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    The Process Auditing and Techniques Guide
    The Process Auditing and Techniques Guide
    The Process Auditing and Techniques Guide
    Ebook146 pages1 hour

    The Process Auditing and Techniques Guide

    By James Paul Russell

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    About this ebook

    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.
    LanguageEnglish
    PublisherASQ Quality Press
    Release dateNov 18, 2009
    ISBN9781636941776
    The Process Auditing and Techniques Guide

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      Book preview

      The Process Auditing and Techniques Guide - James Paul Russell

      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-Print

      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

      asq-logo-quality-press-address-black

      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

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