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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 Communitys Seventh Framework
Programme (FP7/2007-2013)

Ta bl e of Cont e nt 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
Mo
nth
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.
CONSIDERs 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 projects 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 projects 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 deliverables 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 deliverables 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 its 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 managers 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 projects
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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19
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 Consortiums 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 CONSIDERs
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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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
W
o
r
k

P
a
c
k
a
g
e

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
W
o
r
k

P
a
c
k
a
g
e

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
W
o
r
k

P
a
c
k
a
g
e

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
W
o
r
k

P
a
c
k
a
g
e

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
W
o
r
k

P
a
c
k
a
g
e

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
W
o
r
k

P
a
c
k
a
g
e

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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Annex I: Internal Reports Template and Codification


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<<SubLlLle>>


CCnSluL8 ro[ecL
(CA number 288928)

uellverable u<<number>>
<< uaLe>>


Authors

<<name 1, llrsL name 1>>
<<AfflllaLlon>>

<<name 2, llrsL name 2>>
<<AfflllaLlon>>



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Table of Contents

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Executive Summary
no more Lhan Lwo pages. ConLalns relevanL facL, flgures, concluslons, recommendaLlons. noL an
absLracL, noL an lnLroducLlon.


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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 Communitys 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:
Projects 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
Communitys 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




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<<AfflllaLlon>>

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.123
4516789 -::5;1<=3 >1<1?3;
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: CONSIDER Financed by the European Communitys Seventh Framework
Programme (FP7/2007-2013)

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List of abbreviations

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Table of contents

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List of Figures






List of Tables

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EXECUTIVE SUMMARY

(Text no more than two pages)




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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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Annex/es









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Annex III: Peer Review Report template

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Peer Revi ew 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

CuallLy Assurance:
.123
4516789 !D17;
+3@73A3; B
+3@73A3; C












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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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W
P
n
Deliverabl
e 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 Bshen
1 28/02/2013 Analytical Grid FUNDP Karen Bultitude Emilie Spruyt
Simon
Pfersdorf
1 30/06/2013 Governance Models DMU Philippe Goujon Stefan Bshen
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 Bshen
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 Bshen
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
Micharikopoul
os
Ivelina
Fedulova
5 31/01/2015
EC Presidency
Activities Report
SIGNO
SIS
Terry Martin Kate Duffy
Michael Raider
6 31/01/2015
Project database of
internal documents
DMU Kate Duffy
Dimitris
Micharikopoul
os
Stephen
Rainey
6 30/04/2012
Quality Assurance
Plan & Risk
Management Plan
SIGNO
SIS
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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Deliverable: Partner: Author:
WP No: Task No: Date:
No DEVIATION DISPOSITION





































NON CONFORMING REPORT FOR
DELIVERABLE D.x.x. ____________________
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49

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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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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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: 15
th
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

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