1、A PRACTICAL FIELD GUIDE FOR AS9100CAlso available from ASQ Quality Press:A Practical Field Guide for ISO 9001:2008Erik Valdemar MyhrbergISO 9001:2008 Explained, Third Edition Charles A. Cianfrani, John E. “Jack” West, and Joseph J. TsiakalsISO Lesson Guide 2008: Pocket Guide to ISO 9001-2008, Third
2、EditionJ.P. Russell and Dennis R. ArterISO 9001:2008 Internal Audits Made Easy: Tools, Techniques, and Step-By-Step Guidelines for Successful Internal Audits, Second EditionAnn W. PhillipsProcess Driven Comprehensive Auditing: A New Way to Conduct ISO 9001:2008 Internal Audits, Second EditionPaul C.
3、 PalmesISO 9001:2008 Interpretive Guide for the Design and Construction Project Team (e-Book)Prepared by members of the ASQ Design and Construction Division and edited by John R. BroomfieldHow to Audit the Process-Based QMSDennis R. Arter, John E. (Jack) West, and Charles A. CianfraniThe ASQ Auditin
4、g Handbook, Third EditionJ.P. Russell, editing directorQuality Audits for Improved Performance, Third EditionDennis R. ArterThe Quality Toolbox, Second EditionNancy R. TagueMapping Work Processes, Second EditionBjrn Andersen, Tom Fagerhaug, Bjrnar Henriksen, and Lars E. OnsyenLean Kaizen: A Simplifi
5、ed Approach to Process ImprovementsGeorge Alukal and Anthony ManosRoot Cause Analysis: Simplified Tools and Techniques, Second EditionBjrn Andersen and Tom FagerhaugThe Certified Manager of Quality/Organizational Excellence Handbook, Third EditionRussell T. Westcott, editorTo request a complimentary
6、 catalog of ASQ Quality Press publications, call 800-248-1946, or visit our Web site at http:/www.asq.org/quality-press.ASQ Quality PressMilwaukee, WisconsinA PRACTICAL FIELD GUIDE FOR AS9100CErik Valdemar Myhrberg withDawn Holly Crabtree and Rudolph “RE” HackerAmerican Society for Quality, Quality
7、Press, Milwaukee 53203 2010 by ASQAll rights reserved. Published 2010Printed in the United States of America16 15 14 13 12 11 10 5 4 3 2 1Library of Congress Cataloging-in-Publication DataMyhrberg, Erik V.A practical field guide for AS9100C / Erik Valdemar Myhrberg ; with Dawn Holly Crabtree and Rud
8、olph “RE” Hacker. p. cm.Includes bibliographical references.ISBN 978-0-87389-793-8 (alk. paper)1. Aerospace engineeringQuality controlStandards. 2. Aerospace industriesManagement. 3. ISO 9000 Series Standards. I. Crabtree, Dawn Holly. II. Hacker, Rudolph. III. Title.TL671.28.M94 2010629.10684dc22 20
9、10021511ISBN: 978-0-87389-793-8No 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: William A. TonyAcquisitions Editor: Matt T. MeinholzProject Editor: Paul
10、OMaraProduction Administrator: Randall BensonASQ 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 P
11、ress books, video, audio, 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
12、 to request ASQ membership information, call 800-248-1946. Visit our Web site at http:/www.asq.org/quality-press.Printed on acid-free paperWe dedicate this combined work to our loving families.(This page intentionally left blank)viiCONTENTSPreface . ixSection 4: Quality Management System 14.1 Genera
13、l Requirements 24.2 Documentation Requirements 5Section 5: Management Responsibility . 175.1 Management Commitment 185.2 Customer Focus . 205.3 Quality Policy 225.4 Planning 245.5 Responsibility, Authority, and Communication 285.6 Management Review . 34Section 6: Resource Management . 416.1 Provisio
14、n of Resources . 426.2 Human Resources . 446.3 Infrastructure 486.4 Work Environment . 50Section 7: Product Realization 557.1 Planning of Product Realization 567.2 Customer-Related Processes . 597.3 Design and Development 657.4 Purchasing . 807.5 Production and Service Provision . 867.6 Control of M
15、onitoring and Measuring Devices 97Section 8: Measurement, Analysis, and Improvement 1158.1 General . 1168.2 Monitoring and Measurement 1188.3 Control of Nonconforming Product . 1278.4 Analysis of Data 1298.5 Improvement . 131Conclusion 145AS9100 Documented Requirements by Section 147Glossary 149Refe
16、rences . 151viii ContentsixPREFACEWith the dawning of the twenty-first century, companies are being pushed to the extremes of their limited resources. At one time it was sufficient to meet most of our customers requirements, but not now. On a global scale, we are all being asked to do more with less
17、and for less. At some point soon the cur-rent internal systems will not be able to hold back the deluge, and companies will be faced with a stark decisionconsistently improve or perish.Companies, teams, and individuals are still trying to meet customer expectations in an effective and efficient mann
18、er, worldwide competition still drives the need for innovation, and internal process pressures still demand continual improvement in order to remain functional. One of the best and most widely accepted ways in which companies can face these challenges is to implement an effective and efficient quali
19、ty man-agement system, which not only adds value to the organization but also satisfies the customer. It is extremely challenging to stay competitive in the aerospace industry; the need for assurance of good material is paramount and has driven cost, sometimes unnecessarily due to the continued exis
20、tence of outdated manufacturing and quality system thinking and practices. Cost is primarily due to small order quantities, product complexity, and special processes and materials. Yet, traditional production, over-inspection, and processing techniques are also extremely costly, as typically many re
21、dundant tests of the same feature occur to assure conformance.When MIL-Q-9858 was retired, the aerospace industry started to feel the ill effects of the absence of aerospace-specific mandated criteria. Though many companies registered to ISO 9001, which provided a fantastic yet generic business qual
22、ity management system, it did not address the needs of the aerospace industry. To those of us who could see the wastes in the traditional “product realization” system, the creation of AS9000, and subsequently AS9100 based on ISO 9001, was by divine providence. Here was a QMS that focused on process
23、control that is efficient and effective, not redundant inspection, and commu-nicated the industry-specific needs of aerospacesuch as first inspection and product traceability. When ISO 9001 became a process-oriented standard in the year 2000 it better supported the process control structure of AS910
24、0; hence, AS9100:2001 is the best QMS standard for aerospacebar none!From working with and within aerospace primes, medium-size suppliers, job shops, and software design, it has become apparent how little the concept of process control has caught on. Combining the experience of over 150 QMS implemen
25、tations with responsibilities covering internal and supplier quality engineering, and training and implementing of lean manufacturing and Six Sigma quality, we readily see how businesses could avoid long-term costs of redundant non-value-adding tasks like inspections, scrap, rework, and customer ret
26、urns by following the requirements of AS9100 using proven quality tools. AS9100 is not prescriptive, but gives hints as to the use of these tools.The purpose of this field guide is to assist the reader, step by step, in implementing a QMS in con-formance with AS9100. This field guide has been create
27、d in order to facilitate an inner reliance between senior management, middle management, functional teams, and the individual. Users of the field guide will find within it practical tools, tips, and techniques useful for not only implementing a quality manage-ment system but also for maintaining one
28、.In keeping with ISO 9000s definition of “quality” as the “degree to which a set of inherent character-istics fulfils requirements,” we have identified the requirements and inherent characteristics (distinguish-ing features) of AS9100. Within this field guide, each subclause containing requirements
29、is the focus of a two-page spread that consistently presents the features listed below.Provisions (or What the Field Guide Will Do) Provide a user-friendly guide to AS9100s requirements for implementation purposes Identify the documents/documentation required, along with recommendations on what to c
30、onsider retaining/adding to a QMS during AS9100 implementation Guide internal auditor(s) regarding what to ask to verify that a conforming and effectiveQMS exists Direct management on what it must do and should consider to satisfy AS9100s enhanced requirements and responsibilities for top management
31、 Depict step by step what must occur to create an effective, conforming QMSDirect Characteristics (or What the Field Guide Provides) The standardA paraphrase of what a subclause of AS9100 requires in easy-to-understand language, with references to information in ISO 9000 and guidance in ISO 9004 to
32、enhance the users understanding of what AS9100 requires and what possible added steps the user can take to improve performance (per the ISO 9004 guidelines) Document requirementsA list of the documentation/documents required by the subclause, with some ideas to consider in satisfying those requireme
33、nts that will take the system beyond the requirements toward continual improvement Internal audit questionsWhat every internal audit team needs to ask at a minimum when assessing the QMS for conformance with the subclausex PrefacePreface xi Management summaryA concise description of what management
34、must do and/or is responsible for in order to achieve conformance to the subclause, along with some guidance on additional steps management can take to enhance the system Process control tipRecommendations of method or tools to best infuse process control into the QMS, as AS9100 was intended to be u
35、sed Subclause flowchartA depiction of the steps that need to be undertaken during an implementation/transition effort to effectively and efficiently satisfy the requirements of the subclause of AS9100, along with a box providing guidance on use of the flowchartThis field guide is designed to provide
36、 you with a consistent approach to implementing an AS9100-conforming QMS, which is appropriate since AS9100 continues to view quality as the ability of an orga-nization to consistently deliver product that meets customer specifications. The field guide examines each subclause of Sections 48 of AS910
37、0, which contain the requirements. Subclause 1.2, ScopeApplication, does not contain requirements but is critical to properly excluding any requirements of AS9100 that do not apply to your organizations QMS and should therefore be treated as an important part of the field guide due to the importance
38、 of establishing the QMSs scope.Paragraphs and items in bold italics delineate AS9100 requirements above and beyond those of ISO 9001. This includes Clauses, Internal Audit Questions, Management Summary, Process Control Tips, and Flowcharts.What separates this field guide from most other books on AS
39、9100 and its implementation are the flowcharts showing the steps to be taken in implementing a QMS to meet a subclauses requirements. But the flowcharts themselves can be overwhelming when you first look at them. For this reason, a box appears with each flowchart that explains pertinent facts and/or
40、 what the flowchart represents and how it is to be used.Remember, the QMS your organization implements must meet the needs of its usersyou and the rest of your organizations employees, from senior management to the most junior employee. So the QMS you create using this field guide will not only sati
41、sfy AS9100s requirements, but provide a set of processes that suits your organization and fosters improved use of the system and improvement in the processes of the organization over time. You may also use the ISO 9004 guidelines for further explanation. Please note that compliance to AS9100 may not
42、 ensure that your organization meets all contractual requirements.A goal throughout this field guide is to provide clear concepts of how to ingrain process control into your business utilizing the AS9100 system. Your goal: for your processes to turn out aerospace conforming parts on time, every time
43、, at a competitive cost. The companies that can compete now and in the future will need to do just that. Our hope is that our AS9100 field guide will help to get you there.To your continued success,Erik Myhrberg with Dawn Crabtree and Rudy Hacker(This page intentionally left blank)1SECTION 4: QUALIT
44、Y MANAGEMENT SYSTEM4.1General Requirements4.2Documentation Requirements2 A Practical Field Guide for AS9100C4.0 Quality Management System4.1 General RequirementsAS9100 The organization must develop, document, set up, and maintain a QMS and continually improve its effectiveness through six activities
45、, including (1) identification of needed processes, (2) making sure adequate resources and (3) information are available to support both the processes and their (4) monitoring, and (5) achieving expected results and (6) continual improvement of the processes though implemented actions. All related a
46、ctivities must conform to ISO 9001s requirements. When outsourcing related to product occurs, the QMS must contain provisions to ensure the organization controls the processes involved. A Note indicates processes that should be included in the QMS.ISO 9004 Offers guidance on activities top managemen
47、t should pursue to create a customer-oriented organization and move it and its QMS toward continual improvement and improved performance. Annexes A and B provide guidance on self-assessment and process improvement.Document Requirements:Required:No specific documents, although this subclause relates
48、to and affects other requirements in ISO 9001:2008 that concern specific QMS documents/documentation.Remember: Processes need to be clearly defined, with the sequence and interactions between stages and with other processes defined. This will require documenting the organizations operations. The def
49、ined processes must include all administration and management activities.A Practical Field Guide for AS9100C 3Internal Audit Questions: Has the quality management system been established, documented, implemented, and maintained? Have processes that are necessary for maintaining the quality management system been determined? Has the organization demonstrated continual improvement? Does the organization have control over processes that are outsourced?Management Summary:Top management must: Define systems and processes Ensu
