Common Safety Method (CSM) for risk assessment (Regulations 352/2009 & 402/2013)

Transcription

1 Common Safety Method (CSM) for risk assessment (Regulations 352/2009 & 402/2013) inland transport of dangerous goods - Lille, 8-9 th October CSM.risk_assessment@era.europa.eu Slide n 1

2 Introduction Common safety instruments for opening railway market When opening the railway market, in order to: 1) Maintain at least the existing level of safety in the EU railways, and increase it when reasonably practicable 2) Create a basis for mutual trust with many new railway actors and interfaces It is necessary to set up a common approach for: Safety regulation (WHO does WHAT?) Safety management (Common Safety Methods) Safety supervision (check of compliance with the applicable legislation) Slide n 2

3 Introduction Impact of Directive 2004/49/EC on the EU railway system Historical railway situation: react and fix approach Existing national railway systems usually based on compliance with national rules and a retrospective review of «bad experiences» from the past. New and proactive approach: Predict and Prevent Directive 2004/49/EC introduces the obligation for RUs, IMs and ECMs to control and manage their risks through a Safety Management System and a Maintenance Management System. The concept of Risk Management requires to look both FORWARD and RETROSPECTIVE. In a risk based approach the key question is: «What are the likely risks and the risk control measures I should put in place to manage safely my business?» Slide n 3

4 History Risk Management Origins Mathematical instruments for the decision making process have been used already in the XVIII century by shipping insurance companies to assess risks. Since then the decision making process based on a probabilistic approach has become a modern tool for forecasting unwanted events, preventing them and ensuring financial benefits to the business. Domains of application Due to continuous refinement and improvement, the Risk Management has become a reliable instrument to perform business and to grant safety in the following domains: Finance, banking, capital investment Medicine Nuclear power Telecommunication Energy Aviation Railways Etc. Slide n 4

5 In many domains a gradual improvement of safety resulted from costly experiences and lessons learnt from accidents Prevention of similar events was regulated reactively (after the occurrence of such events) with the establishment of new national laws, codes of practice, rules or standards Event Reactive approach for risk management Reaction Changes in the legislation, rules, standards or codes of practice were done to avoid the repetition of a new occurrence of the same type of accident. This way of doing does not protect the system from other hazards than those that caused the accident Accidents are used to prevent same accidents Slide n 5

6 Modern and proactive approach for risk management A proactive safety management based on risks ensures, before the event actually occurs, that: Hazards are identified & Causes and Consequences (risks) are analysed Acceptable Risk Control Measures are defined and implemented to prevent the hazard and/or to protect from consequences Analysis Safety measures Event Competence and analysis are used to prevent accidents Slide n 6

7 Comparison of Proactive vs Reactive approaches Reactive approach Accidents are used to prevent same accidents Costly with high impact on the system and the society Unable to control unknown risks Proactive approach Competence and knowledge are used to control risks and then to prevent accidents No impact on the system and the society Can effectively prevent the occurrence of events Slide n 7

8 Risk Management is a logical and systematic method of identifying the hazards and analysing, treating and monitoring the associated risks involved in any activity or process of a company A definition of "Risk Management" Risks can be managed by: building your knowledge looking at the past (Reactive) using your competence and analyses techniques for foreseeing consequences of changes, actions, etc. (Proactive) Risk Management is based on the analysis of past events and probable events i.e. PAST & FUTURE A decision making process based on Risk Management allows the company to improve its efficiency, facilitating the allocation of resources, protecting the business from unexpected financial outcomes, due to sudden and unwanted/unplanned events Slide n 8

9 What is a HAZARD? Different between a hazard and a risk It is a source or situation or act with a potential for harm in terms of human injury or damage to environment or both (e.g. Toxic or flammable substances, electric energy, working at heights etc.) What is a RISK? Combination of the likelihood of an occurrence of a hazardous event and the severity of injury, damage to environment or damage to property that may be caused by the event Risk is the likelihood of harm resulting from a hazard Hazard is something that has a potential to cause harm or injury Slide n 9

10 System Relation between Hazard Risk Importance of the system The system has a relevant importance on the identification of the hazards. Something that could be hazardous in one context, could be totally innocuous in a different one. Slide n 10

11 Frequency Risk Parameters As shown, risk is typically described in two dimensions How often will an event occur? E.g. once per year, once every 10 years, every day Risk= Frequency x Severity Increasing Risk Severity of Consequence If the event does occur what could be the consequences? E.g. one person injured, damage, multiple fatalities Slide n 11

12 Basic principles for assessing the risk Independently on whether complex or simple, Risk Assessment follows a common 4 step process You 1 st identify hazards for each hazard you estimate risk by estimating frequency and severity you then evaluate acceptability of risk and prioritise If necessary you then take action to mitigate/control risk Identify Hazards Estimate Frequency Estimate Severity Estimate Risks Reduce Risks where required Slide n 12

13 Part of SMS Basic 5 Step Process Risk Assessment Regardless of type of business, activity or function of company, Risk Management is 7 step based process Defining context (System Definition) Risk Assessment Hazard/Risk Identification Risk Analysis Risk Evaluation A general overview on Risk Management - ISO Risk Control Risk is dynamic and subject to constant change, so Risk Management process includes continuous Risk Monitoring and Review Communication with and consult staff on company and their activity risks System Definition Hazard/Risk Identification Risk Analysis Risk Evaluation Risk Control Risk Monitoring and Review Communicate and Consult on risks Slide n 13

14 Overview of the Common Safety Method (CSM) for Risk Assessment (Regulations 352/2009 & 402/2013) Slide n 14

15 Auth. for placing in service SMS Syst of Maint. Contracting Entity Applicant for an APIS Overview of existing Regulation N 352/2009 WHO shall apply the CSM? The proposer Art. 3(11) RU IM (a) (b) a railway undertaking or an infrastructure manager which implements risk control measures vs. Art. 4 of Directive 2004/49; an entity in charge of maintenance which implements measures in accordance with Article 14a(3) of Directive 2004/49; ECM Directive 2004/49 - Through RU/IM SMS & ECM Maintenance System (c) (d) a contracting entity or a manufacturer which invites a NOBO to apply the EC verification procedure in accordance with Article 18(1) of Directive 2008/57 or a designated body according to Article 17(3) of that Directive; an applicant for an authorisation for the placing in service of structural sub-systems [Manufacturer, RU or Keeper]; Directive 2008/57 - Authorisation for placing in service (APIS) Slide n 15

16 Overview of existing Regulation N 352/2009 WHEN shall the CSM be applied? WHEN? when making a significant change to railway system which can impose new risks on infrastructure or on operations: applied since 2010 for technical systems, applied since 2012 for operational or organisational Slide n 16

17 Overview of existing Regulation N 352/2009 Risk Management Process and Independent Assessment INDEPENDENT ASSESSMENT HAZARD MANAGEMENT CSM for RA is an iterative process defining: A common risk assessment process (a) System definition (b) Identification of hazards/risks & associated safety measures (c) Risk analysis based on exiting risk acceptance principles (d) Risk evaluation for checking acceptance of risk(s) (e) Definition of safety requirements from identified safety measures Demonstration of system compliance with identified safety requirements Requirements for mutual recognition: (a) Hazard Management (b) Independent Assessment (Body) Preliminary System Definition Codes of Practice Significant Change? SYSTEM DEFINITION RISK ASSESSMENT RISK ANALYSIS HAZARD IDENTIFICATION AND CLASSIFICATION Similar Reference Systems Explicit Risk Estimation RISK EVALUATION (vs. Risk Acceptance Criteria) Safety Requirements (i.e. safety measures to be implemented) Demonstration of Compliance with Safety Requirements Iterative Risk Management Process triggered by a Significant Change Slide n 17

18 Most important concepts to remember about hazards & risks What can go wrong? Hazard Frequency How likely is it to happen? Severity What are the impacts or consequences? What is the level of risk? Manage the risk Risk = Hazard Frequency x Hazard Severity Do not forget that risk management includes control but also monitoring of risks, as well as communicating these risks Slide n 18

19 Why giving importance to Risk Management and Risk Assessment? (1/2) All domains of industry and social life consider "risk" as "source of danger" and a possibility to face damage or accident for their company with financial consequences Risk is understood as potential for damage linked to company activities that can result from current company organisation, current processes and mode of operation of the company, technical systems or from any future events Risk Management is a formal tool to identify and prevent the cause of damage or accident to occur or to reduce the consequences if the occurrence cannot be avoided Slide n 19

20 IMPORTANT Why giving importance to Risk Management and Risk Assessment? (2/2) Risk assessment is a means to an end, not an end in itself. The aim is to keep people safe, not have good paperwork The risk analysis process depends on the experience, knowledge, imagination, creativity and integrity of the individuals doing the analysis. The only application of these techniques without appropriately talented/competent staff does not ensure a proper and thorough risk analysis result. The most important step in any risk assessment is that hazards can only be controlled if they are identified You must not say never. Risk assessment predicts probabilities. Although a particular event may be infinitesimally improbable, the probability is always greater than zero. Slide n 20

21 Send an to Many thanks for your attention! Slide n 21