New product realization audit trail

Figure 5.6

Provision audit trail

Figure 5.7

The relationship of audit programs to audit types to audit forms

Table 5.3

Audit duration by standard: QMS, EMS, OHSMS, and FSMS (ISO 22000 and FSSC 22000)

Table 5.4

Audit duration for FSSC 22000

Figure 5.8

Trend chart of nonconformances by month

Figure 5.9

Pareto analysis of nonconformances between sites

Figure 5.10

Pareto analysis of departments within a site

Figure 6.1

Enterprise process and site process interaction

Figure 6.2

Aligning interested parties/customer expectations, goals and objectives, and metrics

Figure 6.3

Goals and objectives alignment chart

Figure 6.4

Business management system control plan

Figure 6.5

A performance management system

Figure 6.6

Four-panel chart

Figure 6.7

Performance management system model

Figure 6.8

Integration of Lean and Six Sigma with a performance management system

Figure 6.9

Preventive and risk management techniques

Figure 6.10

Manufacturing process control design

Figure 6.11

Steps for effective problem solving

Figure 7.1

Integrated implementation plan for quality and food safety

Figure 7.2

Level I manual table of contents

Figure 7.3

Integrated process map

Table 7.1

HACCP Food Safety and Quality for Old Bakery

Table 7.2

Operator inspection plan

Figure 8.1

Automotive tier-one supplier case study

Figure 8.2

Degree of conformance to integrated management system

Table 8.1

Implementation plan

Figure 8.3

Level 1 manual table of contents

Table 8.2

Standardized enterprise procedures

Figure 8.4

Business process cycle

Table 9.1

Four-phase implementation plan

Figure 9.1

Business process map

Figure 9.2

Control of accident, incident, and near-miss procedure

Table 10.1

Implementation plan

Figure 10.1

Aerco quality manual contents

Figure 10.2

Process map developed

Table 10.2

Level II procedures

Figure 10.3

Recommended format for Level II

Table 11.1

USA and Asia 1 implementation

Table 11.2.

Asia 2 and 3 implementation

Figure 11.1

ISO/TS 16949 and ISO 14001 Manual (Level I)

Figure 11.2

Process map

Table 11.3

Development of Level II procedures

Figure 11.3

Business management system control plan

Figure 12.1

The challenge of enterprise

Figure 12.2

Enterprise integrated management processes

Figure 12.3

Aligning customer expectations, objectives, and result measurables

Figure 12.4

Linkages between objectives, personal objectives, and performance measurement

Figure 12.5

Linkages between risk management, new product introduction, and change management

Figure 13.1

Old Bakery process map

Figure 13.2

Omnex process methodology

Figure 13.3

BMS control plan

Table 14.1

Alignment and interaction of clauses

Figure A.1

I don’t do quality, environmental, or health and safety, I just do my job.

Figure A.2

Processes cut across the functions of the organization

Figure A.3

Management system documentation pyramid

Figure A.4

Stand-alone systems versus integrated management systems

Table A.1

Site–process integration example

Figure B.1

Sustainable value framework

Figure B.2

Creating integrated value

Preface

Organizations today are implementing stand-alone systems for their Quality Management Systems (ISO 9001, ISO/TS 16949, or AS9100), Environmental Management System (ISO 14001), Occupational Health & Safety (ISO 45001), and Food Safety Management Systems (FSSC 22000). Stand-alone systems refer to the use of isolated document management structures resulting in the duplication of processes within one site for each of the management standards—QMS, EMS, OHSMS, and FSMS. In other words, the stand-alone systems duplicate training processes, document control, and internal audit processes for each standard within the company. While the confusion and lack of efficiency resulting from this decision may not be readily apparent to the uninitiated, this book will show the reader that there is a tremendous loss of value associated with stand-alone management systems within an organization.

Worse yet, many organizations continue this duplication of effort among their different sites—including plants, design centers, and sales offices. If there is a lack of efficiency and confusion caused by the duplication in one site, one can imagine the magnification of these same problems when duplication is repeated multiple times in a large organization. The paper Juggling multiple standards, published by this author in 2005, provided a case study of a large European organization and included examples of duplication of management reviews and risk assessments. This same organization had processes such as document control that were repeated no less than 30 to 50 times in their large sites (called campuses) in Silicon Valley or in France.

The reduction of process duplication within one organization is referred to as integration and the reduction of duplication between sites is referred to as standardization. Figure 0.1 illustrates a situation in which the organization is implementing ISO/TS 16949, ISO 14001, and ISO 45001. This graphic is easily extended, as the organization intends to implement other standards such as FSSC 22000, ISO 26000, and so on. This book addresses both lack of integration and lack of standardization. It is a rare occasion when one can read about both topics in one paper or book, although the importance of both integration and standardization to the efficiency of implementation and maintenance of a management system cannot be overstated.

The time for integration and standardization has arrived as organizations are beginning to realize that applying these concepts effectively will produce significant savings. The authors estimate that integration reduces implementation costs by 50% and maintenance costs by 66%. Also, third-party auditing costs are reduced by more than 20%.

Integration and standardization can be applied to service and manufacturing organizations in industries such as automotive, aerospace, and food services. This book will cover the key principles of integrated management systems and includes case studies of its application in a variety of industries.

Integrating and standardizing processes companywide is an important task of quality professionals globally. It is vital to how business processes are managed, including the measurement and monitoring of their effectiveness, and it has far reaching implications on how an organization operates globally. We hope this book provides a guide and road map for organizations wanting to achieve integration and standardization. Omnex’s 30 years of experience in this subject will be put to good use in this book and its companion books on auditing and implementation.

The first article written by this author was on standardization of management systems in 1995 as Omnex implemented standardized processes for 27 Kelsey Hayes plants (now ZF). The first integration article, Juggling Multiple Standards—Save time and money by integrating your various management systems, was written in 2005. This article reflected the experience we had gained in the first integration project, where we integrated and standardized processes between the QMS and EMS for Yazaki of North America in 2001. Also, while Chad Kymal was the