Management of engineering change Process map This process map should be read in the context of the page on the RSSB website on the management of engineering change. Disclaimer Users of documents published by the Rail Safety and Standards Board Limited (RSSB) are reminded of the need to consider their own responsibilities to ensure health and safety at work and their own duties under health and safety legislation. RSSB does not warrant that compliance with all or any documents published by RSSB is sufficient in itself to ensure safe systems of work or operation or to satisfy such responsibilities or duties. Published by: RSSB Block 2 Angel Square 1 Torrens Street London EC1V 1NY © Copyright 2012 Rail Safety and Standards Board Limited Management of engineering change Process map Introduction: Components of the process map: 1. The process map is written primarily for organisations involved in the GB mainline railway system and can be used when the proposer (the organisation introducing the change) has decided to make an engineering change. Example 2. The engineering change ‘process map’ is made up of a series of pages that use the Unified Modelling Language. «role» AsBo -independent «primary legislation» CSM on RA -EC regulation 352/2009 +in force 19/07/10 (RVs & some sub-systems)() +in force 01/07/12 (all significant changes)() Each box is called an ‘element’. 3. The process map illustrates the relationships between elements. It should not be read as a flowchart. <<Stereotype>> 4. Where appropriate, links to relevant documents and websites have been provided. Checks application of4 - Attribute + Operation A ‘Stereotype’ is used to define the element An ‘Attribute’ describes the element An ‘Operation’ shows what the element does Some elements do not have attributes or operations or both (where further description is not necessary). How to read the process map: Follow the arrows and read the relationship between two elements as a sentence (name, verb, name) Symbols used in the process map: = “is a type of...” = “is made up of...” Examples: 1. On page 1 (CSM on Risk Evaluation and Assessment) “The AsBo checks the application of the CSM on RA” 2. On page 6 (Component assessment process - not interoperability constituents, not novel) “British Standards, Euronorms and Company Standards are types of Design and Manufacturing Standards” 3. On page 8 (Sub-system authorisation process – first authorisation) “The Technical File is made up of the certificate of verification (from the NoBo), the certificate of verification (from the DeBo) and the safety assessment report” 05 April 2012 Issue 1.2 i Management of engineering change Process map Stereotypes used in the process map: Abbreviations used in the process map: 1. Role AsBo – Assessment Body ATOC – Association of Train Operating Companies CDM – Construction (Design and Management) Regulations CSM on RA – Common Safety Method on Risk Evaluation and Assessment DeBo – Designated Body DfT – Department for Transport EC – European Commission ECM - Entity in Charge of Maintenance EN - EuroNorm ERA – European Railway Agency GN – Rail Industry Guidance Note HSAW – Health and Safety at Work Act HS1 – High Speed 1 IM – Infrastructure Manager NoBo – Notified Body NSA – National Safety Authority 2. Legislation: i. UK Primary and EU legislation ii. UK Regulation (secondary legislation) 3. Process 4. Decision 5. Document i. Mandatory document ii. Guidance iii. Certificate NSR – National Safety Rule NTR – National Technical Rule ORR – Office of Rail Regulation RACOP – Rail Industry Code of Practice RAMS – Reliability, Availability, Maintainability and Safety RGS – Railway Group Standard RID – Railways (Interoperability) Directive RIR – Railways (Interoperability) Regulations ROGS – Railways and Other Guided Transport Systems (Safety) Regulations ROSCO – Rolling Stock Company RSD – Railway Safety Directive RU – Railway Undertaking RV – Rail Vehicle SMS – Safety Management System SRM – Safety Risk Model TSI – Technical Specification for Interoperability iv. File 6. Requirement 7. Body 05 April 2012 Issue 1.2 ii CSM on Risk Evaluation and Assessment Note: in ROGS, RU is called 'Transport Undertaking' «process» System definition «guidance» EN50126:1999 - RAMS Link A to ROGS / RSD diagram «guidance» ERA guidance supports4 Produces4 Link Q to sub-system and rail vehicle authorisation diagrams Applies4 Requires4 Link C to CSM on RA next-level diagram «process» Selection of risk assessment principles Requires review of4 «decision» Significance of change «process» Comparison with risk assessment criteria «process» Implementation of risk mitigation controls 3 supports «guidance» GN -on risk reduction +to be produced() «process» Significant change «process» Non-significant change 3 Manages «mandatory document» SMS 3 Requires Categorises4 «regulation» ROGS 2006 -if RU or IM -if ECM or keeper Link D to ROGS / RSD diagram Requires review of4 «process» Change Decides4 «document» Safety assessment report «guidance» GN -on hazard identification +to be produced() Requires application of4 «role» AsBo -independent 3 supports +in force 19/07/10 (RVs & some sub-systems)() +in force 01/07/12 (all significant changes)() Defines significant change and enables decision on4 «guidance» ERA tools and examples «process» Hazard identification & classification «primary legislation» CSM on RA -EC regulation 352/2009 Checks application of4 «guidance» ORR guidance Link B to RID / RIR diagram «role» Owner Introduces4 «role» Proposer Appoints4 Is sent to4 «role» IM Link S to subsystem diagram (not covered by RIR) Link T to vehicle diagram (not covered by RIR) «role» RU «role» Manufacturer «role» Project Entity -when NoBo appointed for verification «role» Applicant for placing into service «role» ECM «role» Keeper 05 April 2012 Issue 1.2 No.1 CSM on Risk Evaluation and Assessment – selection of risk assessment principles «process» Similarity with Reference Systems 3 Compares with «process» Selection of risk assessment principles «document» Codes of Practice 3 Requires «mandatory document» TSIs «regulation» RIR 2011 Harmonised with4 Uses4 «process» Application of Codes of Practice Link C to CSM on RA top-level diagram Link F to RIR / RID diagram «guidance» ENs -can be mandatory if called up by a TSI NTRs notified in accordance with4 «document» Reference systems -Documentation referring to sub-systems -or vehicles that have been authorised «mandatory document» Build standards -referring to sub-systems or vehicles that have been authorised «mandatory document» RGSs Sets out method of4 «process» Explicit risk assessment 3 supports «guidance» GN -on risk assessment «mandatory document» SMS supports4 +to be produced() «guidance» British Standards -can be mandatory if called up by a National Rule NSRs notified in accordance with4 «mandatory document» Notified National Rules -NTRs and NSRs -contained in Reference Document 3 supports «document» SRM - Risk Profile Bulletin «guidance» Taking Safe Decisions «document» Railway standards (other countries) «document» Standards from other industries 3 Requires «regulation» ROGS 2006 Link E to ROGS / RSD diagram 05 April 2012 Issue 1.2 No.2 ROGS / Railway Safety Directive Note: in ROGS, RU is called 'Transport Undertaking' Link G to RIR / RID diagram «role» IM +operate and manage assets() +check conformity of products for use in service() +manage authorisation of products for use in service() «guidance» RSSB guidance -ROGS regulation 22 Link E to CSM on RA 2nd-level diagram Enacts4 Is transposed into UK law by4 Link J to sub-system (not RIR) diagram Link P to vehicle (not RIR) diagram Requires4 «regulation» ROGS 2006 Supports4 «guidance» ORR guidance 3 Checks Requires4 «guidance» ORR guidance «role» Owner 3 Supports Link N to vehicle diagrams «process» Authorisation of sub-systems and vehicles for placing into service «process» Authorisation/certification of operations -by ORR Link R to component (not IC) diagrams 3 Checks duty holders' compliance with «mandatory document» SMS Supports4 «European legislation» RSD -Directive 2004/49/EC Link D to CSM on RA top-level diagram Complies with4 Supports4 «primary legislation» HSAW Act «role» ECM «process» Safety verification Requires4 «role» Keeper «guidance» Guidance on HSAW act -issued by HSE Implements4 «role» Organisation -with responsibilities under ROGS Constrains4 «role» RU Link I to sub-system diagrams Compliance supports4 «role» NSA -ORR in UK 3 Requires review of Supports4 «role» Member State -DfT in UK Manages notification of4 «mandatory document» NSRs -on GB mainline railways «guidance» ERA Guidance «regulation» CDM regulations -infrastructure projects only «primary legislation» CSM on RA -application of CSM on RA Link A to CSM on RA top level diagram «mandatory document» HS1 standards -on HS1 only -notified as NSR «mandatory document» NR standards -on GB mainline only -notified as NSR «mandatory document» C06/OS/09/1200 -issue 2, 24/02/09 -process for the assessment of route level compatibility -on HS1 only «mandatory document» ATOC standards -on GB mainline only -guidance if not notified as NSR «mandatory document» RGSs -on GB mainline only -notified as NSR 3 Supports «mandatory document» GE/RT8270 -process for the assessment of route level compatibility -on GB mainline only «guidance» Associated documents -GNs and RACOPs 3 Supports 05 April 2012 Issue 1.2 No.3 Link O to vehicle diagrams «role» Project Entity Link L to sub-system diagrams Is transposed into UK law by4 supports4 «guidance» DfT explanatory memoradum Links to other diagrams «mandatory document» ATOC standards -on GB mainline only -guidance if not notified as NTR Link K to sub-system diagrams «mandatory document» NR standards -on GB mainline only -notified as NTR requires production of4 3 Defines Railway Interoperability Regulations / Railway Interoperability Directive sub-systems and vehicles only Link H to component (IC) diagram «regulation» RIR 2011 supports4 «guidance» DfT Helpnotes Link F to CSM on RA 2nd-level diagram Link M to vehicle diagrams Complies with4 «European legislation» RID -Directive 2008/57/EC -as amended by Directive 2011/18/EC -as interpreted by Recommendation 2011/217/EU «role» Applicant for placing into service Requires notification of4 «mandatory document» TSIs 3 harmonised with «mandatory document» HS1 documents -on HS1 only -notified as NTR «mandatory document» RGSs -on GB mainline only -notified as NTR «guidance» ENs -can be mandatory if called up by TSI 3 Supports 3 Used to demonstrate achievement of checks compliance with4 «mandatory document» NTRs -supports UK Specific Cases in TSIs -fills open points in TSIs -supports derogation from TSIs -defines compatibility with existing rail network 3 Defines «requirement» Essential Requirements «role» Member State -DfT in UK «guidance» Associated documents -GNs and RACOPs «process» Verification of interfaces -RIR regulation 17 para 2b Checks4 «process» Verification of sub-systems and vehicles -requirement for technical compatibility at European level 3 manages notification of Checks4 «process» Safe integration Demonstrated by application of4 «primary legislation» CSM on risk evaluation and assessment Link B to CSM on RA top-level diagram provides for4 Link G to ROGS / RSD diagram «process» Authorisation of sub-systems and vehicles for placing into service 3 Requires «process» Authorisation/certification of operations -by ORR 05 April 2012 Issue 1.2 No.4 Component assessment process – Interoperability constituents «role» Component manufacturer +manufacture component() +manage component assessment process() +sell component() «European legislation» RID -Directive 2008/57/EC -as amended by Directive 2011/18/EU -as interpreted by Recommendation 2011/217/EU supports4 requires conformity with4 «regulation» RIR 2011 regulations 24 & 25 is transposed into UK law by4 «mandatory document» TSIs 3 harmonised with «guidance» ENs -can be mandatory if harmonised with TSI Defines4 «requirement» Essential Requirements 3 Used to demonstrate achievement of demonstrates compliance with4 «guidance» DfT explanatory memoradum Complies with4 supports4 «guidance» DfT Helpnotes Link H to RIR / RID diagram «process» Assessment of conformity and suitability for use Provides for4 «certificate» EC declaration of conformity and suitability for use 05 April 2012 Issue 1.2 No.5 Component assessment process not interoperability constituents, not novel Link R to ROGS/RSD diagram «role» Component manufacturer +manufacture component() +sell component() «document» Design and manufacturing standards 3 Checks compliance with «guidance» Euronorms -compliance maybe enforced by company regulations / contract «role» Customer May require4 «process» In-service testing -as agreed with component manufacturer -may be enforced by contract «document» Company standards Requires notification to the EC of4 «guidance» British Standards -compliance maybe enforced by company regulations / contract «mandatory document» SMS Manages4 Complies with4 Reviews4 «European legislation» Directive 98/34/EC -concerning technical products 05 April 2012 Issue 1.2 No.6 Component assessment process not interoperability constituents, novel Supplies4 «role» Component manufacturer +manufacture component() +sell component() Supplies4 Complies with4 Complies with4 «document» Customer's acceptance requirements 3 Defines «document» Description of component Checks4 «document» Design and manufacturing standards 3 Checks compliance with «role» Customer May require4 «guidance» Euronorms -compliance maybe enforced by company regulations / contract «document» Company standards «process» In-service testing -as agreed with component manufacturer -may be enforced by contract «document» Declaration of compliance -compliance with acceptance requirements Reviews4 3 Manages «mandatory document» SMS Link R to ROGS/RSD diagram Requires notification to the EC of4 «guidance» British Standards -compliance maybe enforced by company regulations / contract Checks4 «European legislation» Directive 98/34/EC -concerning technical products 05 April 2012 Issue 1.2 No.7 Sub-system authorisation process – first authorisation (of a new sub-system) Produces4 «document» Verification declaration of sub-system Checks4 Link L to RIR / RID diagram «role» Project Entity 4 +manage authorisation to place subsystem into service() +manage compliance with TSIs() +manage compliance with NTRs() +manage application of CSM on RA() Applies to4 «Body» NSA +authorise subsystem for placing into service() Obtains4 Produces4 «process» Authorisation for placing into service Applies4 «process» EC verification procedure 3 Sets out Link I to ROGS / RSD diagram «regulation» RIR 2011 regulation 18 Link K to RIR / RID diagram Employs4 Assembles4 Employs4 «Body» NoBo -independence Produces4 «certificate» Certification of verification +checks compliance with TSIs() Employs4 «Body» DeBo -independence Produces4 «file» Technical file -responsibiliy for tech file may be amended by RIR 2011/12 «certificate» Certification of verification +checks compliance with NTRs() «Body» AsBo -independence Produces4 «document» Safety assessment report +checks application of CSM on RA() Link Q to CSM diagram 05 April 2012 Issue 1.2 No.8 Sub-system authorisation process – renewal & upgrading Produces4 «document» Verification declaration of sub-system Link L to RIR / RID diagram Checks4 «role» DfT Produces4 Examines4 «role» Project Entity +manage authorisation to place sub-system into service() +manage compliance with TSIs() +manage compliance with NSRs() +manage application of CSM on RA() Applies to4 «Body» NSA +authorise subsystem for placing into service() Produces4 Obtains4 «process» Authorisation for placing into service Decides4 «file» File +describes renewal / upgrade of sub-system() Requires4 Employs4 Categorises4 Employs4 «requirement» Requirement for authorisation for placing into service «Body» NoBo -independence Produces4 «certificate» Certification of verification +checks compliance with TSIs() +to the extent required by DfT() «Body» DeBo -independence Produces4 +checks compliance with NTRs() +to the extent required by DfT() -independence «process» New authorisation 3 Sets out «regulation» RIR 2011 regulation 18 Link K to RIR / RID diagram Assembles4 «Body» AsBo «process» Existing authorisation «process» EC verification procedure Employs4 «decision» Change to authorisation for placing into service Applies4 Link I to ROGS / RSD diagram Produces4 «file» Technical file -amended by renewal / upgrade -responsibiliy for tech file may be amended by RIR 2011/12 «certificate» Certification of verification «document» Safety assessment report +checks application of CSM on RA() Link Q to CSM diagram 05 April 2012 Issue 1.2 No.9 Sub-system approval process not covered by RIR «role» Sub-system manufacturer -manufacture sub-system -sell sub-system «role» Proposer -compliance checks may be independent -compliance checks may be enforced by contract +decides significance of change() +operate and manage assets() +manage approval of sub-system for use in service() Reviews4 May require4 «process» In-service testing -as agreed with manufacturer -may be enforced by contract Manages4 3 Checks compliance with «process» Installation & Commissioning -as agreed with manufacturer -may be enforced by contract May require4 Manages4 Complies with4 «document» Design and build standards Link S to CSM on RA top-level diagram «mandatory document» SMS Decides4 Requires notification to the EC of4 «guidance» British Standards -compliance maybe enforced by company regulations / contract «guidance» Euronorms -compliance maybe enforced by company regulations / contract «document» Company standards Link J to ROGS / RSD diagram «decision» Significance of change «European legislation» Directive 98/34/EC -concerning technical products 06 January 2012 Issue 1.1 No.10 Rail vehicle authorisation process – First authorisation (of a new vehicle) Link to GB National Reference Document on ORR website (not yet available) Produces4 «process» Declaration of EC verification Checks4 Link M to RIR / RID diagram «role» Applicant for placing into service +manage authorisation to place vehicle into service() +manage conformity with TSIs() +manage application of CSM on RA() +manage conformity with NTRs() Applies to4 «Body» NSA +authorises vehicles for placing into service() Produces4 Obtains4 «process» Authorisation for placing into service Applies4 Employs4 «Body» NoBo -independence «process» EC verification process Produces4 3 Sets out Link N to RSD / ROGS diagram «European legislation» RID Annex VI Link O to RID / RIR diagram «certificate» Certification of verification +checks conformity with TSIs() Employs4 Assembles4 Employs4 «Body» DeBo -independence Produces4 «certificate» Certification of verification +checks conformity with NTRs() «Body» AsBo -independence Produces4 «file» Technical file -responsibiliy for tech file may be amended by RIR 2011/12 «document» Safety assessment report +checks application of CSM on RA() Link Q to CSM diagram 05 April 2012 Issue 1.2 No.11A Rail vehicle authorisation process – Subsequent authorisation (of vehicles conforming to an authorised vehicle type) Produces4 «process» Declaration of EC verification Link to GB National Reference Document on ORR website (not yet available) Checks4 Link M to RIR / RID diagram «role» Applicant for Vehicle Authorisation +manage authorisation to place vehicle into service() +manage conformity with TSIs() +manage application of CSM on RA() +manage conformity with NTRs() Applies to4 «Body» NSA +authorises vehicles for placing into service() Obtains4 Produces4 «process» Authorisation for placing into service Applies4 «process» EC verification process 3 Sets out Employs4 «Body» NoBo -independence +checks conformity with TSIs() +checks vehicle is of a type included in ERATV() Produces4 Link N to RSD / ROGS diagram «European legislation» RID Annex VI Link O to RID / RIR diagram «certificate» Certification of verification 05 April 2012 Issue 1.2 No.11B Rail vehicle authorisation process – Renewed authorisation (of a type authorisation that is not valid anymore) Link to GB National Reference Document on ORR website (not yet available) Produces4 «process» Declaration of EC verification Checks4 Link M to RIR / RID diagram «role» Applicant for placing into service +manage authorisation to place vehicle into service() +manage conformity with TSIs() +manage application of CSM on RA() +manage conformity with NTRs() Applies to4 «Body» NSA +authorises vehicles for placing into service() Obtains4 Produces4 «process» Authorisation for placing into service Applies4 Employs4 «Body» NoBo -independence «process» EC verification process Produces4 3 Sets out Link N to RSD / ROGS diagram «European legislation» RID Annex VI Link O to RID / RIR diagram «certificate» Certification of verification +checks conformity with TSIs() Employs4 Assembles4 Employs4 «Body» DeBo -independence Produces4 «certificate» Certification of verification +checks conformity with NTRs() «Body» AsBo -independence Produces4 «file» Technical file -responsibiliy for tech file may be amended by RIR 2011/12 «document» Safety assessment report +checks application of CSM on RA() Link Q to CSM diagram 05 April 2012 Issue 1.2 No.11C Rail vehicle authorisation process – Additional authorisation (of vehicles already authorised in another EU MS) Link to GB National Reference Document on ORR website (not yet available) Produces4 «process» Declaration of EC verification Checks4 Link M to RIR / RID diagram «role» Applicant for placing into service +manage authorisation to place vehicle into service() +manage conformity with TSIs() +manage application of CSM on RA() +manage conformity with NTRs() Applies to4 «Body» NSA +authorises vehicles for placing into service() Obtains4 Produces4 «process» Authorisation for placing into service Applies4 Employs4 «Body» NoBo -independence «process» EC verification process Produces4 3 Sets out Link N to RSD / ROGS diagram «European legislation» RID Annex VI Link O to RID / RIR diagram «certificate» Certification of verification +checks conformity with TSIs() Employs4 Assembles4 Employs4 «Body» DeBo -independence Produces4 «certificate» Certification of verification +checks conformity with NTRs() «Body» AsBo -independence Produces4 «file» Technical file -responsibiliy for tech file may be amended by RIR 2011/12 «document» Safety assessment report +checks application of CSM on RA() Link Q to CSM diagram 05 April 2012 Issue 1.2 No.11D Rail vehicle authorisation process – ‘New’ authorisation (of a modified vehicle or vehicle type) Link to GB National Reference Document on ORR website (not yet available) Link M to RID / RIR diagram Produces4 «process» Declaration of EC verification Checks4 Produces4 «role» Applicant for placing into service +Manage authorisation to place vehicle into service() +manage conformity with TSIs() +manage application of CSM on RA() +manage conformity with NTRs() «role» DfT Applies to4 «Body» NSA +authorises vehicles for placing into service() Examines4 Obtains4 «process» Authorisation for placing into service «Body» NoBo -independence Requires4 Employs4 «decision» Change to authorisation for placing into service «process» EC verification process Employs4 Decides4 Applies4 «file» File +describes modification to rail vehicle() Employs4 Categorises4 «requirement» Requirement for authorisation for placing into service Produces4 Produces4 3 Sets out Link N to RSD / ROGS diagram «European legislation» RID Annex VI Link O to RID / RIR diagram «document» Certification of verification +checks conformity with TSIs() Assembles4 «Body» DeBo -independence Produces4 «certificate» Certification of verification +checks conformity with NTRs() «Body» AsBo -independence «file» Technical file -amended by modification -responsibiliy for tech file may be amended by RIR 2011/12 Produces4 «document» Safety assessment report +checks application of CSM on RA() «process» Existing authorisation «process» New authorisation Link Q to CSM diagram 05 April 2012 Issue 1.2 No.12 Rail vehicle approval process – not covered by RIR «role» Rail vehicle manufacturer +manufacture rail vehicle() +sell rail vehicle() «role» ROSCO «role» RU «role» DfT Complies with4 «document» Design and build standards 3 Checks compliance with «role» Proposer -compliance checks may be independent -compliance checks may be enforced by contract +operate and manage assets() +manage approval / acceptance of rail vehicles for use in service() Link T to CSM on RA top-level diagram «document» Company standards Manages4 «mandatory document» SMS Manages4 Requires notification to the EC of4 «guidance» Euronorms -compliance maybe enforced by company regulations / contract «process» In-service testing -as agreed with manufacturer and IM (Network Rail) -may be enforced by contract May require4 Reviews4 Reviews4 «guidance» British Standards -compliance maybe enforced by company regulations / contract «process» Installation & Commissioning -as agreed with manufacture and IM (Network Rail) -may be enforced by contract May require4 «decision» Significance of change Link P to ROGS / RSD diagram «process» In-service operation of rail vehicle «European legislation» Directive 98/34/EC -concerning technical products 06 January 2012 Issue 1.1 No.13