TYPE APPROVAL PROCEDURE

Transcription

1 Approval Amendment Record Approval Date Version Description 15/06/ Initial issue under MTM. Replaces Connex documents cml PR-002 & cml-8.21-po /11/ Document revised and updated to simplify process 07/09/ Document revised and updated. (Major update). PRINTOUT MAY NOT BE UP-TO-DATE; REFER TO METRO INTRANET FOR THE LATEST VERSION Page 1 of 21

2 Table of Contents 1. Procedure Purpose Scope Abbreviations and Acronyms Definitions Reference and Legislation Related Documents Type Approval Categories Type Approval Process Process Flow Chart Request for a Type Approval TA Go/NoGo Decision by Process Engineering Type Approval with a Trial Provisional Type Approval Full Type Approval Successful Trial Unsuccessful Trial Full Type Approval without a Trial Engineering Product Approval Grandfather Rights Approval Records Appendix A - Type Approval Request Form Appendix B Guide to Type Approval Request Form Table of Figures Figure 1 - Type Approval Process flow... 8 PRINTOUT MAY NOT BE UP-TO-DATE; REFER TO METRO INTRANET FOR THE LATEST VERSION Page 2 of 21

3 1. Procedure This document describes the Type Approval process that is required to qualify and approve assets (products) for use on the Metro Trains Melbourne (MTM) managed rail network. A Type Approval (TA) is required for any new products that are proposed for use on the MTM rail network that are deemed safety or service critical. Once a product is Type Approved, it will be added the Approved Engineering Product List (AEPL) as a Qualified Product. Any new products proposed for use on the MTM rail network that are not deemed safety or service critical may be approved via the less rigorous Engineering Product Approval process. Once a product is Engineering Product Approved, it will be added the AEPL as an Approved Product. Note: In the case where an engineering approved product is proposed for use in a service or safety critical application, the product will be required to be qualified via the Formal TA process. Legacy assets that where introduced to the rail network prior to the MTM franchise being awarded in 2009 are considered to have legacy Grandfather Rights and may be given approval at the discretion of relevant Head of Engineering (HoE) via Grandfather Rights process detailed in this document. Note: In the case where a legacy item is modified or used in a new application Grandfather Rights are not applicable. 2. Purpose The purpose of this procedure is to ensure So Far As Is Reasonably Practicable (SFAIRP) that the product being introduced to the network is fit-for-purpose, safe, compatible, reliable and all possible risks have been mitigated and controlled prior to its introduction into MTM s Rail network. This procedure also provides prospective suppliers an insight into understanding MTM s expectations for Type Approving products. Funding for the development of the TA Request\Review\Approval for an MTM sponsored product will be the responsibility of the requesting party (i.e. work order number) e.g. Maintenance and Renewals, MTM Projects. Funding for the development of the TA Request\Review\Approval for an external sponsored product will be the responsibility of the requesting organisation. 3. Scope This procedure is applicable to all new Infrastructure operational assets that are introduced to the MTM railway, whether supplied by the Rail industry, custom-built or approved by other Accredited Rail Transport Operators (ARTO). Compliance with this procedure is not required for any enabling equipment (tools) such as hammers or drills; however a TA is required for permanent or semi-permanent equipment, e.g. a TA will be required where safe working or test equipment interface with MTM rail network, however this may be waived at the discretion of applicable HoE or Chief Engineer (CE). Note: In the future, it is intended to also cover new Rolling Stock assets for TA. Current Rolling Stock TAs are conducted via the MTM Engineering Change (EC) process. (A Rolling Stock EC is initially raised to conduct a Trial. If the Trial is successful, then another Rolling Stock EC is raised to implement the actual change covered by the Trial.) PRINTOUT MAY NOT BE UP-TO-DATE; REFER TO METRO INTRANET FOR THE LATEST VERSION Page 3 of 21

4 4. Abbreviations and Acronyms AEPL Approved Engineering Products List ARTO CE EC HoE MDBF MoC MSDS MTBF MTM MTTR PTA Requestor SCA SCI SFAIRP SIL SME TA TAC TARM Accredited Rail Transport Operators Chief Engineer Engineering Change Head of Engineering Mean Distance Between Failures Management of Change Material Safety Data Sheet Mean Time Between Failures Metro Trains Melbourne Mean Time To Repair Provisional Type Approval Person or Organisation making the request for a Type Approval Service Critical Asset Safety Critical Item So Far As Is Reasonably Practical Safety Integrity Level Subject Matter Expert Type Approval Type Approval Certificate Type Approval Recommendation Memorandum PRINTOUT MAY NOT BE UP-TO-DATE; REFER TO METRO INTRANET FOR THE LATEST VERSION Page 4 of 21

5 5. Definitions Approved Products Products that qualify for inclusion in the Approved Engineering Product List (AEPL) after having been: approved via the Full Type Approval process; or approved via the Provisional Type Approval process for specified period of time and only used under specified conditions; or approved via the Engineering Product Approval process; or approved via the Grandfather Rights Approval process. Approved Products are allowed for use on the Rail Network however their use will be limited by the conditions detailed on the TA certificate. Desktop Analysis Full Type Approval Is an activity performed by SME(s) nominated by Head(s) of Engineering (applicable to the candidate product) to determine whether MTM s requirements have been satisfied to issue a Provisional Type Approval (whether a trial is required) or Full Type Approval (TA). It involves assessing the product s compliance with specific standards, specifications and confirming that it has been manufactured to acceptable quality standards. It also includes a determination of the product s final Acceptance Criteria. Depending on the outcome of the Desktop Analysis, a recommendation may be made to grant Provisional or Full TA. A product that has been formally assessed to be qualified as fit for purpose for a defined application within MTM rail network, with, or without, stated conditions and limitations. Grandfather Rights A category of TA for existing products within the MTM rail network that have no current, existing TA. Products with Grandfather Rights may be used, maintained and renewed. These products may only be used in new works or upgraded installations at the discretion of the CE or delegate. Legacy Assets Products Provisional Type Approval Qualified Products All products that were introduced into the metropolitan rail network prior to the MTM franchise. Rolling Stock and Infrastructure operational assets including systems, sub-systems and equipment that are required to be compliant to MTM s operation, functional and technical standards and specifications. It includes commercially available products, modified commercially off the shelf products and products yet to be developed for MTM. A product that has been formally assessed and accepted for trial purposes only. Items that have been successfully approved via the Full Type Approval process. PRINTOUT MAY NOT BE UP-TO-DATE; REFER TO METRO INTRANET FOR THE LATEST VERSION Page 5 of 21

6 Safety Critical Item Service Critical Asset Stakeholder Subject Matter Expert A product that has been assessed to be a Safety Critical Item by the Safety Critical Item Procedure (L1-ASY-PRO-002). A product that has been assessed to be a Service Critical Asset by the Service Critical Assets Procedure, (L1-ASY-PRO-003). Any Division or Department within MTM i.e. Infrastructure, Rolling Stock, Network Strategy and Development, Projects, Safety Environment and Risk, Operations and Commercial that is interested in the outcome of a TA request. A subject matter expert (SME) is a domain expert in a particular area or topic and is nominated by the CE or delegate. 6. Reference and Legislation L1-ASY-PRO-001 Engineering Change Procedure L1-ASY-PRO-002 L1-ASY-PRO-003 L1-SQE-PRO-001 L1-SQE-PRO-002 EN Safety Critical Item Procedure Service Critical Assets Procedure Management of Change Process Risk Management Procedure Railway applications - Communications, signalling and processing systems - Software for railway control and protection systems 7. Related Documents L4-CHE-FOR-009 Type Approval Requisition Form. L4-CHE-FOR-033 L4-CHE-FOR-041 Type Approval Recommendation Memorandum. Type Approval Certificate 8. Type Approval Categories The process below defines four (4) different categories to grant a product approved status and be added to the AEPL: 1) Full Type Approval (Qualified Product); 2) Provisional Type Approval (Approved Product); 3) Engineering Product Approval (Approved Product); and 4) Approval via Grandfather Rights Approval (Approved Product). The AEPL also has a fifth category of Rejected for products that have failed acceptance via any of the above mentioned approval categories. A product may be rejected for various reasons, including but not limited to, the two examples below: Product not fit for purpose; and Inadequate supporting data. PRINTOUT MAY NOT BE UP-TO-DATE; REFER TO METRO INTRANET FOR THE LATEST VERSION Page 6 of 21

7 If feasible (i.e. inadequate supporting data) the product may be resubmitted for approval once the re-submission is in an adequate state. Any product categorised as Rejected is not permitted to be used to the MTM rail network. All proposed products that are candidates for type approval for use on the MTM rail network and have been determined to be either a Safety Critical Item (SCI) or a Service Critical Asset (SCA) shall require a Full TA. In the case where an unapproved product requires access to the MTM rail network for the purpose of a trial, a Provisional TA shall be requested. A Provisional TA will only be approved for a finite time and will generally have conditions and restrictions applied to the product. 9. Type Approval Process 9.1 Process Flow Chart The flowchart in Figure 1 below depicts the four different paths that can be taken to have a product approved for use on MTM rail network. The Grey boxes indicate a generic step that is not unique to an approval path. The Blue boxes depict the Full TA path. The Red boxes depict the Provisional TA path. The Green boxes depict the Engineering Product Approval path. The Yellow boxes depict the Grandfather Rights Approval path. PRINTOUT MAY NOT BE UP-TO-DATE; REFER TO METRO INTRANET FOR THE LATEST VERSION Page 7 of 21

8 Start New Is Product New or Existing on MTM Network? No SME to Conduct Desktop Analysis Is Product Service or Safety Critical? Yes No* Approve Product Via Type Approval process *Products which fail to be approved by the CE or relevant HoE are to be re-evaluated to determine whether the TA application will be re-submitted or withdrawn. If If the product has been rejected it it shall be added to the AEPL as a Rejected product. Existing Is a Trial required? No Engineering Review and Decision Does the CE approve the product? Yes Provide Full Type Approval Certificate No* Approve Product via Grandfather Rights Does the relevant Engineering Head approve the product? No* Yes Does the CE approve the product? Yes Approve Product Via Engineering Product Approval process Raise MoC and EC Provide Provisional Type Approval Certificate SME to Conduct Desktop Analysis Yes Perform Trial & Was Trial Successful? Does the relevant Engineering Head approve the product? No Yes Engineering Review and Decision Yes No* Figure 1 - Type Approval Process flow Update AEPL PRINTOUT MAY NOT BE UP-TO-DATE; REFER TO METRO INTRANET FOR THE LATEST VERSION Page 8 of 21

9 9.2 Request for a Type Approval A request for a type approval is performed by the Requestor. The Requestor shall:- 1) Use the Type Approval Requisition Form (L4-CHE-FOR-009) for the Type Approval Request. Refer to Appendix A - Type Approval Request Form and Appendix B Guide to Type Approval Request Form for details. 2) Assess the Safety Criticality of the product by using the Safety Critical Item Procedure (L1-ASY-PRO-002) and add the result to the Type Approval Requisition Form. 3) Assess the Service Criticality of the product by using the Service Critical Assets Procedure, (L1-ASY-PRO-003) and add the result to the Type Approval Requisition Form. 4) Provide the information identified on the Type Approval Requisition Form in the form of an information pack. 5) Submit the completed Type Approval Requisition Form (L4-CHE-FOR-009) inclusive of the information pack via to the Process Engineering group at typeapproval@metrotrains.com.au. 9.3 TA Go/NoGo Decision by Process Engineering Process Engineering shall:- 1) Create and manage a Type Approval folder structure to store all relevant Type Approval information. All Type Approval information shall be kept within this structure. 2) Upon receipt of the Type Approval Requisition Form (L4-CHE-FOR-009) duly completed by the requestor, check for completeness of information provided by the Requestor. 3) Reject the Type Approval Requisition Form (L4-CHE-FOR-009) if the supplied information is not satisfactory and return the form to the Requestor for his update. This process shall iterate until Process Engineering is satisfied with the information provided by the Requestor. 4) If the supplied information is satisfactory, consult with the CE and HoEs and stakeholders to determine the appropriate Type Approval category. The CE and HoEs shall either accept or reject the TA request. 5) If accepted, the CE and HoEs shall appoint or delegate an appropriate SME(s) to perform the agreed category of Type Approval (refer to sections 9.4 to 9.7 inclusive for details). 6) Create a unique TA number. 7) Complete the Registration section off the Type Approval Requisition Form (L4-CHE- FOR-009) and advise the SME via to perform the chosen category of the Type Approval process inclusive of a link to the folder location for the Type Approval. PRINTOUT MAY NOT BE UP-TO-DATE; REFER TO METRO INTRANET FOR THE LATEST VERSION Page 9 of 21

10 9.4 Type Approval with a Trial Provisional Type Approval When Process Engineering has determined a product requires a Provisional TA (Safety and/or Service critical Item and requiring a Trial), the appointed SME shall:- 1) Perform a Desktop Analysis (Engineering Review) to ensure that all the relevant, supporting information/data has been supplied in a TA Data Pack and that the quality of the provided data is deemed satisfactory, taking into account all affected stakeholders. 2) Perform a mandatory Risk Assessment (as per L1-SQE-PRO-002). 3) Upon completion of the Desktop Analysis:- a) Determine the purpose and success criteria for the trial. b) Complete a Provisional Type Approval Recommendation Memorandum (L4-CHE- FOR-033), detailing their recommendation for Provisional Type Approval and any conditions, restrictions or limitations on the approval of the product. c) Complete a Provisional Type Approval Certificate (L4-CHE-FOR-040), using the information contained on the TARM. 4) Arrange for the Provisional TARM to be endorsed by all affected Engineering Managers, the Process Engineering Manager and then subsequently approved by all relevant Heads of Engineering. Process Engineering shall:- 5) Present the completed Provisional TAC to the CE for his approval, supported by the signed TARM. If the CE signs Provisional TAC, the product is Provisionally Approved. 6) If the product is Provisionally Approved, add it to the AEPL as a Provisionally Qualified product and shall not publish it on the MTM intranet. 7) If the product has been rejected, add it to the AEPL as a Rejected product. If a Provisional TA has been granted, the Requestor shall:- 8) Raise a Management of Change (MoC), Form 1 and Form 2 and EC for the trial. The EC must include the purpose and the success criteria of the trial. 9) Once the EC is approved, a trial can be conducted. Note: All successful Provisional TAs are granted for a finite time only. Once the trial has concluded, the product must be removed from MTMs rail network. The expiry date and any caveats will be identified on the Provisional TA certificate. Note: A successful TA only qualifies the product for use on the MTM network. Any alteration to MTMs network can ONLY be made via an authorised EC which is preceded by an approved MoC Form 1 and Form2. PRINTOUT MAY NOT BE UP-TO-DATE; REFER TO METRO INTRANET FOR THE LATEST VERSION Page 10 of 21

11 9.4.2 Full Type Approval Successful Trial After a successful trial, the SME shall:- 1) Update the Provisional Desktop Analysis with any and all information gained during the trial. 2) Update the Provisional mandatory Risk Assessment (as per L1-SQE-PRO- 002). 3) Upon completion of the updated Desktop Analysis:- a) Complete a Type Approval Recommendation Memorandum (L4-CHE- FOR-033), detailing their recommendation for Type Approval and any conditions, restrictions or limitations on the approval of the product. b) Complete a Type Approval Certificate (L4-CHE-FOR-041), using the information contained on the TARM. 4) Arrange for the TARM to be endorsed by all affected Engineering Managers, the Process Engineering Manager and then subsequently approved by all relevant Heads of Engineering. Process Engineering shall:- 5) Present the completed TAC to the CE for his approval, supported by the signed TARM. If the CE signs the TAC, the product is approved. 6) If the product is approved, it shall be added to the AEPL as a Qualified product and published on the MTM intranet. 7) If the product has been rejected it shall be added to the AEPL as a Rejected product Unsuccessful Trial After an unsuccessful trial, the SME shall determine whether: 1) The Provisional TA is rejected and withdrawn. 2) The success criteria should be re-evaluated or 3) Product modification is required prior to Type Approval. If the Provisional TA is rejected and withdrawn, the SME shall:- 4) Update the Provisional Desktop Analysis with any and all information gained during the trial and detailing the reasons why the trial was unsuccessful. 5) Update the Provisional mandatory Risk Assessment (as per L1-SQE-PRO- 002). 6) Upon completion of the updated Desktop Analysis, complete a Type Approval Recommendation Memorandum (L4-CHE-FOR-033), detailing the recommendation for the Type Approval rejection. 7) Arrange for the TARM to be endorsed as rejected by all affected Engineering Managers, the Process Engineering Manager and then by all relevant Heads of Engineering. PRINTOUT MAY NOT BE UP-TO-DATE; REFER TO METRO INTRANET FOR THE LATEST VERSION Page 11 of 21

12 If the success criteria are to be re-evaluated, the SME shall:- 8) Determine the revised success criteria for the trial. 9) Re-evaluate the trial based on the revised success criteria. 10) If successful, refer to section Successful Trial. If Product modification is required, the SME shall:- 11) Reject and withdraw the Provisional Type Approval 12) Be involved with the new Type Approval process once the modified Product is available from the supplier. Note: A successful TA only qualifies the product for use on the MTM network. Any alteration to MTMs network can ONLY be made via an authorised EC which is preceded by an approved MoC Form 1 and Form Full Type Approval without a Trial When Process Engineering has determined a product requires a TA (Safety and/or Service critical item and does not require a trial), the appointed SME shall:- 1) Perform a Desktop Analysis (Engineering Review) to ensure that all the relevant, supporting information/data has been supplied in a TA Data Pack and that the quality of the provided data is deemed satisfactory, taking into account all affected stakeholders. 2) Perform a mandatory Risk Assessment (as per L1-SQE-PRO-002). 3) Upon completion of the Desktop Analysis:- a) Complete a Type Approval Recommendation Memorandum (L4-CHE-FOR-033), detailing their recommendation for Type Approval and any conditions, restrictions or limitations on the approval of the product. b) Complete a Type Approval Certificate (L4-CHE-FOR-xx), using the information contained on the TARM. 4) Arrange for the TARM to be endorsed by all affected Engineering Managers, the Process Engineering Manager and then subsequently approved by all relevant Heads of Engineering. Process Engineering shall:- 5) Present the completed TAC supported by the signed TARM to the CE for his approval. If the CE signs the TAC, the product is approved. 6) If the product is approved, it shall be added to the AEPL as a Qualified product and published on the MTM intranet. 7) If the product has been rejected it shall be added to the AEPL as a Rejected product. Note: A successful TA only qualifies the product for use on the MTM network. Any alteration to MTMs network can ONLY be made via an authorised EC which is preceded by an approved MoC Form 1 and Form2. PRINTOUT MAY NOT BE UP-TO-DATE; REFER TO METRO INTRANET FOR THE LATEST VERSION Page 12 of 21

13 9.6 Engineering Product Approval When Process Engineering has determined a product requires Engineering Product approval (not Safety nor Service critical), the appointed SME shall:- 1) Perform a Desktop Analysis (Engineering Review) to ensure that all the relevant, supporting information/data has been supplied in a TA Data Pack and that the quality of the provided data is deemed satisfactory, taking into account all affected stakeholders. 2) Consult with the relevant HoE to determine if a Risk Assessment. Perform the Risk Assessment (as per L1-SQE-PRO-002). 3) Upon completion of the Desktop Analysis, complete a Type Approval Recommendation Memorandum (L4-CHE-FOR-033), detailing their recommendation for Engineering Product Approval and any conditions, restrictions or limitations on the approval of the product. 4) Arrange for the TARM to be endorsed by all affected Engineering Managers, the Process Engineering Manager and then subsequently approved by all relevant Heads of Engineering. Process Engineering shall:- 5) If the product is approved, it shall be added to the AEPL as an Approved product and published on the relevant MTM internet web page. 6) If the product has been rejected it shall be added to the AEPL as a Rejected product. 9.7 Grandfather Rights Approval When Process Engineering has determined a product requires Approval by Grandfather Rights, the appointed SME shall:- 1) Complete a Type Approval Recommendation Memorandum (L4-CHE-FOR-033), detailing their recommendation for Grandfather Rights inclusive of any conditions, restrictions or limitations on the approval of the product. 2) Arrange for the TARM to be endorsed by all affected Engineering Managers, the Process Engineering Manager and then subsequently approved by all relevant Heads of Engineering. Process Engineering shall:- 3) If the product is approved, it shall be added to the AEPL as an Approved product and published on the relevant MTM internet web page. 4) If the product has been rejected it shall be added to the AEPL as a Rejected product. Notes: a) Approval via Grandfather Rights only applies to legacy (existing) products that have been in use on the Melbourne metropolitan rail network prior to MTM being awarded the franchise (30/11/2009). b) Products with Grandfather Rights may be used, maintained and renewed. These products may only be used in new works or upgraded installations at the discretion of the CE or delegate. c) A Risk assessment is not required for products seeking Grandfather Rights approval. PRINTOUT MAY NOT BE UP-TO-DATE; REFER TO METRO INTRANET FOR THE LATEST VERSION Page 13 of 21

14 10. Records Engineering Systems (Process Engineering team) shall file original approved and rejected TAs, and all related supporting documents as master copies. The TA register and TA certificates will be made available on the MTM Intranet by Process Engineering. PRINTOUT MAY NOT BE UP-TO-DATE; REFER TO METRO INTRANET FOR THE LATEST VERSION Page 14 of 21

15 Appendix A - Type Approval Request Form PRINTOUT MAY NOT BE UP-TO-DATE; REFER TO METRO INTRANET FOR THE LATEST VERSION Page 15 of 21

16 PRINTOUT MAY NOT BE UP-TO-DATE; REFER TO METRO INTRANET FOR THE LATEST VERSION Page 16 of 21

17 PRINTOUT MAY NOT BE UP-TO-DATE; REFER TO METRO INTRANET FOR THE LATEST VERSION Page 17 of 21

18 PRINTOUT MAY NOT BE UP-TO-DATE; REFER TO METRO INTRANET FOR THE LATEST VERSION Page 18 of 21

19 Appendix B Guide to Type Approval Request Form This appendix provides guidance on completing the TA Request Form and is considered to define the evaluation entry criteria required to conduct a Desktop Analysis for products to be qualified for Full/Provisional Type Approval, Engineering Product Approval and Grandfather Rights approval. The User is required to consider any other criteria which may also be applicable to the product/application under review/consideration. To adequately carry out an evaluation, it is important to gain understanding of the product s performance in the intended application. Comprehensive information on the product s design, operation and maintenance should be supplied. Sections a through to c in the blue section of the form are filled out by the Process Engineering group. Sections d through to f in the section of the form are filled out by the Requestor. Sections g through to p in the grey section of the form, are filled out by either the Requestor or a third party (e.g. contractor). a. TA Request Number TA Request number is issued by Engineering Systems team after the TA request form has been initially submitted and received. Performed by Process Engineering. b. Registered Date The Date the request was registered. Performed by Process Engineering. c. Type of Approval Requested The type of approval being requested, e.g. Type Approval, Engineering Product Approval, Grandfather Rights. Performed by Process Engineering. d. Request Raised By The contact details of the requestor of the TA request including the work order number that will fund the development of the TA and the TA approval of the product. e. Product Information The product particulars e.g. Name, Model, a description of the product. The Application field refers to where or how the product is to be used on the network, e.g. Single Person Operated Train System. f. SCI/SCA Rating of Asset Impacted Safety and Service critical ratings for the product or the system of which the product will be part. g. Product / Functional Description Product Specification. Referencing supporting documentation that identifies the products parameters and limitations, e.g. dimensional data, maximum power rating, temperature rating, IP Rating, vibration, acoustic noise, Electromagnetic Compatibility, Technical Environmental Specifications, Interfaces, etc. h. Functional and Performance Analysis Is the product fit for purpose? Has the product been assessed against the requirements for its proposed application? PRINTOUT MAY NOT BE UP-TO-DATE; REFER TO METRO INTRANET FOR THE LATEST VERSION Page 19 of 21

20 Service Life. What is the product s expected life? This may be described in hours, years or distance. Shelf Life. How long can the product be in storage before being used without any adverse impact or loss of intended designed effectiveness? Service History. The product s service history within other railway operations location, including application, quantity and period in service. MTBF or MDBF. MTTR. Note: This does not take into account travel time; however, MTM needs to ensure that the stated MTTR still conforms with MTM s service level agreements as per Schedule 10 of the 2009 Franchise agreement. i. Compliance Confirmation Indicate which of the following Specifications and Standards the product conforms to: MTM Technical, Functional & Operational Specifications. MTM Standards. Victorian Rail Industry Operators Group Standards (VRIOGS). Australian Standards. Other Relevant Standards. j. Use in other Rail Networks Evidence the product has been of used in: Similar Railway Operations. Similar Railway Environment. Similar Applications. k. Risk Assessment It is mandatory that, as part of a Full/Provisional TA request a risk assessment shall be conducted (in accordance with the Risk Management Procedure- L1-SQE-PRO-002) and attached to the TA Request. l. Safety Analysis Evidence of Fail Safe Capability. In the case of a failure, will the product create or potentially present a safety hazard? Safety Integrity Level. Identify if the product has SIL as described by EN Independent Safety Case. A rail industry recognised, independently endorsed Safety Case for the product. m. Occupational Health & Safety Material Safety Data Sheet (MSDS). Identification of all applicable MSDS documentation. Operator, Maintainer, Passenger and Public Safety. Evidence the product does not pose any hazard to the Operator, Maintainer, Passenger and Public e.g. Human Factors, Safety, manual handling etc. PRINTOUT MAY NOT BE UP-TO-DATE; REFER TO METRO INTRANET FOR THE LATEST VERSION Page 20 of 21

21 n. Environmental Impact Environmental impacts analysis. Evidence the product does not pose any environmental risk or hazard e.g. flora or fauna. Note: This is different to technical environmental specifications. Security (Vandalism/Terrorism). Evidence the product minimise any security risk due to Vandalism/Terrorism. o. Product/Supplier Certification Quality Assurance Compliance Certificate provided? Confirm that the manufacturer has an AS/NZS 9001 certified quality assurance system. Note: Any certification such as Certificates of Conformance may be required to be supplied every time the product is purchased e.g. when spares are purchased to replenish stock levels. Product Certification and testing e.g. in-house or external testing, compliance e.g. RCM (formerly A tick and C tick ). p. Qualifications Identification of any special or new qualifications that may be required to operate/install/maintain the product. This may include training from a manufacturer/supplier or a formal qualification that is to be obtained through registered training organisation. q. Maintainability and Supportability System Impact of product maintenance or repair. Can maintenance and repair be carried out without shutting down the rest of the system? Supportability. The level of technical support available in Australia and overseas. The lead time(s) and cost of spare parts, listing of essential spare parts including cost and lead time(s). Special Tools (safe working or test equipment) that interface with MTM rail network at the discretion of applicable HoE or CE. r. Product Documentation Installation documentation, documentation describing installation process and considerations that should be taken into account e.g. special tooling. This should also include any document regarding commissioning of the product. s. Other Operation & Maintenance Manuals, documentation describing how to operate and maintain the product. Drawings, product and dimensional drawings. Any other information deemed necessary/vital for the TA of the nominated candidate product. PRINTOUT MAY NOT BE UP-TO-DATE; REFER TO METRO INTRANET FOR THE LATEST VERSION Page 21 of 21