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ESS Accelerator Procedure for Review of Safety, RAMI and Quality
Assurance
Name
Authors
Enric Bargallo, Matthew Conlon, Duy Phan, Lali Tchelidze
Reviewer
John Weisend II
Owner
Matthew Conlon
Approver
Mats Lindroos
Chess Controlled Procedure Ed: 1.0
Template Active Date: 11 Mar 2014
Procedure
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TABLE OF CONTENT
PAGE
1. PURPOSE .................................................................................................... 3
2. APPLICABILITY ............................................................................................ 3
3. PROCUREMENT AND IKC DOCUMENTS AND THEIR REVIEW ...................... 3
4. TECHNICAL REVIEWS.................................................................................. 4
5. DESIGN REVIEWS – PDR, CDR ..................................................................... 5
6. ACCEPTANCE REVIEWS – SAR, ORR ............................................................ 6
7. REFERENCES............................................................................................... 7
8. GLOSSARY .................................................................................................. 7
DOCUMENT REVISION HISTORY ....................................................................... 7
APPENDIX 1: INPUT FOR PROCUREMENT AND IKC AGREEMENTS ................... 8
APPENDIX 2: DELIVERABLES AND TOPICS FOR DESIGN REVIEWS ................... 10
APPENDIX 3: DELIVERABLES AND TOPICS FOR ACCEPTANCE REVIEWS .......... 12
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PURPOSE
Accelerator’s Safety, RAMI and QA representatives are responsible for providing input,
review and other support within their areas of expertise to help Work Package (WP)
teams, In-Kind Contributors and supplier partners in managing the design, procurement,
manufacture and assembly, verification, delivery, site acceptance, installation,
commissioning and initial operations of ESS Accelerator systems and components.
The purpose of this Procedure document is for Accelerator’s Safety, RAMI and QA
representative to support WP and Partner teams by:



providing input for procurement documents and In-Kind Contribution (IKC)
agreement documents;
providing input for the charge documents for Design Reviews, and to participate
in these Reviews. This includes identifying Review deliverables, listing questions
or topics to be addressed; and similarly,
providing input for the charge documents for Acceptance Reviews, and to
participate in these Reviews.
The types of Procurement documents, IKC agreement documents, Design Reviews and
Acceptance Reviews that Safety, RAMI and QA can assist WP and their Partners with are
identified in this document. Lists and examples of the suggested inputs and lists of
generic deliverables and topics from Safety, RAMI and QA are included in the Appendices
to this document.
2.
APPLICABILITY
This procedure document was developed by ACCSYS to be applicable for ACCSYS WPs and
their Partners. It is a controlled document, managed in CHESS. It is one of the collection
of procedures documents which make-up the ACCSYS QA Manual, Reference A. The
ACCSYS QA Manual and its procedures are part of the ESS Management System (ESSMS)
framework of documents. This procedure is intended to comply with ESS-level Policies
and Processes, and to compliment existing ESS-level and ACCSYS-level Procedures of the
ESS MS..
3. PROCUREMENT AND IKC DOCUMENTS AND THEIR REVIEW
Safety, RAMI and QA representatives should be invited to provide input for procurement
and IKC documents. Representatives should also be invited to review of documents prior
to their release, to participate in the review and evaluation of tender responses and
proposals from Partners, and where appropriate, participate in negotiation and final
agreement. Procurement and IKC documents of interest for Safety, RAMI and QA
include:

Expressions of Interest (EOI)
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Invitations to Tender (ITT)
Tenders received / tender responses
Tender evaluation criteria and methods and tools for assessments
Procurement contracts, but most specifically their technical Schedules including
Statements of Work (SoW) and Specifications
IKC Heads of Agreement (HoA) and IKC Agreements, but most specifically their
technical Schedules (technical annexes/appendices)
Appendix 1 to this Procedure contains Safety, RAMI and QA clauses, examples of text and
other content, including suggested deliverables, that could be included in particular
procurement or IKC documents. Note that these are a checklist of items for discussion.
The content to be included must be discussed and agreed on case-by-case basis relevant
to scope for the agreement, the nature of the system or component, and the capabilities
of WPs and their partners.
4. TECHNICAL REVIEWS
Reference C, Chapter 5.1.5. Identifies a sample list of controlled1 engineering Baselines,
including identifying lists of generic Controlled / Configuration Items (CI) which each
Baselines may consist of. Each Baseline may be established through a formal review
milestone event (i.e. a meeting) as follows:
Baseline name (Reference C)
‘Review’ milestone (meeting)
description
Functional Baseline
Functional Design Review
FDR
Allocated Baseline
Preliminary Design Review
PDR
Critical Design Review
CDR
Test Readiness Review
TRR
System Acceptance Review
SAR
Operational Readiness Review
ORR
conceptual design or preliminary design
Design Baseline
‘As Designed’, after completing detailed design
Product Baseline
‘As Built’ after manufacture and assembly
Performance Baseline
‘As Verified’ after verification e.g. FAT, SAT
Operational Baseline
‘As Validated’ after installation and commissioning
Note that these Baselines and Reviews may not be universally applicable for the scope of
individual ACCSYS WPs, WUs and agreements with their Partners and for each
Accelerator system or component. WPs, WUs and their Partners should plan engineering
development of systems and components according to technical requirements and work
management needs, and document a programme of agreed controlled engineering
Baselines and milestone Reviews accordingly in contractual agreements and subordinate
1 ‘controlled’ refers to ESS Change Control Process, described in ESS-0001879
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technical schedules and supporting plans. Reference B provides further guidance for this.
For the purposes of this Procedure:
Design Reviews = FDR, PDR, CDR, TRR
Note that FDRs and in some cases PDRs, for Accelerator’s systems and components were
considered to have been informally conducted through the WP Audit programme during
2013 and 2014.
TRRs may be useful for some WPs and their Partners, and for certain Accelerator systems
and components. TRR could be considered either as a final Design Review or as an initial
review in a staged programme of acceptance milestones for systems and components.
Acceptance Review = TRR, SAR, ORR
Note that in the context of procurement and IKC agreements, SAR may be the milestone
in which Accelerator systems and components delivered and verified by Partners are
formally ‘accepted’ by ESS.
5. DESIGN REVIEWS – PDR, CDR
‘Review’ milestone (meeting)
Preliminary Design Review
Comments - see also Reference B
PDR
PDR is a review of inputs and outputs for
preliminary design work by WPs and/or
Partners.
If preliminary design is approved at PDR, then
the WP and/or Partner proceeds with detailed
design work to produce procurement and
manufacturing and assembly specifications and
drawings.
Critical Design Review
CDR
CDR is a review of inputs and outputs for
completed or near complete design work by
WPs and/or Partners.
If design is approved at CDR, then the WP
and/or Partner proceeds to procurement and/or
manufacturing of hardware and software
components.
Appendix 2 to this Procedure contains a list of Safety, RAMI and QA topics to be
addressed during PDRs and CDRs.
Note that the Safety, RAMI and QA reviewers will assist WP teams in the planning of
Design Reviews including if necessary identifying deliverables for review. However,
wherever possible, Safety, RAMI and QA document intended to be delivered for specific
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Design Reviews should be identified in advance in applicable procurement contracts and
IKC agreement documents.
6. ACCEPTANCE REVIEWS – SAR, ORR
‘Review’ milestone (meeting)
System Acceptance Review
Comments - see also Reference B
SAR
SAR is a review of the results of verification.
Verification are tests and other activities which
confirm that manufactured components and
assembled systems:


Comply with design drawings and other
outputs of design
Meet technical requirements,
performance specifications and other
inputs for design work
SAR may be in two stages – first a review of
‘factory acceptance’ and then a review of ‘site
acceptance’.
If a system or component is approved at SAR,
then the WP and/or Partner proceeds to
installation and Accelerator commissioning.
Operational Readiness Review
ORR
to be completed.
Appendix 3 to this Procedure contains a list of Safety, RAMI and QA topics to be
addressed during SAR(s).
Note that the Safety, RAMI and QA reviewers will assist WP teams in the planning of
Acceptance Reviews including if necessary identifying deliverables for review. However,
wherever possible, Safety, RAMI and QA document intended to be delivered for specific
Design Reviews should be identified in advance in applicable procurement contracts and
IKC agreement documents.
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7. REFERENCES
A.
B.
C.
D.
ESS-0037454 ESS ACCSYS QA Manual
ESS-0023097 ESS ACCSYS Procedure for Governance, Project Management and
Technical Reviews
ESS-0003688 Configuration Management Plan
ESS-0001515 Operating Procedure “Standards & Norms applicable for ESS”
8. GLOSSARY
Term
Definition
QA
RAMI
Safety
DOCUMENT REVISION HISTORY
Version
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1.0
New Document
<<YYYY-MMM-DD>>
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APPENDIX 1: INPUT FOR PROCUREMENT AND IKC AGREEMENTS
Example Text for Agreement technical Schedules: Scope of Work (SoW) and Deliverables,
Requirements, Specifications with respect to Safety, RAMI and QA
1. Concept of Operations document or similar functional description and general
description of the equipment
 Objective: Functions, breakdown structure of functions, breakdown
structure of physical system and components or outline Bill of Materials
(BoM), modes of function / operation, states
2. Standards for the Design and Construction of ESS Systems and Components
Reference D ESS-000515 Operating Procedure “Standards & Norms applicable for ESS”
identifies radiation protection Standards and more general engineering Standards
applicable for the design and construction of ESS systems and components.
The following Radiation protection standards are defined as applicable:
- ICRP standards, International Commission on Radiological Protection.
- IAEA standards, International Atomic Energy Agency.
- Euratom council directives, European Atomic Energy Community
The following Engineering standards are defined as applicable:
- SIS standards, Swedish standards institute (www.sis.se)
- CEN standards, European Committee for standardization (www.cen.eu).
- ISO standards, International Organization for standardization (www.iso.org).
The Reference summarises an estimated 4700 applicable ISO, CEN and SIS standards.
WPs and their Partners should identify:
 any Standards other than ICRP, IAEA, Euratom, SIS, CEN, ISO which are intended
to be applied for the design and manufacture of systems and components to be
delivered to ESS, and also.
 in advance, or during design and construction of ESS systems and components,
where WPs or their Partners are non-compliant with ICRP, IAEA, Euratom, SIS,
CEN, ISO.
Objective: For ACCSYS WPs and their Partners to identify the Standards they apply and do
not apply in the design and construction ESS systems and components.
3. Quality Assurance System and Programme of Activities
WPs and their Partners shall implement and maintain a quality assurance system and
programme of activities for the design, procurement, manufacture, verification and
delivery of ESS systems and components which address all aspects of ISO 9001.
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4. Quality Plan
Partner suppliers and IKC shall prepare a consistent and comprehensive Quality plan for
its contribution and submit it to approval by the ESS WU Coordinator on [date] the latest.
The Quality plan shall generally comply with the recommendations of the ISO 10005:2005
Standard.
The documentation required might be principally generated from the Partner’s Quality
Management System when applying a system manual with defined procedures. However,
a Quality plan does not replace such a quality management system, but may complement
to the issues of the cooperation.
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APPENDIX 2: DELIVERABLES AND TOPICS FOR DESIGN REVIEWS
Proposed list of deliverables for Design Review with respect to Safety, RAMI and QA
1. Functional description and general description of the equipment
 Objective: provides a general understanding of the equipment as well as
its breakdown into sub-systems. It should be coherent with and linked to
the ESS PBS.
2. Radiation safety analysis
 Objective: provides a general description of possible radiation fields
generated by the equipment. Gives associated expected values of prompt
and residual dose rates, when possible. Shows results of measured
radiation fields, when existing. Provides list of expected radionuclide
inventory and level of radioactivity in the equipment, for various
irradiation conditions, if possible.
3. Random failures
 Objective: List of the most frequent failures during normal operation
(steady state operation). Related maintenance actions, times to repair and
to restart the system should be provided.
4. Lifetime issues
 Objective: List of the components which wear out will occur within 20
years of operation of the machine. Related maintenance actions, times to
repair and to restart the system should be provided.
5. Catastrophic events
 Objective: List of failures with catastrophic consequences in downtime or
cost. It should include an estimation of the probabilities, cost and
downtime as well as the barriers to avoid it.
6. Conventional hazards
 Objective: List of events that could expose personnel to conventional
hazards (e.g. helium discharge in the tunnel during maintenance).
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7. Conventional hazards
 Objective: List of events that could expose personnel to conventional
hazards (e.g. helium discharge in the tunnel during maintenance).
Safety, RAMI and QA topics to be addressed during design reviews
Safety, RAMI and QA ask for a common presentation in which the following topics should
be addressed:

Presentation of the list of directives, standards or good practices (when
applicable) followed for the design of the equipment (e.g. 97/23/EC for pressure
equipment, 2006/95/EC for Low Voltage Directive, etc.)

Presentation of planning, procedures and sources for procurement and
manufacture of systems and components to be delivered to ESS

Presentation of manufacture processes identified and material and process
specifications for manufacturing of systems and components to be delivered to
ESS

Presentation of planning for verifying manufacture conforms with design, and for
resolving non-conformities. This includes but is not limited to presenting different
non-destructive tests to be done on the equipment according to the application of
the relevant directives and standards (e.g. hydrostatic pressure tests for pressure
equipment, X-ray examination of welds for mechanical equipment, leak tests, etc.)

Presentation of planning for verifying manufactured and assembled systems and
components comply with technical specifications

Presentation of the random, wear out and catastrophic events lists with emphasis
with the most relevant for RAMI:
- Events that could impact on ESS RAMI requirements (ESS-0008886 and
further breakdown of those requirements).
- Frequent events that require maintenance and/or spares - even if the
impact on ESS RAMI goals are not considerable.
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APPENDIX 3: DELIVERABLES AND TOPICS FOR ACCEPTANCE REVIEWS
Safety, RAMI and QA topics to be addressed during Acceptance Reviews
xxxx
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