A "risk management process" describes how a company management addresses risks with their products. It describes responsibilities and functions and the process of risks, hazards and incidents. The "risk assessment" describes the process of determining risk of a device. Techniques for risk assessment are Top-down and bottom-up analysis and FMEA .
Some facts I learned: 1. No risk assessment process will tell you what risks are acceptable or not. 2. The risk assessment will document all risks/aspects you have considered, and if carried out probably allows you to conclude that you did not overlook something: the most important conclusion. 3. Techniques as FMEA allow you to rank risks in order of relevance, so as to cope with highest risks first. 3b. The order is created by multiplying chance , severity and detectability into a arbitrary risk value. 3c. There are not much conventions in valuing those 3 factors and applying numeric values to them. Each analysis is engineer specific. Only the ranking is an objective result. 4. This ranking allows the risk management engineer to define a arbitrary risk threshold value above what any risk needs to be fixed. 5. The result of the full process is a "remaining risks list" that can be addressed in educating your customers. (don't dry the cat in the microwave) If you take a machine directive standard such as the 60204 you can clearly see how risk enabled standards interact with the risk management process. Regards, Ing. Gert Gremmen Approvals manager ------------------------------------------------------------------------------------ + ce marking of electrical/electronic equipment + Independent Consultancy Services + Compliance Testing and Design for CE marking according to EC-directives: - Electro Magnetic Compatibility 2004/108/EC - Electrical Safety 2006/95/EC - Medical Devices 93/42/EC - Radio & Telecommunication Terminal Equipment 99/5/EC + Improvement of Product Quality and Reliability testing + Education Web: www.cetest.nl (English) Phone : +31 10 415 24 26 ------------------------------------------------------------------- This e-mail and any attachments thereto may contain information that is confidential and/or protected by intellectual property rights and are intended for the sole use of the recipient(s) named above. Any use of the information contained herein (including, but not limited to, total or partial reproduction, communication or distribution in any form) by persons other than the designated recipient(s) is prohibited. If you have received this e-mail in error, please notify the sender either by telephone or by e-mail and delete the material from any computer. Thank you for your co-operation. From: Nick Williams [mailto:[email protected]] Sent: Friday 1 April 2016 00:03 To: [email protected] Subject: Re: [PSES] EU's new approach directive transitions David, The risk assessment you refer to below is not same as the risk assessment referred to in the new LVD (and some other NLF directives). The risk assessment below is specifically aimed at determining whether or not the product presents a risk which is sufficient to warrant post market action, and in particular whether or not a product recall is necessary. This is obviously related to the product design risk assessment which is required before placing the product on the market, but it is not the same thing. Nick. On 31 Mar 2016, at 22:09, David K Bell <[email protected]> wrote: Scott, With regard to the risk assessment requirement in the Directives revised under the New Legislative Framework (NLF): This excerpt is from a discussion of the proposed EU Consumer Product Safety Regulation (CPSR): The European Commission will undertake a risk analysis of the product to determine whether the product is likely to pose a 'serious' risk. The default risk analysis methodology to be used is the already established EU Risk Assessment Methodology (Decision 2010/15/EU), by which products can be assessed and classified as posing a 'Low', 'Medium', 'High' or 'Serious' risk. If this risk assessment methodology is not appropriate for the particular product, the Commission must give a detailed description of the methodology used in its place. Appendix 5 of Decision 2010/15/EU on pages 33—64 covers Risk Assessment. This is the methodology that a EU enforcement body would use to determine if a product poses a serious risk and should therefore be withdrawn from the market and notified to other EU member states via the EU RAPEX rapid alert system. Any risk analysis that we do to satisfy the requirements of the new LV and EMC Directives should be no less rigorous. Best regards, David K. Bell Senior Regulatory Compliance Engineer Milestone AV Technologies [email protected] +1.952.225.6782 On Thu, Mar 31, 2016 at 11:35 AM, Scott Xe <[email protected]> wrote: There are two major changes in new LVD. One is the risk assessment that is to be the obligation for the manufacturers. The other one is that the DoC is required to have object of declaration. The risk assessment is unclear how to do it and any reference to follow. Currently there is few testing laboratories to provide such service to the manufacturers. Hope there is harmonised standard and/or guidance for compliance in near future. Scott On 31 Mar, 2016, at 1:50 am, Ronald Pickard <[email protected]> wrote: Hi Charlie, Thank you for your reply along with those linked references. Those ETSI links provide projected target dates for approval and availability for the new/revised standards being drafted for the RED, which are generally targeted to be complete by the 13-Jun-2017 effectivity date for the RED. Kudos to ETSI for that work. Best regards, Ron Pickard Regulatory Compliance Engineer Compound Photonics D | +1 (602) 883-8039 From: Charlie Blackham [mailto:[email protected]] Sent: Tuesday, March 29, 2016 11:34 PM To: Ronald Pickard <[email protected]>; [email protected] Subject: RE: EU's new approach directive transitions Ron Few short answers: • No sign of that happening at all and I cannot see it happening • No, existing Directives are repealed by the new Directives on the dates indicated, but you may wish to look at Recommended format for DoC that can reference existing and new Directives,http://ec.europa.eu/DocsRoom/documents/14886/attachments/1/translations/en/renditions/native (referenced from http://ec.europa.eu/growth/sectors/electrical-engineering/emc-directive/index_en.htm ) • ETSI are working hard on updating over 150 standards, some more information available: o https://docbox.etsi.org/Workshop/2015/201511_RED-WORKSHOP/ for presentations from November workshop o Work program on radio standards: http://webapp.etsi.org/ena/cvp.asp?search=RADIO and a number of RED standards have a been published or are available as final draft o Work program on EMC standards: http://webapp.etsi.org/ena/cvp.asp?Search=emc&Status=&Directive=&submit1=Get+Work+Items • Lists of HS for current standards can be used for new Directives until new lists are published as per relevant article in the directive such as article 27 of the 2014/35/EU LVD. • So far I’m aware of: o LVD guidance on transition to new LVD,http://ec.europa.eu/DocsRoom/documents/13141/attachments/1/translations/en/renditions/native available athttp://ec.europa.eu/growth/sectors/electrical-engineering/lvd-directive/index_en.htm o RED guidance is being worked on, but RED is not mandatory until 2017 so there is more time for this. http://ec.europa.eu/DocsRoom/documents/11983/attachments/1/translations/en/renditions/pdf provides guidance on transitions for equipment moving into and out of R&TTE/RED. • No one is expecting anything. Regards Charlie Charlie Blackham Sulis Consultants Ltd Tel: +44 (0)7946 624317 LinkedIn: uk.linkedin.com/in/charlieblackham/ Web: www.sulisconsultants.com Registered in England and Wales, number 05466247 From: Ronald Pickard [mailto:[email protected]] Sent: 29 March 2016 23:46 To: [email protected] Subject: [PSES] EU's new approach directive transitions Hi to all, and especially to those that are knowledgeable of the EU’s processes on this subject, I know that this subject has been discussed before without resolution, but the time is nearing the end of the transition periods of the EU’s new EMC, LV and RE directives and I (I’m guessing I’m not alone) was wondering if anyone knows what the EU intends to do when these directives reach beyond their respective transition periods with no listed harmonized standards? - Will the directives’ transition dates be extended? - Will a presumption of conformity continue to exist to the repealed directives after the transition period? - What is ETSI’s timeline to revise its harmonized standards to reflect these new directives? - Will harmonized standards under the current respective directives continue to be utilized under the new directives (probable)? - Is there any EU guidance that addresses the above questions? If so, please provide a link(s). - Will the EU pull a rabbit out of its hat at the last moment? Can anyone shed any light on this? I look forward to your reply. Best regards, Ron Pickard Regulatory Compliance Engineer Compound Photonics D | +1 (602) 883-8039 - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. 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