1. 12/04/2005M.Castoldi CERN-SC International HEP Safety Forum Stanford Linear Accelerator Center ESTABLISHMENT OF A QUALITY MANAGEMENT SYSTEM IN THE CERN SAFETY COMMISSION Matteo Castoldi V HEP Safety Forum

2. 12/04/2005M.Castoldi CERN-SC ESTABLISHMENT OF A QUALITY MANAGEMENT SYSTEM IN THE CERN SAFETY COMMISSION  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: Role of SC at CERN Aim of SC Quality Management System CERN Integrated Management System SC Quality Management System Conclusions V HEP Safety Forum

3. 12/04/2005M.Castoldi CERN-SC  The 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 ESTABLISHMENT OF A QUALITY MANAGEMENT SYSTEM IN THE CERN SAFETY COMMISSION V HEP Safety Forum * Safety, with an initial capital letter, is used to cover health, safety and protection of the environment SC organigramme

4. 12/04/2005M.Castoldi CERN-SC  Aim 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 ESTABLISHMENT OF A QUALITY MANAGEMENT SYSTEM IN THE CERN SAFETY COMMISSION V HEP Safety Forum Is there an added value for SC and/or CERN ? If yes  implement quality management

5. 12/04/2005M.Castoldi CERN-SC  CERN Integrated Management System General model of Integrated Management System ESTABLISHMENT OF A QUALITY MANAGEMENT SYSTEM IN THE CERN SAFETY COMMISSION V HEP Safety Forum

6. 12/04/2005M.Castoldi CERN-SC CERN Safety Management System SC Quality Management System + departments Safety related activities quality systems, constitute the CERN Safety Management System ESTABLISHMENT OF A QUALITY MANAGEMENT SYSTEM IN THE CERN SAFETY COMMISSION V HEP Safety Forum

7. 12/04/2005M.Castoldi CERN-SC CERN Integrated Management System Added value? …. but without SC Quality Management System it is not possible to build a CERN Integrated Management System ESTABLISHMENT OF A QUALITY MANAGEMENT SYSTEM IN THE CERN SAFETY COMMISSION V HEP Safety Forum SC control

8. 12/04/2005M.Castoldi CERN-SC  The Safety Commission Quality Management System Based on four pillars (*) : SC organisation quality SC personnel quality SC units/projects quality Continual improvement of the system ESTABLISHMENT OF A QUALITY MANAGEMENT SYSTEM IN THE CERN SAFETY COMMISSION V HEP Safety Forum (*) Jean Menthonnex, Lausanne, Switzerland, 2002

9. 12/04/2005M.Castoldi CERN-SC  I pillar: Organization Quality System Process approach Processes to perform activities are the starting point Input and output requirements shall be clearly identified ESTABLISHMENT OF A QUALITY MANAGEMENT SYSTEM IN THE CERN SAFETY COMMISSION Activity A Activity B Activity C Input for Activity A Input for Activity C Input for Activity B Output for Activity A Output for Activity B Output for Activity C V HEP Safety Forum

10. 12/04/2005M.Castoldi CERN-SC ESTABLISHMENT OF A QUALITY MANAGEMENT SYSTEM IN THE CERN SAFETY COMMISSION Example of process: Mechanical Safety (approval of new device) Conceptual Design Review Engineering file preparation Engineering Design Review Preliminary description of device focussed on mechanical matters SC comments to preliminary description Engineering file, test results SC Safety Study Report Fabrication and testing Final testing at CERN Device and manufacturing certificates, SC Safety Study Report Safety Inspection Report Safety Commission Responsible for the device SC Safety Study Report V HEP Safety Forum

11. 12/04/2005M.Castoldi CERN-SC Documentation is prepared, based on processes ESTABLISHMENT OF A QUALITY MANAGEMENT SYSTEM IN THE CERN SAFETY COMMISSION V HEP Safety Forum 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

12. 12/04/2005M.Castoldi CERN-SC ESTABLISHMENT OF A QUALITY MANAGEMENT SYSTEM IN THE CERN SAFETY COMMISSION 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 V HEP Safety Forum

13. 12/04/2005M.Castoldi CERN-SC ESTABLISHMENT OF A QUALITY MANAGEMENT SYSTEM IN THE CERN SAFETY COMMISSION 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 V HEP Safety Forum

14. 12/04/2005M.Castoldi CERN-SC  II 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 ESTABLISHMENT OF A QUALITY MANAGEMENT SYSTEM IN THE CERN SAFETY COMMISSION V HEP Safety Forum

15. 12/04/2005M.Castoldi CERN-SC  III 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 System Safety Audits Protocol to monitor safety in new projects based on ISO 10006:2003 standard ESTABLISHMENT OF A QUALITY MANAGEMENT SYSTEM IN THE CERN SAFETY COMMISSION V HEP Safety Forum

16. 12/04/2005M.Castoldi CERN-SC 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 [1]  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][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. ESTABLISHMENT OF A QUALITY MANAGEMENT SYSTEM IN THE CERN SAFETY COMMISSION V HEP Safety Forum

17. 12/04/2005M.Castoldi CERN-SC 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 ESTABLISHMENT OF A QUALITY MANAGEMENT SYSTEM IN THE CERN SAFETY COMMISSION The Safety Audits Protocol (2/6 - procedure) V HEP Safety Forum

18. 12/04/2005M.Castoldi CERN-SC 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 ESTABLISHMENT OF A QUALITY MANAGEMENT SYSTEM IN THE CERN SAFETY COMMISSION V HEP Safety Forum

19. 12/04/2005M.Castoldi CERN-SC 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 ESTABLISHMENT OF A QUALITY MANAGEMENT SYSTEM IN THE CERN SAFETY COMMISSION V HEP Safety Forum

20. 12/04/2005M.Castoldi CERN-SC ESTABLISHMENT OF A QUALITY MANAGEMENT SYSTEM IN THE CERN SAFETY 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 V HEP Safety Forum

21. 12/04/2005M.Castoldi CERN-SC ESTABLISHMENT OF A QUALITY MANAGEMENT SYSTEM IN THE CERN SAFETY COMMISSION 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 V HEP Safety Forum

22. 12/04/2005M.Castoldi CERN-SC ESTABLISHMENT OF A QUALITY MANAGEMENT SYSTEM IN THE CERN SAFETY COMMISSION  IV 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. V HEP Safety Forum

23. 12/04/2005M.Castoldi CERN-SC It applies to organisation, personnel and units/projects quality systems Example: PDCA (environmental protection - EMS) Managerial level 1 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 level 3 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 ESTABLISHMENT OF A QUALITY MANAGEMENT SYSTEM IN THE CERN SAFETY COMMISSION V HEP Safety Forum

24. 12/04/2005M.Castoldi CERN-SC  Conclusions 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 ESTABLISHMENT OF A QUALITY MANAGEMENT SYSTEM IN THE CERN SAFETY COMMISSION V HEP Safety Forum Is there an added value for SC and/or CERN ? In our opinion yes !