Relevant Management System & Declaration of Conformity EU compliance Mattias Skafar Head of Quality Division www.europeanspallationsource.se 27 May, 2019

Agenda Relevant Management System ESS response to SSM review comments ESS Management System – Evolvement Task Forces EU compliance/Declaration of Conformity Consultant Expert panel Progress

ESS response to SSM review comments Management System integrated with Safety culture Training, Safety committee, SRR, CE, Bas-P and Bas-U etc. Meeting on topic in Stockholm 18/4 Non-Conformity Report (NCR) handling Tool in confluence Register and handle all NCR and Continual Improvements Template to handle permanent NCR´s Lessons learned handling Handled as NCR and/or Continual Improvements Community benchmarking Barsebäck, Svafo, Ringhals Emergency training with local Rescue Team Audits and safety inspections

ESS response to SSM review comments Mechanical Design code – Why did we select RCC-MRx ? ESS-0033258 “ESS Rules for Radiation Safety Classification of Mechanical Equipment” has been updated with this information. In-service inspections ESS-0053218 “ESS Rules for Principles In-service Inspection” Issued and communicated with SSM No system covered by this issue currently, will need to mature. Archiving Assigning and training of Local Archive Representatives ESS-0082805 “ESS Rules for archiving of documented information” steering document in workflow Directives (RAFS) translated to English Assessment of CHESS as Electronic archive How to handle: Maintenance, Operations, measurements (people & environment) data GDPA

ESS Management System maturity Tailoring license process ESSMS 2.0 ESSMS 3.0 ESSMS 4.0 ESSMS 5.0

ESSMS – Critical Success Factors Organisation Functional Descriptions Role Description ESSMS 2.0 Process Procedure Facility Baselined design

ESS – Task forces Organisation Process Facility Procedure On behalf of Director General Task Forces to be launched Definition of TF and mandates (selected representatives from ESS functions) Organisation Functional Descriptions Role Description Process Procedure Lead Quality Division ESSMS 2.0 (framework) (3.0) Content (documents) Visualizing ESSMS 2.0 (tool) CM/RM and Risk Mgmt. Dedicated resources Facility Baselined design Lead Quality Division Top document Organigram FD’s List with Names & Key roles Dedicated resources Lead EIS Division Engineering Management Requirement Mgmt. Configuration Mgmt. (Risk Mgmt.) Dedicated resources CM – Configuration Management, RM – Requirement Management Access to Decision makers and clearly delegated mandate

Goal of Task Force Vicious to virtuous circle 1 1. No or unclear info structures (with gaps and overlaps) 1. Everything at one defined place in structure, clear owner 1 2 2. Can’t find relevant info 3. Creates more info 3 3. Reuse, revise and improve continuously, honoring the “whole” 3 2 2. Easy to find and “do right”

Declaration of Conformity EU compliance Mattias Skafar Head of Quality Division www.europeanspallationsource.se 27 May, 2019

Declaration of Conformity/CE marking An Consultant have been contracted to work hands on with the DoC/CE work. Available in Lund two days a week. Supports ESS and IKC An “expert panel” is launched to be able to assess with a multidisciplinary approach. Chaired by QD Supported by Consultant Discipline experts attends as needed Documentation Discussed with IKC and Work Package Mngr. + Team

WP 3 (Ion Source and LEBT) Meetings with Expert panel “Functional description” was distributed to support the work to identify applicable directives and standards. Applicable directives identified: ATEX Classification list developed Risk assessment performed Plan for risk mitigation in progress, some mitigation have already been done (e.g. placement of H2 bottle in own ATEX zone etc.) MD, LVD, EMC ATEX - ATmosphères EXplosibles, MD – Machine Directive, LVD – Low Voltage Directive, EMC – Electro Magnetic Compatibility

WP 4 (Spokes) WP 5 (Medium- and High-beta cryomodules) WP 6 (Beam delivery system) Applicable directives are identified based on functional description and presentation from the Work Packages. Meeting to answer remaining questions is planed. Risk assessment performed/ongoing. ESS DoC template sent to MB cryomodule provider

General progress IKC – Technical Annex template updated More detailed and specific information Information sessions/meetings Internal: NSS, ICS, Acc. etc. External: ESRF, XFEL and CERN Brightness Field coordinators – training in Lund IKON#14 – plenary talk and workshop in Paris Accelerator Collaboration Board – in Warsaw Workshop with STFC in Oxford, planned To be continued…

Summary Good progress on the comments from SSM related to Relevant Management System. Living the system is the challenge. Evolvement of Management System approach in line with internal needs and external expectations. Task Forces will address Relevant Management System Initiatives with European Foundation for Quality Management will continue CE marking and Declarations of Conformity approach is maturing and is now exercised in the project. Several projects ongoing Progressing well

Thank You for Your time.