International HEP Safety Forum Stanford Linear Accelerator Center

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

2. 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 M.Castoldi CERN-SC V HEP Safety Forum

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

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

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

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

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

8. ESTABLISHMENT OF A QUALITY MANAGEMENT SYSTEM IN THE CERN SAFETY COMMISSION • 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 (*) Jean Menthonnex, Lausanne, Switzerland, 2002 M.Castoldi CERN-SC V HEP Safety Forum

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

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

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

12. 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 M.Castoldi CERN-SC V HEP Safety Forum

13. 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 M.Castoldi CERN-SC V HEP Safety Forum

14. ESTABLISHMENT OF A QUALITY MANAGEMENT SYSTEM IN THE CERN SAFETY COMMISSION • 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 CERN M.Castoldi CERN-SC V HEP Safety Forum

15. ESTABLISHMENT OF A QUALITY MANAGEMENT SYSTEM IN THE CERN SAFETY COMMISSION • 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 10006:2003standard M.Castoldi CERN-SC V HEP Safety Forum

16. ESTABLISHMENT OF A QUALITY MANAGEMENT SYSTEM IN THE CERN SAFETY COMMISSION • 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. M.Castoldi CERN-SC V HEP Safety Forum

17. Treatment Auditing Process Control Assesment Start Identification ESTABLISHMENT OF A QUALITY MANAGEMENT SYSTEM IN THE CERN SAFETY COMMISSION • The Safety Audits Protocol (2/6 - procedure) • 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 M.Castoldi CERN-SC V HEP Safety Forum

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

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

20. 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 M.Castoldi CERN-SC V HEP Safety Forum

21. 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 M.Castoldi CERN-SC V HEP Safety Forum

22. 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. M.Castoldi CERN-SC V HEP Safety Forum

23. ESTABLISHMENT OF A QUALITY MANAGEMENT SYSTEM IN THE CERN SAFETY COMMISSION • 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 M.Castoldi CERN-SC V HEP Safety Forum

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