AFTER THE QUALITY AUDIT Closing the Loop on the Audit Process J.P. Russell Terry Regel ASQC Quality Press Milwaukee, WisconsinAlso available from ASQC Quality Press Quality Management Benchmark Assessment, Second Edition J.P Russell The Quality Master Plan J.P Russell Quality Audits for Improved Performance, Second Edition Dennis R. Arter Fundamentals of Quality Auditing B. Scott Parsowith The 150 9000 Auditor's Companion and The Audit Kit Kent A. Keeney ISO 9000 Audit Questionnaire and Registration Guidelines Praful (Paul) Mehta Eight-Step Process to Successful ISO 9000 Implementation: A Quality Management System Approach Lawrence A. Wilson Managing Records for ISO 9000 Compliance Eugenia K. Brumm To request a complimentary catalog of publications, call 800-248-1946After the Quality Aueht: Closing the Loop on the Audit Process JP Russell and Terry Regel Library of Congress Catalogng-in-Publication Data Russell, |. P James P), 1945~ After the quality audit. closing the loop on the audit process / J.B Russell, Terry Regel cm Includes bibliographical references and index ISBN 0-87389-363-4 1 Management audit. 2. Quality control—Audiuing, 3. Quality assurance. |. Regel, Terry, 1950- I Title HD58.95 IN PROCESS 658,562—de20 96-1893 cp ©1996 by ASQC All rights reserved. No part of this book may be reproduced in any form ot by any means, electronic, mechanical, photocopying, recording, or otherwise, wuhout the prior written permission of the publisher 10987654321 ISBN 0-87389-365-4 Acquisitions Eduor. Susan Westergard Project Editor: Kelley Cardinal ASQC Mission: To facilitate continuous improvement and increase customer satisfaction by identifying, communicating, and promoting the use of quality principles, concepts, and technologies: and thereby be recognized throughout the world as the leading authority on, and champion for, quality Attention: Schools and Corporations ASQC Quality Press books, audiotapes. videotapes, and software ate available at quantity discounts with bulk purchases for business, educational, or instructional use. For information, please contact ASQC Quality Press at 800-248-1946, or write to ASQC Quality Press, RO. Box 3005, Milwaukee, WI 53201-3005, For a free copy of the ASQC Quality Press Publications Catalog, including ASQC membership information, call 800-248-1946 Printed in the United States of Amenca i) Printed on acid-free paper @ASQC ‘Quality Press 611 East Wisconsin Avenue Miwauke, Wisconsin 53202Se a ee <0 Tf Ee ee SG, 95 hG4 66 It is impossible to solve significant problems using the same knowledge that created them. —Albert EinsteinContents Foreword by Dennis R. Arter xi Acknowledgments _ xiii Introduction xv Chapter1 The Corrective and Preventive Action Process 1 How Did We Get Here? 1 Corrective and Preventive Actions 3 Systems Thinking 11 Real-Life Corrective/Preventive Action Examples 14 Sorting the Trash: Deciding What to Do with the Bad Stuff 17 The Internal Customer 17 Summary 18 Chapter2 Reporting Problems 19 Value Added or Non—Value Added? 19 Purposeful and Focused Reporting 22 Phrasing the Problem 28 Identify the Reason and the Pain: Relate to Customer Interests 33 Quality Costs and the R/P Matrix 40. Don't Forget Intuitive Analysis (Perceived Importance) 41 Use Management Terminology 42 Auditors’ Universal Fallback Position: Do It or Else! 43 Checklist for a Finding Statement 44 viiee viii * After the Quality Audit Formatting and Organizing Reports 45 Summary 46 Chapter3 Deciding Whatto Do About It 49 Paradise Lost 50 PDCA Just Ain't That Simple 52 Revising the Picture 52 Connections 54 The Problem with Data 55 Defining the Process 36 The Importance of Being Earnest. 57 Tracking Performance 37 Prepare for Improvement. 38 Preventive Actions 60 An Example of Corrective Action 61 Summary 67 Chapter4 Taking Action 69 Initiating Corrective Action 70 Evaluate Requests: Stakeholder 78 Develop Action Plans: Stakeholder 82 Acknowledge Action Plans: Auditor 87 Summary 98 Chapter5 Did !tWork? 101 The Corrective Action Must Be Effective 101 Auditor Interface 109 Standardize Improvement Actions: Stakeholder 111 Monitor Long-Term Performance: Stakeholder 112 Auditor Follow-Up Activities 119 Were There Benefits? Time to Celebrate! 122 Summary 125 Chapter6 Effective Audit Program Management 127 Basic Audit Process Elements 129 Modern Audit Process Elements 131 Reporting; The Big Picture 145 Summary 146Contents + ix Chapter7 Closing the Loop on the Audit Process 147 Getting Unstuck from Compliance Audits 149 What If Quality Audits Are Not a Priority to Management? 152 Staying Current with the Latest Technology 153 What If the Environment for Quality Audits Is Not Right? 161 Summary 163 Chapter8 Conclusion: Back to the Future 165 Ghosts from the Past. 169 Is This Really a Good Thing to Do? 171 Preparation for Third-Party Registration 174 Back to the Future 177 Appendices Appendix A: Checklist for Auditing Quality Systems 179 Appendix B: Auditor Qualification Criteria Checklist. 189 Appendix C: Audit Program Management Checklist. 195 Appendix D: Corrective and Preventive Action Procedure 199 Notes 205 Glossary 207 Suggested Reading 217 Index 219Foreword This book is about change. Change is hard. Although this book is easy to read, the concepts will be hard to implement. This book will require sev- eral readings before you totally understand the material Both J. P. Russell and Terry Regel are my personal and professional friends. We have known each other for many years, through ASQC and its Quality Audit Division. In the last five years, we have been pleased with the attention shown to our profession. We have also been concerned by auditing’ misapplication. This book manages to effectively capture many of the discussions we have had during these last few years. J. P and Terry are presenting a system approach to auditing; many people call these management audits. This system approach requires that you engage your brain and move beyond merely complying to a set of tules. We must understand the processes and what affects them. We must also understand how those processes are controlled. This is heavy stuff. It is also the wave of the future The system approach to change has universal application, manufactur- ing, processing, servicing, designing, and entertaining can all use these meth- ods. It also goes beyond strict compliance to procedures. Some will find this difhcult and outside of their comfort zone. Others will enjoy the challenge J. P.and Terry have done a fine job of advancing the practice of audit- ing by forcing us to think about the consequences. They have given us tools and concepts that work. | wish them both continued success. Dennis R. ArterAcknowledgments This book began asa breakfast discussion regarding the possibilities for a presentation at the 4th Annual Quality Audit Division Conference in Balti- more. The reception of that presentation by the quality professionals in at- tendance provided the incentive for us to expand those ideas into this book. In particular, | would like to thank Allan Sayle for his comments on the Audit Function Improvement Flowchart which led to improvements and further development of its application It would be unjust not to acknowledge the contributions of those who reviewed and provided comments on portions of this book as it was being written. One of those is Jim Van Patton, who not only took the time to play devil’ advocate when he should have been spending time with his family, but also took the time to review the completed manuscript. An- other is Randy Grindstaff, the real-life “Mr. Electrician,” who verified the plausibility of the example in Chapter 3. And finally, there is my wife, Pat She reviewed portions of the text (both as a quality practitioner and as an Associate Professor of English), offered encouragement, and scheduled her own writing of gardening books and articles around my work on this book. Terry First | would like to acknowledge fellow quality professionals who en- couraged us to write this book after a talk that Terry and I gave in Balti- more. I would like to thank Terry for agreeing to work with me on this xiiixiv © After the Quality Audit book. Joining forces and coauthoring this book has not diluted the mes- sage, but has added value By combining our knowledge we were able to bring together ideas from our varied experiences that neither of us could have done alone. | would also like to thank the quality audit professionals who donated their valuable time to review the models, flowcharts, and cause-and-effect diagrams used in this book. In fact, a special thanks is due Dennis Arter, who reviewed the final draft of the manuscript in spite of a busy schedule, No acknowledgment would be complete without rec- ognizing my in-house reviewer, my wife Jan. She spent endless hours re- viewing manuscripts to point out problems—maybe she was an auditor in another life. Her input ts highly valued and has resulted in a more com- plete, professional literary work iPIntroduction The past few years have brought a proliferation of ISO 9000-based quality systems. Correspondingly, the number of consultants and auditors avail- able to help organizations prepare for ISO registration has increased. We have noticed in our work that no matter how good the consultant or the client organization, there is a recurring pattern. The same problems are found, reported, and corrected in one audit after another, but they still continue to occur. After reviewing many occurrences of this phenomenon, we came to realize that the solution lies between the performance of the audit and the follow-up audit. In other words, somewhere between the delivery of the auditor’s product (the audit report) and the customer’ use of the product (corrective action) there is a breakdown. As quality profes- sionals and auditors, this concerns us because we know that this is not the way the process should work Now, this book is not about the audit process. There are already many good books on quality auditing that discuss the preparation, performance, reporting, and closure of audits, but most of these leave the reader with the impression that follow-up audits are the rule rather than the excep- uon. The reality is that many clients view the audit report as the end of the audit and the end of the auditors involvement in the process. In other words, only three-fourths of the process is being completed. As a result, customers are not getting the benefits of the audit process Neither is this book written just for auditors. It is written for general management, supervisors, audit program managers, auditors, examiners and anyone who seeks improvement from audits. To succeed (get benefits), all the players in the improvement process (auditors, auditees, general wv &= xvi * After the Quality Audit management, supervisors, audit managers) must work together as a team. rather than being at odds with each other. Contrary to popular belief, the purpose of an audit is not just to iden- tily those things that are wrong. We have found time and again that the auditee already knows that not only are “things” wrong, but also knows which “things” are wrong. However, the auditee (all too frequently) can- not idenuly the system failures. The purpose of an audit, then, is to iden- ufy the system failures so that the auditee may initiate appropriate corrective/preventive actions. Appropriate corrective/preventive actions change the process or system so that the problems are fixed for good. Before we started to work on this book, we found that the fundamen- tal problem with most audit programs is not with auditor techniques dur- ing the audit. The problem is the auditee’s failure to benefit from the audit process through corrective action. We also identified several reasons for this: * The “problem” is not investigated thoroughly by the auditors. * The “problem” is not communicated effectively to the auditee + The corrective action process is not understood by the auditee * The corrective action process does not address the root cause: * The auditee does not understand the auditor’ role in this process. With that in mind, this book does not address the initial stages of the audit process. The portion ‘of the audit that ts of primary concern in this book is after the performance of the audit (.e., from audit report prepara- tion through the corrective action process). The focus of the book is as fol- lows’ * Finding problems, * Making sure the problem is understood, + Acknowledging the interrelationships between problem finders and problem solvers, * Ensuring the solutions work, and + Ensuring the audit program is managed effectively. Auditing, with its various aliases (assessment, evaluation) has become popular in the 1990s. The audit process is responsible for identifying problems that organizations often “sweep under the rug.” Hiding prob- lems, which has been our MO (modus operandi), is not good for business and certainly does not promote continuous quality improvementintroduction * xvii We will address continuous quality improvement only to a limited de- gree. While we recognize its importance, it is outside the scope of this book Of what Jim Van Patton, of Trinity Performance Systems, Inc , calls the “three quality improvement camps,” we will, for the most pant, limit our discussion to solving problems identified in audits (assessments, evaluations, etc.) A dependable process to ensure that we find the underlying causes of a problem and then determme a long-term solution for that problem has been evading us. This situation should not surprise us, since we are inun- dated with poor examples of problem resolutions within organizations and society. Many organizations seem to have the time to do things over, but not enough time to fix them correctly. Furthermore, there is a media frenzy to point out problems and ensure that the guilty are punished, but rarely do we hear about how the system was changed to prevent recur- rence of problems. We must conclude that the media has decided that the long-term solutions are not newsworthy. For example, most of us know about the Hubble Telescope problem and that it was repaired, but few know about the efforts to change design and production systems to ensure that a similar problem does not occur with future projects Another major concer preventing the résolution of problems is that many managers feel the same way about quality system auditors as you feel about IRS auditors. An observer might easily identify your lack of trust through your change of posture and the tightening around your eyes as you hear the words, “Hello, | am from the IRS. | am here to help you.” In the same way, most managers cannot accept that an auditor truly has come to help. The sad part about this situation is that we, the auditors, have done little to dispel their fears. One of the goals of this book is to provide techniques for improving the relationship between auditors, auditees, and management while improving the corrective action process. In order to achieve this goal, we have devel- oped the Audit Function Improvement Process. Of course, we also discuss effective audit reports, presenting the audit results, and the problem-solving, process before we introduce the Audit Function Improvement Process This book progresses through the following steps * Understanding the meaning of the terms corrective and preventive action—we need to be able to see the big picture and understand the lingo * Discussing the relauonship of audit inputs to the corrective action process and how to provide effecuve inputs to corrective action—if we start with garbage we will end up with garbageS xviii * After the Quality Audit * Understanding the principles of corrective/preventive action process—we cannot do it unless we know what it is we are doing * Presenting and discussing the Audit Function Improvement Process—step-by-step activities and examples. * Discussing methods for ensuring that organizations are maximizing the benefits of the corrective action process—why do itif we don't benefit? + Evaluaung audit program management and providing methods for improving effectiveness—-poor audit program management may be the major roadblock to improvement. * Closing the loop by discussing other potential causes of ineffective corrective action from audit investigations using cause-and-effect analysis—leaving no stone unturned unul we uncover all causes of ineffectiveness We provide many examples throughout the book, and we “call them like we see them.” It is not our intention to offend any individual, group, or organization, but if it looks like a duck, walks like a duck, and sounds like a duck, then it probably is a duck. This book serves as a reality check to see if you are serious about reaping the benefits of the audit process or are just going through the motions in order to get credit for conducting the audits or checking off the audit results. An organization’s audit program should result in improved perfor- mance. If your organization is like many, you have trained auditors. But 90% of the training was in the interpretation of performance standards (ISO 9000, the Malcolm Baldrige National Quality Award criteria, etc.) and how to detect failures. This book describes closing the loop on the audit process and the relationship between auditors, stakeholders, and management for getting results that benefit (not hinder) the organization. After all, that is what the audit process is all about. Isn't i?Chapter 1 The Corrective and Preventive Action Process How Did We Get Here? Everybodys doing it, and doing it... and doing it. "It" represents auditing and what is happening today. Yes, we used the “A-word.” The word that even the Internal Revenue Service avoids within the inner circles of the col- lection division in Washington, D.C. The A-word is so unpopular that every possible pseudonym is used to replace it, such as evaluation, review, self-assessment, or appraisal. Lots of organizations are doing it (the A- word) and some are doing a good jab of it, However, most are in the “fair” to “lousy” category: Organizations are sending hordes of trained and untrained auditors and examiners to look under every rock and in every nook and cranny to find problems that need to be fixed and opportunities for improvement They are checking things forward, backward, and upside down—just to be sure. We have seen literally volumes of tabulated problems stored in books, three-ring binders, and spreadsheets as a type of monument to all the auditors, assessors, and examiners. The difficulty with these problem lists is that organizations are doing a lousy job of getting any benefit from this massive effort to find what they are doing wrong. In short, organiza- tons are doing a great job pointing out the problems, but a poor job of de ciding which are important and then fixing the problems so that they do not happen again= 2 + After the Quality Audit What about your organization? Are you constantly advancing, or are you taking one step backward for every two steps forward? Many organiza- tions are taking as many steps backward as forward, or worse, losing ground. One common step backward comes from wasting internal re- sources due to poorly managed corrective action and evaluation programs. You may be using auditing and employee suggestion systems to iden- ufy problems or opportunities within your organization, business, or pro- cess. You may be assessing your system compared to intermational quality management standards. Your organization may be assessing against quality award criteria, environmental management, or for safety. Most organiza- tions, however, are not getting the benefits that they should from their cor- rective/preventive actions programs. The primary focus of this book is how to get the desired improvement from audits, from the identification of problems through their resolution. Our pledge is to stay true to this focus, so we will not be able to accommo- date every term to fit every nuance of the improvement process. We will, however, define and clarify terms that we use so that we all have a com- mon understanding as we travel along the corrective/preventive action process road together. Correcting vs. Improving: Is the Glass Half Empty, or Half Full? Some people want to call any improvement process a corrective or preven- tive action program, while others say we should focus on the positive and talk about new opportunities for improvement. Real-world experiences lead us to believe that people don’t start correcting or improving until they hgure out that there will be some benefit to them or their organization for their ef- forts: the WIIFM (“Whats in it for me?”) theory. Sometimes they figure out for themselves that they have a problem (opportunity?), and other times someone else tells them (through audits, assessments, examinations) Improvement actions may stem from a problem statement, whether the result of a recognized noncompliance or the realization that a new product design will probably cause excessive returns. So, in many cases, correcting is improving, preventing is improving, improving is correcting, and improving is preventing. In other words, things equal to the same thing are equal to each other. Correcting a problem presents an opportu- nity to improve, and initiating action to take advantage of an opportunity presupposes the existence of a problem for the organization or individual Such action also indicates that potential concerns (that have yet to make themselves known) may be lurking in the shadows. In this book we will use the term corrective/preventive action to describe the process, and the term problem as the input to the process.The Corrective and Preventive Action Process « 3 Continuous Correcting Is Not Continuous Quality Improvement Some taining organizations teach that corrective action is continuous im- provement. Corrective action is a part of continuous improvement but cer- tainly does not represent an entire continuous quality improvement program. Continuous quality improvement has many aspects, elements, and ingredients. In order to ensure profitable continuous improvement activities, the following elements or attributes should be integrated into your organizational culture * A process to reduce variation that is integrated into the manage- ment philosophy + Apreventive style of management for doing all work might the first ume + A feedback system for customers and suppliers (both internal and external) * Ameans for promoting and motivating people to participate Although continuous improvement is not the focus of this book, we want you to understand that these attributes are important for continu- ous improvement activities to succeed. We also want to make it per- fectly clear that just because you have a corrective action program does not mean that you have achieved continuous quality improvement We also want to remind you that continuous quality improvement is not just about solving problems. While continuous quality improvement may begin with the investigation of a problem, or an identified concern which has the potential for becoming “a problem,” there are always issues or opportunities for improvement which are raised through this process that will lead to further improvement. Continuous quality improvement is not a linear process, but a cyclical process for achieving optimal perfor- mance and customer satisfaction Corrective and Preventive Actions Corrective/ Preventive Action, ISO Style The ISO 9000 and ISO 10011 series standards provide a good frame- work for corrective and preventive action that will be used in this book The 1994 issue of the ISO 9000 series standards added the word pre- ventive action to the corrective action clause of the ISO 9001 and ISO 9002 standardsS 4+ After the Quality Audit Uf you have read clause 4.14 of ISO 9001, “Corrective and Preventive Action,” two things may come to mind 1. Subclause 4.14.2, “Corrective Action,” emphasizes corrective actions related to external (outside your organization) failures (problems), and Subclause 4.14.3, “Preventive Action,” emphasizes preventive actions related to internal (inside the organization) failures (prob- lems) w If that is the impression you have when you read clause 4.14, you are not alone. You are actually in the company of a great many others who are also incorrect, including consultants and registrars (caveat emptor!). But, at least, you are not alone in this belief. This preventive action thing is new to a number of people, present company excluded, of course. For that reason, this clause has led to an astonishing amount of discussion and confusion However, like you, we are practitioners who believe the confusion can be remedied, and provide the following explanation to clarify this issue. First, let us take a look at the requirement standards, ISO 9001 and 1SQ 9002, clause 4.14.1 (General), 4.14.2 (Corrective action) and 4.14.3 (Preventive action). The first part, 4.14.1, states the basic stuff about pro- cedures and implementation, eliminating the cause of actual and potential nonconformities, assessing risk, and changing documentation as a result of corrective and preventive action—not exactly breathtaking stuff. The fun begins with 4.14.2, which start with a statement regarding the han- dling of customer complaints. Clause 4.14.2.a sets the stage for all correc- tive action procedures and activities to be focused on external events involving the customers of the organization. By default, one would think that 4.14.3 must be related to internal events. Although a simple interpre- tation, it has one minor flaw: it is wrong! While it is true that clause 4.14.2 begins with a statement regarding customer complaints, 4.14.2.a is the only portion that relates specifically to customer complaints. The subclauses that follow, 4.14.2.b and c, indi- cate that procedures shall address corrective actions for product or service, process or quality system nonconformities, and failures (i.e., you detected a problem), whether they are discovered internally or externally. The statements that follow in 4.14.3 address the analysis of internal data to iden- tify and eliminate the potential causes of product or service, process or qual- ity system nonconformities whether they may be found internally or by the customer. Just the addition of the word preventive has been confusing to some people, some don't care as long as they can continue to satisfy their regis-The Corrective and Preventive Action Process * § war, while others seek an ironclad (black and white) definition that will clearly explain the difference between corrective and preventive action. We would like to clarify these terms by providing a slight variation to the ISO 8402 definitions in order to provide some insight into the difference between them. Corrective Action: an action taken to eliminate the cause(s) of existing nonconformities (problems) or any other undesirable sit- uation in order to prevent recurrence Your house roof is more than 20 years old and has started to leak. You replace the roof and repair the ceiling in the master bedroom where the roof leaked Preventive Action: an action taken to eliminate the cause(s) of potential nonconformities (problems) in order to prevent occur- rence You determine that your house roof is more than 20 years old and that 20 year shingles were installed. You replace the roof before it starts to leak. . These definitions say you must eliminate causes to either prevent oc- currence or prevent recurrence of potential problems (nonconformities). When done correctly, determining the cause (i.e., the underlying or root cause) of a problem (nonconformity) and taking action to prevent it from happening again is not always easy. This is because for our actions to be effective, we must have reliable information about our process and service or product performance and we must employ systems thinking (systems thinking is discussed later in this chapter) In many cases, people within organizations may decide that they can get by with implementing a quick fix or remedy for a problem that does not address the underlying cause. People implement quick fixes either be- cause the problem seems minor or as a “band-aid” to take some action while awaiting a final resolution. It is an interim action between the iden- tification of the undesirable situation and implementing a corrective ac- tion. Quick fixes are common, so we need a term to define this type of action. We will call quick fixes remedial (or interim) actions. Remedial Action: an action taken to alleviate the symptoms of existing nonconformities or any other undesirable situation Your house roof is more than 20 years old and has started to leak. You patch the roof with roofing tar to stop the leak and replaster the ceiling in the master bedroom where the roof already leaked.e 6 + After the Quality Audit Remedial action may be taken as an intermediate step in the corrective action process. For example, you have defined a problem but you need to take steps to minimize its effects before you can identify the root cause and determine the best solution. In that case, you might initiate 100% sorting activities, or retesting, to avoid the possibility of questionable product reaching the next stage in the process or, worse, your customers. There may be times when you do not have enough data to be convinced that a problem is serious enough for you to initiate full-blown corrective action. At other times, you may rationalize that taking remedial action is acceptable because you do not have ume to initiate full-blown corrective action for everything, Caution: The practice of taking remedial action should not be abused. Though we recognize the practice of taking remedial ac- tion, this should not be used as a license to avoid implementing, corrective/preventive action on “the important stuff.” A good example of when remedial action is appropriate happened the same week as we were developing this chapter. A facility was audited by a third-party auditor who issued a nonconformity stating: “Some of the pro- cedures are not referenced in the quality manual.” This type of trash is dis- appointing and demoralizing to the audited organization. If an auditor cannot do any better than report some microscopic nit, then he/she should change careers. Would you initiate a full-blown corrective action investigation to determine underlying causes, evaluate the process of de- veloping quality manuals and putting all procedure numbers in the docu- ment, and possibly issuing new procedures for writing a quality manual? We hope not! What you should do is add the missing procedure reference to the manual at the next issue. This is remedial action: no underlying causes were investigated, and the system didn't change. It isn't worth con- suming 160 hours of a person’ time to investigate and implement a root- cause solution. When you are addressing the root cause of a problem because of a known defect, you are implementing corrective (and not preventive) ac- tions. When you are fixing the root cause of a potential problem as a re- sult of analysis, you are implementing preventive (not corrective) actions. The input to remedial, corrective, and preventive action are shown in Figure 1-1. The numbers in Figure I-1 refer to [SO 9001 and ISO 9002 clause numbers. The process starts with the identification of the product or service problem (nonconforming product). An example of a problem may be that a product does not meet specifications, such as a report with errors, aThe Corrective and Preventive Action Process * 7 Figure 1-1: Corrective/ Preventive Action Inputs and Outputs. rental car that was not properly cleaned to be customer ready, or merchan- dise that was damaged. Then problem detection is combined with defi- ciencies found from audits and customer complaints to form the inputs to corrective action. All the inputs are existing problems identified with a product or service. The problems are then reviewed (filtered or screened) to determine what action to take. The choices are: (1) do nothing because itis a isolated error or a minor issue, (2) take remedial action, or (3) take corrective action. Thus corrective action is being reactive: reacting to every product, service, or quality system (from audits) failure The second input to the corrective/preventive action process is from the analysis of performance data All records can be analyzed to reveal positive and negative trends or outcomes. The records analyzed should in- clude all quality records such as nonconforming product or service (its bad, it's wrong, it didn't work), audit results, and customer complaints. In many cases, statistical techniques (statistical process control charts, trend charts, histograms, Pareto charts, scatter diagrams, cause-and-effect dia- grams, etc.) are used to analyze data and processes. Analyzing data will point out potential improvement areas so that action can be taken to pre- vent (proactive) the occurrence of an “unplanned event.” Other common proactive iniuatives include analyzing the results of customer surveys. conducting capability studies of processes, and failure mode and effects analysis (FMEA)2 8 + After the Quality Audit In fact, the FMEA may be the most frequently documented example of preventive action available. There are two kinds of FMEAs: design FMEAs and process FMEAs. Design FMEAs are applied during the design stages of product or service. Process FMEAs are applied to new or existing processes (a defined series of steps that lead to desired result). The purpose of both is to identify potential failure modes (problems with the design or process) and eliminate or, at least, minimize their effects. The methodology em- ployed is to evaluate the system—systems thinking—to ensure that all po- tential failure modes are considered, whether product or process related. Although all possible failure modes cannot be eliminated, controls can be implemented to minimize or eliminate their effects. We have included the word informal in the corrective/preventive model be- cause the identification of the need to practice preventive action is not al- ways the result of a formal analysis. There are informal and intuitive inputs (for example, you believe performance could be better than it is now), In many ways, the informal intuitive analysis (what many of us do every day in our job) is superior to formal analysis because the human brain can consider a vast number of variables at one time and sort out irrelevant information. The problem with relying solely in intuitive analysis is that it is inconsis- tent—we don't always have enough relevant data for our brains to process. We recognize that there are times that facts, or data, are not the prob- lem. It is often the case that it is not the facts, but our interpretation of the facts that is the problem. In our own experience, we have found that the “facts” indicate that a specific action is appropriate, but we “know” (our in- tuition has “kicked in") that the action indicated by the facts is incorrect. In that case, we have two options: We can either stop until we can obtain more data, or we can act. Unfortunately. the reality is that we either do not always have the luxury of time or we do not always take the time to analyze a situation thoroughly. Sometimes people do not always have sufficient in: formation on hand for a good intuitive analysis Intuitive analysis is a very valuable (if not the most value-added) input into the preventive action process. It would not surprise us to learn that many preventive action projects are initiated when someone within the organization is able to foresee a potential problem (or opportunity) when the facts did not indicate the possibility of such an occurrence. You don't need to be a psychic or clairvoyant to provide input to the improve- ment process, it comes from being a good manager, supervisor, or associ- ate. You are collecting information and interpreting it rather than waiting for a computer to do it for you