12/04/2005M.Castoldi CERN-SC International HEP Safety Forum Stanford Linear Accelerator Center ESTABLISHMENT OF A QUALITY MANAGEMENT SYSTEM IN THE CERN.

12/04/2005 M.Castoldi CERN-SC

International HEP Safety ForumInternational HEP Safety ForumStanford Linear Accelerator CenterStanford Linear Accelerator Center

ESTABLISHMENT OF A QUALITY MANAGEMENT SYSTEM IN ESTABLISHMENT OF A QUALITY MANAGEMENT SYSTEM IN THE CERN SAFETY COMMISSIONTHE CERN SAFETY COMMISSION

Matteo CastoldiMatteo Castoldi

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ESTABLISHMENT OF A QUALITY ESTABLISHMENT OF A QUALITY MANAGEMENT SYSTEM IN THE CERN MANAGEMENT SYSTEM IN THE CERN

SAFETY COMMISSIONSAFETY COMMISSION

Aim:Aim: Present a complete model of Quality Management System Present how it could be applied to the CERN Safety Commission

(SC) Understand if Quality Management brings added value to SC

Content:Content: Role of SC at CERN Aim of SC Quality Management System CERN Integrated Management System SC Quality Management System Conclusions

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The role of SC at CERNThe role of SC at CERN Perform all the centralized activities of CERN directly related with

health, safety and protection of the environment. Some of the SC fields of activity are:

draw up and application of Safety* rules occupational health Safety divulgation and training emergency management radiation protection environmental protection chemical safety

SC offers a service to the entire CERN



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* Safety, with an initial capital letter, is used to cover health, safety and protection of the environment

SC organigramme


Aim of a Quality Management System in SCAim of a Quality Management System in SC Demonstrate SC ability to consistently provide the services it is

deemed for Demonstrate SC ability to meet regulatory requirements of Host

States (France, Switzerland) Enhance the satisfaction of the CERN personnel profiting from SC

services



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Is there an added value for SC and/or CERN ? If yes implement quality management


CERN Integrated Management SystemCERN Integrated Management System General model of Integrated Management System



Safety Management

System

Integrated Management System

Environment Management

System

Quality Management

System

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CERN Safety Management System

SC Quality Management System + departments Safety related activities quality systems, constitute the CERN Safety Management System



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SC QMS

Dept’s Safety


CERN Integrated Management System

Added value? …. but without SC Quality Management System it is not possible to build a CERN Integrated Management System



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SC control

CERN QMS

CERN Integrated Management System

EMS


SC QMS

Dept’s Safety


The Safety Commission Quality Management SystemThe Safety Commission Quality Management System Based on four pillars(*):

SC organisation quality SC personnel quality SC units/projects quality Continual improvement of the system



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SC QMS

Organisation Quality Syste m

Personnel Quality Syste m

Unit/ pr ojec t Quality Syste m

Maintenance & Improve ment

(*) Jean Menthonnex, Lausanne, Switzerland, 2002


I pillar: Organization Quality SystemI pillar: Organization Quality System Process approach

Processes to perform activities are the starting point Input and output requirements shall be clearly identified



ActivityA

ActivityB

ActivityC

Input for

Activity A

Input for

Activity C

Input for

Activity B

Outputfor

Activity A

Outputfor

Activity B

Outputfor

Activity C

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Example of process: Mechanical Safety (approval of new device)

ConceptualDesignReview

Engineering file

preparation

EngineeringDesignReview

Preliminarydescriptionof devicefocussed

on mechanicalmatters

SCcomments

to preliminary description

Engineeringfile,

test results

SC Safety StudyReport

Fabricationand

testing

Finaltesting at

CERN

Device andmanufacturing

certificates,SC Safety Study

Report Safety InspectionReport

Safety Commission Responsible for the device

SC Safety StudyReport

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Documentation is prepared, based on processes



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Level A Manual

quality policy, objectives of SC implementation, review, approval and revision

of the system structure of SC, responsibility, authority and

interrelations key processes of SC reference to SC procedures for key processes




Level B Procedures

for SC processes or complex activities responsibility and authority of SC and other parties scope, needs of SC and third parties input and output of processes or complex activities definition of records reference to work instructions

Example: procedure for final mechanical testing (commissioning) of an equipment

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Procedure example




Level C: Work instructions

description of important activities

Requirements and scope

Activities description following the operations sequence

definition of related records reference to parent procedure

Example of work instruction: how to perform a pressure test, how to perform a chemical analysis on a water specimen

Form/record record data to demonstrate compliance with procedures or work

instructions permanently stored into CERN Engineering Data Management System

Examples of form/record: accident declaration, Safety Study Report

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Form example

Record example


II pillar: Personnel Quality SystemII pillar: Personnel Quality System Based on standard CERN tools

Merit Advancement and Promotion Scheme (MAPS) short-term training needs evaluation

If no training is available to match post requirement: Skills and Talents Inventory

inventory of the human skills currently available at CERN

Personnel certification whenever possible and convenient

Example of SC personnel certification the firemen are certified ambulance officers by Swiss authorities



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III pillar: Units Quality SystemIII pillar: Units Quality System Whenever necessary, SC units certified by independent body SC auto-certification when no certifier is available or convenient

Example of SC certified unit the Laboratory of Occupational Health Medicine certified QUALAB by

the Quality Control Centre Switzerland

Project Quality SystemProject Quality System Safety Audits Protocol to monitor safety in new projects

based on ISO 10006:2003 standard



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The Safety Audits Protocol (1/6 - definitions) Audited project

selected by the Safety Commission based on the advancement of the activities and risk involved

Safety responsible the GLIMOS[1] of the experiment, or the Project Safety Responsible

Audit coordinator a member of SC appointed by the Head of SC technical competences, leadership skills

Safety Commission team of experts chosen by the Audit coordinator individually competent, motivated, and supportive

[1] For Safety matters, an experiment is represented by a Group Leader in Matters of Safety (GLIMOS), who is responsible for Safety, with the necessary authority, from the design stage and subsequently throughout the development, construction, and operational stages of the equipment until it is dismantled and correctly disposed of. The GLIMOS is appointed by the parent Department Head with the consensus of SC.



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Audit procedure

initiated by SC systematic meetings four steps (see picture) terminated at the end of the

project final audit report registered in the Risk

Management Plan



The Safety Audits Protocol (2/6 - procedure)

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Risk Management Plan


The Safety Audits Protocol (3/6 - steps) Hazard identification

at the initiation of the project the Safety responsible presents information and documents hazards with significant impact noted in the Risk Management Plan a responsible for the risk assigned for each hazard

Risk assessment

criteria and techniques decided by SC experts the responsible for the risk presents analyses assessment performed by SC following CERN Safety rules non acceptable risks noted in the Risk Management Plan



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The Safety Audits Protocol (4/6 - steps) Risk treatment

non-acceptable risks treated the responsible for the risk presents solutions SC decides whether to retain a solution Retained solutions noted in the Risk Management Plan and implemented

Risk control

SC experts monitor the implementation of solutions SC experts and the Safety responsible watch on new risks Personnel anticipate and identify risks and report to the Safety responsible



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SAFETY COMMISSIONSAFETY COMMISSION The Safety Audits Protocol (5/6 - example)

Roles Audited project: LHCb gantry structure Safety Responsible: LHCb deputy-GLIMOS Audit Coordinator: SC-GS/MS section leader Team of expert: SC mechanical engineer, SC safety inspector

Hazard identification the LHCb deputy-GLIMOS presents the envisaged structure and information

relevant to the gantry hazard mechanical safety is identified as unique hazard an LHCb engineer is assigned as responsible for the risk

Risk assessment the SC mechanical engineer gives details on the calculations and

documents to be submitted to SC. Safety requirements are recalled the LHCb engineer prepares and presents the calculations and documents the SC engineer assesses the submitted design and other documentation the SC engineer and the SC-GS/MS section leader prepare a Safety Study

Report

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The Safety Audits Protocol (6/6 - example) Risk treatment

in case of negative Safety Study Report the LHCb engineer presents options the SC engineer and SC-GS/MS section leader may issue a positive Safety

Study Report Retained solutions are implemented and the gantry manufactured

Risk control the SC safety inspector monitors the correct construction of the gantry and

on new hazards arising in case of new hazards during the gantry construction a new hazard

identification step is undergone

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SAFETY COMMISSIONSAFETY COMMISSION IV pillar: Maintenance & ImprovementIV pillar: Maintenance & Improvement

Based on the PDCA approach Actions to improve quality are planned (Plan) Actions are implemented (Do) Result of actions is monitored (Check) Corrective actions are undergone if necessary (Act)

Both at managerial level and at process/activity level

From: D.Hortensius, et all., Towards a generic model for integrating management systems, ISO Management Systems Special Report, Jan. – Feb. 2004.

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It applies to organisation, personnel and units/projects quality systems

Example: PDCA (environmental protection - EMS)

Managerial level1 SC management wants more efficient environmental protection

2 SC-IE group receives resources

7 results of environmental protection is reviewed by the SC management

8 environmental policy and resources review by the SC management

Process level3 SC-IE establishes the EMS (manual, procedures, etc.)

4 SC-IE implements the EMS at CERN (other Departments involved)

5 SC-IE audits EMS performance and reports to SC management

6 SC-IE modifies EMS, when necessary



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ConclusionsConclusions The presented Quality Management System model

can be extended to an Integrated Management System for the entire CERN

improves SC organisation, personnel, units/projects quality allows to enhance the satisfaction of CERN Director General,

Personnel, Host States

The strategic decision of implementing quality management and allocate necessary resources is under evaluation by the Safety Commission top management



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Is there an added value for SC and/or CERN ? In our opinion yes !

12/04/2005M.Castoldi CERN-SC International HEP Safety Forum Stanford Linear Accelerator Center ESTABLISHMENT OF A QUALITY MANAGEMENT SYSTEM IN THE CERN.

Documents

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