SIST EN 61160:2007

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EUROPEAN STANDARD
EN 61160 NORME EUROPÉENNE EUROPÄISCHE NORM
November 2005 CENELEC European Committee for Electrotechnical Standardization Comité Européen de Normalisation Electrotechnique Europäisches Komitee für Elektrotechnische Normung
Central Secretariat: rue de Stassart 35, B - 1050 Brussels
© 2005 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 61160:2005 E
ICS 03.120.01; 03.100.40
English version
Design review (IEC 61160:2005)
Revue de conception (CEI 61160:2005)
Formale Entwicklungsbewertung (IEC 61160:2005)
This European Standard was approved by CENELEC on 2005-11-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CENELEC member into its own language and notified to the Central Secretariat has the same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.



EN 61160:2005 - 2 - Foreword The text of document 56/1044/FDIS, future edition 2 of IEC 61160, prepared by IEC TC 56, Dependability, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 61160 on 2005-11-01. The following dates were fixed: – latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement
(dop)
2006-08-01 – latest date by which the national standards conflicting
with the EN have to be withdrawn
(dow)
2008-11-01 Annex ZA has been added by CENELEC. __________ Endorsement notice The text of the International Standard IEC 61160:2005 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following notes have to be added for the standards indicated:
IEC 60300-1 NOTE Harmonized as EN 60300-1:2003 (not modified).
IEC 60300-2 NOTE Harmonized as EN 60300-2:2004 (not modified).
IEC 60721-2 NOTE Harmonized in HD 478.2 series (not modified).
IEC 60721-3
NOTE Harmonized in EN 60721-3 series (not modified).
IEC 61078 NOTE Harmonized as EN 61078:1993 (not modified).
ISO 9000 NOTE Harmonized as EN ISO 9000:2000 (not modified).
ISO 9001 NOTE Harmonized as EN ISO 9001:2000 (not modified). __________



- 3 - EN 61160:2005
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. NOTE Where an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. Publication Year Title EN/HD Year IEC 60050-191 1990 International Electrotechnical Vocabulary (IEV) Chapter 191: Dependability and quality of service
- - IEC 62198 2001 Project risk management - Application guidelines
- -







NORME INTERNATIONALECEIIEC INTERNATIONAL STANDARD 61160Deuxième éditionSecond edition2005-09 Revue de conception
Design review
Pour prix, voir catalogue en vigueur For price, see current catalogue IEC 2006
Droits de reproduction réservés

Copyright - all rights reserved Aucune partie de cette publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie et les microfilms, sans l'accord écrit de l'éditeur. No part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from the publisher. International Electrotechnical Commission,
3, rue de Varembé, PO Box 131, CH-1211 Geneva 20, SwitzerlandTelephone: +41 22 919 02 11 Telefax: +41 22 919 03 00 E-mail: inmail@iec.ch
Web: www.iec.ch CODE PRIX PRICE CODE V Commission Electrotechnique InternationaleInternational Electrotechnical Commission



61160  IEC:2006 – 3 –
CONTENTS FOREWORD.5 INTRODUCTION.9
1 Scope.11 1.1 General.11 1.2 Application.13 1.3 Types of application.13 2 Normative references.15 3 Terms and definitions.15 4 Management of the design review process.17 4.1 General recommendations.17 4.2 Documentation requirements.19 5 Management responsibility.19 5.1 Top management.19 5.2 Design manager.19 5.3 Management review.19 6 Design review process.19 6.1 General.19 6.2 Planning for the design review.25 6.3 Design review personnel.25 6.4 Preparation of input package.31 6.5 Meeting notification and agenda.31 6.6 Conduct of meeting.33 6.7 Design review minutes.37 6.8 Actions and recommendations.39 6.9 Follow-up and completion of action items and recommendations.39
Annex A (informative)
Example of design stages and type of design review.41 Annex B (informative)
Example of objectives for design review at different stages
of a design’s development.43 Annex C (informative)
Example of design review panel attributes.47 Annex D (informative)
Example of design review meeting topics.49 Annex E (informative)
Example of team member responsibilities.53 Annex F (informative)
Example design review checklists questions.55
Bibliography.69
Figure 1 – Design and development process.11 Figure 2 – Design review process.23
Table A.1 – Example of design stages and type of design review.41 Table E.1 – Examples of responsibilities.53



61160  IEC:2006 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION ____________
DESIGN REVIEW
FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user. 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any equipment declared to be in conformity with an IEC Publication. 6) All users should ensure that they have the latest edition of this publication. 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and members of its technical committees and IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is indispensable for the correct application of this publication. 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. This International Standard has been prepared by IEC technical committee 56: Dependability. This second edition cancels and replaces the first edition published in 1992 and its amendment 1(1994) and constitutes a technical revision. The major changes with regard to the previous edition concern the inclusion of the previous amendment
which dealt with environmental effects (10.2.7), human factors (10.2.9) and legal matters (10.2.10), as well as clarification of responsibilities for the design review process and the design review process itself. This bilingual version (2006-02) replaces the English version. The text of this standard is based on the following documents: FDIS Report on voting 56/1044/FDIS 56/1064/RVD
Full information on the voting for the approval of this standard can be found in the report on voting indicated in the above table.



61160  IEC:2006 – 7 –
The French version of this standard has not been voted upon. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. The committee has decided that the contents of this publication will remain unchanged until the maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in the data related to the specific publication. At this date, the publication will be
• reconfirmed, • withdrawn, • replaced by a revised edition, or • amended.



61160  IEC:2006 – 9 –
INTRODUCTION The dependability of a product is enhanced through implementation of necessary disciplines during the design and development phases of a product’s life cycle. Like other technical and engineering disciplines, a design review needs to be properly managed in order to achieve its objectives. Properly implemented, design reviews enhance the potential for delivering a product of the required dependability, quality, performance, safety and potential for reduction in costs and delivery schedule. Both supplier and customer can utilize it. A design review is an advisory activity. It is intended primarily to provide verification of the work of the design development team, and to provide recommendations, where possible, to improve the product or process and its realization. Thus design reviews should be considered as a confirmation and refining procedure and not a creative one. Design reviews, regardless of frequency or depth cannot replace good product definitions, design specifications, and management of the design and development process. Used as a control process, design reviews can provide the necessary verification of the successful outcome of the design effort at a given time. Design reviews should not be confused with day-to-day management of a design project. The design manager carries the responsibility for the design and the final decisions for the response to a design review’s actions and recommendations. Design reviews when properly conducted, increase confidence that design and development activities were carried out with due regard to all pertinent requirements for a product throughout its life cycle. The application of this standard needs to be tailored to the needs of the design and development project or task in question and the organization preparing the design.



61160  IEC:2006 – 11 –
DESIGN REVIEW
1 Scope 1.1 General This International Standard makes recommendations for the implementation of design review as a means of verifying that the design input requirements have been met and stimulating the improvement of the product’s design. The intention is for it to be applied during the design and development phase of a product’s life cycle. It provides guidelines for planning and conducting a design review and specific details concerning contributions by specialists in reliability, maintenance, maintenance support and availability.
The process for design and development is outlined in Figure 1 and requirements for management of the design and development process overall are given in ISO 9001:2000. The stages at which the design review or reviews are to be held should be determined during the development of the plan for the design.
Design
planning ISO 9001:2000 – 7.3.1Design
input ISO 9001:2000 –7.3.2Need for product or process identified Design
outputs ISO 9000:2000 –7.3.3Completed design Design
verification ISO 9001:2000 – 7.3.5Design
validation ISO 9001:2000 – 7.3.6 Design processISO9001 7.3.4 Design
change ISO 9001:2000 – 7.3.7 D E S I G N
R E V I E w IEC
1541/05
NOTE Reference to the clauses of ISO 9001:2000 is for information only. Figure 1 – Design and development process



61160  IEC:2006 – 13 –
The objectives of a design review include: • assessing whether the proposed solution meets the design input requirements that include, but are not limited to: specified general performance requirements, dependability, lifecycle costs, safety, endurance, environment, electromagnetic compatibility, human factors; • assessing whether the proposed solution is the most robust, efficient and effective solution to achieve the product requirements; • providing recommendations as required for achieving the design input requirements;
• assessing the status of the design in terms of the completeness of the drawings and specifications; • assessing the evidence to support the verification of the design performance; • proposing improvements. Design review facilitates assessment of the status of the design against the input require-ments, identification of opportunities for improvement and guides the design manager towards appropriate action. It accelerates maturing of the product by reducing the time needed to stabilize design details, and allows product realization to proceed without frequent interruptions. Design review can also stimulate early product improvement. 1.2 Application The stage or stages at which a design review is to be performed should be determined in the design and development planning stage of a project or a design task. Influencing factors should include customer requirements, regulatory requirements, the size and complexity of the product, the use to which the product is to be put, and the consequences of failure. The cost to correct deficiencies in a design and the potential consequences increase as the design nears completion. Also, as the design progresses towards completion, so the flexibility to implement a change to correct a deficiency or to optimize the design decreases. Each organization undertaking design and development should adopt either a comprehensive design review programme as presented in this standard, or tailor a more limited one to meet specific product and/or process needs. The design review should be incorporated into the organization’s overall management system and, as applicable, each project’s schedule. Limitations of size and resources of the organization, project value, product benefits, risks and complexity, all influence the size and frequency of design reviews. In smaller organizations, it could be necessary to supplement staff with personnel from suppliers, consultants and other outside advisors. 1.3 Types of application There are two types of application: either an in-house created requirement for a new design, or a design requirement from an external source. In the case of the latter, the risk of a misunderstanding is much greater. Any misunderstanding could become a contractual issue and design review meetings with the client will be of primary importance to ensure that the emerging design meets the client's requirements.



61160  IEC:2006 – 15 –
A design review should be held: • prior to order acceptance to ensure that the scope of work is established together with all the parameters that need to be met for an acceptable design; • prior to detail design to ensure that the members of the design team have first-hand knowledge of all detail requirements. Interface provisions should be established and a list of defining documentation scheduled for submission and approval between the parties; • at suitable points during detail design to review all interface provisions and agree on the test procedures for verifying that the design meets contract requirements. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. IEC 60050-191:1990, International Electrotechnical Vocabulary (IEV) – Chapter 191: Depend-ability and quality of service IEC 62198:2001, Project risk management – Application guidelines 3 Terms and definitions For the purposes of this document the terms and definitions of IEC 60050(191) apply, together with the following additional definitions. 3.1
action item question to be resolved by the design manager or nominated person 3.2
review activity undertaken to determine the suitability, adequacy and effectiveness of the subject matter to achieve established objectives [ISO 9000:2000, definition 3.8.7] 3.3
design and development set of processes that transforms requirements into specified characteristics or into the specification of a product, process or system NOTE 1 The terms “design” and “development” are sometimes used synonymously and sometimes used to define different stages of the overall design and development process. NOTE 2 A qualifier can be applied to indicate the nature of what is being designed and developed (e.g. product design and development or process design and development). [ISO 9000:2000, definition 3.4.4]



61160  IEC:2006 – 17 –
3.4
design review
planned, documented independent review of an existing or proposed design NOTE 1 Objectives include evaluation of the design’s capability to fulfil the specified requirements, identify any actual or potential deficiencies, proposing enhancements. NOTE 2 Design review by itself is not sufficient to ensure proper design. NOTE 3 The design can be for a product or process. NOTE 4 The design review can be achieved by means of a meeting or other documented process. 3.5
design manager
person responsible for the product or process’ design and development NOTE For the purposes of this standard, the term “design manager” is used. In practice, other titles are used for this function depending on the organization’s size and structure, and/or the contractual arrangements. 3.6
verification confirmation, through the provision of objective evidence, that specified requirements have been fulfilled
[ISO 9000:2000, definition 3.8.4] 3.7
validation confirmation, through the provision of objective evidence, that the requirements for a specified intended use or application have been fulfilled. [ISO 9000:2000, definition 3.8.5] 4 Management of the design review process 4.1 General recommendations The organization should establish and maintain a management system to direct and control those design review activities that are part of the organization’s overall management system. For designs reviews this should include: a) identifying the functions and activities needed for the organization’s design reviews; b) establishing the design review objectives and plan to achieve these objectives during design planning; c) ensuring timely implementation of the design review activities during all applicable design phases; d) assessing the criteria and methods for performance assessment, evaluation and accept-ance of the product; e) providing resources and information necessary to achieve required design reviews; f) monitoring the design review activities and, measuring and analysing the results for continual improvement.



61160  IEC:2006 – 19 –
4.2 Documentation requirements The management system documentation for design review should include: a) documented commitment and objectives for design review; b) documented procedures for management of the design review process; c) records arising from the design review activities; d) records of completion of action items and recommendations. 5 Management responsibility 5.1 Top management Top management of the design organization should communicate and demonstrate its commitment to the design review process to all personnel involved.
Achieving this includes: • defining the management responsibilities and authorities for design review; • ensuring the required resources for design reviews are available.
5.2 Design manager The design manager’s responsibilities should include but not limited to: • developing and implementing a design plan that includes the points at which design reviews are required; • selecting an independent suitably experienced person to chair the design review meeting or meetings, as applicable, or otherwise defined; • preparing and providing the design data required for each scheduled design review’s input package; • ensuring that actions and recommendations arising from a design review meeting are responded to and completed in a timely manner. NOTE For external designs, the contract may define requirements for some of these. 5.3 Management review At planned intervals, top management should review its procedures and practices for design reviews to ensure their continuing suitability, adequacy and effectiveness. This can be carried out as a part of an organizational management review process. The design review records can be analysed for opportunities for process improvement. 6 Design review process 6.1 General Design reviews require careful planning, organization and reporting. This clause provides a framework for implementation of the design review process itself. Specific details will depend on the product and the type of design review (see Annex A).



61160  IEC:2006 – 21 –
Care should be taken to prevent the design review from dictating the ultimate design. Decisions are made everyday which bear on the design of the product or process under review. If each decision is subjected to an independent review, the review team would, in essence become the designer with the potential for increased development time and costs. Conversely, if the first design review occurred only just before production or use, its benefit could be questionable as there may be little opportunity to influence the situation without a significant time or cost penalty.
The process for design review is outlined in Figure 2. The stages at which design reviews are held should be established during the development of the design plan. In determining the stage or stages at which a design review is to be held, factors to be taken into account include: a) The size and complexity of the product. For example: • is it a simple design or a minor upgrade; • is it a product involving multiple systems; • is it a complex system? b) What would be the impact of a delay in delivery or failure of the product? Project risk management tools given in IEC 62198 can be utilized in assessing this. The most critical design stage will be the conceptual design. This is usually carried out in support of a submission for authorisation to proceed with a design project or to enable a proposal to be submitted to a client. The major objective will be to verify the design feasibility, estimate the cost and to plan its execution.
The design feasibility or risk can be ranked as follows:
a) customized design based on the selection from a range of proven components and materials; b) design that involves the use of an unproven component, material or subcontractor; c) design based on the interpolation of existing experience; d) design based on the extrapolation of existing experience; e) a completely new design or application of unproven technology. Designs that have a high risk will require more design reviews as a measure of risk management. In the case of a new design to be released for series production the detail design could be considered to be that of a prototype. The need for an intensive design review of the results of prototype testing will be critical for deciding on the features needed to ensure a reliable final design. In extreme cases it could even result in a decision for abandonment.



61160  IEC:2006 – 23 –
Planning of design review 6.2 Start Selection of design review team
6.3 Preparation of
input package
6.4
Meeting notification and agenda 6.5Conducting
design Review meeting 6.6Prepare and
distribute
the design review minutes 6.7 Design manager Responses to actions and recommendations 6.8Follow up and completion of actions and recommendations 6.9 All completed End Design managerSigns the minutes closing the minutes
6.9 No YesReview of design Response and completion
of actions and recommendationsIEC
1542/05
NOTE Numbers refer to the applicable clause in this standard. Figure 2 – Design review process The principal objectives of a design review are to provide confidence that the product’s requirements have been identified and can be met in an efficient and effective manner, and will result in a dependable and useful product. In particular, the objectives of a design review include, but are not limited to: 1) the product meets specified requirements in a cost-effective manner; 2) the design and development plan includes the strategy for confirming and demonstrating that performance requirements can be met; 3) the design satisfies customer and interfacing requirements; 4) the product and its elements, as required, can be safely and economically disposed of; 5) required design, manufacturing and installation methods are being utilized; 6) costs have been optimized after considering all product requirements; 7) scheduling considerations are taken into account; 8) recommendations are provided for improvement of d
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