1、 ASQC D33bO 95 0759506 0003749 227 ANSVASQC D1160-1995 AMERICAN NATIONAL STANDARD Formal Design Review I AMERICAN SOCIETY FOR QUALITY CONTROL 611 EAST WISCONSIN AVENUE MILWAUKEE, WISCONSIN 53202 ASQC DLLbO 95 m 0759506 OOOL750 T49 m ANSUASQC D1160-1995 Contents 1 Scope 1 2 References 1 2.1 Normative
2、 references 1 2.2 Relateddocumen ts 1 3 Delkitions 2 4 Application of formal design review 2 5 Management of the process 2 5.1 Policy statement 2 5.2 Precautions . 2 6 Formal design reviews during life cycle phases 2 6.1 Types 2 6.2 Generalobjectives 3 6.3 Specific objectives 3 7 Team composition an
3、d qualities . 7.2 Specific considerations . 7 5 7.1 Commonqualities 5 7.3 Chairperson . 7 7.4 Secreta sl . 7 7.5 Specialists 8 7.6 Designers and developers . 8 8 Planning and scheduling 8 8.1 Introduction . 8 8.2 Timllig . 8 8.3 Schedule . 8 9 Implementation . 9 9.1 General 9 9.2 Notification and ag
4、enda 9 9.4 Topics . 9 . 9.3 Inputdata 9 9.5 Conduct of formal design review meetings . 11 9.6 Documentation . 12 9.8 Legalapproval . 13 9.7 Follow-Up 12 . 111 ASQC DLLb0 95 m 0759506 000L75l1 985 m ANSI/ASQC D1160-1995 1ORoleofspecialists . 13 10.1 Allspeciali sts 13 10.2 Individual specialists . 13
5、 10.2.1 Reliability . 13 10.2.3 Maintainability 14 10.2.4 Maintenance support performance 14 10.2.5 Availabili sl . 14 10.2.6 Quality . 14 10.2.7 Environmental effects . 15 10.2.8 Productsafety 16 10.2.9 Humanfacto rs 16 10.2.10 Legalma tters . 16 10.2.2 Maintenance . 13 Annex A EC Publications Prep
6、ared by Technical Committee No . 56 (informative) . 19 iv ASQC DllbO 95 0759506 OOOl752 8ll m Introduction The objective of conducting design reviews during the development cycle is to ensure that products or services satisfy spec- ified dependability, life, safes, endurance, environment, electromag
7、netic compatibility, and performance requirements at a minimum cost and are deliverable within a prescribed schedule. Design review enhances the development of products or processes through cost reduction, delivery schedule improvements, and better quality, performance, and safety. It can be employe
8、d by both supplier and customer. Design review is an advisory activity. It is intended primarily to provide synergistic verification of the work of the devel- opment team, and only secondarily to provide input to the creative process. Design review should thus be considered a refming procedure and n
9、ot a creative one. Design reviews, regardless of frequency or depth, cannot replace good product dehitions, design specifications, design, and engineering. Used as a control process, design review can provide the necessary verification of the successful com- pletion of the design effort at a given t
10、ime. Design review should not be confused with day-to-day management of a project. The manager of the project carries the design responsibility and the hal decisions should be hishers. Design review is an independent activity, and, when prop- erly done, increases confidence that design and engineeri
11、ng activities were camed out with due regard to all pertinent requirements throughout the product life cycle. V ASQC DllbO 95 075950b 0003753 758 ANSVASQC D1160-1995 AMERICAN NATIONAL STANDARD Formal Design Review Prepared by American Society for Quality Control Standards Committee for American Nati
12、onal Standards Committee Z- I on Quality Assurance An American National Standard Approved on September II, 1995 American National Standards: An American National Standard implies a consensus of those substantially concerned with its scope and provisions. An American National Standard is intended as
13、a guide to aid the manufacturer, the consumer, and the general public. The existence of an American National Standard does not in any respect preclude anyone, whether he or she has approved the standard or not, from manufacturing, purchasing, or using products, processes, or procedures not conformin
14、g to the standard. American National Standards are subject to periodic review and users are cautioned to obtain the latest edition. Caution Notice: This American National Standard may be revised or withdrawn at any time. The procedures of the American National Standards Institute requirt that action
15、 be taken to reaffirm, revise, or withdraw this standard no later than five years from the date of publication. Purchasers of American National Standards may receive current information on all standards by calling or writing the American National Standards Institute. ASQC DI160 95 0759506 OOOLi5Y 69
16、4 O 1995 by ASQC Ail rights reserved. No part of this book may be reproduced in any form or by any means, electronic, mechanical, photo- copying, recordmg, or otherwise, without the prior written permission of the publisher. ASQC Mission: To facilitate continuous improvement and increase customer sa
17、tisfaction by identifying, communicating, and promoting the use of quality principles, concepts, and technologies; and theIeby be recognized throughout the world as the leading authority on, and champion for, quality. 109 8 7 65 4 3 2 1 Printed in the United States of America Printed on acid-free pa
18、per Published by: ASQC 611 East Wisconsin Avenue Milwaukee, Wisconsin 53202 - ASQC DLLb0 95 E 075950b 0003755 520 ANSIIASQC D1160-1995 FORMAL DESIGN REVIEW 1 SCOPE This American National Standard makes recommenda- tions for the implementation of design review procedures as a means of stimulating pro
19、duct and/or process improve- ment. It includes guidelines for planning and conducting design reviews and specific details concerning contribu- tions by reliability, maintenance, maintenance support, and availability specialists. This American National Standard also includes subclauses on contributio
20、ns by other specialists dealing with related subjects such as quality, environment, safety (product and user), human factors, and legal matters. In addition to the common understanding of “product,” it is expedient to include other aspects, e.g., hardware and software, catalog listings, specificatio
21、ns describing the item, shipping package, installation and assembly, instruc- tions and operating manuals, labels and warnings, mainte- nance, spare parts lists, warranties, sales brochures, and advertising literature. 2 REFERENCES 2.1 Normative references The following standards contain provisions
22、which, through reference in this text, constitute provisions of this American National Standard. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this American National Standard are encouraged to investigate the
23、possibility of applying the most recent edition of the standards listed below. The American National Standards Institute and members of IEC and IS0 maintain registers of currently valid American National Standards and International Standards. IEC SO( 191): 1990, International Electrotechnical Vocabu
24、lary (IEVJ, Chapter 191: Dependability and qual- ity of service. ANSIIISOIASQC-A8402, Quality Management and Quality Assurance-Vocabulary, 2.2 Related documents The following are listed in this document but are not shown in the IEC 1160 standard on Formal Design Review. These are for the readers use
25、, but are not a part of the international standard. IEC 319: 1978, Presentation of reliability data on elec- tronic components (or parts). IEC 362:1971, Guide for the collection of reliability, availability, and maintainability data from field pej5or- mance of electronic items. IEC 409:1981, Guide f
26、or the inclusion of reliability clauses into spec$cations for components (or parts) for electronic equipment. IEC 60s: 1978, Equipment reliability testing series of standards for different conditions. IEC 706-1: 1982, Guide on maintainability of equipment, Part I: Sections One, Two and Three-Introdu
27、ction, requirements and maintainability program. IEC 706-2: 1990, Guide on maintainability of equipment, Part 2: Section Five-Maintainability studies during the design phase. IEC 706-3: 1987, Guide on maintainability of equipment, Pari 3: Sections Six and Seven-Verijkation and collec- tion, analysis
28、 and presentation of data. IEC 812:198S, Procedure for failure mode and effects analysis (FMEA). IEC 863: 1986, Presentation of reliability, maintainability and availability predictions. IEC 1014: 1989, Programs for reliability growth. IEC 1025: 1990, Fault tree analysis (FTA). IEC 1070: 1991, Compl
29、iance test procedures for steady- state availability. IEC 1078: 1991, Analysis techniques for dependability- Reliability block diagram method. ANSVISOIASQC 49000- 1 - 1994, Quality Management and Quality Assurance Standards-Guidelines for Selection and Use. ANSIIISOIASQC 49001 - 1994, Quality System
30、s- Model for Quality Assurance in Design, Development, Production, Installation, and Servicing. 1 ASQC DIiL60 95 0759506 0003756 467 ANSIIASQC D1160-1995 ANSIIISOIASQC Q9002- 1994, Quality Systems-Model for Quality Assurance in Production, Installation, and Servicing. ANSVISOIASQC 49003- 1994, Quali
31、ty Systems-Model for Quality Assurance in Final Inspection and Test. ANSIASOIASQC 49004- 1 - 1994, Quality Management and Quality System Elements-Guidelines. 3 DEFINITIONS For the purpose of this American National Standard the terms and desnitions of IEC(50)191: 1990 apply together with the followin
32、g additional definitions. 3.1 formal design review: A formal and independent examination of an existing or proposed design for the pur- pose of detection and remedy of deficiencies in the requirements and design which could affect such things as reliability performance, maintainability performance,
33、maintenance support performance requirements, fitness for the purpose, and the identification of potential improvements. NOTE: Design review by itself is not sufficient to ensure proper design IEV 191-17-131. NOTE: Design can relate to a product, process, or procedure. 3.2 action item: A question to
34、 be resolved before the formal design review is completed. 3.3 recommendation: A specific proposal to change a product, process, or schedule, to be acted upon or for- mally rejected before the design review is completed. 4 APPLICATION OF FORMAL DESIGN REVIEW Every organization should adopt a compreh
35、ensive design review program as presented in this American National Standard, or else tailor a more limited one involving spe- cific needs. The design review should be incorporated into the over- all operating procedures and integrated with product safety, electromagnetic compatibility, quality, and
36、 relia- bility programs. Limitations of size and resources of the organization, project value, product benefits, risks, and complexity, all influence the review process. In smaller organizations, it may be necessary to supplement staff with personnel from suppliers, consultants, and other outside ad
37、visors. 5 MANAGEMENT OF THE PROCESS 5.1 Policy statement Each organization, e.g., corporation, plant, division, agency, project, as appropriate, should issue a policy state- ment governing the practice of design reviews authorized by the chief operating officer of the organization. The policy statem
38、ent should include the following: -Formal design review should be conducted for all new products, processes, and applications, and for revisions to existing products and manufacturing processes which would affect function, performance, safety, dependability, electromagnetic compatibility, ability to
39、 cost, or other characteristics affecting the product andor process, users, observers, or the population at large; -Design reviews should be conducted at appropriate intervals to consider changes in technology which may affect the specified characteristics. A senior member of management should be re
40、sponsible for executing the policy on design review and implement- ing the policy statement by developing specific procedures and practices in accordance with this American National Standard. 5.2 Precautions Care should be taken to prevent the design review process from dictating the ultimate design
41、 by directing the detailed engineering work. Decisions are made every day which bear on the product or process under review. If each deci- sion were subjected to an independent review, the review team would, in essence, design the product, requiring an excessive time. Conversely, if the fmt formal d
42、esign review occurred only just before production, its benefit would be questionable. At that point, no corrective action could be taken, short of stopping the project because of a critical problem with potentially catastrophic consequences. 6 FORMAL DESIGN REVIEWS DURING LIFE CYCLE PHASES 6.1 Types
43、 This American National Standard adopts the philosophy that an appropriate type of design review should be con- ducted before taking any major decisions. 2 ASQC DZlbO 95 W 0759506 0003757 3T3 W ANWASQC D1160-1995 Life cycle phase Type of design review Acronym Concept and definition Preliminary PDR D
44、esign and development Detailed; Final DDR; FDR Manufacturing Manufacturing MDR Installation Installation IDR Operation and maintenance Use UDR To achieve the desired objectives, design reviews should be held at several decision points, or “milestones,” during the product life cycle phases (see IEC 3
45、00-2). The various types are listed in Table 1. A separate review for the disposal phase is normally not applicable. Disposal considerations should be covered during PDR, FDR, MDR, and UDR. Clause 6.3.1 6.3.2; 6.3.3 6.3.4 6.3.5 6.3.6 6.2 General objectives The principal objective of a design review
46、program is to ensure that the product requirements are correct and met and will result in a reliable, useful, and saleable product. Particularly, the design review process is designed to ensure: -the product meets specified requirements cost effectively; -the product satisfies customer needs; -the p
47、roduct and its elements can be safely and econom- ically disposed of; -required design, manufacturing, and installation meth- ods are being utilized; -costs have been optimized after considering all product requirements; -scheduling considerations are taken into account; -components are used within
48、their specified perfor- mance and stress ratings. Formal design review facilitates assessment of the status of the design, identifies weaknesses, and guides the proj- ect team toward appropriate corrective action. It acceler- ates maturing of the product or process by reducing the time needed to sta
49、bilize design details, and allows produc- tion to proceed without frequent interruptions. Design review also stimulates early product improvement. Disposal As a result of the action items identified and recommen- dations made, the product development team should con- sider changes in design concepts, specifications, plans, schedules, costs, and in safety, quality, manufacturing, installation, operation, and maintenance procedures. For an effective program, the subjects and results of dis- cussions during each formal design review should be doc- umented to permit continuity and foll
