Common Rules for Quality Management Administrator(s) Project Administrator / Monika Sieberová Approved by Operational Director / Emilie Zichová 30.11.2011 Executive Director / Tomáš Hruda 30.11.2011 Coordination Board 14.12.2011 Applicable from 1.1.2012 Version 001/2012 Annexes Overview of Common Rules and Policies, Supplement to Risk Management Process Common Rules for Quality Management, version 001/2012 2 / 26 Content 1. INTRODUCTION ............................................................................................................................................ 3 1.1 PURPOSE................................................................................................................................................. 3 1.2 GOAL....................................................................................................................................................... 3 1.2.1 Specific Goals ............................................................................................................................... 3 2. CONTENT ...................................................................................................................................................... 5 2.1 ACTIVITY SUMMARY .................................................................................................................................. 5 2.2 PRINCIPAL ACTIVITIES ............................................................................................................................... 6 2.2.1 Common Evaluation of the Scientific Excellence........................................................................... 6 2.2.1.1 Measure 1: Peer review ............................................................................................................ 6 2.2.1.2 Measure 2: Common evaluation of the organisational system and operation of the Core Facilities 6 2.2.2 Evaluation / monitoring of complementary projects....................................................................... 7 2.2.3 IP protection in R&D cooperation .................................................................................................. 8 2.2.4 Risk management ......................................................................................................................... 9 2.2.4.1 Measure 1: Initiation.................................................................................................................. 9 2.2.4.2 Measure 2: Identification, assessment, response planning..................................................... 10 2.2.4.3 Measure 3: Implementation..................................................................................................... 10 2.2.4.4 Measure 4: Reporting ............................................................................................................. 11 2.2.4.5 Measure 5: Review ................................................................................................................. 11 2.2.4.6 Measure 6: Risk management training ................................................................................... 12 2.2.5 Procurement management.......................................................................................................... 12 2.2.6 Project monitoring (monitoring report and application for payment compilation) ......................... 14 2.2.7 Change management in the OP RDI project ............................................................................... 14 2.2.8 OP RDI project irregularities........................................................................................................ 14 2.2.9 Scheduling and result-oriented planning ..................................................................................... 14 2.2.10 Confidential and other data processing....................................................................................... 14 2.2.11 Communication among partners and the Central Management Structure................................... 16 2.2.12 Communication among CEITEC Researchers ............................................................................ 16 2.2.13 Communication to third parties.................................................................................................... 16 2.2.14 Marketing documents .................................................................................................................. 17 2.2.15 Infrastructure exploitation ............................................................................................................ 17 2.2.16 Violation of the Code of Ethics .................................................................................................... 18 2.2.17 Support of publications................................................................................................................ 18 2.2.18 CEITEC website.......................................................................................................................... 18 2.2.19 Quality management control, update and training....................................................................... 18 3. LIST OF ABBREVIATIONS ......................................................................................................................... 20 4. GLOSSARY.................................................................................................................................................. 21 5. CHANGES FROM PREVIOUS VERSION.................................................................................................... 23 6. ANNEXES .................................................................................................................................................... 24 6.1 ANNEX 1 OVERVIEW OF COMMON RULES AND POLICIES ............................................................................. 25 Common Rules for Quality Management, version 001/2012 3 / 26 1. Introduction CEITEC (Central European Institute of Technology) is a project focused on the establishment of a European centre of excellence in the area of life sciences and advanced materials and technologies. Common Rules for Quality Management, Human Resources Management, Cooperation with the Application Sphere, Code of Ethics and Common Publication Policy are an integral part of the management and coordination of the centre in all CEITEC Organisational Units and the Central Management Structure. A detailed description is available in Annex 1 Overview of Common Rules and Policies. 1.1 Purpose The Common Rules for Quality Management describe the overall policies, organisational responsibilities, procedures, and the means of ensuring that all items of work are in conformance with the obligations pursuant to the OP RDI grant and, in particular, with theproject’s overall objectives reflected in the specific goals stated below. 1.2 Goal The main goal of the document is to identify and stipulate principle activities of quality management and to introduce a unified approach on the levels of CEITEC Organisational Units and the Central Management Structure. 1.2.1 Specific Goals The accomplishment of the main goal is assured through the following specific goals:  To ensure common evaluation of the scientific excellence  To promote evaluations of complementary projects  To assure risk management  To ensure proper procurement management  To guarantee project monitoring  To assure change management in the OP RDI project  To promote scheduling and result-oriented planning  To guarantee efficient processing of confidential and other data  To ensure document control  To guarantee efficient communication among partners and the Central Management Structure  To encourage harmonisation of communication to third parties  To assure marketing documents Common Rules for Quality Management, version 001/2012 4 / 26  To promote effective infrastructure exploitation  To assure management of the Code of Ethics violation  To ensure support of publications  To ensure CEITEC website  To promote the quality management control, update and training Common Rules for Quality Management, version 001/2012 5 / 26 2. Content 2.1 Activity Summary The following table indicates who should pay attention to individual principle activities and specific measures. ED 1 SD OD CD CB ISAB OUD RPC RGL Researcher Common Evaluation of the Scientific Excellence         Evaluation of complementary projects        Principles of institutional support allocation     Risk management Facilitate the risk management process      Initiation      Identify, assess the risks and plan responses      Implement actions / responses    Report progress of actions / responses    Review risk status and produce reports   Procurement management Public procurement plan   Public procurement guidelines   Procurement management   Announcement to the MEYS 2  Public announcement of commencement   Evaluation board nomination and organisation   Choice of the contractor   Contract negotiation and signature   Project monitoring    Change management in the OP RDI project        OP RDI project irregularities      Scheduling and result-oriented planning        Confidential and other data processing          Document control   Communication among partners and CMS 3        Marketing documents          Support of exploitation of infrastructure        Violation of the Code of Ethics       Support of publications       Quality management control and update       Quality management training                                                                   1 ED Executive Director, SD Scientific Director, OD Operational Director, CD Commercial Director, CB Coordination Board, ISAB International Scientific Advisory Board, OUD Organisational Unit Director, RPC Research Programme Coordinator, RGL Research Group Leader.  2 Ministry of Education, Youth and Sports  3  Central Management Structure  Common Rules for Quality Management, version 001/2012 6 / 26 2.2 Principal Activities 2.2.1 Common Evaluation of the Scientific Excellence 2.2.1.1 Measure 1: Peer review Every two years, beginning in 2012, the Common Evaluation of Scientific Excellence with independent peer review will be organised by the Scientific Director. Moreover, the first evaluation shall also focus on implemented internal norms and processes, especially common rules, human resources management and management in general. Process of peer review: 1) Input data from self-evaluation 2) Benchmarking with strategic partners 3) Presentations of research groups The evaluation commission will always be nominated by the Scientific Director with taking into the account the ISAB opinion. The relevant ISAB member is automatically the member of evaluation commission. The evaluation commission has at least two members for each research programme. Research programme coordinator has the right to participate in the evaluation and he/she can have comments however without the vote. Coordination Board approves the final form of evaluation. The system of evaluation will be approved by the end of 2011. 2.2.1.2 Measure 2: Common evaluation of the organisational system and operation of the Core Facilities The Scientific Director shall organise an independent evaluation of the organisational system and operation of the Core Facilities. The Scientific Director shall provide concrete guidelines and define the structure of the evaluation report for the evaluation no later than 6 months before the evaluation itself. The evaluation of the organisational system shall consider some or all of the following aspects:  Administrative and technical planning of work  Record keeping and document control  Staff qualifications, training and supervision of staff  Equipment and computer controlled equipment  Subcontracting  Analytical task quality elements (definition of task, project design, project work plan, resource management of task)  Efficiency of the organisational system  Optimization of the organisational system Each Core Facility shall be evaluated at the commencement of its operation. The Organisational Unit Director responsible for the running of the Core Facility shall announce the start of its operation in the Common Rules for Quality Management, version 001/2012 7 / 26 Plan of Further Activities of the Organisational Units as a part of the Annual Activity Plan of the Project. The Scientific Director shall arrange an independent evaluation of the operational start-up of the Core Facility no later than 3 months after it begins operation. The evaluation will be conducted by at least 3 independent (foreign) experts and it shall consider some or all of the following aspects in assessing the technical quality and readiness of the Core Facility:  Unit operations  Technical capability of laboratory  Methodology  Reagents, reference materials and calibrants  Calibration and traceability  Instrument performance  Technical requirements related to particular unit processes (sampling, measurement, validation, measurement uncertainty)  External verification (formal assessment against published quality assurance standards, benchmarking, external proficiency testing) 2.2.2 Evaluation / monitoring of complementary projects To ensure the quality and effectiveness of further CEITEC complementary projects at least a threestage evaluation and control of complementary projects shall be conducted: ex-ante, interim, ex-post evaluation. The Operational Director is responsible for development of the evaluation methodology no later than 3 months after the issue of the Decision on grant. Complementary projects are defined as national grants, international grants, contract research or collaborative research projects. It is up to the Organisational Unit Director to identify complementary projects during the operation of the Organisational Unit. In the case of the Central Management Structure, the Operational Director is responsible. All projects of the Central Management Structure are subject to controls. Projects of partners are subject of monitoring only if they complying with at least one of the following criteria:  Providing that:  The overall costs of a project on the side of the respective Organisational Unit reach at least 10,000,000 CZK (VAT excluded).  There is a project in which a company participates in implementation and their financial share of the project’s budget on the side of the respective Organisational Unit reaches 500,000 CZK (VAT excluded).  The above-mentioned limits are set for cooperation with one subject defined by one identification number (IČO) within one calendar year.  If requested by the person responsible for the preparation of the project Ex-ante evaluation Common Rules for Quality Management, version 001/2012 8 / 26  Organisational Unit provide a brief description of planned projects (for defined project call) within CEITEC Grant Office regular meetings in terms stated by Operational Director. Interim evaluation  Organisational Unit is obliged to enable access to all relevant documents (esp. Monitoring report) to Operational Director, or delegated person. Ex-post evaluation  Take place after the end of the project.  Organisational Unit is obliged to provide all relevant documents to Operational Director, or delegated person, on request.  The Operational Director shall provide annual overall report relating to complementary projects. 2.2.3 IP protection in R&D cooperation R&D projects should be properly treated as regards the field of IP protection. In the case where there is only one institution implementing a project the respective legal regulations, the conditions of grant provider and internal regulations shall be followed regarding IP protection. In the case where there is more than one institution implementing a project and there is no contractual IP protection required by the grant provider, there must be contractual IP protection in addition to the respective legal regulations, the conditions of grant provider and internal regulations.  IP created in the CEITEC centre (foreground knowledge): The property rights to the IP created within the CEITEC centre are derived from the labour relations of the researcher generating the concerned R&D results.  IP brought into the CEITEC centre (background knowledge): IP brought into the project will be identified in advance. In cases where it is necessary to transfer IP rights to the research party ordering the use of the results of research and development, it will be performed on the basis of licence provided at usual price. The following procedure will be applied in the case of basic research with a partner where the financial volume of this research exceeds the amount of CZK 10,000,000 (VAT excluded). The Organisational Unit, represented by the Organisational Unit Director, whose Research Group is the originator of the IP is responsible for ensuring the Author’s Announcement of Invention4 . The announcement must be submitted to the Commercial Director at least 10 working days before signing the contract. It is suggested however to consult the properties of any R&D cooperation on regular basis with designated technology transfer expert.                                                              4 Czech term: Oznámení původce o vytvoření vynálezu.  Common Rules for Quality Management, version 001/2012 9 / 26 2.2.4 Risk management This project is considered to be a major project in accordance with Article 39 of EC Directive No. 1083/2006. With respect to its complexity and scope, the following risk management process will be applied. Figure 1 Overview of the risk management process Initiation Identification Assessment Response planning Implementation, reporting & review - Risk tresholds - Process rules - Risk management plan - List of risks - Risk owners - Risk register set up / update - Probability, impact - Root causes, importance - Prioritized list - Risk register update - Strategies, Actions - Action owners, timing - Risk register and master schedule update - Status, trends in risk exposure - Reporting - Minor / major reviews incl. reports Risk management process is meant to be fully compatible with other project management processes. Moreover, it shall provide valuable information especially to planning, budgeting, cost control, quality and scheduling. However, master schedule of the project shall be updated if necessary after each project review. 2.2.4.1 Measure 1: Initiation This phase defines the details of the risk process to be implemented as depicted in the description of the risk management within this document. All designated representatives of the Organisational Units shall be consulted and approve on the settings of the risk management process. This phase does not repeat throughout the project cycle.  Output of the process: risk management process description within this document. Common Rules for Quality Management, version 001/2012 10 / 26 2.2.4.2 Measure 2: Identification, assessment, response planning There will be risk workshop(s) organised by the Central Management Structure represented by the Operational Director to identify and assess key risks (both threats and opportunities). This phase will be completed within first quarter after the issue of the Decision on grant. Partners are responsible for ensuring full participation in the process. Organisational Unit Directors and Operational Director identify key employees to participate in the identification, assessment and response planning. This phase does not repeat throughout the project cycle, but its outputs shall be updated or supplemented within the reviews. Identification  Risks (both threats and opportunities) will be identified using the following techniques: o Brainstorming with all members of the project team plus representatives of key stakeholders o Analysis of all project assumptions and constraints, both implicit and explicit o Review of a standard risk checklist o Ad hoc identification of risk by project team members at any time during the project o Initial risk register to record identified risks for further assessment, following the standard format  Output of the process: Risk Register set up Assessment  Following steps will be applied: o Probability and impact assessment for each identified risk Double P-I matrix prioritize risks for action, using the standard risk scoring calculations based on probability (P) and impact (I) Top risk list for priority management attention (included into the reports) o Risk categorization using the standard risk breakdown structure and the project work breakdown structure to identify patterns of exposure o Risk register update to include assessment data  Output of the process: Risk Register update Response planning  Following steps will be applied: o Response strategy selection as appropriate for each identified risk, including owner allocation o Identification of specific actions and action owners o Risk register update to include response data  Output of the process: Risk Register update, project master schedule update 2.2.4.3 Measure 3: Implementation Organisational Unit Directors are responsible forimplementing the actions they have had planned. The Organisational Unit Directors are responsible in general for ensuring that the planned actions (agreed response strategies) are followed. In case of the Central Management Structure, the Operational Director is responsible for the same.  Actions owners (as identified in the Risk Register) are responsible for: Common Rules for Quality Management, version 001/2012 11 / 26 o Implementing agreed response strategies via their agreed actions o Reporting their progress to the risk owner  Output of the process: reports on action progress 2.2.4.4 Measure 4: Reporting Organisational Unit Directors or identified risk owners in the risk register are responsible for:   Communicating the dynamic status of risk to the Operational Director: o General risk status trimonthly (simultaneously with risk review process) o Top risks on ad hoc basis and as agreed with the Operational Director o In case of occurrence of top risk, the Operational Director shall be notified immediately  Output of the process: structured information via e-mail 2.2.4.5 Measure 5: Review Risk exposure of the OP RDI project will be reviewed trimonthly within minor reviews and annually by major review during the life of the project. In the month in which minor and major review should have been conducted together, only major review will be executed. At these reviews new risks can be identified and assessed, existing risks will be reviewed, progress on agreed actions will be assessed, and new actions and/or owners will be allocated where required. The effectiveness of the risk process will be reviewed as part of a major review to determine whether changes to the approach, tools or techniques are required. Where process changes are agreed by the Executive, Operational Director and Organisational Unit Directors, the description of the risk management process within this document will be updated and reissued to document the revised process. There will be risk workshop(s) organised and facilitated by the Central Management Structure to conduct reviews. A risk report will be issued by the Operational Director to the Executive Director after each major or minor review. The participants in the risk process will be provided with an extract from the current risk register after each review, listing those risks and actions for which the individual is responsible. Organisational Units shall participate in:   Updating the risk assessment at regular intervals through a series of major and minor reviews, identifying additional risks  Submit suggestions of lessons learned record for both the improvement of risk management and project management in general  Review shall proceed in following steps: o Major reviews: Risk workshops will take place as part of a major review to identify new risks, review progress on existing risks and agreed responses, and assess process effectiveness o Minor review: Risk review meeting as part of minor review to identify new risks, review progress on existing risks and agreed responses  Output of the process: Minutes of the meeting, update of the Risk Register, Summary / Full Risk Report Common Rules for Quality Management, version 001/2012 12 / 26 2.2.4.6 Measure 6: Risk management training Risk management training shall be conducted regularly to ensure update information about the risk management process within the CEITEC centre. Operational Director is responsible for the preparation of the training package and delivery of necessary training events.Organisational Unit Directors are responsible to ensure that a personnel participating in the risk management process understands the process.  Output of the process: training package, reports form training events The first training and training package shall be prepared no later than 3 months after the issue of the Decision on grant. The target group of risk management training are Organisational Unit Directors, or delegated project managers. 2.2.5 Procurement management The Operational Director is responsible for development of the Procurement guidelines, which shall provide clear principles of tendering, responsibility assignment, workflow, archiving and communication principles, sample tender documentation, contract and business conditions applying only to public procurements for the OP RDI project. The Procurement guidelines shall be prepared no later than 3 months after the issue of Decision on Grant. The Organisational Unit Directors are responsible for all public procurements for their respective Organisational Units. In the case of the Central Management Structure it is the responsibility of the Operational Director.  The public procurement sponsor shall be responsible for preparing the Public Procurement Plan (part of the annual Activity Plan of the Project)  Specifications for all relevant construction work, purchases or services shall by prepared by the public procurement sponsor designated for the respective Organisational Unit by its Organisational Unit, in the case of the Central Management Structure by the Operational Director  Control of an Organisational Unit’s compliance with the public procurement procedure as stated in OP RDI guidelines is the responsibility of the respective Organisational Unit Director, in the case of the CMS it is the responsibility of the Operational Director  If the Organisational Unit Director requires the Central Management Structure to review the public procurement process or the documentation of the tender, he or she shall provide the documents 5 working days prior the day the CMS is expected to give its suggestions  The Operational Director is responsible for ensuring the aforementioned review of the public procurement process or the documentation of the tender; in cases where it is not possible to provide a technical or expert opinion, the Operational Director shall seek external expertise Common Rules for Quality Management, version 001/2012 13 / 26  The Executive Director considers and decides on whether to make the Annual Public Procurement Plan public  In cases of public procurements for delivery of equipment as planned in the OP RDI project for which the price is set out-in excess of 10,000,000 CZK (VAT excluded), a special regime applies in which the Scientific Director has an obligation to provide an independent expert opinion regarding points 2 and 3 (as defined further) within 5 working days and the Operational Director’s opinion on point 1 within 5 working days; the Central Management Structure shall pay particular attention to the following aspects: 1. Formal compliance 2. “Adequacy” and economy 3. Non-discriminatory specification of technical parameters including corresponding assessment of technical and economic interdependencies with the existing infrastructure In this case the documents shall be provided 10 working days prior the publishing of the public procurement.  The Central Management Structure shall secure an independent assessment of potential joint public procurement proceedings; in cases where it is reasonable to expect significant savings resulting from joining the public procurement proceedings, the proposal for joining the public procurement shall be proposed by the Central Management Structure  In the case that the suggestions of the Central Management Structure are not accepted by the Organisational Unit Director, a meeting shall convene to provide an opportunity to resolve the issues raised; the Operational Director and the Organisational Unit Director shall meet in person with additional personnel invited by any one of them to discuss the unresolved issues  All purchases of items and all procurement of services are subject to the review of the public procurement sponsor who is responsible for the assurance that proposed items and services satisfy all technical and quality requirements defined in the project  Once an item or service is procured, it shall be the responsibility of the Organisational Unit Director of the respective Organisational Unit to examine the deliverables to verify that the item or service is of an adequate quality and eventually performance of technologies, in the case of the CMS the Operational Director bears the responsibility  The Organisational Unit Directors shall apply the guidelines and templates developed by the Central Management Structure without change, if a change of certain provisions is necessary, the CMS shall be notified and it shall be consulted with the public procurement manager; the same procedure applies to public procurements conducted by the CMS Common Rules for Quality Management, version 001/2012 14 / 26  Employees of the Organisational Units that deal with public procurements will undertake CEITEC public procurement training; the Operational Director is responsible for public procurement training package development and the provision of training. The first training should be undertaken no later than 3 months after the issue of the Decision on grant. 2.2.6 Project monitoring (monitoring report and application for payment compilation) Details will be specified and regularly updated in a separated document. 2.2.7 Change management in the OP RDI project Pursuant to article 24.1 of the Contract on Cooperation and Partnerships, the Organisational Unit Directors are obliged to inform the Operational Director without delay of any facts that result or might result in any change in the project The Organisational Unit Director proposes the classification of the change to the Operational Director; the Operational Director approves the classification but can seek consultation with the Managing Authority in this subject matter if necessary The Operational Director oversees the overall consistency of activities to obligations set out by the OP RDI project and its Managing Authority. 2.2.8 OP RDI project irregularities Should anOrganisational Unit or its employee come to the conclusion that an irregularity in OP RDI project has occurred; the Operational Director shall be informed without delay. 2.2.9 Scheduling and result-oriented planning Result-oriented Activity Plan of the Project (governing documents) Each Organisational Unit and the Central Management Structure shall provide necessary inputs for the compilation of the Activity Plan of the Projecteach year. The Activity Plan of the Project is result-oriented, e.g. the planning shall provide information in a structure of the result chain (inputs, activities and outputs) and be linked to target values of monitoring indicators for that particular year. The development, maintenance and eventual changes in the structure of the plan are the responsibility of the Executive Director, however changes are subject to the approval of the Coordination Board. Master schedule of the project The Operational Director is responsible for maintaining and updating the master schedule of the project. Moreover, it oversees the overall schedule of the key project outputs, especially those that represent obligations to the MEYS, partners or milestones of project activities. 2.2.10 Confidential and other data processing For the purposes of this policy, the term confidential data refers to private project or other private organisational information not intended to be disclosed outside the context of the project or organisation responsible for that information Common Rules for Quality Management, version 001/2012 15 / 26 Confidential data definition  All personal data necessary for the implementation of the project shall be disposed of as confidential  Any other data are considered as confidential only if marked as defined below Marking the confidential data  All submissions, either in hard copy or in electronic form, should be reviewed by the submitter to ensure that they contain no confidential data; furthermore, it is the responsibility of the submitter to ensure that this review takes place  Data shall be disposed of as confidential if marked as confidential by the submitter in a following way:  In the case of submitting confidential data electronically, the document will be marked visibly in the header with the word CONFIDENTIALand/or DŮVERNÉin red, bold capital letters.  In the case of submitting confidential data in hardcopies, the word CONFIDENTIALand/or DŮVERNÉ in red, bold capital letters shall be placed visibly in the header on the first or cover page of the document. Submission of confidential data  Submission of confidential data to the Central Management Structure:  Data will be delivered in an encrypted form on DVD/CD, either personally to the Operational Director or a designated person, or to the information system.  If submitted in a hardcopy, it shall be delivered directly to the Operational Director or a designated personthe Central Management Structure provides / communicates the confidential data to partners exclusively through the respective Organisational Unit Director. Other provisions concerning confidential data.  Employees of the Central Management Structure must not download and store confidential information on their private computers, external hard drives, thumb/pen/USB flash drives, CD/DVD, or on any removable device  Printed reports that contain confidential data must not be left available to the public; all printed confidential data which are not of immediate use, must be shredded except for purpose of dealing with Managing Authority, internal audit or other control authority as defined by the OP RDI rules  Employees must not discuss, present or otherwise reveal confidential data in public  For authorised personnel, confidential data may be made available on a need-to-know basis as and when required; for all other persons, access to such information is prohibited  The Organisational Unit Directors and the Operational Director appoint the authorised personnel responsible for working and processing the confidential data; these personnel have primary access to confidential data and are responsible for processing them Common Rules for Quality Management, version 001/2012 16 / 26  Unauthorised modification, transmission or other dissemination of confidential information is strictly prohibited  Confidential information should be safely stored and protected while on file servers, network drives, workstations, and during any type of transmission; authorised access should be enforced; confidential information should be erased securely from network drives, file shares etc. after proper authorisation  Rules for authorised access and disposal of confidential data at the Central Management Structure shall be set out by the Operational Director  The Central Management Structure shall send confidential data electronically only to those Organisational Units adhering to the same level of data protection as applied by the Central Management Structure Processing non-confidential data  Non-confidential data being sent by the employees of the Organisational Unit or the Central Management Structure in open format and electronically (e.g. *.doc, *.xls) shall be secured by a password agreed upon with the Operational Director 2.2.11 Communication among partners and the Central Management Structure The communication matrix shall be developed and maintained by the Operational Director to ensure that all CEITEC personnel is involved in communication and information distribution including contact e-mails. 2.2.12 Communication among CEITEC Researchers CEITEC researchers meet at regular meetings. The structure and participants of these meetings are described in table below. Type of meeting Participants Frequency Meeting of Research Programme Coordinators headed by Scientific Director Scientific Director and Research Programme Coordinators at least twice a year Meeting of Research Programme Research Programme Coordinator and Research Group Leaders of respective Research Programme at least four times a year Meeting of Research Group Research Group Leader and members of respective Research Group depending on Research Group Leader decision 2.2.13 Communication to third parties In external communication, all employees of the Central Management Structure and Organisational Units are obliged to clearly state their affiliation to CEITEC including their respective Research Programme. Common Rules for Quality Management, version 001/2012 17 / 26 It is strongly suggested that any communication with non-scientific media, both national and international, is consulted with CEITEC Public Relations and Communication Manager. CEITEC Visual Identity The Uniform visual style (UVS) with the help of the graphics manual unifies the appearance of all material of the CEITEC centre and makes it easy recognizable. Each person who presents the CEITEC centre should maintain graphics manual rules and rules stated below. The UVS shall be prepared no later than 31th March 2012. The basic structure of the Uniform visual style consists of:  The logotype in the form of the CEITEC Internet domain,  The CEITEC logo,  The graphics manual rules. The obligation of adhering and usage of UVS applies to all presentation materials and documents. CMS is obliged to providethe graphics manual within templates of individual documents to all partners. As the Co-operation and partnership agreement stipulates in Art. 14.2.6. the partner shall be obliged to promote project in compliance with the mandatory publicity rules. CEITEC logo and graphics The use of the logo and of the Uniform visual style (UVS) of the CEITEC centre is subject to the following conditions:  The logo and the UVS may be used solely for the purpose of providing information about and promoting the CEITEC centre. Neither the logo nor the UVS may be used for commercial purposes, for self-promotion or for the promotion of products or services.  The logo and the UVS may be used exclusively in a manner complying with the templates / graphic manual of the UVS. The logo, UVS and individual elements of the UVS may neither be changed or modified, nor used in any way that degradesits value. The CEITEC Public Relations and Communications Manager is responsible for dealing with questions or suggestions related to the visual identity of the CEITEC. 2.2.14 Marketing documents The Central Management Structure ensures the management of the marketing document database. An overview of documents and a brief description of their content are available upon request to the Commercial Director. Marketing documents are available upon request to the Commercial Director or to the responsible person on CMS. 2.2.15 Infrastructure exploitation The information system will be implemented by the partners and the Central Management Structure during 2011 and operational since 2012. After the first six months of its operation, the Operational Director shall regularly propose actions to ensure optimal exploitation of the research Infrastructure.Thanks to the laboratory information management system, which shall be implemented Common Rules for Quality Management, version 001/2012 18 / 26 till the start of the first Core Facility operation (2012),dataon exploitation of the Infrastructure or specific technologies will be regularly collected, monitored and evaluated by the Operational Director. 2.2.16 Violation of the Code of Ethics All CEITEC employees have the right to notify violations of the Code of Ethics to the Executive Director. Should the violation not be resolved internally, the Executive Director has an obligation to request the Coordination Board to resolve the conflict. The Coordination Board must resolve the violation at the forthcoming regular meeting. Any of the concerned participants has the right to require the comments of the ISAB, especially in the matters concerning the ethics at research. 2.2.17 Support of publications Above all the promotion of co-publications among CEITEC Research Groups / Research Programmes, between CEITEC and foreign research universities and institutes, between CEITEC and application sector should be ensured. Also the publications produced by the CEITEC researchers should contribute to the CEITEC Common Research Objectives. 2.2.18 CEITEC website The CMS shall create CEITEC central website. The website will have two language versions - English and Czech. The Czech version will include a brief description of the OP RDI project and Research Groups in a form understandable to the public. The English version will include a detailed description of the OP RDI project and profiles of Research Programmes and Research Groups focusing on expert community. The CEITEC central website must always provide the following information / services:  Complete contact list / search  Important events  Open tenders Partners are not obliged to set up their own CEITEC website. It is recommended however to use the central website of CEITEC if possible. Partners are obliged to mention the CEITEC central website on the websites of their Organisational Unit (including first level heads frame from the CEITEC central website). The graphics of partner’s websites shall be in the same visual style. The CMS is obliged to mention the partners CEITEC website on the central website if exist. 2.2.19 Quality management control, update and training The Operational Director shall appoint the employee of the CMS responsible for quality management (hereafter: quality manager). The quality manager will periodically audit CMS employees to insure Common Rules for Quality Management, version 001/2012 19 / 26 compliance and enforcement of policy, any incidents of non-compliance shall be reported to the Operational Director. The Operational Director decides on the frequency and scale of the audit. The same obligation rests upon the Organisational Unit Directors towards their respective Organisational Units.Nevertheless, the quality audit shall be conducted at least once a year. Its conclusions shall constitute a part of the annual Summary Report on the Activity of the Project and be approved by the Coordination Board. All CEITEC employees are responsible for keeping records of quality assurance. If a breach in quality management principles occurs, the Organisational Unit Director, or the Operational Director in the case of the Central Management Structure, must be notified and must submit a notice of the breach to the quality manager. The quality manager keeps records to track these breaches to be regularly submitted to the Coordination Board. The Executive Director is responsible for proposing changes and adjustments in the quality management policy based on the results of the quality management control. These changes are subject to the Coordination Board’s approval. Quality management training shall be conducted regularly after each major update of any of the documents concerned with quality management to ensure updated information. The Operational Director is responsible for the preparation of the training package and the delivery of necessary training events. Common Rules for Quality Management, version 001/2012 20 / 26 3. List of Abbreviations CB Coordination Board CD Commercial Director CEITEC Central European Institute of Technology CMS Central Management Structure ED Executive Director IČO Identification number ISAB International Scientific Advisory Board MEYS Ministry of Education, Youth and Sports OP RDI Operational Programme Research and Development for Innovations OD Operational Director OU Organisational Unit OUD Organisational Unit Director P-I Probability – impact RBS Risk breakdown structure RGL Research Group Leader RPC Research Programme Coordinator SD Scientific Director UVS Uniform visual style VAT Value added tax Common Rules for Quality Management, version 001/2012 21 / 26 4. Glossary Activities The entirety of all actions which are necessary to produce the intended consequences from the resources, or create certain products CEITEC centre CEITEC centre is formed by Organisational Units of the CEITEC project, including Central Management Structure. CEITEC employee Employee of an Organisational Unit of a CEITEC partner or of the Central Management Structure. There are two basic categories of CEITEC employees: (1) research employees and (2) non-research employees. CEITEC project CEITEC (Central European Institute of Technology) is a project financed through the Operational Programme Research and Development for Innovations focused on the establishment of a European centre of excellence in the area of life sciences and advanced materials and technologies Confidential data Private project / centre information or other private organisational information not intended to be disclosed outside the context of the company or organisation responsible for that information Governing documents Are represented by the Activity Plan of the Project and Summary Report on the Activity of the Project which are proposed to the Coordination Board for approval by the Executive Director on an annual basis Impact Expression of the effect of a risk on a project Inputs Financial, human and material resources which are necessary for the implementation of a development intervention Opportunity An uncertain event or condition that can have a positive effect on project´s objectives Outputs The products, things or goods produced through the development intervention Partners All Organisational Units except the Central Management Structure Personal data Personnel records, payroll records and information regarding an employee's salary, length of service, performance or other personnel information, personally identifiable information such as personal identification number, professional license numbers, names of spouses, children, parents, guardians, beneficiaries, marital status, physical description, education, financial matters, medical or employment history and other non-public personal information Common Rules for Quality Management, version 001/2012 22 / 26 Probability Expression of the uncertainty dimension of a risk (likelihood) Quality assurance The process that provides oversight of CEITEC’s quality management measures to assure their effectiveness in the production and delivery of quality products and services Risk Project risk is an uncertain event or condition that, if it occurs, has a positive or negative effect on project’s objectives Risk breakdown structure A list of defined categories of risk sources Risk checklist A list of risk that occurred on previous or comparable projects, it is a tool that helps to not overlook some risks related to a project Threat An uncertain event or condition that can have a negative effect on project’s objectives Common Rules for Quality Management, version 001/2012 23 / 26 5. Changes from previous version Date Chapter Description   Common Rules for Quality Management, version 001/2012 24 / 26 6. Annexes ANNEX 1 Overview of Common Rules and Policies Common Rules for Quality Management, version 001/2012 25 / 26 6.1 Annex 1 Overview of Common Rules and Policies Document Issues covered in the document Common Rules for Quality Management CommonEvaluation of the Scientific Excellence Evaluation of complementary projects Risk management Procurement management Project monitoring Change management in the OP RDI project OP RDI project irregularities Scheduling and result-oriented planning Confidential and other data processing Document control Communication among partners and the Central Management Structure Communication to third parties Marketing documents Infrastructure exploitation Violation of the Code of Ethics Support of publications CEITEC website Quality management control, update and training Common Rules for Cooperation with the Application Sphere Marketing strategy Cooperation with regional partners in the area of technology transfer System of identification, assessment and protection of IP Contract research, collaborative research and other forms of cooperation with the application sphere Services provided by CEITEC centre Common Rules for Quality Management, version 001/2012 26 / 26 Common rules for using CEITEC infrastructure State aid compliance Common Rules for Human Resources Management Recruitment policy Career development and further education of CEITEC employees Ensuring of merit based non-discriminatory remuneration policy Mobility of CEITEC researchers Equal opportunities Common Publication Policy Defining authorship Classification of scientific publications Publication process activities Monitoring of written publications Production of scientific publications with an IF higher than the median in the respective scientific category Code of Ethics Ensuring ethical conduct in research and development and management of the centre