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

2. 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

3. 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

4. ESS response to SSM review comments
Mechanical Design code – Why did we select RCC-MRx ?
ESS “ESS Rules for Radiation Safety Classification of Mechanical Equipment” has been updated with this information.
In-service inspections
ESS “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 “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

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

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

7. 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

8. Goal of Task Force Vicious to virtuous circle1
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”

9. Declaration of Conformity EU compliance
Mattias Skafar
Head of Quality Division
27 May, 2019

10. 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

11. 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

12. 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

13. 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…

14. 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

15. Thank You for Your time.