IRIS International Railway Industry Standard - SIRTS

1 1 iris International Railway Industry StandardA Quality Standard for the Railway industryANIE - ASSIFER information sessionMilan, 11th July 2006 Giuseppe GrecoUNIFEIRIS iris -- International Railway Industry StandardInternational Railway Industry Standard2 What is iris ? iris stands for International Railway Industry Standard . iris aims at developing and implementing a common global systemfor the evaluation of Business Management Systems specific to the Railway Industry , including: One internationally recognized Standard based on the key principles of ISO 9001 and specific to the Railway Industry ; One harmonized evaluation process to be performed by approved certification bodies; A web-based iris Portal (common database) and Audit-Tool (software).2 iris iris -- International Railway Industry StandardInternational Railway Industry Standard3 Why iris ?

2 Operators have complained about the quality of some Rolling Stock and requested to improve the quality of the Supply Chain. Railway equipment manufacturers have complained about the number of different requirements and audits from Rolling Stock Manufacturers and requested is an answer to these requestsIRIS iris -- International Railway Industry StandardInternational Railway Industry Standard4 The Challenge The goal of iris is to improve the quality of the Railway Industry supply chain. The systems aims at a global recognition and acceptance of audit results, the avoidance of multiple auditing and therefore increased cost efficiency. Audit records and audit results will be collected and stored in a central database. iris will enable high quality in iris -- International Railway Industry StandardInternational Railway Industry Standard5 The Guiding principles The development of the Standard is transparentand involve all market participants via UNIFE.

3 The Standard is owned and managed by UNIFE (ensure independency). Audit results are traced confidentiallyand published only with allowance of the Audit Client. Rules for protection of data privacy will be followed. Approval of certification bodies isfair and iris -- International Railway Industry StandardInternational Railway Industry Standard6 Benefits Improved product quality & supply chain efficiency. Reduction of effort and cost. More accurate and reliable Information about suppliers to the Railway Industry . Fair evaluation by independent certification s a win - win situationfor all those concerned 4 iris iris -- International Railway Industry StandardInternational Railway Industry Standard7 The Standard (1/3) Is based on the ISO 9001 Structure. iris adds a layer, which contains Railway specific requirements for the Business Management System, Project Management, Design, iris contains: Mandatory requirements with Shall wording.

4 Optional requirements with Should wording. Some requirements are KnockOut iris -- International Railway Industry StandardInternational Railway Industry and Management General Requirements Documentation Requirements Knowledge managementKnowledge Management of multi sites Management of multi sites Management , authority & Provision of Human EnvironmentThe Standard (2/3)5 iris iris -- International Railway Industry StandardInternational Railway Industry related ManagementTender ManagementProject & ManagementConfiguration Production & Service provision / Customer Commissioning / Customer / LCCRAMS / of monitoring & measuring , analysis and and of nonconforming products of nonconforming Control of nonconforming of data Standard (3/3) iris iris -- International Railway Industry StandardInternational Railway Industry Standard10 Evaluation methodology Audit results are scored, its not a fail/pass system Questionnaire has 253 questions.

5 - 111 questions relative to ISO Requirements- 142 questions relative to iris Requirements 10 questions, not scored, fulfilment mandatory 32 Closed questions Yes/No question 211 Open questions scored using maturity levels Threshold Section score 50% of maximum possible score Global score 50% of maximum possible score6 iris iris -- International Railway Industry StandardInternational Railway Industry Standard11 What makes the difference to ISO?1. additional Railway specific requirements, such as Knowledge management Management of multi sites projects Requirements management Competences, awareness and training Infrastructure management Tender management Integration management Scope management Time management Cost management Communication management Risk and opportunity management Change management First article inspection Configuration management Outsourcing (Make or Buy) Supply chain management Commissioning / Customer service RAMS / LCC Control of nonconforming processes.

6 iris iris -- International Railway Industry StandardInternational Railway Industry Standard122a. Assessment m anagem entKnock-Out & processDo es t he o r g anizat io n imp lement a p r o ject manag ement ( PM ) or new product development process addressing the applicable areas of PM , describing roles and responsibilities, integrating the whole functions of the organisation in a multidisciplinary team? DeThe o r g ani zat i o n has defined criteria for p r o ject / no n- p r o ject s business including appropriate procedures. New product development has to be r un as p r o ject . Pr o ject s have def ined roles and responsibilities for the act o r s; int eg r at ing t he who le f unct io ns QUESTION 13 procedures to be documented (ISO 9001: 6) 19 processes required (ISO 9001: 3)What makes the difference to ISO?

7 7 iris iris -- International Railway Industry StandardInternational Railway Industry Standard132b. Maturity levels & scoring of points / max points Threshold (~ 50 % )OPEN QUESTIONCLOSED QUESTIONC lauseQue s tionPOOR (1 point)DEFINED(2 points)QUAL IFIED(3 points)OPTIM IZ ED(4 points) m anagem entHo w are r isks r elat ed t o t he p r o d uct r eview ed ? Do es t he organization has a multidisciplinary approach prior to commitment t o st art t he quot at ion process?- Pr o cess d ef ined and multi-disciplinary approach, prior to the submission of the q uo t at io n and r eco r d s maintainedPlus:- formal review and d ef ined p r o cess availab le- risks are continuously mo nit o r ed , up d at ed Plus:The ef f ect iveness o f t he risk assessment w as analysed o n a regular basisPlus:C o nt inuo us imp ro vement o f t he risk assessment process including toolsA s a minimum, ar e p r o ject / p r o d uct r eq uir ement s id ent if ied , co nt r o lled and valid at ed ?

8 Identification of r eq uir ement s as b ef o r e f o r mal valid at io n p ro cess- f o r mal ap p r o val p r o cessWhat makes the difference to ISO? iris iris -- International Railway Industry StandardInternational Railway Industry Standard14 What makes the difference to ISO?3. Corrective or improvement actionsConcluding the answers of each individual requirement (question)there might be corrective or improvement actions required. Therefore the following scheme shall be applied:Actions requested Compliance Level Pointsopen question closed question optimized 4 no specific action expected qualified 3 improvement action might be expected Compliant defined 2 improvement action requested; to be closed within 12 months no specific action expected poor 1 corrective action requested; to be closed within 90 days Non Compliant insufficient 0 corrective action requested; to be re-audited within 90 days corrective action requested; to be re-audited within 90 days 8 iris iris -- International Railway Industry StandardInternational Railway Industry Standard15 What makes the difference to ISO?

9 4. Compensative and rewarding approachOnce certified, the client has to undertake so-called surveillance audits on a regular basis, however a minimum of once per compensative and rewarding approach will apply for audited organizations with a global score of 75%: iris requirements main clauses scoring individually 80% - will not be audited during surveillance audits - will be dealt with only during the re-certification process (after 3 years) iris requirements main clauses scoring individually between 75% and 80% - will be partially audited with the purpose to improve the related processes and achieve 80% iris -- International Railway Industry StandardInternational Railway Industry Standard16 What makes the difference to ISO?5. Requirements to auditors (experiences/examination) Auditors shall comply with ISO 19011 Auditing Experience:Auditors shall have participated in at least 4 certification audits or for a minimum of 20 audit days covering all the requirements of ISO 9001 within the last 4 years.

10 Work Experience:After the implementation phase, new iris auditors shall have a minimum of 3 years Railway Industry experience in the last 10 years. Railway Certification:Auditors shall have passed the iris training and examination. Communications skillsBasic English & local iris -- International Railway Industry StandardInternational Railway Industry Standard17 What makes the difference to ISO?6. Certification Body may only carry out audits in the areas of the particular Railway equipment in which its Auditors are Passenger Information Systems 1 Car body11 Communication systems2 Car body fittings12 Cabling and Cabinets3 Guidance (Bogies and running gear)13 Door System4 Power System14 HVAC5 Propulsion15 Tilt System6 Auxiliary systems16 Lighting7 Braking System17 Coupler8 Interiors9 On board vehicle controlFirst levelIRIS iris -- International Railway Industry StandardInternational Railway Industry Standard18 What makes the difference to ISO?