UNE 166002 Spanish standard

May 2006 TITLE

R&D&i management: R&D&i management system requirements Gestión de la I+D+i: Requisitos del sistema de gestión de la I+D+i. Gestion de la R+D+i: Exigences de du système de management de la R+D+i.

NORMATIVE

REMARKS

This document is the English version of UNE 166002:2006 standard.

In case of disputes concerning the accuracy of this translation into English, the Spanish original version should be consulted.

This standard supersedes UNE 166002:2002 EX standard.

FOREWORD

This standard has been prepared by the Technical Committee AEN/CTN 166Research, technical Development and innovation activities (R&D&i) the Secretariat of which is held by AENOR.

THE REMARKS TO THIS DOCUMENT MUST BE SENT TO:

24 Pages

Published and printed by AENOR Depósito legal: M 5005:2007 AENOR 2007 All rights reserved. Forbidden reproduction. C Génova, 6

28004 MADRID-Spain Telephone + 34 91 432 60 00 Fax + 34 91 310 40 32

Group 12

S

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CONTENTS

Page 0 INTRODUCTION............................................................................................................ 5 0.1 Characteristics of the R&D&i process ........................................................................... 6 0.2 Model of an R&D&i process ........................................................................................... 7 0.3 Compatibility with other management systems............................................................. 8 1 SCOPE .............................................................................................................................. 8 2 DEFINITIONS ................................................................................................................. 9 3 NORMATIVE REFERENCES....................................................................................... 9 4 REQUIREMENTS........................................................................................................... 9 4.1 R&D&i management system and model ........................................................................ 9 4.1.1 General.............................................................................................................................. 9 4.1.2 Documentation ................................................................................................................. 10 4.1.2.1 Control of documents....................................................................................................... 10 4.1.2.2 Control of records ............................................................................................................ 10 4.2 Responsibility of top management.................................................................................. 11 4.2.1 Commitment of top management ................................................................................... 11 4.2.2 Interested parties approach............................................................................................. 11 4.2.3 R&D&i policy................................................................................................................... 11 4.2.4 Planning ............................................................................................................................ 12 4.2.4.1 R&D&i objectives ............................................................................................................ 12 4.2.4.2 R&D&i management system planning........................................................................... 12 4.2.5 Responsibility, authority and communication............................................................... 12 4.2.5.1 R&D&i Management Unit .............................................................................................. 13 4.2.5.2 R&D&i Unit...................................................................................................................... 13 4.2.5.3 Establishment and structure of the R&D&i units and R&D&i management ............ 13 4.2.5.3.1 Establishment ................................................................................................................... 13 4.2.5.3.2 Structure ........................................................................................................................... 14 4.2.5.4 Top management representative..................................................................................... 14 4.2.5.5 Internal communication .................................................................................................. 14 4.2.6 Management review......................................................................................................... 14 4.2.6.1 General.............................................................................................................................. 14 4.2.6.2 Information to be reviewed ............................................................................................. 14 4.2.6.3 Review results................................................................................................................... 15 4.3 Resource management ..................................................................................................... 15 4.3.1 Provision of resources ...................................................................................................... 15 4.3.2 Human resources.............................................................................................................. 15 4.3.2.1 General.............................................................................................................................. 15 4.3.2.2 Motivation of the personnel............................................................................................. 15 4.3.2.3 Competence, awareness and training ............................................................................. 15 4.3.3 Infrastructure ................................................................................................................... 16 4.3.4 Work environment ........................................................................................................... 16 4.4 R&D&i activities .............................................................................................................. 16 4.4.1 Tools .................................................................................................................................. 16 4.4.1.1 Technology watch............................................................................................................. 16 4.4.1.1.1 Identification of information needs ................................................................................ 16 4.4.1.1.2 Search, treatment and dissemination of information.................................................... 16 4.4.1.1.3 Information assessment ................................................................................................... 16

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4.4.1.2 Technology foresight........................................................................................................ 16 4.4.1.3 Creativity .......................................................................................................................... 16 4.4.1.4 External and internal analysis ........................................................................................ 17 4.4.1.4.1 External analysis .............................................................................................................. 17 4.4.1.4.2 Internal analysis ............................................................................................................... 17 4.4.2 Identification and analysis of problems and opportunities .......................................... 17 4.4.3 Analysis and selection of R&D&i ideas .......................................................................... 18 4.4.4 Planning, monitoring and control of the project portfolio ........................................... 18 4.4.5 Technology transfer ......................................................................................................... 18 4.4.6 R&D&i product................................................................................................................ 19 4.4.6.1 Basic design....................................................................................................................... 19 4.4.6.2 Detailed design.................................................................................................................. 19 4.4.6.3 Pilot test............................................................................................................................. 19 4.4.6.4 Redesign, demonstration and production ...................................................................... 20 4.4.6.5 Marketing ......................................................................................................................... 20 4.4.6.6 Change control ................................................................................................................. 20 4.4.7 Purchasing ........................................................................................................................ 20 4.4.7.1 Purchasing process........................................................................................................... 20 4.4.7.2 Purchasing information ................................................................................................... 20 4.4.7.3 Purchasing verification.................................................................................................... 20 4.4.8 Results of the R&D&i process......................................................................................... 20 4.4.8.1 Documentation of the results........................................................................................... 21 4.4.8.2 Monitoring and Measurement ........................................................................................ 21 4.4.9 Protection and exploitation of the results of R&D&i activities.................................... 21 4.5 Measurement, analysis and improvement...................................................................... 21 4.5.1 General.............................................................................................................................. 21 4.5.2 Internal audits .................................................................................................................. 22 4.5.3 Monitoring and measurement of the R&D&i process .................................................. 22 4.5.4 Monitoring and measuring the results of the R&D&i process..................................... 22 4.5.5 Control of the deviations from the expected results...................................................... 22 4.5.6 Data analysis..................................................................................................................... 22 4.5.7 Improvement .................................................................................................................... 23 4.5.7.1 Continual improvement................................................................................................... 23 4.5.7.2 Corrective action .............................................................................................................. 23 4.5.7.3 Preventive action .............................................................................................................. 23 BIBLIOGRAPHY ............................................................................................................................. 24

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0 INTRODUCTION

The technological innovation undertaken in a country constitutes, to a more and more noticeable extent, a critical factor when determining the economic growth of that country, its level of welfare and its international competitiveness. In view of its complex nature and due to its interactions, the technological innovation management and the R&D require a standardization framework that will systemise and support the optimisation of these activities. Research and development, as well as technological innovation, are sometimes considered as unique, creative processes lacking a structure. Nevertheless, the standardization techniques used in other activities, such as quality management, environmental management or ethical and social management systems in organisations, are also applicable to R&D&i management systems. The determination of excellence of international organisations is growing in importance and interest among them, as well as the assessment to establish a ranking of excellent organisations. Corporate reputation is used as a means to assess the excellence of an organisation. A corporate reputation management system includes R&D&i management and, in order to assess the degree of validity of an R&D&i management system, it is necessary to have a standard which systematises the R&D&i activities, without restricting them with set rules that can limit the imagination and emotional intelligence of researchers. The adoption of an R&D&i management system should be a strategic decision of the organisation. The design and implementation of the R&D&i management system in an organisation are influenced by the different needs, specific objectives, manufactured products, services provided, processes used and the size and structure of the organisation. The aim of this standard is not to advocate the uniformity of the structure of R&D&i management systems or of their documentation. The requirements of the R&D&i management system stated in this standard are complementary to those of any other management system implemented in the organisation such as the following: quality management, environmental management, ethical and social management, security management, risk management, etc. This standard has been prepared to be used both by the internal and external parts of an organisation, including certification bodies, in order to evaluate the ability of an organisation to fulfil the requirements of an R&D&i management system and the requirements of the organisation itself. This standard does not aim to establish the requirements needed for an organisation to set up its own R&D&i policies, but once these have already been created. The implementation of a management system following the scheme proposed in this standard will provide the following advantages: 1. Promotion of R&D&i activities 2. Provision of guidelines for the effective organisation and management of R&D&i

− Analysis of the internal and external technological situation

− Identification and assessment of the threats and opportunities created by the technological evolution

− Definition of the basic objectives of R&D&i activities

− Selection and management of an appropriate R&D&i project portfolio 3. Ensuring that no activities that can generate the organisation�s own technologies and patents are lost, activities

through which additional benefits can be obtained through technology transfer or tax relieves. 4. Promotion of R&D&i as a competitiveness differential factor, and consideration of it as such in the corporate

reputation schemes. 5. Assistance in the planning, organisation and control of R&D&i units, resulting in a saving of resources and in the

improvement of the motivation and implication of employees.

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This standard has been prepared to be applicable to any organisation, regardless of its size or the economic sector where it performs its activity. This standard as a whole identifies the general requirements to establish and manage an R&D&i unit. The UNE 166001:2006 standard establishes the requirements of the R&D&i projects that constitute the project portfolio that can be managed with the system set in this standard. There is also the UNE 166006:2006 EX standard, where the technology watch system is defined. This standard has been prepared given the experience in R&D&i management of relevant professionals and organisations in this field.

0.1 Characteristics of the R&D&i process

The R&D&i process in organisations has its own differential characteristics that need to be taken into account and to receive special attention from top management in the organisation wishing to implement and maintain an R&D&i management system. The specific characteristics of the R&D&i process are the following: − The constant use of information, data and knowledge, as well as their transformation and generation. − The use of technology watch and foresight and the promotion of creativity in the identification and description of

ideas, objectives and technological scenarios. − Risk and uncertainty management in the obtaining of results. − Industrial and intellectual property management and the protection of the property generated in the process. − The multidisciplinary and open structure of the R&D&i unit, the motivation and enthusiasm of the members that

make part of it and its permanent intercommunication with the interested parties in a simultaneous engineering process that does not have to be sequential.

− The lengthy duration of the R&D&i process, its requirements for constant investment with no results and the

discouragement management throughout the process. − The certainty indicating that there could be technological innovations which do not require R&D and that research

studies could be carried out without leading to innovation. R&D plays an essential but not unique role in technological innovation.

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0.2 Model of an R&D&i process

Figure 1 − Model of an R&D&i process The R&D&i process (see figure 1), taking the Kline �chain link� modified model as a starting point, as indicated above, tries to represent the complexity and uncertainty involved in an R&D&i process, and the relationship between innovation and the research and development activities. The R&D&i activities are difficult to measure and a constant coordination between the technical knowledge required and the market needs is required in order to simultaneously solve the economic and technological obligations as well as obligations of all sorts, imposed by the R&D&i process. This model is a general scheme that can be used as a point of reference by any organisation, regardless of its size, in order to define or establish its own R&D&i process. Although the R&D&i process is changeable and unforeseeable, it can definitely be systematised and organised through an R&D&i management system based in the application of the methodology known as �Plan-Do-Check-Act� (PDCA) where: − Plan: Establish the necessary R&D&i objectives to achieve the R&D&i results in conformity with the technological

strategy set by top management and the potential market requirements. − Do: Implement the R&D&i systematisation procedure. − Check: Monitor and control the R&D&i process with regard to the R&D&i objectives and inform about the results. − Act: Make decisions to continuously improve the R&D&i process within the organisation.

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According to the model, the R&D&i process can follow five different paths, all interrelated with each other but not mutually exclusive. The main path arises from the Potential Market, and through the appropriate activities (technology watch, and/or technology foresight, and/or creativity, and/or internal and external analysis), a series of ideas are identified to fulfil the new market needs or improve existing products or processes. These ideas are studied and analysed, and those considered as viable from a technological and economic point of view are selected and become part of a base of ideas. From this base of selected ideas, the R&D&i projects are prepared, leading to an invention or to a first basic design. Once the problem of the basic design has been solved, the project moves on to the detailed design of prototypes and the pilot testing stage that enables us to redesign, if appropriate, or to initiate the production tests. If all the problems arising in the production stage are solved, the project moves on to the marketing stage of the new product or process, or of an improved version of an existing one. The second path is closely related to the path described above and represents the constant feedback loops produced among the different stages of the process, since solving the problems and unpredictable events arising in each stage implies certain changes in the previous stage. Special attention should be drawn to the feedback loops produced between the marketing stage and the design and test stage, since the user information will be used to improve the designs and prototypes. Furthermore, information on the market needs is obtained from the marketing stage, enabling us to generate new ideas. The third path explains the connection between Innovation and Research; in any of the central stages of the R&D&i process it could be necessary to rely on the internal and external technological knowledge in order to solve the arising problems. However, if the solution to the problem does not exist yet, it will be necessary to undertake the relevant research activities that will provide us with the technological solution we need. The option of turning to research will delay the process and could even cancel it, if for instance, the research results are not economically viable or not technically feasible. The forth path represents the R&D&i projects directly arising from brilliant Research results, even from unexpected results. These are directly turned into inventions, since their viability is ensured due to the improvement or novelty they represent, and they even give rise to new industries. The fifth path represents the feedback loop between the R&D&i results and research. In addition, it represents the research activities related to the results of the R&D&i process, directly receiving information on the monitored use of these results, that can be used at any stage of the chain.

0.3 Compatibility with other management systems

This standard is aligned with ISO 9001:2000 and ISO 14001:2004 in order to increase the compatibility of standards in the interests of the user community. 1 SCOPE

The aim of this standard is to provide guidelines that go beyond the requirements established in other management system standards, in order to consider both the effectiveness and efficiency of an R&D&i management system and, therefore, the potential to improve the results, as well as the improvement of the procedures for the internal transfer of these results to optimise the technological innovation processes of the organisation. This standard also considers the technology transfer and assimilation as an integrating part of the technological innovation process. The implementation of the R&D&i management system, according to provisions stated in this standard, provides the organisations with the ability to recognise emerging or new technologies not applied in their sector, the assimilation and ultimate development of which will provide them with the basic grounds to strengthen their R&D&i activities and improve their competitiveness.

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This standard stems from the commitment of the organisations� top management to continual improvement, through the establishment of an R&D&i policy and of a continual management review. The requirements and guidelines included in this standard enable an organisation to formulate and develop a technological innovation policy and a series of objectives according to their specific activities, products and services, but without establishing prescriptive aspects for the formulation of R&D&i policies. It applies to those aspects that can be controlled by the organisation and over which it can expect to have an effect. The standard in itself does not establish precise criteria or specific demands for a technological performance, nor does it determine the significance that the technological innovation management shall have in the organisation, but it starts from the recognition that R&D&i activities are a key element for organisations to achieve excellence. All requirements in this standard are generic and are meant to be applied to all sorts of organisations, regardless of their type of size which, after a previous diagnosis of their R&D&i situation, wish to: a) Establish the basic grounds to initiate their R&D&i activities. b) Define, implement, update and improve an R&D&i management system in accordance with their policy. c) Demonstrate fulfilment of the requirements of this standard before a third party and/or certify their R&D&i

management system. In the event that one or several requirements of this standard cannot be applied due to the nature of the organisation, their exclusion can be considered. When exclusions are undertaken, conformity to this standard cannot be claimed, unless these exclusions are restricted to the requirements expressed in clause 4.4.6, and such exclusions do not affect the capability or responsibility of the organisation to undertake the R&D&i process that meets the needs of the interested parties and the applicable regulatory requirements. 2 DEFINITIONS

For the purpose of this document, the definitions provided in the UNE 166000:2006 standard �R&D&i management: Terminology and definitions� apply. 3 NORMATIVE REFERENCES

UNE 166000:2006 R&D&i management: Terminology and definitions. 4 REQUIREMENTS

4.1 R&D&i management system and model 4.1.1 General

The organisation shall establish, document, implement and maintain a model of the R&D&i process, for instance like the one indicated in the introduction of this standard, as well as its R&D&i management system and continuously improve its effectiveness in accordance with the requirements of this standard. The organisation shall: a) Identify the R&D&i activities to which the R&D&i management system shall be subject and apply them throughout

the organisation. b) Determine the sequence and interaction of these activities.

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c) Determine the necessary criteria and methods to ensure the effective operation and control of these activities. d) Guarantee the availability of the necessary resources and information to support the operation and monitoring of

these activities. e) Monitor, measure and analyse these activities and establish the procedures to carry them out. f) Implement the necessary actions to achieve the expected results and the continual improvement of these activities. g) Establish and document the mechanisms for the protection and exploitation of results. The organisation shall manage the activities in conformity with the requirements of this standard. In those cases where the organisation chooses to hire, outside the organisation, any R&D&i activity affecting the conformity of the R&D&i management system to the requirements, the organisation shall ensure the control of such activities. The control over these activities hired externally to the organisation shall be identified within the R&D&i management system. 4.1.2 Documentation

The R&D&i management system documentation shall include the following: a) Documented statements of an R&D&i policy and of R&D&i objectives. b) Documented procedures required in this standard. c) The documents needed by the organisation to ensure the effective planning, operation and control of the R&D&i activities. d) The records required in this standard. 4.1.2.1 Control of documents

Documents required in the R&D&i management system shall be controlled. Records are a special type of document and shall be controlled in accordance with the requirements mentioned in clause 4.1.2.2. A documented procedure shall be established to define the necessary measures to: a) Approve documents in terms of their suitability before they are issued. b) Review and update documents whenever necessary and approve them once again. c) Ensure that all changes are identified, as well as the current review state of documents. d) Ensure that the relevant versions of the applicable documents are available at point of use. e) Ensure that the documents remain legible and are easy to identify. f) Ensure that the documents coming from outside the organisation are identified and their distribution controlled. g) Prevent the unintended use of deprecated documents and identify them in the event they are kept for any reason. 4.1.2.2 Control of records

Records shall be established and maintained to provide evidence regarding the conformity with the requirements as well as the effective operation of the R&D&i management system. Records shall remain legible and easy to identify and recover. A documented procedure shall be established to define the necessary measures for the identification, storage, protection, recovery, preservation time and disposal of records.

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4.2 Responsibility of top management 4.2.1 Commitment of top management

Top management shall provide evidence of their commitment to the development and implementation of the R&D&i management system, as well as to the continual improvement of their effectiveness by: a) Communicating the importance of the R&D&i activities to the organisation. b) Establishing the R&D&i policy. c) Ensuring that the R&D&i objectives are established. d) Carrying out top management reviews. e) Setting up the R&D&i Management Unit and, when appropriate, the R&D&i Unit. f) Ensuring the availability of material resources. g) Approving and reviewing the R&D&i budget. h) Establishing the policy regarding the protection and exploitation of the results obtained. 4.2.2 Interested parties approach

Top management shall ensure that the needs and expectations of the interested parties in the R&D&i process and considered and analysed. At least, attention should be drawn to: − Demands of providers and customers. − Motivation and involvement of employees. − Demands of shareholders. − Legal and regulatory requirements. − Innovations and technological changes required by the market. 4.2.3 R&D&i policy

Top management shall ensure that their R&D&i policy: a) Is suitable for the organisation�s aim. b) Includes the commitment to meet the requirements of this standard and to continuously improve the effectiveness of

the R&D&i management system. c) Provides a reference framework to establish and review the R&D&i objectives. d) Is communicated and understood within the organisation. e) Is reviewed for its continual adaptation.

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4.2.4 Planning 4.2.4.1 R&D&i objectives

Top management shall ensure that the R&D&i objectives are established in the relevant functions and levels within the organisation. The R&D&i objectives shall be measurable and consistent with the R&D&i policy. 4.2.4.2 R&D&i management system planning

Top management shall ensure that: a) The R&D&i management system planning is carried out in order to meet the requirements mentioned in clause

4.1.1, as well as the R&D&i objectives. b) The R&D&i management system integrity is maintained when changes are planned and implemented in the system

itself. c) The R&D&i investment policy is set, bearing in mind the risk level criteria. 4.2.5 Responsibility, authority and communication

Top management shall ensure, in accordance with the requirements set in this standard, that an R&D&i management unit is constituted and operational, and if appropriate, an R&D&i unit too. The former will manage the R&D&i system and both its internal or external R&D&i projects, the latter will be in charge of undertaking the R&D&i activities it has been assigned (see figure 2). There are certain cases where both units might coincide in one.

R&D&i Management Unit

− Uses the R&D&i tools described in clause 4.4.1.

− Identifies and analyses problems and opportunities.

− Analyses and selects R&D&i ideas.

− Is in charge of planning, monitoring and controlling the project portfolio.

− Carries out the technology transfer.

− Is in charge of monitoring and controlling the results, as well as of preparing the result documentation procedure.

− Carries out the protection and exploitation of results.

− Carries out the measurement, analysis and improvement.

R&D&i Unit

− Uses the R&D&i tools described in clause 4.4.1.

− Undertakes the R&D&i projects it has been assigned.

− Generates knowledge.

− Develops new technology and improves the existing one.

AA

Figure 2 − Functions of the R&D&i Management Unit and of the R&D&i Unit

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4.2.5.1 R&D&i Management Unit

Top management shall ensure that the functions and responsibilities within the R&D&i management unit are defined and communicated within the organisation. The R&D&i management unit shall be in charge, at least, of the following functions: a) Using the R&D&i tools described in clause 4.4.1. b) Identifying and analysing problems and opportunities. c) Analysing and selecting R&D&i ideas. d) Planning, monitoring and controlling the project portfolio. e) Carrying out the technology transfer. f) Controlling, monitoring and documenting the results. g) Protecting and exploiting the results. h) Measuring, analysing and improving. 4.2.5.2 R&D&i Unit

Top management shall ensure that the following functions and responsibilities within the R&D&i unit are defined and communicated within the organisation. The R&D&i unit shall be in charge, at least, of the following functions: a) Using the R&D&i tools described in clause 4.4.1. b) Undertaking the R&D&i projects it has been assigned. c) Generating knowledge. d) Developing new technology and improving the existing one. 4.2.5.3 Establishment and structure of the R&D&i units and R&D&i management 4.2.5.3.1 Establishment

Top management shall define the degree of centralisation or decentralisation of the R&D&i units. With this aim: a) Certain organisations and operational structures enabling the appropriate management and execution of R&D&i

projects shall be implemented. Each project shall consider the need to: − Structure flexible teams that will adapt to projects of different types and sizes. − Temporarily incorporate external experts to the R&D&i unit and/or subcontract, partially or completely, the

project or some of the tasks or stages of the latter. b) The activities shall be developed in line with the authority and responsibility established in the project teams, and

between these and other units.

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4.2.5.3.2 Structure

Top management shall define the general structures and the functional dependence on the R&D&i units, with this aim: a) The organisational structures of the R&D&i units and/or R&D&i management shall be developed. c) The authority and responsibility lines shall be defined and established. d) The operational procedures shall be established, including the types of reports. 4.2.5.4 Top management representative

Top management shall designate one of its members who shall, in addition to other responsibilities, control the R&D&i activities, including the following: a) Ensure that the necessary activities for the R&D&i management system are established, implemented and

maintained. b) Inform top management about the performance of the R&D&i management system and about any improvement need. c) Ensure that awareness of R&D&i activities is promoted within all the organisation levels. 4.2.5.5 Internal communication

Top management shall ensure that the appropriate communication processes are established within the organisation and that communication is performed considering the effectiveness of the R&D&i management system. 4.2.6 Management review

4.2.6.1 General

Top management shall, at planned intervals, review the organisation�s R&D&i management system, in order to ensure its continual convenience, adaptation and effectiveness. The review shall include the evaluation of the improvement opportunities and the need to make changes in the R&D&i management system, including the R&D&i policy and the R&D&i objectives. Management review records shall be maintained. 4.2.6.2 Information to be reviewed

The information of the management review shall include: a) Audit results. b) Feedback from the interested parties. c) Monitoring and measurement of the R&D&i process. d) Information on the monitoring and measurement of the results of the R&D&i process. e) Status of corrective and preventive actions. f) Monitoring actions of previous management reviews. g) Changes that could affect the R&D&i management system. h) Recommendations for improvement.

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4.2.6.3 Review results

The results of the management review shall include all the decisions and actions regarding: a) The improvement of the R&D&i management system effectiveness. b) The use of resources. c) The need for resources.

4.3 Resource management 4.3.1 Provision of resources

The organisation shall determine and provide the necessary resources to:

a) Implement and maintain an R&D&i management unit and continuously improve its effectiveness.

b) Increase the satisfaction of the interested parties, by meeting their needs and expectations.

c) Foster cooperation with external entities that will provide knowledge, methodologies, instruments, funding, etc.

4.3.2 Human resources 4.3.2.1 General

The personnel carrying out and managing the R&D&i activities in an organisation shall meet the appropriate levels of qualification, education, skills and professional experience, that will make him/her competent to undertake the activities s/he has been assigned. The key to be successful in R&D&i lies in the ability of the personnel to work as a team and in their motivation and enthusiasm to obtain results. 4.3.2.2 Motivation of the personnel

The organisation shall establish the necessary procedures to:

− Promote the awareness of the importance of R&D&i.

− Motivate and raise the enthusiasm of the personnel.

− Encourage the participation of all members of staff.

− Promote creativity and teamwork.

− Simplify and facilitate the information inputs of the different departments. 4.3.2.3 Competence, awareness and training

The organisation shall:

a) Determine the necessary competence for the personnel undertaking and managing R&D&i activities.

b) Provide training courses or take other actions to meet these needs.

c) Evaluate the effectiveness of the actions carried out.

d) Ensure that the personnel undertaking and managing R&D&i activities in the organisation are aware of the relevance and importance of their activities and of their contribution to the achievement of the R&D&i objectives.

e) Maintain the relevant records in terms of education, training, skills and experience.

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4.3.3 Infrastructure

The organisation shall determine, provide and maintain the infrastructure required for the R&D&i process. The infrastructure includes the following, when applicable: a) Buildings, working area and associated services. b) Equipment to undertake R&D&i activities. c) Support services. 4.3.4 Work environment

The R&D&i unit shall determine and manage the work environment required to achieve the R&D&i objectives.

4.4 R&D&i activities

R&D&i activities are those performed by the R&D&i Unit in order to undertake the R&D&i projects it has been assigned for the generation of knowledge and the development of technology or improvement of the existing one, those hired externally and those performed by the R&D&i management unit in order to manage the R&D&i system. 4.4.1 Tools

The R&D&i unit and the R&D&i management unit shall use the following tools to develop their activities: 4.4.1.1 Technology watch

The R&D&i management system shall include a technology watch process, with the following objectives: − To carry out, in a systematic way, the compilation, analysis, dissemination and exploitation of the scientific or

technical information that can be useful for the organisation. − To alert about the scientific or technical innovations which can create opportunities or threats. 4.4.1.1.1 Identification of information needs

The R&D&i unit and the R&D&i management unit shall identify the needs for technological information of the organisation. 4.4.1.1.2 Search, treatment and dissemination of information

The R&D&i unit and the R&D&i management unit shall establish the nature and sources of information and the resources. The information shall be analysed and a system shall be established for its dissemination: support and addressees. 4.4.1.1.3 Information assessment

The accumulation of information gathered by the watch system shall be integrated in the organisation and adequately presented for the decision making process. (An example of how to integrate the information is the use of technological maps and profiles that offer an overview of what is happening in the relevant sector.) 4.4.1.2 Technology foresight

In the R&D&i unit and the R&D&i management unit, meditation shall be encouraged in order to identify new ideas that will enable the provision of guidance for the future development of products and/or processes in the organisation. 4.4.1.3 Creativity

Creativity, as a mental process contributing to the generation of new ideas, shall be fostered within the organisation by promoting the ability to discard the usual structured channels and ways of thinking to reach an idea that will allow to solve a specific problem.

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4.4.1.4 External and internal analysis

The R&D&i unit and the R&D&i management unit shall establish a system to compare their situation with the reality outside and show how the information flows among the different parts of the organisation. 4.4.1.4.1 External analysis

The R&D&i unit and the R&D&i management unit shall establish a system to carry out the external analysis as an instrument that provides guiding elements in order for an organisation to assess the importance of different innovative ideas, comparing them with the external reality by: − Identifying and describing the evolution scenarios, based in technological developments. − Identifying cases of success and failure of external projects with technological component. − Obtaining data on the evolution of markets in their sector. − Undertaking comparative technological studies of products from the competition. − Identifying, assessing and proposing opportunities for technological partnerships. 4.4.1.4.2 Internal analysis

The R&D&i unit and the R&D&i management unit shall establish the procedure to analyse the current structure of the organisation and the integration mechanisms among its different parts, in order to establish the necessary changes for them to effectively contribute to the generation of innovative ideas. The internal analysis shall consider aspects such as the following: − Making an inventory of the human and material resources that can be used in R&D&i tasks. − Classifying skills and knowledge. − Analysing success and failure factors of internal projects. − Identifying the basic functions developed in the organisation and assessing its adaptation to generate innovative ideas. 4.4.2 Identification and analysis of problems and opportunities

The R&D&i management unit shall establish the system to analyse the problems and opportunities arising, bearing in mind the main R&D&i results of interest for the markets of the organisation. For the identification and analysis of problems and opportunities, aspects such as the following shall be considered: − Analysis of the scientific and technological results in accordance with the R&D&i policy of the organisation. − Monitoring of the scientific and technological results in order to anticipate the changes. − Identification of the barriers jeopardising the use of new knowledge in the organisation, and definition of a plan to

acquire the necessary knowledge to overcome the problems arising during the innovation process. − Identification of the possible external collaborations in terms of research and acquisition of knowledge. − Estimation of the success probabilities of the alternatives proposed. − Collaboration in the estimation of the cost of innovation projects and in the marketing of their results. − Analysis of the consistency between the organisation�s business strategy and the R&D&i projects.

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4.4.3 Analysis and selection of R&D&i ideas

The R&D&i management unit shall identify and establish the general criteria for the evaluation and selection of ideas to be adopted and developed. With this aim, a method for the selection of ideas shall be defined. The selection method shall assess a series of factors that will try to guarantee the success of the idea. Among these factors we find economic, productive, legal and social factors, as well as those of technological nature. The selection method shall ensure that, for each idea, aspects such as the following are identified and defined: − The evolution scenarios. − The necessary resources. − The main tasks. − The impact in terms of cost, as well as with regard to its contribution to the R&D&i objectives and their position in

the market. − The risk factors. − The probability of success. − The expected benefits. 4.4.4 Planning, monitoring and control of the project portfolio

Once they have been selected, the ideas contribute to the definition of the R&D&i activities. When the R&D&i activities reach a considerable degree of complexity and specificity, R&D&i projects, where the results to be expected can be described and the resources required can be quantified, shall be defined. The R&D&i management unit shall establish a system enabling to plan, monitor and control the project portfolio, bearing in mind aspects such as the following: − Review and approval of documents. − Priority proposals. − Supervision of global progress and management of periodic reviews. − Drafting of reports on the state-of-the-art and progress of projects, in view of the information provided by the

R&D&i Unit. − Search for sources of funding. − Search for internal and external collaborations. − Assessment of the impact caused by the evolution of the state-of-.the-art concerning the products. 4.4.5 Technology transfer

The R&D&i management unit shall establish a systematic way to maintain and document a technology transfer system that will consider both their own technology and the possibility to integrate external technology, bearing in mind aspects like the following: − Intellectual and industrial property (patents, utility models, etc.). − Technology acquisition and sale contracts.

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− Technical assistance. − Creation of joint ventures. − Cooperation and partnerships to undertake R&D&i projects. − Technology transfer from the university/R&D&i bodies to the organisation. 4.4.6 R&D&i product

The organisation, once the projects have been defined and counting on the collaboration of all the interested parties, shall plan and develop the process required to undertake the R&D&i product and shall include, where appropriate, the subsequent stages, that will not need to be sequential. 4.4.6.1 Basic design

The selected ideas that lead to the R&D&i projects shall be specified in a first basic design which shall include the existing scientific-technical knowledge or, in the event that Research is the way chosen, the resulting inventions of the new knowledge that has been generated. This first basic design shall consider aspects such as the following: − Description of the design and outline of the characteristics. − Planning of resources. − Preliminary maps. 4.4.6.2 Detailed design

The information generated at the basic design stage completes the design details before the tests. Both at this stage and at the design stage, problems requiring external or internal Research to be solved can arise. The Research results will lead to modifications and changes in the basic designs. The detailed design shall consider aspects such as: − Description of the design. − Support elements or infrastructure. − Design team. − Communication structure. − How to implement the design process. 4.4.6.3 Pilot test

From the detailed design arises a prototype to be tested in this stage. During this stage, the technical problems that could arise will be solved and the information generated will be circulated to the design stages to improve the features of the prototype according to the project specifications, it can even lead to the redefinition of the latter. The pilot test shall consider aspects such as: − Description of the actual work situation. − Procedures for a change adaptation and update. − Procedures to validate the prototype.

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4.4.6.4 Redesign, demonstration and production

The product resulting from the R&D&i process shall be manufactured according to the prototype approved, and therefore it is necessary to define the production means and resources during the stage of real demonstrations. This way, the facets, aspects and elements of the prototype to be modified, retouched or changed can be rediscovered. The information generated during the demonstrations will be re-circulated to the previous stages to define the final production prototype. 4.4.6.5 Marketing

Once all the production problems have been solved the product marketing stage of the product is reached. At this moment in time, the new development faces up to the market to see how the latter satisfies the interested parties. There will most probably be further modifications and changes to be made, as well as subtle aspects not considered in the previous stages that shall be borne in mind. 4.4.6.6 Change control

All the information generated in the stages mentioned in clause 4.4.6 and the changes produced shall be documented. Change control involves the following activities: − Systematic surveillance of the project, especially with regard to features, costs and timeframes. − Approval of the deviations considered. − Appropriate records of all the changes introduced. 4.4.7 Purchasing 4.4.7.1 Purchasing process

The organisation shall ensure that the personnel subcontracted and/or the products acquired meet the requirements indicated by the R&D&i management unit. The organisation shall select its providers according to their ability to meet the needs of the R&D&i management unit. 4.4.7.2 Purchasing information

The information shall describe the work to be subcontracted and the product to be purchased, including the following, where appropriate: − Requirements for the approval of the products purchased. − Requirements for the qualification of the subcontracted personnel. 4.4.7.3 Purchasing verification

The organisation shall establish and implement the inspection or other necessary activities to ensure that the subcontracted entity or the product purchased meet the specified requirements. Whenever the organisation wishes to carry out the verification in the facilities of the subcontracted entity, the organisation shall establish the provisions for the intended verification in the subcontracting information. 4.4.8 Results of the R&D&i process

The results of the R&D&i process shall be provided in such a way that they will enable to evaluate that the objectives planned in the R&D&i policy have been effectively fulfilled.

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4.4.8.1 Documentation of the results

The R&D&i management unit shall establish a system to inform on the R&D&i results, considering aspects such as the following: − Final reports on the projects. − Description of the protection of the results obtained. − Basic data, diagrams, drawings and intermediate reports. − Problems and specific solutions, with the techniques, procedures and equipment used. − Written evaluations of the projects as a whole, including the knowledge acquired for future R&D&i activities. 4.4.8.2 Monitoring and Measurement

The R&D&i management unit shall undertake the monitoring and measurement of the results of the R&D&i process, considering aspects such as the following: − Definition of the criteria for the review, selection and approval of results. − Establishment of the necessary mechanisms to quantify the results achieved and compare them with the objectives

planned in the R&D&i policy and, this way, obtain evidence of the technological effectiveness and efficiency attained.

− Availability and use of monitoring and measuring mechanisms, as applicable. − Design and implement the corrective measures and actions required. − Identify, during the monitoring, new R&D&i ideas or deepen into existing ones. 4.4.9 Protection and exploitation of the results of R&D&i activities

The R&D&i management unit shall assess the viability and opportunity to protect and exploit the results obtained, considering aspects such as the following: a) Define the internal mechanisms for technology transfer. b) Implement the mechanisms for technology transfer. c) Define the agreements for technology transfer. d) Identify the alternatives to protect the results. e) Start the patent procedures on the new findings. f) Establish the levels of confidentiality of the results and determine the measures to ensure it.

4.5 Measurement, analysis and improvement 4.5.1 General

The organisation shall plan, programme and implement the processes to monitor, measure, analyse and improve the following: a) the execution of R&D&i activities;

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b) the R&D&i management system; c) its continual improvement. The organisation shall monitor the perception of the interested parties with regard to the fulfilment of their needs and expectations. 4.5.2 Internal audits

The organisation shall carry out internal audits at planned intervals in order to determine whether the R&D&i management system: a) complies with the planned provisions, with the requirements set in this standard and with the requirements of the

R&D&i management system established by the organisation. b) has been effectively implemented and maintained. The audit criteria, the scope of the audit, its frequency and methodology shall be defined. The selection of auditors and the undertaking of audits shall ensure the objectivity and impartiality of the auditing process. The auditors shall not audit their own work. In a documented procedure, the responsibilities and requirements for the planning and execution of audits shall be defined, in order to inform of the results and maintain the records. 4.5.3 Monitoring and measurement of the R&D&i process

The organisation shall apply the appropriate methods for the implemented R&D&i process. These methods shall demonstrate the capacity of the R&D&i activities to achieve the expected results. When the expected results are not achieved, the actions to be taken shall be determined. 4.5.4 Monitoring and measuring the results of the R&D&i process

The organisation shall measure and monitor the results of the R&D&i process, in order to verify that the requirements of these are fulfilled. This shall be undertaken in the suitable stages of the process, in accordance with the provisions planned. 4.5.5 Control of the deviations from the expected results

The organisation shall ensure that the deviations from the expected results are identified and recorded, so that they can be reused in the future, if appropriate. 4.5.6 Data analysis

The organisation shall determine, compile and analyse all the appropriate data to demonstrate the suitability and effectiveness of the R&D&i management system and to evaluate where the continual improvement of the effectiveness of the R&D&i management systems can be carried out. This shall include the data generated by the result of the monitoring and measurement of the R&D&i process and by any other relevant sources. The data analysis shall provide information on: a) The satisfaction of the interested parties. b) The conformity with the requirements of the results of the R&D&i process. c) The characteristics and tendencies of the R&D&i process and its results.

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4.5.7 Improvement 4.5.7.1 Continual improvement

The organisation shall continuously improve the effectiveness of the R&D&i management system through the application of the R&D&i policy, the R&D&i objectives, the results of the audits, the data analysis, the corrective and preventive actions and the management review. 4.5.7.2 Corrective action

The organisation shall take actions to eliminate the cause of any nonconformity detected in the R&D&i management system, in order to prevent them from recurring. Corrective actions shall be appropriate to the nonconformities detected. A documented procedure shall be established to define the requirements in order to: a) Review nonconformities. b) Determine the cause of any nonconformity. c) Evaluate the need to adopt actions to ensure that nonconformities will not recur. d) Determine and implement the necessary actions. e) Record the results of the actions taken. f) Review the corrective actions taken. 4.5.7.3 Preventive action

The organisation shall determine actions to eliminate the causes of potential nonconformities that could be detected in the R&D&i management system in order to prevent them form occurring. Preventive actions shall be appropriate to the impact of potential problems. A documented procedure shall be established to define the requirements in order to: a) Determine the potential nonconformities and their causes. b) Evaluate the need to adopt actions to prevent the emergence of nonconformities. c) Determine and implement the necessary actions. d) Record the results of the actions taken. e) Review the preventive actions.

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BIBLIOGRAPHY

UNE 166001:2006 R&D&i management: R&D&i project requirements UNE 166005:2004 IN R&D&I management: Application guide of UNE 166002:2002 EX to equipment sector. UNE 166006:2006 EX R&D&i management: Technology Watch System ISO 9000:2005 Quality management systems. Fundamentals and vocabulary. ISO 9001:2000 Quality management systems. Requirements. ISO 14001:2004 Environmental management systems - Requirements with guidance for use. S. Mehrdad Mohammadi, Omid Ameli and S. Farzad Mohammadi. New Quality model for R&D organizations. Magazine ISO 9000/14000, nº 10 July/August 2000, p. 25-28. Ley 55/1999 de 29 de diciembre de 1999, de medidas fiscales, administrativas y de orden social. (B.O.E. Estado de 30 de diciembre de 1999). Iniciativa ATYCA del Ministerio de Industria y Energía. Manual de Gestión de la I+D � Bienes de Equipo. Proyecto �Espejo I+D�. SERCOBE. Madrid 1999. ESCORSA CASTELLS, Pere Y MASPONS, Ramón. De la Vigilancia Tecnológica a la Inteligencia Competitiva. Prentice-Hall-Financial Times 2001. Frascati Manual. OECD. Green Paper on Innovation. European Union. (Luxembourg 1996) CICYT. Plan Nacional de Investigación Científica, Desarrollo e Innovación Tecnológica 2004-2007. Oslo Manual. OECD 2005. PALOP, Fernando y VICENTE, José M. Vigilancia Tecnológica e Inteligencia Competitiva. Su potencial para la Empresa Española. Informe COTEC. Febrero 1999. PAVÓN MOROTE, Julián; HIDALGO NUCHERA, Antonio. Gestión e innovación. Pirámide 1999. ESCORSA CASTELLS, Pere y VALLS PASOLA, Jaume. Tecnología e Innovación en la Empresa. Edición UPC 1997. TORRECILLA, José Miguel. La Innovación en la Práctica. Editorial. CISS PRAXIS, septiembre 2000.

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