1、BRITISH STANDARD BS 7373-2:2001 Product specifications Part 2: Guide to identifying criteria for a product specification and to declaring product conformity ICS 03.120.20 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBS 7373-2:2001 This British Standard, having been prepared
2、under the direction of the Management Systems Sector Policy and Strategy Committee, was published under the authority of the Standards Committee and comes into effect on 15 July 2001 BSI 07-2001 The following BSI references relate to the work on this standard: Committee reference MS/4/-/7 Draft for
3、comment 00/402851 DC ISBN 0 580 37630 3 Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Committee MS/4, Design management systems, and its Panel MS/4/-/7, Product specifications, upon which the following bodies were represented: As
4、sociation of Innovation Management Association of MBAs Association of Project Managers BEAMA Ltd. British Standards Society BSI Consumer Policy Committee Chartered Society of Designers Defence Manufacturers Association Design Council Department of Trade and Industry (Design Policy and Services) Elec
5、tricity Association Federation of Small Businesses Forum for Private Business Institute of Quality Assurance Institution of Civil Engineers Institution of Engineering Designers Institution of Electrical Engineers Institution of Mechanical Engineers Ministry of Defence Royal Institute of British Arch
6、itects UMIST University of Glasgow University of Leeds The committee and panel wish to acknowledge the invaluable contribution to the drafting of this standard, in terms of time and resources, of Cambridge Consultants. Amendments issued since publication Amd. No. Date CommentsBS 7373-2:2001 BSI 07-2
7、001 i Contents Page Committees responsible Inside front cover Foreword ii Introduction 1 1S c o p e 2 2 Normative references 2 3T e r m s a n d d e f i n i t i o n s 2 4 Rationale for preparing a specification 3 5 Identifying the criteria 4 6 Recording the criteria 14 7 Reviewing the criteria 17 8 V
8、erifying product design against chosen criteria 18 9 Validation 19 10 Declaring product conformity 20 Annex A (informative) The interrelationship of product documents 22 Annex B (informative) Product development process 24 Annex C (informative) Related management standards and guidance publications
9、25 Annex D (informative) Legislation and technical standards 26 Annex E (informative) Quality function deployment (QFD) 28 Annex F (informative) Example of a product specification template 30 Annex G (informative) Sources of information 36 Bibliography 37 Figure 1 Steps in identifying the criteria 5
10、 Figure 2 How acquiring criteria builds up the documentation 15 Figure 3 Safeguarding commercial intelligence 16 Figure A.1 Interrelationship of product documentation 23 Figure B.1 Product development process 24 Figure C.1 Management standards and guidance publications 25 Figure D.1 Some examples of
11、 the relationship between legislation and standards 27 Figure E.1 Simple QFD analysis matrix 28 Figure E.2 Relationships among QFD, Taguchi Methods, and JIT/TQM operating principles 29 Table 1 Checklist for use when establishing customer needs 6 Table 2 Checklist for use when identifying the market,
12、 competitor information and commercial viability 7 Table 3 Checklist for use when characterizing the potential product 9 Table 4 Checklist for identifying applicable legislation and standards 11 Table 5 Checklist for use when considering how to manufacture the product 12 Table 6 Checklist for identi
13、fying verification criteria 13 Table 7 Checklist for identifying production testing criteria 13 Table 8 Checklist for establishing product support 14 Table 9 Checklist for disposal criteria 14 Table F.1 Information useful when describing interface requirements 33BS 7373-2:2001 ii BSI 07-2001 Forewor
14、d This British Standard has been prepared by Technical Committee MS/4 and its Panel MS/4/-/7. BS 7373:1998, Guide to the preparation of product specifications, has been renumbered by amendment to become BS 7373-1:2001, Product specifications Part 1: Guide to preparation. Annex A, Annex B, Annex C, A
15、nnex D, Annex E, Annex F and Annex G are informative. Annex F of this standard has been reproduced by kind permission of Cambridge Engineering Design Centre/Cambridge Consultants from SHEFELBINE, S., P.J. CLARKSON, and L.T.M. BLESSING. Requirements capture for medical devices (Workbook) (CUED/C-EDC/
16、TR90). Cambridge: Cambridge Engineering Design Centre/Cambridge Consultants, December 1999. Figure E.2 has been reproduced by kind permission of CSC Consulting inadequate understanding between customer and producer; inadequate profit margins; the product being too expensive; failure to meet regulato
17、ry requirements; failure to meet performance targets; the time to market being too long; development expenditure being too high; insufficient in-house skills and knowledge to cover the process; excessive warranty, delivery or other commitments creating serious financial obligations. The main benefit
18、 in dealing properly with these problems is a better product for which the commercial and technical risks have been assessed and eliminated or reduced to an acceptable level. The benefit to the producer can be significant both in reducing the cost of the product and/or in improving the quality, reli
19、ability and commercial viability of the product. The purpose of this guide is to ensure attention is focused on the key areas that need to be addressed in order to assess viability and to acquire the data necessary to produce a product specification. These key areas are: a) commercial considerations
20、 (see 4.2); b) product performance (see 4.3); and c) regulatory requirements (see 4.4). Each of these areas is introduced in clause 4. Further information about the process of gathering information is contained in clause 5, drawing up and reviewing specifications in clause 6 and clause 7, verifying
21、and validating the product in clause 8 and clause 9, and declaring conformity in clause 10. Informative Annex A, Annex B, Annex C, Annex D, Annex E, Annex F and Annex G provide material to support the preparation of specifications. BS 7373-2:2001 2 BSI 07-2001 1 Scope This British Standard gives gui
22、dance on identifying the criteria necessary for producing a product specification. It also includes guidance on declaring the conformity of the product. NOTE 1 This British Standard considers common themes applicable to many products, which when examined by those responsible for development, help th
23、em to focus on the important criteria for individual products. NOTE 2 The context in which product information is gathered and ultimately transcribed into one or more specifications is explained in Annex A. The nature of the resulting specification(s) will vary widely depending upon the complexity a
24、nd scope of the final product. 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of this British Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do
25、 not apply. For undated references, the latest edition of the publication referred to applies. BS 6001-0, Sampling procedures for inspection by attributes Part 0: Introduction to the BS 6001 attribute sampling system (ISO 2859-0:1995). BS EN ISO 9001:2000, Quality management systems Requirements. BS
26、 EN 45014:1998, General criteria for suppliers declaration of conformity. 3 Terms and definitions For the purposes of this standard the following terms and definitions apply. 3.1 criterion decisive factor, measure or standard by which something can be judged or decided NOTE This is usually expressed
27、 in terms of a parameter with limits, or a “yes” or “no”. 3.2 design review documented, comprehensive and systematic examination of a design to evaluate its capacity to fulfil the requirements for quality and fitness for purpose, identify problems, if any, and propose the development of solutions 3.
28、3 performance specification document that specifies the totality of needs expressed by features, characteristics, process conditions, boundaries and exclusions defining the performance of a product or process, including quality requirements 3.4 product specification documentation that details for pr
29、oduction, end-use and other purposes the item concerned 3.5 test specification documentation that describes in detail the methods of conducting tests including if necessary the criteria for assessing the results NOTE A test specification may contain clauses for conformity and reliability assessment.
30、 BS 7000-10:1995BS 7373-2:2001 BSI 07-2001 3 3.6 requirement need or expectation that is stated, generally implied or obligatory NOTE 1 “Generally implied” means that it is custom or common practice for the organization, its customers and other interested parties, that the need or expectation under
31、consideration is implied. NOTE 2 A qualifier can be used to denote a specific type of requirement, e.g. product requirement, quality management requirement, customer requirement. NOTE 3 A specified requirement is one which is stated, for example, in a document. NOTE 4 Requirements can be generated b
32、y different interested parties. BS EN ISO 9000:2000 3.7 verification confirmation through the provision of objective evidence that specified requirements have been fulfilled NOTE 1 The term “verified” is used to designate the corresponding status. NOTE 2 Confirmation can comprise activities such as:
33、 a) performing alternative calculations; b) comparing a new design specification with a similar proven design specification; c) undertaking tests and demonstrations; and d) reviewing documents prior to issue. BS EN ISO 9000:2000 3.8 validation confirmation through the provision of objective evidence
34、 that the requirements for a specific or intended use of application have been fulfilled NOTE 1 The term “validated” is used to designate the corresponding status. NOTE 2 The use conditions for validation can be real or simulated. BS EN ISO 9000:2000 4 Rationale for preparing a specification 4.1 Ove
35、rview It is easy to become obsessed with an innovative idea, or a new technology, without looking dispassionately at its overall viability or other justification to pursue it. By gathering sufficient information to understand the potential product its viability can be properly assessed. Gathering th
36、is information in a disciplined way facilitates decision making, and also exposes conflicts or trade-offs, allowing them to be resolved at an early stage and so avoiding problems later. This clause looks at the three main areas that need to be understood when making decisions about the development o
37、f a new product. These areas are: a) commercial considerations; b) attributes of product performance necessary to satisfy the customer; and c) regulatory requirements. Only when all the requirements for a new product have been understood is it possible to ensure that the product is safe or to review
38、 or test it adequately. Thus the development of a specification is the precursor to assuring safety, quality and reliability. Background on the product development process is given in Annex B. BS 7373-2:2001 4 BSI 07-2001 4.2 Commercial considerations An overview of the commercial issues, skills and
39、 knowledge necessary in bringing the product to the market should be established. The potential size of the market and share of that market which is being targeted should be determined. The latter can be vital in determining the viability of the product. The financial implications to the company, pa
40、rticularly in terms of budgetary provision for the development programme and working capital, should also be considered. The way in which the product reaches the customer (e.g. direct selling, agents, distributors, retailers) should be understood as should the promotional effort that will be necessa
41、ry. This promotional effort should be understood both in terms of developing links with those selling the product and in terms of developing links with those producing the product advertising and literature. For indirect sales selling to agents may demand as much effort as selling to the final custo
42、mer. Whichever route to market is chosen the financial cost of sales and marketing should be known. This will almost certainly be a significant contributor to the overall selling price. By examining these and related commercial issues, the key parameters that make the product a success become appare
43、nt. This information should be recorded to ensure that the required facts are available. Recording this information reduces the likelihood of misunderstandings and increases the chances of the right design decisions being made. In the case of one-off or special purpose equipment, where the justifica
44、tion or demand would appear to be self-evident, it is still important to consider the commercial issues. 4.3 Product performance All the pertinent information on the features of the products performance that make the new product attractive and enable the performance targets to be met should be gathe
45、red. Performance is used here in its broadest sense to incorporate the function, quality, reliability and durability of the product so that the end-user is satisfied at an acceptable price. Recording this information for use in the specification document keeps the minds of the designers focused, hel
46、ping them to reach appropriate design solutions. Ultimately the specification will provide the criteria against which the product performance can be assessed. These test and acceptance criteria are generally established by putting maximum/minimum limits on each of the relevant product requirements.
47、4.4 Regulatory requirements Many products are covered by statutory regulations, other countries national standards or product standards that agents or customers will seek. It is necessary to understand exactly which regulations, EC Directives and standards are going to apply. This is particularly im
48、portant during the development of the product because the way the design is executed can have a bearing on which regulations or standards are invoked or what product approvals might need to be sought. Thus the inclusion of regulatory requirements in the specification is important to the success and
49、acceptance of the product in the market-place. Annex C and Annex D give examples of standards that may be relevant and their relationship with legislation. 5 Identifying the criteria 5.1 An overview of criteria to be gathered This subclause describes the process of identifying criteria using a model and terminology consistent with BS 7000-2. Identification of the criteria is inevitably iterative as more information becomes available and decisions are made about user needs, design solutions, the
