Quality Assurance and Risk Assessment in the Framework of the Research Projects

1
Quality Assurance and Risk Assessment in the
Framework of the Research Projects
2nd International Workshop on Very Large Volume
Neutrino Telescope
D. Mazzini, C. Sollima INFN Sezione di Pisa,
DIMNP-Università di Pisa

• CATANIA 8 11 November 2005

2
San Piero a Grado Group

• Content
• Dipartimento di Ingegneria Meccanica, Nucleare e
  della Produzione (DIMNP), Università di Pisa
• The expertise and the experience of the group
• Quality Assurance
• Risk Assessment

3
Department of Mechanics, Nuclear and Production
Engineering of Pisa University

• The (DIMNP) is a research and teaching structure
  of the University of Pisa.
• Since its institution, the Department has been
  characterised by a strong orientation of the
  activities towards collaborations with Italian
  and international Industries in applicative
  research projects with wide scientific and
  technological significance.
• The main research activities regard safety
  analysis in nuclear and conventional fields,
  management of risk and emergency in industrial
  plants, quality assurance, characterisation and
  machining of conventional and innovative
  materials, design of machines and two- and
  four-wheel vehicles, and related studies on
  strength, reliability, lubrication, robotics and
  automation in industrial processes, and rapid
  prototyping technologies.
• Among the most important collaborations, the
  following companies can be mentioned ENEA, ENEL,
  FIAT, AVIO, INFN, PIAGGIO, NUOVO PIGNONE, BREDA,
  ANSALDO, AGIP, APAT, WESTINGHOUSE.....

4
San Piero a Grado Group

• The aim of this Group is
• Manage and develop the TACIS Project R2.03/97
• create a scientific center for supporting the
  national and international industries,
  organizations and consortia
• establish a joining between University and
  Industry
• It is collaborating with
• European Community
• TACIS subcontractor (NIKIET, Gidropress, EREC,
  Kurchatov Institute)
• CEA
• SOGIN
• ANSALDO
• INFN
• Framatome ANP

5
San Piero a Grado Group

• The expertise and the experience of the group

Nuclear Safety Thermal-hydraulic analysis,
Accident Management and plant analysis,
Collaboration for code development and design
Mechanical and Nuclear Technology Structural
mechanical analyses, Leak-Before-Break
methodology applications, FEM and CFD calculation
Education Training Training courses on the
uncertainty methodology (CIAU), Structural
Mechanics and COCOSYS code and on safety, risk
analysis and maintenance
Industrial Safety Environment Non destructive
testing of plant damages, Maintenance design of
small pressure devices, Industrial procedures for
the worker safety, Risk assessment Quality
assurance and Quality engineering
Project Management EC Projects (TACIS, PHARE,
CARDIS, V FRAMEWORK), Service contracts\
6
Quality Assurance

• There is still much discussion on how to apply
  the various established quality
  standards/protocols, such as ISO Guide 25, EN
  45001, ISO 9000, and OECD Principles of Good
  Laboratory Practice (GLP), to non-routine work
  (like research projects).
• It is widely argued that non-routine work does
  not fit easily into a highly documented and
  formalized quality system.
• For this reason guidance exist which recommend
  good practice rather than compliance with formal
  standards.
• The two approaches are not necessarily at odds
  with one another. Compliance for some aspects may
  place requirements which are considered to be
  over and above what is considered to be best
  practice. Conversely no single quality standard
  necessarily covers all the elements of activity
  which might be considered relevant as best
  practice.

7
Quality Assurance

• 1. The Quality Assurance is a tool of the
  management of the project

• 2. The Quality Assurance Programme describes
• the responsibilities and
• the needed rules
• to guarantee the requests for the realisation of
  the Project.

• 3. It is needed to distinguish
• Quality Assurance
• Quality Control
• Audit
• Improvement Process

8
Quality Assurance

• The Quality Assurance (QA) is defined as - All
  the planned and systematic actions implemented
  within the quality system, and demonstrated as
  needed, to provide adequate confidence that an
  entity will fulfill requirements for quality.
  (ISO 8402)

The Quality System consists of the high level
policy statement issued by the top management of
the organization which reflects the commitment to
attain and continuously improve the quality
A Policy Statement for commitment to quality in
the organization is the first basic step to
ensure the related importance and priority in the
strategy
The implementation of the quality system is the
responsibility of all managers and personnel of
the organization including external consultant
experts
9
Quality Assurance

• To facilitate the establishment and maintenance
  of the QS an appropriate communication from the
  top to bottom and vice versa is promoted.

Internal discussion and presentation of the
system to staff and external consultants are
organized to ensure that all involved people
understand the policy and the requirements for
quality
One top manager is in charge of performing the
role of QS Manager, who keeps monitoring the
implementation of the QS, its effectiveness and
necessary resolution of non conformity or issues
To manage corrective actions and internal audits
specific procedures have to be elaborated
10
Quality Assurance

• The quality system documentation could be made,
  as minimum, by the following
• Quality Policy Statement
• Organization Manual
• Quality Procedures

11
Quality Assurance

• Quality Policy Statement
• The Organization has established a Quality System
  which is implemented and maintained throughout
  the organization.
• The objective is that the rendered services are
  performed to meet the agreed contractual
  requirements and correspond to the organization
  aim to ensure effective design of required
  facility and related and construction,
  maintenance testing and operation requirements
• The organization
• aims at providing consistent, competent and
  independent services which meet the specific and
  known expectations of customers.
• continuously strives to improve and maintain its
  own processes and capabilities, adding value to
  the rendered services and providing satisfaction
  to partners and customers.
• provides rewarding to the staff and consultants
  and maintains safe environment through open
  communication.
• This Quality Policy is supported by continuous
  improvement objective and goal, which are
  monitored regularly, and supported with necessary
  resources.
• Date _______ Signature _________

12
Quality Assurance

• QUALITY ASSURANCE PROGRAMME INDEX
• 1. AIM AND APPLICATION FIELD
• 2. REFERENCE DOCUMENTS
• 3. TERMS AND DEFINITIONS
• 4. PROJECT ORGANIZATION
• 4.1 ORGANISATIONAL STRUCTURE AND
  RESPONSABILITIES
• 5. RESPONSIBILITIES AND INTERFACES
• 5.1 PROJECT STAFF RESPONSIBILITIES
• 6. PROCESSES FOR THE DEVELOPMENT OF THE PROJECT
• 7. QA PROGRAMME ELEMENTS
• 7.1 PRIMARY PROCESSES
• 7.2 SUPPORTING PROCESSES
• 7.2.1 INTERFACES AND COMMUNICATIONS
• 7.2.2 DOCUMENTATION MANAGEMENT
• 7.2.3 USE AND EVALUATION OF THE SOFTWARE
• 7.2.4 TESTING INSTRUMENTS AND EQUIPMENT
  MANAGEMENT
• 7.2.5 NON CONFORMITIES AND MODIFICATIONS
• 7.2.6 PREVENTIVE AND CORRECTIVE ACTIONS
• 7.2.7 PERSONNEL TRAINING AND
  QUALIFICATION

13
Quality Assurance

• DOCUMENTATION CONTROL INDEX
• 1. AIM AND APPLICATION FIELD
• 2. REFERENCE DOCUMENTS
• 3. TERMS AND DEFINITIONS
• 4. RESPONSIBILITIES
• 5. OPERATIVE MODALITIES
• 5.1 PROJECT DOCUMENT MANAGEMENT
• 5.2 QUALITY REGISTRATION DOCUMENTS
• 5.3 EXTERNAL DOCUMENTS MANAGEMENT
• 5.4 DOCUMENT MANAGEMENT AND ISSUE
• 6. IDENTIFICATION
• 7. DOCUMENT FORMAT
• 8. DOCUMENT DISTRIBUTION AND FILING
• 9. ATTACHMENTS
• 9.1 Document classification and
  responsibility matrix
• 9.2 First page and the successive ones of
  technical and work documents, and inception
  report
• 9.3 Flow chart illustrating the documents
  issue proceeding

14
Quality Control

• The Quality Control (QC) is defined as -
  Operational techniques and activities that are
  used to fulfill requirements for quality (ISO
  8402)

QC is a system of technical routine activities,
to measure and control the quality (of the
activity, service or product) as it is been
developed
15
Quality Control

• Quality control is achieved through the
  integration of
• checks on data correctness and completeness
• design verifications
• calculations checks
• calculations or estimates of uncertainty
• tests
• use of statistical analysis based on extensive
  data
• detailed procedures
• planning for human factors
• etc.

16
Audit

• All Quality Systems should be subject to external
  and internal audits.

An audit is a systematic and independent
evaluation to determine if the Quality Management
System related to the activities and results
complies with the planned arrangements, and if
these arrangements are implemented effectively,
efficiently and are suitable to achieve the
objectives.
The main objective of the audit is to verify
compliance with standards, and to support the
improvement of quality management
The findings of an audit are recorded as
Non-Conformities (NC) and observations
17
Audit

• When a NC is raised, corrective action must be
  carried out within due time

The corrective action is then verified (the
choice of verification method depends on the
severity of the NC) according to established
verification requirements, and if the corrective
action is satisfactory, it is closed according to
internal procedures
18
Procedure

• The Procedure is a document that defines
  conditions, modality and responsibility to
  perform a specific activity either technical or
  management

It can be general (if more groups are involved)
or detailed (if it is referred to a specific
action). A possible index is

• Summary
• Objective
• Reference documents
• Applicability
• Responsibility (including interface among
  different groups)
• Description of the activity (including flux
  diagram, schema and documents issued, etc.)
• Forms and attached

19
Improvement

• Deming PDCA (Plan Do Check Action) sequence

Do
Check
Plan
Action
20
An Application KM3NET

• Project Management
• Policy Statement

WP1

• QA RA Management
• QAP and RA Development
• Procedures (General)
• Audit
• Data Base of the Final Documents

WP7

• QA RA Interface
• QC (Development and Application)
• Procedures (General /or Detailed)
• Data Base of the Work Documents

WPi
21
RISK ASSESSMENT
RISK ANALYSIS METHOD FOR THE RELIABILITY OF AN
EXPERIMENTAL APPARATUS
22

• THANKS

23
QA APPLICATIONS
QUALITY ASSURANCE PROGRAMME
DOCUMENTATION CONTROL