Re: [SystemSafety] "Serious risks" in EC 765/2008

From: Braband, Jens < >
Date: Mon, 8 Apr 2013 16:44:15 +0200

I think the EU directive 352/2009 has more to offer than the dictionary definition (at least compared to 765/2008)

"When the proposed change has an impact on safety, the proposer shall decide, by expert judgement, the significance of the change based on the following criteria:

(a) failure consequence: credible worst-case scenario in the event of failure of the system under assessment, taking into account the existence of safety barriers outside the system;

(b) novelty used in implementing the change: this concerns both what is innovative in the railway sector, and what is new just for the organisation implementing the change;

(c) complexity of the change;

(d) monitoring: the inability to monitor the implemented change throughout the system life-cycle and take appro-priate interventions;

(e) reversibility: the inability to revert to the system before the change;

(f) additionality: assessment of the significance of the change taking into account all recent safety-related modifications to the system under assessment and which were not judged as significant.

The proposer shall keep adequate documentation to justify his decision. " 

It should also be noted that several stakeholders e. g. ORR in UK, DB in Germany have developed guidance which gives a more pragmatic interpretation of this definition. So these stakeholders seem to know how to interprete the legal text.

PS Note that this expresses my personal opinion, not neccessarily that of my employer.

Best regards

Jens Braband

Siemens AG
Infrastructure & Cities Sector
Mobility and Logistics Division
Rail Automation
Ackerstr. 22
38126 Braunschweig, Deutschland

Gesendet: Montag, 8. April 2013 14:24
An: Thierry.Coq_at_xxxxxx
Cc: systemsafety_at_xxxxxx Betreff: Re: [SystemSafety] "Serious risks" in EC 765/2008

There is probably as much chance of finding a definition of "serious risk" in the IEC standards as there is in defining what a "significant change" is in the European Railway Authority, Common Safety Method!



Peter Sheppard
Senior Safety Engineer and Validator

Mobile: +44 7920 247931

Please consider the environment before you print / Merci de penser à l'environnement avant d'imprimer / Bitte denken Sie an die Umwelt bevor Sie drucken

Bombardier Transportation UK Ltd
Registered Office: Litchurch Lane, Derby, DE24 8AD, England TEL +44 1332 344666, FAX +44 1332 266271 Registered in England
Registration No. 2235994

Sent by: systemsafety-bounces_at_xxxxxx 08/04/2013 11:03
<systemsafety_at_xxxxxx cc
[SystemSafety] "Serious risks" in EC 765/2008


In EC 765/2008, what is considered a "serious risk"? Is there a reference? How are the "serious risk" mitigations assessed, especially when "The feasibility of obtaining higher levels of safety or the availability of other products presenting a lesser degree of risk shall not constitute grounds for considering that a product presents a serious risk."? This standard also mandates that the product should be recalled when the serious risk has materialized... and there is wording here to update the risk assessment with field reports. So is a "serious risk" in this standard in fact a materialized danger...?

Thanks for comments.
Best regards,
Thierry Coq
DNV -----Original Message-----
From: systemsafety-bounces_at_xxxxxx Sent: 07 April 2013 10:46
To: systemsafety_at_xxxxxx Subject: [SystemSafety] Solar Storms and Charging Procedures for Electric Cars


I am running a group producing a risk analysis (in the sense of IEC Guide 51) of the charging process for electric road vehicles. There was and is stiff resistance from some quarters. I have pointed out that, first, IEC Guide 51 says that a risk assessment (compromising a risk analysis and risk evaluation) should be required in any safety-related IEC standard. Second that EC 765/2008 on product quality requires (Article 20) that products representing a serious risk be withdrawn from European markets, and that the judgment that products represent a serious risk be made through a risk assessment. This is European law. Since I have pointed that out in sufficiently general meetings, suggestions that the group's work is pointless have all but disappeared (although the will to limit its work has of course not, for this has other bases). <cut>

Prof. Peter Bernard Ladkin, University of Bielefeld and Causalis Limited _______________________________________________
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systemsafety_at_xxxxxx Received on Mon Apr 08 2013 - 16:44:24 CEST

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