SIST EN 61160:2007

Design review

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.

Entwicklungsbewertung

Revue de conception

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.

Pregled zasnove (IEC 61160:2005)

General Information

• Status: Published
• Publication Date: 31-Dec-2006
• ICS: 03.100.40 - Research and development
• ICS: 29.020 - Electrical engineering in general
• Technical Committee: I09 - Imaginarni 09
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 01-Jan-2007
• Due Date: 01-Jan-2007
• Completion Date: 01-Jan-2007
• Ref Project: EN 61160:2005 - Design review

Overview

EN 61160:2005 (IEC 61160:2005) is a European adoption by CENELEC of the international standard for design review. It gives recommendations for implementing design reviews during the design and development phase to verify that design input requirements are met and to stimulate product improvement. The standard is advisory in nature and is intended to increase product dependability, reduce lifecycle costs, and support timely product maturation.

Key Topics

• Purpose and scope: Verification that design inputs (performance, safety, dependability, lifecycle cost, environment, EMC, human factors) are satisfied and opportunities for improvement are identified.
• Design review process: Guidance on planning, scheduling and integrating reviews into the design lifecycle. The document outlines preparation of input packages, meeting notification and agenda, conduct of meetings, recording minutes, and follow-up of actions and recommendations.
• Roles & responsibilities: Management responsibilities (top management, design manager), and the role of the design review panel and specialists.
• Specialist contributions: Explicit guidance for including reliability, maintenance, maintenance support and availability experts in the review.
• Documentation & traceability: Requirements for documenting review outcomes, action items, evidence for verification, and closure criteria.
• Practical tools: Examples and annexes (e.g., objectives by stage, panel attributes, checklists) to tailor reviews to project size and complexity.

Applications

Who uses EN 61160:2005:

• Design managers and engineering teams managing product development
• Systems and reliability engineers conducting dependability assessments
• Quality and project managers integrating reviews into ISO 9001-aligned processes
• Maintenance planners, support engineers and procurement specialists
• Regulators and customers seeking structured verification of design deliverables

Practical uses:

• Structuring formal design reviews for complex electrotechnical products or safety‑critical systems
• Contractual design acceptance and customer/vendor design verification
• Early-stage risk reduction by identifying design deficiencies before production
• Ensuring maintenanceability, availability and lifecycle supportability are considered during design

Related Standards

EN 61160:2005 aligns with and references other standards and guidance such as ISO 9000 / ISO 9001:2000 (design and development controls), IEC 62198 (project risk management), and vocabulary/dependability references (IEC 60050-191). These references help integrate design review into broader quality and risk management systems.

Keywords: design review standard, EN 61160:2005, IEC 61160, design and development, dependability, reliability and maintenance, design review process.

Standards Content (Sample)

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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.

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: [phone] Telefax: [phone] E-mail: [e-mail]
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 design; 9) components are used within their specified performance and stress ratings; 10) earlier recommendations have been addressed; 11) that the design’s drawings, software codes and specifications is full and complete. Normally only the recommendations from the review should be documented, but for safety issues it is important to list all the risks considered and the reason for recommending or not recommending actions. As a result of the action items identified and recommendations made, matters the design manager should consider include, but are not limited to, changes in the design’s concepts, specifications, plans, schedules, or, impact on safety or environmental requirements, product quality, manufacturing, installation, operation and maintenance procedures and costs.

61160  IEC:2006 – 25 –
For an effective design review, the subjects and results of discussions during each design review need to be documented to permit continuity and follow-up until design decisions have been completed. Sufficient documentation should be contained in the meeting’s minutes so that successive design reviews avert repeated coverage of the same problems and avoid significant loss of insight and understanding of relevant issues. If continuity and follow-up are achieved, succeeding review effort can be directed to more pressing aspects of the product’s design. The meeting’s minutes supporting documentation and follow-up are discussed in 6.7 and 6.9. The specific objectives depend on the type of design review being undertaken and the product or process being designed. Clear explanations by the chair of objectives and scope of each design review will focus attention on specific areas of the design, and minimize misplaced comments. Typical objectives and activities for each type of design review are given in Annex B. Design review meetings are independent of those meetings undertaken as a part of the ongoing planning, scheduling and development of the design. The design manager or those directly involved in the design should not chair design reviews.
Depending on whether the design project is internally or externally funded, the conduct of the review and the stances taken by the individuals can vary. 6.2 Planning for the design review The point or points at which design review occurs should be determined during the design planning stage. Ideally design reviews should be conducted before taking a decision that can prove costly, time consuming, or difficult to reverse. This should take into account the identified risks for the design and/or project. In this way any changes arising from a design review can be made with less impact on schedule or cost. Additionally, cost, schedule and performance improvements can more readily be adopted if reviews are conducted before making a significant commitment at major points in the design process. The design manager should consider the conditions and constraints imposed by a particular project in the scheduling of design reviews and the optimum number should be determined to maximize return on time spent. Only a few organizations or projects will have a need for all types of design review. 6.3 Design review personnel 6.3.1 General Design reviews are normally carried out by an independent review panel who receive presentations and information from those responsible for the design. The personnel involved are normally: a) the design review panel that includes but is not limited to: • the chair; • the secretary;

61160  IEC:2006 – 27 –
• persons representing functions which could affect the product or process quality, but not directly involved in the design; • relevant specialists, not involved in development of the product under review; • customer/users, as practical; b) the design manager and the design team members as necessary to present the design and answer questions.
To avoid conflicts of interest the persons authorizing or approving further steps in the design process should normally not be a panel member.
The design review panel should include people with special knowledge and experience from different spheres. The composition should be such that the participants, collectively, cover a sufficiently wide and detailed field of knowledge to permit consideration of all pertinent aspects of the product. Care should be taken to keep the team to a workable size.
6.3.2 Design review chair The chair should have broad technical knowledge and experience that includes design, the ability and confidence to manage personnel and to work equally well with technical and non-technical persons. Leadership and understanding in dealing with others is of utmost importance. The chair's responsibilities and authority should include: a) agreeing to the objectives and scope for the design review; b) agreeing to selection of panel members in consultation with management; c) establishing meeting agendas for delegated meeting or meetings; d) ensuring that participants understand what is required of them; e) ensuring that sufficient time is allocated for design review activities; f) ensuring that the meeting’s input package is issued to designated persons; g) assigning tasks to participants in preparation for meetings; h) chairing the design review meeting; i) ensuring that relevant issues from the meeting are recorded; j) ensuring that actions and recommendations from earlier meetings have been satisfactorily addressed and closed, as appropriate;
k) ensuring that the focus of the meeting is the design and not individuals; l) ensuring that there is input from all present; m) reviewing and approving the design review meeting’s minutes; n) ensuring that the meeting’s minutes are issued to designated persons; o) striving for consensus in the review team in case of differences of opinion. If consensus cannot be reached forward minority as well as majority view(s) for decision.
To maintain the integrity and objectivity of the design review team, where possible, the chair should not be associated with the project’s design activities. However, in a small company, an employee with all necessary qualifications and not participating in some way in the project may not be available. Consideration should then be given to engaging an outsider. In any event, the chair should be able to maintain the respect of all participants.

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6.3.3 Design review secretary A secretary should be appointed to record the results of the meeting and enable the chair to maintain focus on the meeting. Where possible, the same person should serve as the secretary for the defined design reviews for a specific product. The qualifications and experience for the secretary should be similar to those for the chair, but can be less stringent. The secretary's duties and responsibilities should include: a) sending out invitations with sufficient time for members to prepare for the meeting; b) distributing agendas; c) follow up on distribution of input data for review by participants; d) organizing, assembling and distributing responses to inquiries or assignments; e) taking minutes; f) preparing the meeting’s minutes; g) issuing the meeting’s minutes to designated persons; h) assisting the chair in following up action items and recommendations, as applicable. NOTE If a separate, independent, secretary cannot be appointed, it is usually better for a representative from the design team to act as the secretary. If the organization is of sufficient size, the position of secretary can be used as training for future service as design review chair. In selecting a secretary, the following factors should be considered: – previous participation in design review activity; – technical training and comparable experience; – communication skills; – involvement in similar projects; – non-involvement in work on the product or process under review. 6.3.4 Specialists
The specialists should be selected taking into account the product, the product’s objectives, and the type of design review (see Annex A). Specialists should be represented on the design review panel at the appropriate stage in the product’s development. Their specializations can include, but are not limited to: reliability and maintainability engineering, performance estimation, testing and acceptance/certification, quality management, structures engineering, manufacturing engineering, safety, environ-mental engineering, legal matters, advertising and marketing, finance, logistics. 6.3.5 Design manager The design manager, or at least one representative of the design team, needs to participate in the whole review in order to explain the rationale of the design decision taken, answer questions and help the review panel identified and evaluate potential problems, their probable consequences and possible actions. Representatives should be selected to attend design review meetings pertaining to their respective roles in the design and development process. It may not be possible for all such persons to attend throughout in light of team size

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restrictions. Participants can therefore be invited only to those portions of a meeting that pertain to the area where they should contribute. However, all potential participants should receive the agenda and any portion of the input data package that is relevant to their expertise. Additional representatives from the design team can participate as observers where agreed by the chair. These observers do not have the right to speak unless the chair gives permission. 6.4 Preparation of input package The design manager is responsible for putting together the information relevant to the design review to be undertaken.
According to the design stage the input data package should include some or all of the following: a) design plan; b) original requirements (these can include: the customer’s request for quotes, specifications, standards, regulatory requirements); c) anticipated customer needs, developed and supported by market surveys and competitors' activities; d) documented design assumptions; e) design trade-off studies and analyses; f) a list of any questions from the design review panel on the design to be reviewed; g) reliability, availability and maintainability allocations and predictions; h) planned logistics support; i) designer's proposals and alternative considerations which include drawings and calculations; j) information and data on similar products; k) competitive product data; l) cost estimates and trade-off rationale; m) specifications and drawings; n) manufacturing, tooling and producibility studies; o) performance test reports, analyses and requirements; p) field failure or malfunction reports; q) quality control analyses of processes and supplies; r) inspection reports; s) life cycle targets and cost data. 6.5 Meeting notification and agenda The secretary, in conjunction with the chair, should prepare a notification and agenda for the meeting and circulate them to participants, and as applicable, their supervisors, sufficiently in advance of the design review to allow participants to prepare for the meeting. The notification and agenda should state: a) the date, time and venue of the meeting b) the scope and objectives for the design review meeting; c) the project name and identification number;

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d) participants and their functions; e) the type and duration of the design review; f) the section of the project under review, if appropriate; g) topics to be discussed can include, for example: • a review of the objectives of the design project; • a description of the design features and performance characteristics of the product; • a review of design and technical progress to date and problems encountered; • a review of outstanding and future areas of work and any concerns arising; • an assessment of all pertinent aspects of the design against a Design Review checklist; • a summary of findings by the review panel; h) the persons who will make presentations; i) reference documents and the contents of any attached input data package. 6.6 Conduct of meeting 6.6.1 General If the panel members are not experienced in design reviews, an orientation session should be conducted explaining the general objectives, philosophy, and practice.
The introductory comments should set a constructive tone and climate. The chair should review the objectives of the meeting and relate them to the overall objectives and procedures for the design review process. The chair should stress the need to ask questions and to avoid negative and personally oriented comments. Questions that imply pre-judgement should be avoided. Panel members should feel free to question their peers. They should not see their responsibility as being solely to ask why something was done in a particular way. Whenever necessary, the review participants should be assured that all questions raised, subsequent investigations requested, and opinions expressed do not reflect on anyone's personality, ability or integrity. The entire team, under the direction of the chair, should ensure that the design review process does not become a personality contest either among the panel members or between the panel and the design team.
The panel members should always remember that they serve in an advisory capacity and that their prime purpose is to assist those responsible for the product’s design in achieving the optimum result. They are not there to provide a solution to any deficiencies identified.
6.6.2 Presentations The design manager and the other members representing the design and development team should present, as required, aspects of the design under review.

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6.6.3 Meeting protocol The chair should ensure that presentation and questioning proceed systematically. The review process is one of constructive questions and answers. Derogatory questions or responses should not be permitted, nor should there be a flat refusal to discuss a topic unless there are specific issues of commercial confidentiality or national security involved. Questions should be framed in terms of requests for information or inquiry as to reasons for design and development decisions. Panel members can submit questions to the chair in advance to allow for a prepared response. These questions can be considered complex or minor. To facilitate progress of the meeting, minor questions can be closed before start of the meeting. These questions would be a part of the meetings input package. Typographical errors, or minor editorial matters relating to the input data themselves should not be discussed at the design review. The secretary should arrange for correction of these as needed. Any substantive corrections should be discussed review participants. The design review process should not confer approval or disapproval of the design and development documents reviewed. 6.6.4 Action items Whenever an action is required, the name of the person assigned, the task given and
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