quality assurance achievements development of qa according to iso 9001 km3net quality standard, to...

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QUALITY ASSURANCE ACHIEVEMENTS Development of QA according to ISO 9001 To be considered as the starting point to implement the KM3NeT Quality Standard, KM3NeT Quality Standard, through the experience gained in the qualification and optimization processes To be distributed within KM3NeT collaboration through training on ISO 9000 and the KM3NeT QA System. Development of the database prototype its future implementation is already planned Need to define a qualification process for components and systems, then to design tests Following the study of possible quality standards, the ISO 9000 family is applied, both for its wide application in industry and its freedom to implement the QMS to the needs of KM3NeT project. The QAS is implemented to follow two requirements both of QA and RA: - the quality control process through the Deming cycle - the needs of the RA to proceed in parallel and interact with the design. According to ISO 9001, KM3NeT is developed in processes. The detector is represented by a tree logic scheme from the upper layer to the lower. Once a function of the availabilities of the components is determined two general questions can be answered: Given the availabilities Given the availabilities of the components of the system, determine the availability of the system. Given a performance criterion Given a performance criterion as a required system availability level, determine the component availabilities that satisfy this criterion. The required function required function of the telescope is to have an appropriate number of optical modules available to detect neutrino interactions. An additional requirement is that the telescope is available for A% of its useful life, assumed here to be equal to 10 years. As a first approximation, the steady state dependability of the system was calculated. Assumptions made at this stage included that: a) parts of the neutrino-detector will be designed in such a way that they will be retrievable , serviceable and replaceable; b) failure of a component is assumed immediately detectable; and c) repair can either start immediately, or may be only possible after predetermined time delays. The implementation of the QA and RA procedures follows the Deming cycle (“PDCA”: Plan, Do, Check, Act). It is a quality control process that allows the optimization of the design and of the project. Goals Define a suitable methodology for RA & QMS Perform a Risk Analysis of design and operation of the telescope, by a suitable methodology for the RA investigation Define and diffuse Define and diffuse the “Quality Culture” Obtain a common standardisation by an integrated strategy (QMS & RA, Health-Safety-Environment). REFERENCES [1] KM3NeT, “Conceptual Design for a Deep-Sea Research Infrastructure Incorporating a Very Large Volume Neutrino telescope in the Mediterranean Sea”, ISBN 978-90-6488-031-5 [2] UNI EN ISO 9001 – 2008 Quality Management Systems Requirements. [3] Mirandola R., Bonechi L., Carmignani G., “La gestione della qualita’ nelle organizzazioni”, Edizioni Plus 2004. [4] MIL-STD-1629, Standard developed by the United States Military, “Procedures for performing a failure mode, effect and criticality analysis”, AMSC N3074, 24 November 1980 [5] ECSS-Q-30-02A “Failure modes, effect and criticality analysis (FMECA)”, ECSS Secretariat, ESA- ESTEC Requirements & Standards Division, Noordwijk, The Netherlands, 7 September 2001. [6] Kececioglu, D., Reliability Engineering Handbook, Volume 2, Prentice Hall, Inc., New Jersey, 1991. FRAMEWORK and STRATEGIES for QUALITY ASSURANCE and RISK ASSESSMENT FRAMEWORK and STRATEGIES for QUALITY ASSURANCE and RISK ASSESSMENT in the KM3NeT NEUTRINO TELESCOPE PROJECT in the KM3NeT NEUTRINO TELESCOPE PROJECT The KM3NeT detector, currently being designed [1], is expected to be operated in the Mediterranean Sea at a depth of up to 5.000 meters (implying an ambient pressure of up to 500 bar) in the chemically-aggressive deep sea environment for at least 10 years without significant degradation. This requirement also applies to each sub-system, component or part of the detector, imposing strict standards to each step of the detector production, transportation and deployment on the sea bed. Through actions planned along well-defined procedures, quality assurance (QA) allows for achieving the defined requirements with a calculable level of confidence [2] [3]. Through qualitative and qualitative analysis, RA allows for the identification of critical points in the design and/or operation of the detector and for devising improvements and corrective and mitigation actions [4][5][6]. Within the framework of KM3NeT, QA and RA are coupled to form an integrated system, that allows for simultaneous monitoring both of the critical points and of the quality control (QC) actions developed to assure the fulfilment of the defined requirements. Abstract Abstract KM3NeT is an undersea neutrino detector currently KM3NeT is an undersea neutrino detector currently being designed. The poster describes the framework being designed. The poster describes the framework and the strategy for the introduction of the and the strategy for the introduction of the quality assurance system (QAS) and risk assessment quality assurance system (QAS) and risk assessment (RA) into the KM3NeT project. (RA) into the KM3NeT project. QAS and RA are set up as an integrated system for QAS and RA are set up as an integrated system for the improvement and optimisation of components of the improvement and optimisation of components of the KM3NeT neutrino detector as well as its the KM3NeT neutrino detector as well as its production and operation production and operation . . Nuclear Science Symposium – IEEE 2009 – 25 -31 October 2009, Nuclear Science Symposium – IEEE 2009 – 25 -31 October 2009, Orlando, Florida, USA Orlando, Florida, USA Dr. C. Sollima*, for the KM3NeT Consortium Dr. C. Sollima*, for the KM3NeT Consortium INFN – GRNSPG Universita’ di Pisa, Pisa, INFN – GRNSPG Universita’ di Pisa, Pisa, Italy Italy * E-mail: [email protected] * E-mail: [email protected] Quality Assurance Road Map Studying of the KM3NeT project to identify the required standards and normatives for each process Collection and selection of several suitable normatives and standards [3] related to the KM3NeT application Definition of links between the different normative and standards and its applications Development of a QA Questionnaire Implementation of QA software Development of a preliminary QA manual according to KM3NeT specifications Risk Assessment Road Map Studying of the KM3NeT project to identify the processes involved Functional Analysis of the processes Division of the Project in Units, Sub-Units, Components and Elements Development of a RA Questionnaire Study of FMEA/FMECA standards [4][5] and methodology [6] and analysis of the KM3NeT systems and processes Dependability analysis of the KM3NeT detector FMEA analysis of the critical points of the KM3NeT detector Definition of compensating provisions and remarks in RA deviations according to KM3NeT specifications STUDY OF THE PROJECT AND ORGANIZATION OF THE INFORMATION METHODOLOGY METHODOLOGY ISO 9001: Standard Start – up Process Requirements (QA and RA Analysis) Risk Assessment Quality Assurance Check Process: Quality Management System Corrective Actions Project Assessment and Quality Management Functional Analysis of the operative processes Document and Data Flow Management (DB) Standard Document Sheet, Conformity of Procedures Quality Manual FMEA/FMECA Processes & Project) Risk Index Procedures Quality Assurance Manual Quality Management Documentation QA Data Base Quality Plans Quality Assurance Management KM3NeT Quality Assurance System H-S-E Risk Assessment SYTEM LAYER SUBSYTEM LAYER COMPONENT LAYER ITEM LAYER UPPER LAYER LOWER LAYER KM3NeT Block Diagram: model based on the method of successive decomposition Dependability: First Order Results MTTF of the components MTTF DSI DNOMs DNOMs + 12% DNOMs + 30% 10 years Immediately repairable in one month (MTTR) 205 – 375 y 150 y 75 y 12 years not immediately repairable MTTR = one month, once per year 245-700 y 220 y 68-140 y MTTF: Mean Time To Fail MTTR: Mean Time To Repair DSI: Deep Sea Infrastructure DNOMs: Designed Number of Optical Modules RISK ASSESSMENT ACHIEVEMENTS Qualification of the methodology and models through many calculations performed on the concept designs Application of the methodology and models also to the construction and operation life of KM3NeT Needs to obtain the failure rates of the components: From database Government or commercial data Test Maintenance is an issue that affects the availability of the detector and the MTTF of the components and systems of KM3NeT detector KM3NeT model Success criteria MTTF The activities related to the QA included : Development of the Quality Assurance Manual Quality Assurance Manual: plan and organization of the activities of KM3NeT in all its phases to insure that the level of quality defined is achieved; Definition of the Quality plans Quality plans and general general procedures procedures Definition of the Quality Management System Quality Management System Definition of the Quality Management Document Quality Management Document Definition of a Database Database for the qualification, construction and operation of KM3NeT QUALIFICATION PROCESS QUALIFICATION PROCESS MTTF

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Page 1: QUALITY ASSURANCE ACHIEVEMENTS  Development of QA according to ISO 9001 KM3NeT Quality Standard,  To be considered as the starting point to implement

QUALITY ASSURANCE ACHIEVEMENTS

Development of QA according to ISO 9001

To be considered as the starting point to implement the KM3NeT Quality Standard,KM3NeT Quality Standard, through the experience gained in the qualification and optimization processes

To be distributed within KM3NeT collaboration through training on ISO 9000 and the KM3NeT QA System.

Development of the database prototype

its future implementation is already planned

Need to define a qualification process for components and systems, then to design tests

QUALITY ASSURANCE SYSTEM

Following the study of possible quality standards, the ISO 9000 family is applied, both for its wide application in industry and its freedom to implement the QMS to the needs of KM3NeT project.

The QAS is implemented to follow two requirements both of QA and RA:

- the quality control process through the Deming cycle

- the needs of the RA to proceed in parallel and interact with the design.

According to ISO 9001, KM3NeT is developed in processes. The detector is represented by a tree logic scheme from the upper layer to the lower.

DEPENDABILITY ANALYSIS

Once a function of the availabilities of the components is determined two general questions can be answered:

Given the availabilitiesGiven the availabilities of the components of the system, determine the availability of the system.

Given a performance criterionGiven a performance criterion as a required system availability level, determine the component availabilities that satisfy this criterion.

The required functionrequired function of the telescope is to have an appropriate number of optical modules available to detect neutrino interactions. An additional requirement is that the telescope is available for A% of its useful life, assumed here to be equal to 10 years.

As a first approximation, the steady state dependability of the system was calculated. Assumptions made at this stage included that: a) parts of the neutrino-detector will be designed in such a way that they will be retrievable , serviceable and replaceable; b) failure of a component is assumed immediately detectable; and c) repair can either start immediately, or may be only possible after predetermined time delays.

The implementation of the QA and RA procedures follows the Deming cycle (“PDCA”: Plan, Do, Check, Act).

It is a quality control process that allows the optimization of the design and of the project.

Goals• Define a suitable methodology for RA & QMS• Perform a Risk Analysis of design and operation of the telescope,

by a suitable methodology for the RA investigation• Define and diffuseDefine and diffuse the “Quality Culture”• Obtain a common standardisation by an integrated strategy (QMS

& RA, Health-Safety-Environment).

REFERENCES[1] KM3NeT, “Conceptual Design for a Deep-Sea Research Infrastructure

Incorporating a Very Large Volume Neutrino telescope in the Mediterranean Sea”, ISBN 978-90-6488-031-5

[2] UNI EN ISO 9001 – 2008 Quality Management Systems Requirements. [3] Mirandola R., Bonechi L., Carmignani G., “La gestione della qualita’ nelle

organizzazioni”, Edizioni Plus 2004.[4] MIL-STD-1629, Standard developed by the United States Military,

“Procedures for performing a failure mode, effect and criticality analysis”, AMSC N3074, 24 November 1980

[5] ECSS-Q-30-02A “Failure modes, effect and criticality analysis (FMECA)”, ECSS Secretariat, ESA-ESTEC Requirements & Standards Division, Noordwijk, The Netherlands, 7 September 2001.

[6] Kececioglu, D., Reliability Engineering Handbook, Volume 2, Prentice Hall, Inc., New Jersey, 1991.

FRAMEWORK and STRATEGIES for QUALITY ASSURANCE and RISK ASSESSMENTFRAMEWORK and STRATEGIES for QUALITY ASSURANCE and RISK ASSESSMENT in the KM3NeT NEUTRINO TELESCOPE PROJECTin the KM3NeT NEUTRINO TELESCOPE PROJECT

The KM3NeT detector, currently being designed [1], is expected to be operated in the Mediterranean Sea at a depth of up to 5.000 meters (implying an ambient pressure of up to 500 bar) in the chemically-aggressive deep sea environment for at least 10 years without significant degradation. This requirement also applies to each sub-system, component or part of the detector, imposing strict standards to each step of the detector production, transportation and deployment on the sea bed.Through actions planned along well-defined procedures, quality assurance (QA) allows for achieving the defined requirements with a calculable level of confidence [2] [3].Through qualitative and qualitative analysis, RA allows for the identification of critical points in the design and/or operation of the detector and for devising improvements and corrective and mitigation actions [4][5][6].Within the framework of KM3NeT, QA and RA are coupled to form an integrated system, that allows for simultaneous monitoring both of the critical points and of the quality control (QC) actions developed to assure the fulfilment of the defined requirements.

AbstractAbstractKM3NeT is an undersea neutrino detector currently being KM3NeT is an undersea neutrino detector currently being designed. The poster describes the framework and the strategy designed. The poster describes the framework and the strategy for the introduction of the quality assurance system (QAS) and for the introduction of the quality assurance system (QAS) and risk assessment (RA) into the KM3NeT project. risk assessment (RA) into the KM3NeT project. QAS and RA are set up as an integrated system for the QAS and RA are set up as an integrated system for the improvement and optimisation of components of the KM3NeT improvement and optimisation of components of the KM3NeT

neutrino detector as well as its production and operationneutrino detector as well as its production and operation. .

Nuclear Science Symposium – IEEE 2009 – 25 -31 October 2009, Orlando, Florida, USANuclear Science Symposium – IEEE 2009 – 25 -31 October 2009, Orlando, Florida, USA

Dr. C. Sollima*, for the KM3NeT ConsortiumDr. C. Sollima*, for the KM3NeT Consortium

INFN – GRNSPG Universita’ di Pisa, Pisa, ItalyINFN – GRNSPG Universita’ di Pisa, Pisa, Italy

* E-mail: [email protected]* E-mail: [email protected]

Quality Assurance Road Map Studying of the KM3NeT project to identify the required

standards and normatives for each process Collection and selection of several suitable normatives and

standards [3] related to the KM3NeT application Definition of links between the different normative and

standards and its applications Development of a QA Questionnaire Implementation of QA software Development of a preliminary QA manual according to

KM3NeT specifications

Risk Assessment Road Map Studying of the KM3NeT project to identify the processes

involved Functional Analysis of the processes Division of the Project in Units, Sub-Units, Components

and Elements Development of a RA Questionnaire Study of FMEA/FMECA standards [4][5] and methodology

[6] and analysis of the KM3NeT systems and processes Dependability analysis of the KM3NeT detector FMEA analysis of the critical points of the KM3NeT

detector Definition of compensating provisions and remarks in RA

deviations according to KM3NeT specifications

STUDY OF THE PROJECT

AND ORGANIZATION OF THE INFORMATION

METHODOLOGYMETHODOLOGY

ISO 9001: Standard Start – up

Process Requirements (QA and RA Analysis)

Risk Assessment

Quality Assurance

Check Process:

Quality

Management System

Corrective Actions

Project Assessment and Quality Management

Functional Analysis

of the operative processes

Document and Data Flow

Management (DB)

Standard Document Sheet,

Conformity of Procedures

Quality Manual

FMEA/FMECA

Processes & Project)

Risk Index

Procedures

Quality Assurance Manual

Quality Management Documentation

QA Data BaseQuality Plans

Quality AssuranceManagement

KM3NeTQuality Assurance System

H-S-E

Risk Assessment

SYTEM LAYER

SUBSYTEM LAYERCOMPONENT LAYER

ITEM LAYER

UPPER LAYER

LOWER LAYER

KM3NeT Block Diagram: model based on the method of successive decomposition

Dependability: First Order ResultsMTTF of the components

MTTF DSI DNOMs DNOMs + 12% DNOMs + 30%

10 yearsImmediately repairable in one month (MTTR)

205 – 375 y 150 y 75 y

12 years not immediately repairable MTTR = one month, once per year

245-700 y 220 y 68-140 y

MTTF: Mean Time To FailMTTR: Mean Time To RepairDSI: Deep Sea InfrastructureDNOMs: Designed Number of Optical Modules

RISK ASSESSMENT ACHIEVEMENTS Qualification of the methodology and models through many calculations performed on the concept designs Application of the methodology and models also to the construction and operation life of KM3NeT Needs to obtain the failure rates of the components:

From databaseGovernment or commercial dataTest

Maintenance is an issue that affects the availability of the detector and the MTTF of the components and systems of KM3NeT detector

KM3NeT model Success criteria

MTTF

The activities related to the QA included :

Development of the Quality Assurance ManualQuality Assurance Manual: plan and organization of the activities of KM3NeT in all its phases to insure that the level of quality defined is achieved;

Definition of the Quality plansQuality plans and general proceduresgeneral procedures

Definition of the Quality Management SystemQuality Management System

Definition of the Quality Management DocumentQuality Management Document

Definition of a DatabaseDatabase for the qualification, construction and operation of KM3NeT

QUALIFICATION PROCESSQUALIFICATION PROCESS MTTF