First Assembly Validation (FAV)

STANDARD PRACTICE PROCEDURE SPP-318 FIRST ASSEMBLY VALIDATION (FAV) 1. PURPOSE The purpose of this procedure is to define the requirements and process required to perform a comprehensive FAV review at the location where it is proposed that the assembly process will take place. The FAV process is to use the proposed assembly sequences and processes in order to prove all assembly jigs fixtures and tooling and identify any manufacturing or design related problems associated with the assembly task, or functionality of the completed assembled. This procedure complements the First Article Inspection (SPP-315) process of components. 2. SCOPE This procedure shall be applied to selected assembly operations carried out in both Downer EDI Rail’s manufacturing facilities and those of its suppliers. The scope of the FAV includes assessing any difficulties or quality issues associated with performing and reliably repeating the assembly task, the functionality and conformance to specification of the completed assembly together with an assessment of any potential impacts on system RAMS. The assembly process shall be conducted utilising actual production personnel, equipment and process. This procedure applies to assemblies produced internally within Downer EDI Rail and / or externally by outside subcontractors. 3. REFERENCES Downer EDI Rail Management System Manual SPP-050 Job Safety Analysis SPP-209 Engineering Change Control SPP-217 Failure Modes, Effect and Criticality Analysis SPP-218 Hazard Identification & Control – Rail Safety Management SPP-307 Control of Nonconforming Product SPP-315 First Article Inspection SPP-319 Inspection and Testing SPP-329 Process Failure Modes and Effects Analysis CWI-3301 Clyman NCR Register 4. DEFINITIONS Bill of Material (BOM) – the list of parts that outlines the components and extent of an assembly. First Assembly - a sample of one or more assemblies representing the first output from the production tooling or supplier’s manufacturing process for a new product, new process, and new manufacturing location or associated with an engineering design change. First Assembly Validation (FAV) – an assessment conducted by Downer EDI Rail representatives to review first off assemblies with regards to assessing any difficulties or quality or safety issues associated with performing and reliably repeating the assembly task, the functionality and conformance to specification of the completed assembly and any potential impact on system RAMS. RAMS – is an abbreviation for Reliability, Availability, Maintainability and Safety. FAV team – representatives from each department required to conduct the FAV and sign off the FAV results. Category – aspect of the assessment to which FAV on an assembly is conducted. As minimum, the assembly shall be assessed with regards to the ability to perform the assembly task in a reliable, repeatable and safe manner and to ensure the specified functional and RAMS requirements are met as set out in the First Assembly Validation Checklist (Form:SPP3181). Manufacturing Manager – means Executive Manager (Operations), Facility Manager, Production Manager or Train Manufacturing Manager (PPP) or their delegates. Rating – the following rating is used for FAV - NA – Not Applicable, A - adequate, RA – adequate with recommendations, IA – inadequate. OIL (Open Issue List) – list of issues identified during the First Assembly Validation (FAV). Approval – an approval of the first off assembly by FAV team for its conformance to specified requirements and for release into production. 5. PROCESS FLOW CHART The flowchart in Appendix 1 outlines the part approval process with required inputs, outputs and responsibilities. 6. PROCESS & RESPONSIBILITIES 6.1 Need for FAV Identified 6.1.1 The need to conduct a FAV shall be identified via a risk assessment process. Prior to release to standard production control, first off assemblies that have been identified as requiring assembly validation shall be reviewed on the designated production line, under standard production conditions and controls in order to determine if any deviations, concerns or risks exist with the design, functionality, assembly processes, jigs fixtures and tooling etc. 6.1.2 It is not necessary for all assemblies or stages of assembly to be reviewed. The extent of the assemblies that need to be validated using this FAV process shall be established by the relevant Site Quality Officer / Manager and the associated Manufacturing Manager. This shall be done with reference to appropriate risk assessment and control processes and associated documentation. These shall include but shall not be limited to: Job Safety Analysis (SPP-050), Failure Modes, Effect and Criticality Analysis (SPP-217), Hazard Identification & Control – Rail Safety Management (SPP-218), Process Failure Modes and Effects Analysis (SPP-329), Inspection & Test Plans (SPP-319), etc. 6.1.3 Where build to print assembly activities have been subcontracted out, the assemblies that are to be subjected to FAV and the associated FAV requirements shall be defined by the Manufacturing Manager and Quality Assurance Officer / Manager with the support of Engineering & Manufacturing functions as specified in this SPP and First Article Inspection (SPP-315). 6.2 Planning for FAV 6.2.1 The Manufacturing Manager in conjunction with the Project Manager shall develop a Master FAV Programme for the relevant Project / Contract based on the project program, production schedule and the Bill of Material (BOM). The Program shall identify those assemblies that require a FAV review and approval, the number of assemblies for each FAV, the target dates, estimated duration, minimum participants (FAV team) and any input documentation needed for the execution of the FAV’s. The FAV Program shall be developed in conjunction with Design Engineering, Manufacturing Engineering, Production, Procurement, Quality Assurance and representation from Downer EDI Rail’s Maintenance / Through Life Support teams where applicable. The master FAV Program shall be reviewed and authorised by the Manufacturing Manager and the Project Manager. 6.2.2 The FAV team shall be nominated by each Department involved in the FAV (Engineering, Manufacturing, Procurement, Quality, Maintenance / Through Life Support and suppliers as required). 6.2.3 The Manufacturing Manager, together with the site Quality Officer / Manager, shall communicate the FAV program, target dates and estimated duration of FAV’s to the FAV team as well as to the Train Design Manager, Systems Assurance Manager & Project Manager. 6.2.4 As part of the FAV Program, the First Assembly Validation Checklist (Form:SPP3181) shall be used which defines the relevant aspects, characteristics and risks to be checked / assessed during the FAV review process. The relevant aspects to be assessed during the FAV process shall include, but shall not be limited to: determining the suitability of any proposed process control(s), assessing any quality and conformance related issues associated with the assembly or process, evaluating the ease of assembly including ergonomic and worker safety considerations, assessing the likelihood that the assembly process can be repeated reliably and consistently, evaluating the suitability and adequacy of any jigs, fixtures or tooling required to perform the assembly task, evaluation of procurement and material supply approach used (eg: adequacy of packaging, kitting etc), ensuring the design and functional requirements associated with the assembly meet the identified specification and RAMS contract compliance requirements. 6.3 Implementation of FAV Program 6.3.1 The site’s Production Manager, or representative, where the assembly process shall occur, shall be responsible for planning and preparing the FAV on the production line. In general, this assessment shall be planned in a manner to allow for the assessment / review to cover major assemblies at one review, or as few assessment sessions as possible. Any issues and observations found during the FAV review shall be recorded on the First Assembly Validation Checklist (Form:SPP3181). 6.3.2 The FAV shall be carried out in an environment that enables a thorough review of all the applicable criteria as defined by the First Assembly Validation Checklist (Form:SPP3181). The following requirements shall be met before the FAV takes place; a) the planned production line or work station set up shall be available (i.e. the production line shall be fully representative of future production conditions); b) all required development sub-assemblies and components have been completed, and a number of serial production sub-assemblies and components as specified by the FAV Program, have been assembled by the production team and are available to be assembled / mounted in a representative environment of serial production; c) the FAV team shall review the FAI status of those components with the planned FAV event and determine the impact on the integrity of the FAV evaluation: d) the FAV team members have reviewed their relevant section of the First Assembly Validation Checklist (Form:SPP3181) and amended it as necessary to depict all required checks for the assemblies to be assessed / reviewed; e) the FAV team has reviewed the scope of work to be met so as to enable a quick understanding of any deviations identified. 6.3.3 The FAV process is a review of an assembly operation from all its aspects. The FAV shall be based on a structured review approach supported by the First Assembly Validation Checklist (Form:SPP3181) comprising all reviewing aspects. Each reviewed aspect shall be represented by a relevant stakeholder participating in the FAV on the production line. The following aspects as a minimum shall be included in the FAV: ( Engineering (drawing revisions, ECR’s, EI’s, critical dimensions, etc.) ( Procurement (conditioning of parts on production line, kitting, storage controls, packaging, etc) ( Manufacturing (standard time targets, tooling, integration process, OH&S issues, special process requirements, Work Instructions, BOM, workplace organization, etc) ( Quality (ITP, acceptance criteria, capability & repeatability, etc) ( RAMS representative (accessibility for maintenance) 6.4 Review of FAV Results and Issue Resolution 6.4.1 A review of the results of the FAV shall be coordinated by the Site Quality Officer / Manager. Each FAV review shall generate an Open Issue List (OIL) with actions defined for each concern raised, (the action owner being the representative of the relevant concern raised during the FAV review. The Site Quality Officer / Manager shall manage the Open Issue List (OIL) and maintain the current status of the Open Item List as necessary. 6.4.2 The issue resolution process shall be driven by the Manufacturing Manager or representative. If defined actions on the Open Issue List (OIL) are not closed within the stipulated timeframe the Manufacturing Manager shall escalate these issues to a higher level of management for actioning and review. 6.4.3 The issues identified during the FAV process may generate NCR’s / ECR’s and EI’s. All ECR’s and EI’s raised in this process shall be managed as per Engineering Change Control (SPP-209). 6.5 Approval for Release of the First Assembly to Continue in Manufacturing 6.5.1 If there are no issues identified during the FAV the Site Quality Officer/ Manager shall coordinate the formal sign off of the First Assembly Validation Checklist (Form:SPP3181). 6.5.2 If any issues have been identified during the FAV and are on the OIL, the Manufacturing Manager shall liaise with the Site Quality Officer / Manager and relevant staff to resolve these issues. These issues shall be then resolved or concessions as per Control of Nonconforming Product (SPP-307) and Engineering Change Control (SPP-209) shall be approved accordingly. The Site Quality Officer / Manager shall be responsible for the final verification of these issues and arranging for the final sign off of the First Assembly Validation Checklist (Form:SPP3181) and release of the assembly to continued manufacturing. 6.5.3 In some circumstances, these may be a list of FAV open issues which can not be closed before the start of manufacture but do not require ECR’s / EI’s and are minor and can be resolved at a later stage (eg. not all tools have been entered into the calibration register at the time of FAV but this shall be completed on the agreed later date). The site Quality Officer / Manager shall obtain a sign off from the Manufacturing Manager to maintain these issues on the OIL for further resolution and follow up on the agreed date. In this case where assemblies are moved into the next stage of the assembly process, a non-conformance shall be raised in the Clyman system for the issue and an ORANGE Positive Recall Tag (Form:SPP3135) shall be attached to the assembly until the issue is resolved and the NCR can subsequently be closed. (Refer Control of Nonconforming Product (SPP-307) and Clyman NCR Register (CWI-3301)). 7. DOCUMENTATION Form:SPP3135 ORANGE Positive Recall Tag Form:SPP3181 First Assembly Validation Checklist 8. APPROVAL J. Rzetelski M. Camp Executive Manager Quality Executive General Manager Manufacturing APPENDIX 1 – Flowchart SPP-318 Rev - Date: 27.04.2009 Page 5 of 5 _1302521288.vsd Develop Master FAV Program FAV Program Need for FAV identified PROCESS OUTPUTS / RESP INPUTS / RESP Manufacturing Manager Manufacturing Manager Manufacturing Manager Manufacturing Manager Implement FAV Program FAV team - production schedule - BOM Manufacturing Manager - Assemblies - FAV Program - FAV team - FAI Approval for required parts - ITP Approval Production Manager Hold FAV review with the FAV team First Assembly Validation Checklist (Form:SPP3181) Site Quality Officer / Manager Site Quality Officer / Manager / FAV team Completed checklist / results, FAV team Any issues? Record issues in the Open Item List (OIL) Yes No Close off minor outstanding issues from OIL as necessary Drive the issue resolution with all relevant staff Up-date the Open Item List (OIL) Open Item List (OIL) Site Quality Officer / Manager Site Quality Officer / Manager Site Quality Officer / Manager / FAV team Site Quality Officer / Manager Issues resolved or concession approved?? Yes No Completed checklist / results Concessions required to resolve issues? Site Quality Officer / Manager Issues as per OIL Yes Issues as per OIL Complete FAV Sign Off No Issues as per OIL Release of first assembly to continue manufacturing Signed off checklist Manufacturing Manager / Site Quality Officer / Manager Site Quality Officer / Manager Finalised checklist Site Quality Officer / Manager Continue to review FAV Program Completed checklist/ results FAV team Signed off checklist Approved Concessions Issues as per OIL Up-date the Open Item List (OIL) Site Quality Officer / Manager Site Quality Officer / Manager Control of Nonconforming Product (SPP-307)