The Process Auditing and Techniques Guide

James Paul Russell

Description

Best-selling author J.P. Russell focuses on the methods and techniques of conducting internal and external process audits. Learn how to evaluate process controls, use process flow, turtle, spider and tree diagrams, verify process conformity and effectiveness, and compose an audit report assessing compliance, controls, risk and process optimization. This guide is ideal for individuals who have a general understanding of auditing techniques and is written for auditors who conduct first-, second-, and third-party audits to any standard or work instruction.

Sujets

• Business
• Qualité, hygiène, sécurité, environnement
• Auditing
• Economie gestion
• ISO 9000
• International Organization for Standardization
• Economics
• QMS
• ISO 9001

Informations

• Publié par: ASQ Quality Press
• Date de parution: 18 novembre 2009
• Nombre de lectures: 0
• EAN13: 9781636941776
• Langue: English
• Poids de l'ouvrage: 2 Mo

Extrait

The Process Auditing and Techniques Guide
Also available from ASQ Quality Press:
ISO Lesson Guide 2008: Pocket Guide to ISO 9001-2008, Third Edition Dennis R. Arter and J. P Russell
The Internal Auditing Pocket Guide: Preparing, Performing, Reporting and Follow-up, Second Edition J. P. Russell
Continual Improvement Assessment Guide: Promoting and Sustaining Business Results J. P. Russell
The ASQ Auditing Handbook, Third Edition J.P. Russell, editing director
Quality Audits for Improved Performance, Third Edition Dennis R. Arter
ANSl/ISO/ASQ QE19011S-2004: Guidelines for quality and/or environmental management systems audtting — U.S. Version with supplemental guidance added ANSl/ISO/ASQ
The Process Approach Audit Checklist for Manufacturing Karen Welch
The Management System Auditor's Handbook Joe Kausek
Process Driven Comprehensive Auditing: A New Way to Conduct ISO 9001:2008 Internal Audits, Second Edition Paul C. Palmes
The Certified Manager of Quality/Organizational Excellence Handbook:
Third Edition
Russell T. Westcott, editor
To request a complimentary catalog of ASQ Quality Press publications, call 800-248-1946, or visit our Web site at http://qualitypress.asq.org .
The Process Auditing and Techniques Guide
Second Edition
J. P. Russell

ASQ Quality Press Milwaukee, Wisconsin
American Society for Quality, Quality Press, Milwaukee 53203 © 2010 by J. P. Russell All rights reserved. Published 2010 Printed in the United States of America
12 11 10 09 08 07 06 5 4 3 2 1
Library of Congress Cataloging-in-Publication Data
Russell, J. P. (James P.), 1945—  The process auditing and techniques guide / J. P. Russell. — 2nd ed.   p. cm.  Includes bibliographical references and index.  ISBN 978-0-87389-782-2 (alk. paper)  1. Auditing. I. Title.
 HF5667.R838 2010  657’.45—dc22
2009052462
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.
ASQ Mission: The American Society for Quality advances individual, organizational, and community excellence worldwide through learning, quality improvement, and knowledge exchange.
Attention Bookstores, Wholesalers, Schools, and Corporations: ASQ Quality Press books, videotapes, audiotapes, and software are available at quantity discounts with bulk purchases for business, educational, or instructional use. For information, please contact ASQ Quality Press at 800-248-1946, or write to ASQ Quality Press, P.O. Box 3005, Milwaukee, WI 53201-3005. To place orders or to request a free copy of the ASQ Quality Press Publications Catalog, including ASQ membership information, call 800-248-1946. Visit our Web site at http://www.asq.org or http://www.asq.org/quality-press
Table of Contents
Cover
Title page
Copyright
Introduction
Chapter 1 What Is a Process?
PROCESS DESCRIPTION
CONTROL OF PROCESSES
PROCESSES MAKE THE SYSTEM
ADVANCED PROCESS AND SYSTEM MODELING
SUMMARY
Chapter 2 Prepare for the Audit
SECTION I: ORGANIZING THE AUDIT
SECTION II: PROCESS AUDIT PREPARATION ACTIVITIES
Chapter 3 Start the Audit
OPENING MEETING
TOUR
OTHER MEETINGS DURING THE AUDIT
DATA COLLECTION PLANS
Chapter 4 Use Process Audit Techniques
SECTION I: INVESTIGATING (COLLECTING EVIDENCE)
SECTION II: USING PLAN-DO-CHECK-ACT FOR CONTROL AND ANALYZE-CHANGE-DO-PROSPER FOR IMPROVEMENT
SECTION III: AUDITING OPEN-ENDED REQUIREMENTS
Chapter 5 Verification Audits: Checking Products, Services, and Processes
VERIFICATION METHODS
NEED
PREPARING
PERFORMING
CONCLUSION
Chapter 6 Analyze and Report Findings
ANALYZE DATA
COMPLIANCE/CONFORMANCE AUDIT DATA
PERFORMANCE AUDIT DATA
SYSTEM AUDITS
THE REPORT
CLOSING MEETING
ENDING THE PROCESS AUDIT
CLOSING REMARKS
Appendix A IDEF3 Model Description
Appendix B Process Control Checklist
Appendix C Process Audit Report and Corrective Action Record
Appendix D Standard Flowchart Symbols
Appendix E Example Process Map
Appendix F Turtle Diagram
Appendix G Lean—Eight Wastes
Glossary
Notes
References
Introduction
This book focuses on methods and techniques to conduct process audits for verification and validation purposes. Internal and external process audits provide very valuable information to management and oversight organizations about day-to-day work and operations. Though process audit is defined in several texts, there is no standard of common conventions or accepted practices. While management system audits are about what Joseph Juran called the “Big Q,” process audits are about the “little q,” for quality assurance and quality control purposes.
In this book we will follow the steps shown in Figure I.1. Every attempt has been made to focus on process audit techniques and not repeat common system audit practices found in books such as the third edition of The ASQ Auditing Handbook. Readers of The Process Auditing and Techniques Guide should already know basic auditing techniques, such as how to conduct interviews or develop a checklist. The techniques presented in this book can be used by auditors who conduct first-, second-, or third-party audits on any standard, procedure, or work instruction. ISO 9001 examples are used in the book, but other controls and standards—such as FAA, FDA, EPA, OSHA, ISO 13485, ISO/TS 16949, ISO 14001, and AS9100— could also be used.

Figure I.1  Process auditing steps.
Process audits are used to verify and validate manufacturing processes, software and service processes, and products. A chapter on verification audits is included as well as a brief section on product/service audits.
Chapter 1 What Is a Process?
In order to audit a process, you must first understand what it is. With my background in chemical engineering and business management, I am very familiar with processes. Chemical engineering could more appropriately be called process engineering. The very first engineering class I took was called “Process Principles.” It was considered a difficult and demanding class. In this beginner class, the students were taught about designing processes, determining duties to be performed, establishing specifications and requirements, and integrating the various units (activities) into a coordinated plan. Additionally, we were told that “problems cannot be segregated and each treated individually without consideration of the others” (Houge 1965). So the first principle we learned was that process activities are connected or linked. Whether you want to make up a liquid solution, bolt beams together, drill a hole in a plate, or perform a medical treatment on a patient, one step follows the next until the process is complete. Second, we learned that processes are responsible for the changes that take place within a system. Processes convert ingredients into paint, connect beams into a structure, assemble parts to make a wagon, and treat patients' needs to make them well. Some call this conversion a transformation.
The balancing and equilibrium of inputs and outputs is called the Law of Conservation. The Law of Conservation requires that the sum of the inputs equal the sum of the outputs for a given process. For example, the uncut metal plate input equals the fabricated bracket, plus scrap and metal filings. The completed cement pour equals the rebar used, the foundation, and the wasted cement. The cut lawn equals the grass clippings, gasoline, and oil used.
The third principle is that the Law of Conservation applies to a defined process. For processes to work, inputs and outputs must balance. If process elements do not balance, the objectives will not be achieved and the process will not be effective. The output objective demands certain inputs; if you don't have sufficient inputs, the outputs will never be achieved.
The fourth principle is that processes can be operated at a set of optimum conditions for best utilization of resources and achievement of objectives. Economics is an important consideration of design and process operation. Every process has a set of optimum operating conditions for achieving both economic and performance objectives. In traveling to work or to the store, there may be a shortest way, a fastest way, or a most economical way. Optimization depends on your objectives.
Process principles
1.
Activities are linked as sequential steps
2.
Change (transformation) takes place
3.
The Law of Conservation applies to a defined process
4.
Optimization results in best utilization of resources
PROCESS DESCRIPTION
A process transforms inputs into outputs. This transformation or change takes place as a series of activities or steps that lead to a desired result (objective). The process way (sequential steps) of doing things is more effective in achieving objectives than a haphazard or random approach. Establishing a process is good, but it could be either a good process or a bad process. There could be extra steps, unnecessary steps, wrong steps, or not-understood steps.
Inputs can be tangible or intangible. Inputs may come in the form of people, equipment, materials, parts, assemblies, components, information, money, and so on (see Figure 1.1). The process transforms, changes, or converts the inputs into an output. Inputs are the things that will be transformed.
An output may be a product or service. Outputs can include parts, assemblies, materials, information, energy, money, machines, devices, completed treatment, completed installation/ construction (plumbing, foundation, rigging), performance of a skill (such as a haircut, massage, test, examination), and so on. The output product/service is a result of the process.

Figure 1.1  Process inputs and outputs.
There are many other inputs to a process (other than the object of the transformation) that make it possible to complete the transformation. These inputs can be conveniently categorized as pro