quality assurance risk management plan

CIVIL SOCIETY ORGANISATIONS

IN DESIGNING RESEARCH GOVERNANCE

Quality Assurance & Risk Management Plan

CONSIDER Project (GA number 288928)

Deliverable D6.4

30 April 2012

Authors

Micharikopoulos Dimitris Tavlaki Elena

SIGNOSIS

©: CONSIDER Financed by the European Community’s Seventh Framework Programme (FP7/2007-2013)

T a b l e o f C o n t e n t s

1 General Introduction...............................................................................................3 2 Quality Assurance Plan..........................................................................................4

2.1. Context of Quality Assurance ......................................................................... 4 2.1.1. Scope of Approval....................................................................................5 2.1.2. Responsibility for Quality.......................................................................... 5 2.1.3. Quality Plan Review.................................................................................7

2.2. DELIVERABLES AND DATA QUALITY CONTROL PROCESS....................7 2.2.1. Document referencing and template ........................................................8 2.2.2. Deliverables Layout..................................................................................9 2.2.3. Data Communication protocols ................................................................9 2.2.4. Dissemination Event Scheduling and Reporting...................................... 9 2.2.5. Quality Requirement Definition ..............................................................10 2.2.6. Production Procedure ............................................................................11 2.2.7. Nomination of reviewers......................................................................... 11 2.2.8. Review procedure ..................................................................................11

2.3. CORRECTIVE AND PREVENTATIVE ACTIONS ........................................ 13 2.4. CONTROL OF QUALITY RECORDS...........................................................14 2.5. INTERNAL QUALITY AUDITS ..................................................................... 14

3 Risk Management Plan ........................................................................................16 Annex I: Internal Reports Template and Codification ................................................21 Annex II: Deliverable Presentation Standard.............................................................29 Annex III: Peer Review Report template.................................................................... 37 Annex IV: External Reviewer's Confidentiality Declaration........................................ 42 Annex V: Deliverables reviewers list.......................................................................... 45 Annex VI: Non-Conformity Report on a Deliverable ..................................................47 Annex VII: Corrective and Preventive Action Request ..............................................50 Annex VIII: Internal Audit Report ...............................................................................53 Annex IX: Template Risk Statement Form................................................................. 56

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1 General Introduction

The CONSIDER project is a research project implemented in the context of the 7th EU Framework Programme, in Science in Society strand. Its main focus is the participation of Civil Society Organisations (CSOs) in research with a view to broaden and strengthen this participation. Broader stakeholder engagement in technical and scientific research may be desirable for a variety of reasons. CSOs can be optimal actors to realise the promise of participative research governance. Despite much activity to stimulate and implement CSO participation in research, there is no agreement on how to evaluate the success of participation.

The CONSIDER project will undertake conceptually sound and empirically rich research to establish a model of CSO participation in research. This will contrast theoretical views on benefits and limitations with empirical findings on the practice of CSO participation. Based on a grid of analysis, the project will survey all FP7 research projects. It will investigate 30 relevant projects as in-depth case studies. Using the conceptual grid of analysis and empirical data, a model of CSO participation in research will be developed. This model, representing relationships and causal effects of factors influencing CSO participation, will allow for comparative analysis of such to determine the role they play in achieving participation objectives. No such model currently exists, which renders it difficult to plan, implement and evaluate CSO participation in research. Stakeholders requiring such a model include researchers, research funders, policy makers and CSOs.

The specific objectives of CONSIDER are: • The development of a sound model on the role of CSOs in research and

research governance. • The exploration of the dynamics of participation in research and the

identification of the characteristics of CSOs, which participate in research. • The assessment of new partnerships that CSOs are developing with research

organisations and of the influence that these developments have on scientific research and research policy.

The implementation of these blocks of activities is distributed in the following work packages (WP):

− WP1: CSO participation in research governance − WP2: Practice of CSO participation − WP3: Model of CSO participation − WP4: Guidelines − WP5: Dissemination − WP6: Project Management

In Annex VII the list of the work-packages, deliverables and the partners' responsibilities are described as they are also briefly shown in Table 1.

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Table 1: Schedule of deliverables

WP n° N°

Delivery date from Annex I

Month

Deliverables Responsible Partner

1 1 30/06/2012 5 Glossary UL 1 2 31/07/2012 6 The theoretical landscape FUNDP 1 3 28/02/2013 13 Analytical Grid FUNDP 1 4 30/06/2013 17 Governance Models DMU

2 1 30/06/2012 5 Methodology definition and observation

tools KIT 2 2 31/01/2013 12 FP7 Survey report UL 2 3 31/05/2014 28 Main Findings Report UL

3 1 31/01/2013

12 Framework for the Comparison of Theories of CSO Participation in Research Governance KIT

3 2 31/01/2014

24 Report on the analysis of theory and practice of CSO participation in research governance FUNDP

3 3 31/07/2014 30 Model of CSO Participation in

Research Governance DMU 4 1 30/11/2014 34 Guidelines Handbook DMU 4 2 31/07/2014 30 Expert workshops proceedings UCL 5 1 30/04/2012 3 Dissemination Strategic Plan UCL

5 2 31/01/2015 36 Project Dissemination Dossier and

Engaging more CSOs UCL 5 3 31/01/2015 36 EC Presidency Activities Report SIGNOSIS 6 1 29/02/2012 1 Project Management Guide SIGNOSIS 6 2 31/01/2015 36 Project database of internal documents DMU 6 3 31/01/2015 36 Project Monitoring Report SIGNOSIS

6 4 30/04/2012 3 Quality Assurance Plan & Risk

Management Plan SIGNOSIS 6 5 31/07/2012 6 Project Website DMU

The implementation and effective conclusion of CONSIDER depends upon various elements including inputs from stakeholders, entities and human resources that make the project vulnerable to various unexpected changes. The Quality Assurance and Risk Management Plan is the document setting out the quality and risk management practices for the project, and is to provide assurance, that the quality requirements are planned appropriately and that the measures taken for protecting the smooth progression of the project ensure that internal and external project risks are effectively dealt. The first part of the Plan refers to the quality assurance procedures whereas the second part addresses the procedures for managing project risks. 2 Quality Assurance Plan 2.1. Context of Quality Assurance

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Quality assurance of deliverables of the CONSIDER project will be implemented using the principles of peer review. All deliverables will be reviewed by at least two members of the consortium who were not involved in the creation of the deliverable. The review process will be overseen by a further senior member of the consortium who is not involved in either the creation of the deliverable or the reviews.

2.1.1. Scope of Approval This Quality Assurance Plan is to be used by: - Consortium Partners, responsible for preparing and amending deliverables, - Internal Reviewers appointed by Consortium Partners responsible for reviewing

completed deliverables and sign-off, - Anybody working on behalf of of a Consortium Partner responsible for approving

works to be done by associated partners of other third parties, in order to complete deliverables.

The current Quality Plan is applicable to all the activities, which are related to the project. Hence, compliance of its execution with the Quality Plan is mandatory for all involved. CONSIDER’s quality policy is as follows:

− to implement and maintain a quality system, − to identify for all involved their responsibilities regarding quality, − to ensure that all deliverables comply with the grant agreement. − to ensure that all processes relevant to the project are organised and

monitored at a high level of effectiveness and quality. Quality and its pursuit are regarded as important for every individual activity within the CONSIDER project.

2.1.2. Responsibility for Quality The Project Manager assisted by the Project Coordination Committee (PCC) formulates and safeguards an overall policy for quality in the project and takes all actions necessary to ensure that there are no deviations. The Project Manager is also responsible for ensuring the quality of all project deliverables, and the application of the procedures, described in this quality plan. The Quality Assurance Manager is responsible for the administration of the Quality Plan, and has the authority to identify problems during internal audits, and to initiate actions, resulting in complete solutions to them. Its role is of an administrative facilitator of quality related procedures. Signosis is responsible for the nomination of QAM. All problems are raised within PCC or Consortium meetings, and the minutes should also record the agreed solution and the time bound action to be taken. There is a requirement to provide evidence that the problem has been solved. Everybody involved in providing the Consortium with services has to be qualified in the area they are to work within, inspect or verify. The Quality Assurance Manager is the person who has the authority to organise and verify all work affecting quality. This is documented in the plan and is meant to encompass the following aspects:

a. Initiate action to prevent the occurrence of any non-conformity,

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b. identify and record any relevant problem, c. initiate, recommend and/or provide solutions through the reporting system, d. verify the implementation of solutions, e. monitor and control further processing, delivery or installation of any preferred

solution to ensure that any reported non-conformance has been corrected. The CONSIDER Project Coordination Committee, in general will be responsible, for ensuring scientific and technical quality of all deliverables, according to the approved quality strategy and criteria and for monitoring quality of the Work Packages by implementation of the procedures, described in this Quality plan. For each deliverable a QUALITY CONTROL COMMITTEE (CQCC), will be nominated: The CQCC, will consist of 3 members per each deliverable, i.e.: - The 2 representatives of the Consortium Members, acting as internal reviewers

(Reviewer 1 and Reviewer 2), which will be the most relevant (scientifically wise) with the deliverable under consideration / examination,

- The Quality Chair (QC), who has the role of the Chair of the CQCC, and decides in the cases of conflicts.

- The Quality Chair makes a recommendation to the PCC as to whether to accept a deliverable for submission to the EC or require further work.

A full list of the members of the OQCC members who are responsible to review each Project Deliverable follows in Annex III. For each deliverable the QCC will: - assure the conformity of all deliverables, with the initial criteria defined for them

and guaranteeing that the deliverables are in accordance with the approved Description of Work (Annex I) of the Grant Agreement,

- consult the Work Package Leaders, on the expected technical characteristics of the deliverables.

Thus, the main Tasks of this Committee are: - Review of the technical reports produced - Quality control of all deliverables submitted - Guidance (upon request) to the Deliverable owners on the expected

characteristics and contents of the relevant Deliverables Its main objective is to ensure that: - All the outputs are consistent, with their requirements - All the project reports / documents do have the highest quality, regarding their

overview / context The Dissemination Manager (the representative of the leader of the WP - Dissemination) is responsible for ensuring proper contact with the users and for the quality and appropriateness of project related information that will be communicated between interested parties and the consortium. All partners are responsible for ensuring high quality for the deliverables under their responsibility.

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2.1.3. Quality Plan Review The Quality Assurance Plan is to be reviewed within the Project Coordination Committee (PCC) meetings. In subsequent reviews the following will be taken into account: • the results from project reviews, • the results from internal audits, • the official project Deliverables (Reports and Other), • the corrective action requests from all the above, • the preventive actions on all the above, • any project deliverable deficiencies and problems, • project partners staff adequacy for the tasks undertaken, • level of used resources per category and adequacy of spent resources for the

particular task. The outcomes from the above shall be discussed at PCC and Consortium meetings, and their results shall be minuted and include: - Satisfaction with the audits, corrective actions and the results of complaints, - Dissatisfaction and requirements for further auditing or more corrective actions, - Satisfaction with the corrective actions taken by the relevant partner(s). An agenda of such a meeting may include some of the following topics: 1. Results of Internal Audits 2. Corrective actions requests received 3. Defects in deliverables 4. Complaints 5. Results of external reviews 6. Subcontractors problems 7. Preventive actions 8. Review of quality policy and objectives 9. Introduction of new quality plans 10. Date of next meeting Records to be kept are the minutes of the meeting, which are to record those attending and the summary of the points raised/resolved. The records are to be archived by the Quality Assurance Manager.

2.2. DELIVERABLES AND DATA QUALITY CONTROL PROCESS The Quality Chair of each deliverable is responsible for ensuring that the deliverable is reviewed effectively.

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Within the framework of CONSIDER, two levels of documents are recognized, i.e. external deliverable reports and internal reports. The external deliverable reports are described in this part. A deliverable report in a project generally aims to provide information concerning the research work, its progress or its results. Each and every deliverable report should thus be carefully drafted with rich content, a clear structure and a professional presentation. All project deliverable reports together should comprise a set of informative material with continuity, clear interfacing and free of information overlaps or gaps. It is therefore important to ensure standardisation in the presentation and structure of the deliverable report and adopt common standards for the development of their contents. At the same time, it is important that the information is provided timely and in relation to the particular phase of the project’s development, in order to allow smooth development of the consecutive work and deliverables dependent on previously provided information. Summarized, the three basic aspects for building quality into the project deliverables reports are:

1. content, 2. appearance and structure, 3. prompt supply of information.

There will be a unique project document coding system, as indicated below: Table 2: Types of CONSIDER documents

Document Code

Document Type Type of Forms to be used

D Deliverable Deliverable Template, Peer Review Report, Summary of main Feedback and Actions taken, Non Conforming Report

WP Working Papers Internal Report Template PR Workpackages Plans and Progress

Reports Internal Report Template

M Minutes, Action Lists, Decision Lists Internal Report Template C Correspondence between Partners Internal Report Template L Legal documents Internal Report Template

COM Commercial documents Internal Report Template GI Documents of general interest Internal Report Template QA Quality Assurance, Reviews,

Inspections, Audits Internal Review Report, Corrective Actions Request

OTH Other subjects Internal Report Template

All official Consortium documents in the above table, except from the Deliverables, are cumulatively characterised hereafter as Internal Reports (IR).

2.2.1. Document referencing and template There is a unique document referencing scheme. This is not applicable however for informal data and views exchange between Partners. It is only valid for official Consortium documents, falling in one of the above categories of the previous section. Moreover, the Consortium has decided to use the Sharepoint platform for sharing

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files and communicating actions and all Partners shall classify their communications according to sharepoint functions, in order to claim that the other participants have consider them. The project internal documents template and referencing scheme follows in Annex I. Note, that official Deliverables have a different template and referencing scheme, which is presented in the following section.

2.2.2. Deliverables Layout Official Project Deliverables should have a first page template as in Annex II. They should also use the page layout (headers / footers) suggested in the same Annex. Furthermore, they should abide to the following rules: • Have a list of abbreviations used within the Deliverable • Have a table of contents • Have a list of Figures (including the ones of the Annexes) • Have a list of Tables (including the ones of the Annexes) • Start with an one-page Executive Summary • End the main part with a Conclusions section of around 1 page • Include a References section after the Conclusions section • Include all detailed technical and other information in Annexes

2.2.3. Data Communication protocols All documents and computer data files sent either by email or uploaded in the Sharepoint are to be virus checked before issue and to be screened on receipt. If a virus is found then action is to be implemented to purge both the system infected and to notify the sender to prevent a re-occurrence. If acknowledgement is requested, an explicit request will be included by the sender at the end of the message (email, fax, etc.), stating “PLEASE ACKNOWLEDGE”. Then, the recipient is required to send a message acknowledgement within the next two (2) working dates.

2.2.4. Dissemination Event Scheduling and Reporting The following are considered dissemination events: • Publications in Scientific Magazines • Presentations in Conferences • Exhibition stands and demos • Participation in non-project workshops, forums and/or events The participation of any Participant in an event, involving a formal presentation of CONSIDER and /or its results, should follow the procedure decribed in the Consortium Agreement.

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2.2.5. Quality Requirement Definition The content The content of each deliverable report depends on the type of provided information. As a general principle, the responsibility for the content of each deliverable report is always with the author(s). Nevertheless, the reports should always meet a set of requirements, based on the three aspects for quality of information namely, completeness, correctness and punctuality, described below. These requirements result in a set of quality criteria for project deliverable reports. Information must address all aspects related to the purpose for which research is conducted and the information is produced. On the other hand, a redundancy of information must be avoided, as in some cases it might obscures the clarity of research findings. CRITERION 1: Completeness. Information provided in the deliverable report, must be reliable and must correspond with reality. This means that all background information used in the reports should be appropriately supported by references. Foreground information should be supplied in a clear fashion and be sufficiently supported, such that misinterpretation will be avoided. CRITERION 2: Accuracy. Information used in the deliverable report should be focused on the key issues and be written in a fashion that takes into consideration the scope of the specific research work and its target audience. CRITERION 3: Relevance. All information used should be provided to the depth needed for the purpose of the reports. CRITERION 4: Depth. Appearance and structure. Although deliverable reports will be authored by different partners within the framework of CONSIDER, it is important that reports are prepared with uniform appearance and structure, such that they appear as originating from a single initiative. It is therefore necessary to observe the Project Deliverable Report Presentation Standard (Annex II), which has been already made available to partners by the leader of WP 5 - Dissemination, which specifies the structure, organisation of content, lay out and appearance of project deliverable reports. Within the framework of Quality Assurance, a template (and associated instructions, Annexes I and II) is developed in order to help the different partners by the preparation of deliverables with a uniform appearance and structure. CRITERION 5: Adherence to standard CRITERION 6: Writing features Prompt supply of information. The information must be provided in relation to the particular phase of the project’s development and according to the Project Plan. CRITERION 7: Punctuality

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2.2.6. Production Procedure Every CONSIDER deliverable research report is reflected in its list of contents expressing its structure. It is therefore strongly recommended that before the first full draft is written, an outline aiming to specify the deliverable’s contents together with a brief outline of these contents, is composed and reviewed prior to implementation of the full report. In this way, already in an early stage, structural problems are detected and the possibility of having to perform drastic changes in the written deliverable, is minimised. In addition, exchange of opinions on the outline, stimulates contact between the author(s) and the reviewers and promotes a better and more efficient co-operation. The above described quality criteria shall be observed by authors when drafting any project deliverable report. They also form the basic standard against which reports will be evaluated during the project internal evaluation procedures.

2.2.7. Nomination of reviewers Reviewers are persons from the CONSIDER consortium and are the “judges” in the review-procedure for a particular deliverable report to check if the report complies with the before described criteria. The two reviewers participating each time in the CQCC are selected on the basis of their expertise and experience on the subject treated in the deliverable report under consideration. The Quality Chair is the individual, responsible for the overall quality management of the deliverable, having the overall responsibility for the qualitative integrity of the deliverable and therefore a more complete overview of the overall quality assurance process. The Quality Chair has the same function with regards to a deliverable as an editor will normally have with regards to a research publication in a journal. S/he oversees the review process and makes recommendations on acceptance / further requirements to the PCC which makes the final decision with regards to a deliverable. The QC is free to voice his / her opinion on a deliverable but is expected to incorporate the views of the reviewers in decisions and recommendations. The two reviewers will normally be members of the consortium; however, the author may choose to invite one external expert or a CSO representative, to act as a reviewer whenever this is considered of benefit to the workpackage, the research work and the project. In case that the QC invites an external expert or CSO representative to act as a reviewer, Form in Annex V has to be filled out. In this case external reviewers are contacted by the author in due time and their availability is confirmed.

2.2.8. Review procedure The proposed evaluation procedure for the deliverable reports, called “the review-procedure”, is executed in parallel to the deliverable’s production process and applies to all project deliverables that are defined for "Public Use". This review-procedure

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forms the key-mechanism for monitoring compliance with the quality criteria (described in section 3.6 of this deliverable). The degree of compliance is characterized by assessing the indicators, summarized in table 3, which relate to the defects or points that require amendments in the text. These indicators concern categories of non-conformity and they are identified in this form during the deliverable evaluation.

Table 3: Relation of the indicators with the quality criteria BASIC

ASPECTS QUALITY CRITERIA

QUALITY INDICATORS QI CODE

CONTENT Completeness Missing content Redundancy

MC RE

Accuracy Error in content References Insufficient documentation Ambiguity

E R ID A

Relevance Irrelevant information I Depth Lacking detail

Excessive detail LD ED

APPEARANCE &

STRUCTURE

a) Adherence to Standard b) Writing features

Lack of uniformity in presentation Spelling and Grammar errors

U SG

TIMELINESS a) Punctuality Delay T

Significance +++ Very Important Ranking: ++ Important + Less Important The deliverable under consideration / examination, will be forwarded, through the Work Package Leader, to all members of the CONSIDER Quality Control Committee (CQCC). The deliverable will be in its draft version, and will be received one (1) month before its official publication to allow for thorough reading of the draft. The review of the outline is performed in written and comments may be exchanged through email with the reviewers. The two Consortium reviewers, within five (5) working days from Deliverable draft receipt, do study and send their Peer Review Reports to Quality Chair (QC). The QC has within two (2) working days to synthesize the Overall Peer Review Report and send it to the responsible Partner and to the Project Manager. In doing the synthesis, he/she may disregard some comments of the reviewers or decide upon conflicting comments, coming from different reviewers. The final rating of the Deliverable draft will be marked as: • Fully accepted

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• Minor revisions required • Major revisions required • Rejected The relevant Partner has to send back a document entitled “Summary of main feedback and actions taken”. In this, proper explanation should be given about each action taken as a result of the comments in the Overall Peer Review Report. The relevant form is to be found in Annex VI. In case the quality of the deliverable is not satisfactory and / or it fails to conform to the quality criteria described above the reviewers revise the deliverable and prepare a draft «Non Conformance Report», which are all collected by the Quality Chair (QC). The former upon receiving the above report and consulting his own «Non Conformance Report» (Annex VIII), compiles a list with all the approved deviations that have to be repaired. Furthermore, he compiles a «Corrective Actions List» (also in Annex VIII), along with the person responsible for carrying this action and the required date to be done, always up to two (2) working days. The above list is also forwarded to the corresponding Work Package Leaders, for their information, and at the end all corrections should be incorporated immediately within the specific deliverable. The «Corrective Actions List» may be discussed and further explained, however under no circumstances, can become subject of dispute. As the responsibility of the deliverable report always is with the author, the findings of the reviewers are considered by the author(s). The defects are recorded in a Review Log sheet, and are ranked according to their significance. The author(s) proceeds with the amendments, as one sees appropriate and communicates to both the Quality Chair and the reviewers a summary of the corrective actions undertaken, with full justification of his decisions not to implement suggested changes, if any. The relevant comments will be included in a Deliverable Peer Review Report, as indicated in Annex IV. Summarised, the full text is developed on the basis of the accepted outline and is formatted according to the accepted standard (Annex IV + template). This first draft is reviewed according to the procedure described. If the review report indicates that the deliverable has presented several significant non-conformities and a «Non Conformance Report» is prepared a second review may be indicated before the submission. Minor defects will be normally corrected at the authors’ responsibility and the final draft will be forwarded to the prime contractor, together with the review report for submission. The above procedure should take no more than 15 days . The Quality Chair, as chairman of the CONSIDER Quality Control Commitee (CQCC), will report to the Project Manager, who heads the Project Consortium Committee, after the finalisation of the quality assurance procedure. The final decision on acceptance / rejection of the deliverable will be taken by the PCC.

2.3. CORRECTIVE AND PREVENTATIVE ACTIONS The issues below are related to general performance of a Partner and the quality of his work outcome and not to Project Deliverables, for which the particular procedure of the previous Section is to be followed.

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An analysis of all Partners reports and records shall be completed in order to determine areas for corrective action investigation. Observations requiring corrective action are documented on the appropriate form of Annex IX. Any partner may raise such an issue on the work of another partner or external subcontractor work. The QAM is responsible for implementing and recording changes in procedures, resulting from corrective actions. Procedures established are to ensure:

− effective handling of all complaints, − reports of non conformities, − investigation of the cause of non conformities in relation to quality system, − recording the results of the investigation, − determining the corrective / preventing action needed to eliminate the cause of

the non conformity, − application of controls to ensure that corrective action is taken and is effective, − initiation of preventative action and application of controls to ensure that it is

effective, − ensuring that relevant information on actions taken is submitted for review.

The Quality Assurance Manager and the Project Manager are responsible for resolving matters of complaint under this procedure, within their own areas of responsibility. All complaints are to be investigated and corrective action agreed. The Quality Assurance Manager informs all involved in the complaints and the actions being taken. The complaints are recorded in a Complaint Register and are being controlled. Corrective actions are recorded and all involved are informed of the action taken, according to the Form of Annex IX.

2.4. CONTROL OF QUALITY RECORDS The quality records are to be maintained by the Consortium and can be made available when necessary. All quality records are to be filed to allow easy retrieval. The records are retained for the time required under the Grant Agreement. An analysis of the records is carried out to indicate unsatisfactory trends so that corrective action can be taken. All records are kept in a suitable environment to minimise damage.

2.5. INTERNAL QUALITY AUDITS In special cases, when a problem of paramount importance comes up, an Internal Audit Procedure will be carried out by the corresponding group. This will be done on the corresponding site, where the problem has appeared. All personnel listed below will have to travel to the corresponding site:

− The Project Manager − The Quality Assurance Manager − Two (2) Consortium Representatives, selected among the partners and

appointed by the Project Coordination Committee (PCC), who will be the most relevant (technically-wise) for the problem under inspection.

All the findings of the Internal Audit will be documented in the Internal Audit Report (included in Annex X) by the QAM. Then, she will issue corrective actions, which again will be documented by him in the corresponding form, in order to make all the

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discrepancies obsolete, within the appropriate time period. Follow-up actions will be arranged, so as to ensure the effectiveness of the corrective actions. The results of the Internal Quality Audits will be distributed to all Partners, related to the specific WP. The QAM will be responsible for the implementation of this procedure. In all other cases, the progress of the project will be monitored by him through contacts (mainly by email) with all the partners involved. All day to day and trivial barriers of the project have to be dealt with in this way.

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3 Risk Management Plan For the purposes of this deliverable; Risk is defined as an event that has a probability of occurring, and could have a negative impact on a project. A risk may have one or more causes and, if it occurs, one or more impacts. For example, a cause may be requiring an environmental permit to do work, or having limited personnel assigned to design the project. The risk event is that the permitting organization may take longer than planned to issue a permit, or the assigned personnel available and assigned may not be adequate for the activity. If either of these uncertain events occurs, there may be an impact on the project cost, schedule or performance. All projects assume some element of risk, and it’s through risk management where tools and techniques are applied to monitor and track those events that have the potential to impact the outcome of a project. Risk management is an ongoing process that continues through the life of a project. It includes processes for risk management planning, identification, analysis, monitoring and control. Many of these processes are updated throughout the project lifecycle as new risks can be identified at any time. It is the objective of risk management to decrease the probability and impact of events adverse to the project. On the other hand, any event that could have a positive impact should be exploited. The implementation and effective conclusion of the CONSIDER project depends upon various elements including inputs from stakeholders, CSOs and human resources that make the project vulnerable to various unexpected changes. The CONSIDER consortium is committed to establish risk management standards in order all partners to be aware of the vulnerabilities and the measures they have to take for protecting the smooth progression of the project. The procedures are designed to ensure that internal and external project risks are appropriately dealt. Internal project risks will be minimised and managed by using established methodologies for cost estimations, project planning and project control. Such methodologies are standard practice in the professional work of the consortium members. External project risks relate to low response of the researchers, community and industry (e.g. low participation of CSOs in the field research, identification of low number of research projects involving CSOs) and will be eliminated by adopting mitigation strategies at the early stages of the project. There are four stages to risk management planning at both stages (assessment and control):

− Risk Identification − Risk Quantification − Risk Response − Risk Monitoring and Control

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Figure 1: Stages of Risk Management

The CONSIDER project is undertaking a considerable amount of collaborative work, with researchers and associated partners (CSOs) that come from different cultures. This effort should be carried out by all partners, individually and as a whole. Projects with such extent and dimensions should take the necessary provisions so as to be able to tackle with possible obstacles or major problems. The CONSIDER project takes safety measures for confronting impending difficulties, at least in the most frequent areas where such problems occur. The categorization of risk is according to two levels: the first level refers to the general potential risks of the project and the second level to risks per workpackage. The following table represents the possible general risks, their probability and action to be taken in their occurrence:

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Table 4: General Risks & Contingency Strategies

Risk assessment and management is an on-going task. Just because a certain set of risks was identified at the beginning of the project or, even, during the design stage, it does not mean that during the life of the project other risk/issues will not arise that will affect partners to meet the goals of the project. As the Work Packages' activities inter-relate to each other, it is very crucial to be able to deal with any deviations that

CONSIDER responses

Risk Researchers’ and CSOs' response is less than expected Probability Low Mitigation Strategy

Interaction through associated organizations and other established partnerships with CSOs that some of the CONSIDER partners have cultivated for years. If such a problem occurs, an intensive engagement will be launched start engaging all the relevant stakeholders and intermediaries. All the partners have broad network of contacts that can be utilized in the project

Risk Unanticipated Project Manager workload and Personnel availability

Probability Medium Mitigation Strategy

A Deputy Project Manager is in place. He/she will be constantly informed of the processes taking place in the project and will be ready to take on the role, in case of manager’s exception from the project. There is also a range of experts already identified to participate in CONSIDER. The staff will work together to share knowledge so that no one person is critical to the project’s success. The work will be documented as it proceeds, thus minimizing the time to bring a new person up to speed.

Risk Internal consortium difficulties resulting to low productivity Probability Medium Mitigation Strategy

Redistribution of resources among the team members in a fast and efficient way. More precisely, as project partners have multidisciplinary skills and competencies could collaborate effectively even if a partner for a specific task has not (as a result of an unfortunate event) the capacity to fulfill its obligations

Risk Failure one or more partner to complete tasks Probability Medium Mitigation Strategy

All participants are entering the process with great enthusiasm. However, in all institutions, problems do arise from time-to-time due to personal reasons, change of post or other causes. We are working with a consortium that enables a certain degree of flexibility. All the partners have the abilities, in an emergency situation, to secure expertise in areas beyond their remit.

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might occur as they will affect the quality of the future work and the time-schedule of the deliverables. Part of effective risk management is the process of identifying and dealing with issues as they occur. The following describes the Protocol for an on-going risk management:

• Identification of a risk – Work Package Leader documents and describe the risk, including the date and who reported it

• Analysis of risk – WP Leader and/or PM assesses how and to which level it may affect the Consortium’s capacity for completion of the Project

• Determine the priority of the risk – low, medium or high • Assign the problem to a partner/team member, and schedule a timeframe for

proposal of action to resolve it. • Track the status of resolution – WP Leader and/or PM label it: open, in-

progress or closed. • Document the process by which the issue was resolved and share the finding

with partners. This will help the team to identify lessons that could be learnt from the problem resolution.

The procedure and the action of risk mitigation will be reflected in a Risk Statement Form, (Annex XI) that will be filled by each workpackage leader in close collaboration with all partners involved in the specific workpackage, every six months, namely the months 6, 12, 18, 24 and 30 of the project and will be part of the reporting of project management to the European Commission. Accordingly, an unforeseen threat that is considered at any time of the CONSIDER’s project implementation will use the same procedure. Mitigation strategies for the main risks/threats that might take place in the WPs are presented below:

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20

Table 5: WP Risks and Contingency Strategies

CONSIDER responses Risk Lack of common understanding among partners on the notions of participation and

engagement and on the terminology Probability Medium

Wor

k P

acka

ge

1 Mitigation Strategy

The researchers involved in the project are highly experienced and well known experts in the field and they have cooperated in similar projects in the past. They have already provided for the development of glossary that would clarify the terminology and will establish a common set of terms and concepts for the project.

Risk The data mining in FP7 projects doesn't result in a representative and diversified sample of CSOs - Low response of CSOs to the field research

Probability Medium

Wor

k P

acka

ge 2

Mitigation Strategy

The partners have already well established networks and links with a great number of CSOs and therefore they are prepared, if necessary, to mobilize use them for this task by integrating in the research experiences from other cases of CSOs who have participated in research activities outside the FP7 projects. In addition by shortening the questionnaire they will make it easy and more attractive for the CSOs to take part in the field research.

Risk Some of the case studies analyzed showed that participation of CSOs in research had rather negative impacts / results.

Probability High

Wor

k P

acka

ge 3

Mitigation Strategy

The development of the model(s) will adopt a bottom up approach, which will take into consideration the conditions on which the expectations of CSOs from participation can be met with a critical view on the idea of participation itself.

Risk The research findings of WPs 1, 2 and 3 are controversial and / or dubious on how to address specific situations - No specific guidelines relevant to concrete situations could be developed

Probability Low

Wor

k P

acka

ge 4

Mitigation Strategy

The partners have wide experience on FP7 projects and on the requirements regarding policy recommendations. The WP leader will prepare and agree with the leaders of the other WPs the specific terms on how the findings shall provide input for the guidelines. In addition the consortium will approach CSOs at an early stage and by informing them continuously and inviting them to act as external advisors for CONSIDER, it will ensure that the guidelines developed would be context specific and would be tested with CSOs through specific examples.

Risk Low participation of CSOs and researchers in the workshops and other activities organized

Probability Low

Wor

k P

acka

ge 5

Mitigation Strategy

The CONSIDER consortium has strong institutional links to CSOs and to the research community. This will guarantee adequate response to the events that will be organized. However, synergies with relevant events and conferences will be explored too. A special tool listing all events that CONSIDER could participate that will be updated regularly has been uploaded in the Sharepoint platform and a special magazine will be issued.

Risk Not keeping the schedule - Lack of coordination / communication Probability Low

Wor

k P

acka

ge 6

Mitigation Strategy

The Project Manager has significant experience in project management and therefore the probability of that to occur is minimal. However, to mitigate such an unexpected event, some p/m have been allocated to the partners to undertake management tasks. If needed, more time will be spent from the whole consortium in dealing with delays. Processes will be established and documented in a project management handbook, delivery month 1 of the project. A special platform (Sharepoint) provided by KIT will facilitate the exchange of information. Regular meetings and Skype conferences will take place.

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21

Annex I: Internal Reports Template and Codification

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Quality Assurance and Risk Management Plan for CONSIDER 22



<<Deliverable Title>>

<<Subtitle>>


Deliverable D<<number>>

<< Date>>

Authors

<<Name 1, First Name 1>> <<Affiliation>>

<<Name 2, First Name 2>>

<<Affiliation>>

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Table of Contents

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Executive Summary

No more than two pages. Contains relevant fact, figures, conclusions, recommendations. Not an abstract, not an introduction.

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Introduction, Main Report, Heading 1 Main Body Sub-Heading 1 Sub-Heading 2 Sub-Heading 3 No more than three levels of headings should be used References

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More generally, this document is designed to act as a template for deliverables created for the CONSIDER project. It includes:

• Initial document header clearly branding the document as part of CONSIDER. • Automatic inclusion of the document name and page numbers at the foot of

each page. • Pre-defined heading and paragraph styles. • Clear recognition of European Commission funding via logos at the bottom of

each page. • Spaces for document title, date and author details in order to assist with

version control etc. Note that file name should follow the agreed conventions i.e.:

• Deliverable number- deliverable title- date of last modification- acronym of organisation doing the last modification.

• The date should take the form YYYY-MM-DD • There should be no blanks in file names, as these can cause problems when

uploading or making available on the web. • Example: D1.1-Glossary-2012-09-04-DMU.docx

The CONSIDER project will last three years. A lot of documents will be written and read by all the participants. So it is necessary to define a template available for the CONSIDER internal reports in order to facilitate administration and document exchange. This document contains some recommendations about the publication of CONSIDER documents. It aims at defining:

− the elements that should always appear in a document. This document itself could be used as template.

− the naming of the resulting files. 1. First page of a CONSIDER Internal Document / Report The first page of an CONSIDER document should at least contain:

− the project number and the project name : FP7- 288928- CONSIDER − the title of the deliverable, − the author(s) (persons or organisation), − the creation date, − the last revision date. − Copyright: CONSIDER Financed by the European Community’s Seventh

Framework Programme (FP7/2007-2013). There are several kinds of Internal Reports: Workpackages Plans and Progress Reports - Minutes, Action Lists, Decision Lists - Correspondence between Partners - Legal documents - Documents of general interest - Quality Assurance, Reviews, Inspections, Audits - Other subjects Minutes of a meeting: in this case there are no work package and task. The title will be "Minutes of the Consortium (or PCC) meeting held in XXX the YYY". The type and

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reference will be MnYYYYMMDD with YYYYMMDD the year/month/day of the meeting. Working Paper: its reference is XXXNNN with : XXXX: the first characters of the organisation which has written the document, that is: DMU: De Montfort University CNRS: Centre National de la Recherche Scientificque – University of Lille EN: EUCLID Network FUNDP: University of Namur KIT: Karlsruhe Institute of Technology SIGN: SIGNOSIS SPIA: Science-Policy Interface Agency UCL: University College London NNN : an incremented number managed by each partner. 3. The other pages of a CONSIDER document At the top of the pages should appear:

− the project number / name: FP7- 288928- CONSIDER, − the project logo − the EU Research Area and the FP7 logo

At the bottom of the pages should appear: − the title of the document, − the page number

4. Structure and Appearance of the Documents

Word processor: Microsoft Word (.docx)

Font character: Arial

Font size 12 pt.

Line spacing: Single line spacing.

Paragraph alignment: Justified.

Space between paragraphs: 6 pt

Header

FP7- 288928- the project logo

Footer Title of the deliverable report

Margins (top, bottom, left, right): All 2.5 cm

Texts reports:

The title-page Includes: Project’s number and name

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Title (and subtitle) Work package and task number Creation date & revision date Author(s), CONSIDER Financed by the European Community’s Seventh Framework Programme (FP7/2007-2013) Names of the reviewers / members of the Quality Assurance Panel

Page i Table of Contents

Page ii Foreword (optionally)

Page iii Abstract (optionally)

Page 1 Definitions, Abbreviations

Main-text The structure should follow the template provided in the Quality Plan for each type of deliverable

Annexes Optionally

References According to the Harvard System of Referencing

4. Naming of the resulting files Because the files will be uploaded onto the Sharepoint and then accessible to everyone, it is important to have a standard for naming the files. The deliverable number and title of the resulting files is the reference of the document with the date amended (except for the minutes of meetings) and the acronym of the organization doing the last version. So the files can be easily sorted by deliverable number. For example, the names of the following documents are simply For this document: D6.4-Quality-Assurance-Risk-Management-Plan-2012-03-17-SIGN.docx All the following draft documents of this deliverable, being in the process of review, should have later dates (D6.4-Quality-Assurance-Risk-Management-Plan-2012-03-21-SIGN.docx, D6.4-Quality-Assurance-Risk-Management-Plan-2012-04-03-SIGN.docx., etc) For the minutes of the kick-off meeting: Mn2012-02-06-08-SIGN.docx

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Annex II: Deliverable Presentation Standard



<<Deliverable Title>>

<<Subtitle>>


Deliverable D<<number>>

<< Date>>

Authors

<<Name 1, First Name 1>> <<Affiliation>>

<<Name 2, First Name 2>>

<<Affiliation>>

Quality Assurance: Name Quality Assurance Manager Reviewer 1 Reviewer 2

©: CONSIDER Financed by the European Community’s Seventh Framework Programme (FP7/2007-2013)

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31

List of abbreviations

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32

Table of contents

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33

List of Figures

List of Tables

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34

EXECUTIVE SUMMARY

(Text no more than two pages)

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35

Introduction

Chapters Sub-Heading 1 Sub-Heading 2 Sub-Heading 3 No more than three levels of headings should be used

Conclusions

References

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36

Annex/es

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37

Annex III: Peer Review Report template

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Peer Rev iew Repor t D.x.x

Deliverable No. D.x.x Deliverable Title

Workpackage No. WP.x Workpackage Title

Task No. x.x Task Title

Deliverable Authors Per partner, if more than one partners provide it together)

Date of Review Document:

Document ID / File Name D.x.x.-xxxxxxxxx-2013-06-22.docx

Quality Assurance:

Name Quality Chair Reviewer 1 Reviewer 2

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PROCEDURES USED FOR PEER REVIEW The CONSIDER Consortium uses the Peer Review process for its internal quality assurance for deliverables to assure consistency and high standard for documented project results. The Peer Review is processed individually by selected reviewers. The allocated time for the review is about two weeks. The author of the document has the final responsibility to collect the comments and suggestions from the Peer Reviewers and decide what changes to the document and actions are to be undertaken. Reviewers: XXXXXXXX (Quality Chair) – Organization name YYYYYYYYY (Quality expert) – Organization name ZZZZZZZZZ (Quality expert) - Organization name Overall Peer Review Result: Deliverable is:

Fully accepted Accepted with reservation

Rejected unless modified as suggested

Fully rejected

Suggested actions: 1. The following changes should be implemented ………………… 2. Specify missing chapters / subjects ……………………….. 3. Required changes on deliverable essence and contents …………………….. 4. Further relevant required improvements ……………………………. COMMENTS OF PEER REVIEWERS Comments of XXXXX …………………………………… General comment

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These refer to: − Deliverable layout − Deliverable contents thoroughness − Innovation level − Correspondence to project and programme objectives − Particular remarks in format, spelling, etc.

Specific comments Topic A: Completeness Reviewer comment Author response Topic B: Accuracy Reviewer comment Author response Topic C: Methodological framework soundness Reviewer comment Author response Topic D: Relevance Reviewer comment Author response Topic E: Adherence to standard Reviewer comment Author response

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Topic F: Depth Reviewer comment Author response Topic G: Writing features Reviewer comment Author response Topic H: Punctuality Reviewer comment Author response

Annex IV: External Reviewer's Confidentiality Declaration

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CONSIDER (FP7- 288928) REVIEWER DETAILS (Distribution: Reviewer, Project Manager). All external reviewers should sign a confidentiality form in order to protect the project. External reviewers are not be members of the consortium but are people who are either experts in the specific subject covered by the deliverable report and/or represent the stakeholders addressed by the deliverable.

DELIVERABLE REPORT: WORKPACKAGE: RESPONSIBLE PARTNER:

NAME OF REVIEWER: ORGANISATION: PROFESSION: SHORT CV (up to 5 lines)

DECLARATION OF CONFIDENTIALITY I hereby declare that I will treat all information, contained within the above mentioned deliverable and which has been disclosed to me through the review of this deliverable report, with due confidentiality. Signed Place and date (Reviewer)

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Annex V: Deliverables reviewers list

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WP n°

Deliverable due date

from Annex I

Title Lead Partner

Quality Chair 1st Reviewer 2nd Reviewer

1 30/06/2012 Glossary UL Terry Martin Thomas Alam Ivelina Fedulova

1 31/07/2012 The theoretical landscape FUNDP Bernd Carsten

Stahl Martin Revel Stefan Büshen

1 28/02/2013 Analytical Grid FUNDP Karen Bultitude Emilie Spruyt Simon Pfersdorf

1 30/06/2013 Governance Models DMU Philippe Goujon Stefan Büshen Jean-Gabriel Contamin

2 30/06/2012 Methodology definition and observation tools KIT Bernd Carsten

Stahl Karen Bultitude

Stephen Rainey

2 31/01/2013 FP7 Survey report UL Philippe Goujon Simon Pfersdorf

Bernd Carsten Stahl

2 31/05/2014 Main Findings Report UL Bernd Carsten Stahl Stefan Büshen Philippe Goujon

3 31/01/2013

Framework for the Comparison of Theories of CSO Participation in Research Governance

KIT Martine Revel Simon Pfersdorf

Stephen Rainey

3 31/01/2014

Report on the analysis of theory and practice of CSO participation in research governance

FUNDP Martine Revel Kutoma Wukumuma

Stefan Büshen

3 31/07/2014 Model of CSO Participation in Research Governance

KIT Philippe Goujon Martine Revel Dimitris Micharikopou-los

4 30/11/2014 Guidelines Handbook DMU Karen Bultitude Dimitris Micharikopou-los

Terry Martin

4 31/07/2014 Expert workshops proceedings UCL Elena Tavlaki Michael Raider Stephen

Rainey

5 30/04/2012 Dissemination Strategic Plan UCL Simon Pfersdorf Elena Tavlaki Ivelina Feulova

5 31/01/2015 Project Dissemination Dossier UCL Simon Pfersdorf

Dimitris Micharikopoulos

Ivelina Fedulova

5 31/01/2015 EC Presidency Activities Report

SIGNOSIS Terry Martin Kate Duffy Michael Raider

6 31/01/2015 Project database of internal documents DMU Kate Duffy

Dimitris Micharikopoulos

Stephen Rainey

6 30/04/2012 Quality Assurance Plan & Risk Management Plan

SIGNOSIS Philippe Goujon Bernd Carsten

Stahl

Michael Raider

6 31/7/2012 Project Website DMU Simon Pfersdorf Emilie Spruyt Kate Duffy

The Deliverable D6.1 will not be peer reviewed according to this Plan, as has been already reviewed and submitted. The Deliverable D6.3 due to its importance and administrative character will be reviewed by the PCC.

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Annex VI: Non-Conformity Report on a Deliverable

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CIVIL SOCIETY ORGANISATIONS IN DESIGNING RESEARCH

GOVERNANCE

Deliverable: Partner: Author: WP No: Task No: Date: No DEVIATION DISPOSITION

NON CONFORMING REPORT FOR DELIVERABLE D.x.x. ____________________

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CORRECTIVE ACTIONS

No Item & Deviation Decision Responsible

Partner Expected Date for

correction CHECKED BY DATE

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Annex VII: Corrective and Preventive Action Request

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GOVERNANCE

CORRECTIVE ACTION REQUEST Organization: Name: Date: SECTION 1 PROBLEM AND OBSERVATION DETAILS. Relevant Procedures: ............................................... Signed: ........................................................................ Date: .......................... SECTION 2 CAUSE OF PROBLEM AND OBSERVATION. Signed: ........................................................................ Date: ......................... SECTION 3 IMMEDIATE CORRECTIVE ACTION TO BE TAKEN SECTION 3A PREVENTIVE ACTION TO BE TAKEN Signed : ........................... To be Implemented By ....................... Date ...................

CORRECTIVE ACTION REQUEST FOR PARTNER _________________________________

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SECTION 4 FOLLOW UP ACTION AND EFFECTIVENESS MONITOR List Effective Changes Made: 1. 2. 3. The Corrective/Preventive Action has been completed and has/has not* effectively cured the problem. Further action has been requested on .......................... Quality Assurance Manager Signed: ........................................ Project Manager Signed: ........................................ Dated: ...............................

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Annex VIII: Internal Audit Report

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GOVERNANCE

AUDITED PARTNER

REF.: NO:

REFERENCE: DATE:

PART 1 Deficiency Details

Inspected by: Partner Representative: Date:

TO:

FOR ACTION TO COMPLETE PARTS 2 AND 3

PART 2 CAUSE

INTERNAL AUDIT DEFICIENCY REPORT. No _________________________________

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PART 3 CORRECTIVE ACTION

Name: Implementation Date: Date:

PART 4 FOLLOW UP AND CLOSE OUT

Name: Date:

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Annex IX: Template Risk Statement Form

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RISK STATEMENT FORM

Risk ID: 1 Title: Not keeping the schedule - Lack of coordination / communication Status: Monitor Date Identified: Category: Probability: Owner: Impact: Description:

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IMPACTS Project Milestones: Schedule:

MITIGATION & CONTINGENCY PLANS Mitigation: Estimated Mitigation cost: Contingency:

RISK STATEMENT FORM –Sample for WP6. Risk ID: 1 Title: Not keeping the schedule - Lack of coordination / communication Status: Monitor Date Identified: 15th November 2012 Category: Schedule Probability: Low Owner: Bernd Carsten Stahl Impact: High Description: Not following the project implementation description as presented in the DOW document of the CONSIDER project

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IMPACTS Project Milestones: it affects all project milestones Schedule: if lead times are properly accounted for, any tasks or activities that are dependent on the lack of coordination from the management of the project, the project will be delayed. It is possible, that overall delays could be averted through proper planning and redeployment of resources to other tasks. MITIGATION & CONTINGENCY PLANS Mitigation: The Project Manager has significant experience in project management and therefore the probability of that to occur is minimal. However, to mitigate such an unexpected event, some p/m have been allocated to the partners to undertake management tasks. If needed, more time will be spent from the whole consortium in dealing with delays. Processes will be established and documented in a project management handbook, delivery month 1 of the project. The Sharepoint platform will facilitate the exchange of information. Regular meetings will take place Estimated Mitigation cost: more than 30% of total project resources Contingency: it has no occurrence during the implementation phase of the first ten months of the project

quality assurance risk management plan

Documents

quality assurance plan

quality plan review

context of quality assurance

internal quality audits

control of quality records

annex iv

annex vi

quality requirement