Yess, Google is our friend, but in an explanation, all abbreviations should be spelled-out when first used. It's a matter of courtesy.
With best wishes OOO – Own Opinions Only www.jmwa.demon.co.uk J M Woodgate and Associates Rayleigh England > -----Original Message----- > From: ce-test, qualified testing bv - Gert Gremmen > [mailto:g.grem...@cetest.nl] > Sent: Friday, April 1, 2016 8:40 AM > To: John Woodgate <jmw1...@btinternet.com> > Cc: EMC-PSTC@LISTSERV.IEEE.ORG > Subject: [SPAM] RE: [PSES] EU's new approach directive transitions > > FMEA: Failure Mode and Effect Analysis > And Google is your friend.... thousands of examples and graphs available. > > > 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. > > -----Original Message----- > From: John Woodgate [mailto:jmw1...@btinternet.com] > Sent: Friday 1 April 2016 09:30 > To: ce-test, qualified testing bv - Gert Gremmen > Subject: RE: [PSES] EU's new approach directive transitions > > A good explanation, but people not experts in the field want to know what > 'FMEA' > is, please. > > With best wishes OOO – Own Opinions Only www.jmwa.demon.co.uk J M > Woodgate and Associates Rayleigh England > > > > -----Original Message----- > > From: ce-test, qualified testing bv - Gert Gremmen > > [mailto:g.grem...@cetest.nl] > > Sent: Friday, April 1, 2016 7:00 AM > > To: EMC-PSTC@LISTSERV.IEEE.ORG > > Subject: Re: [PSES] EU's new approach directive transitions > > > > 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:nick.willi...@conformance.co.uk] > > Sent: Friday 1 April 2016 00:03 > > To: EMC-PSTC@LISTSERV.IEEE.ORG > > 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 <davidkbell...@gmail.com> 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 > > david.b...@milestone.com > > +1.952.225.6782 > > > > > > On Thu, Mar 31, 2016 at 11:35 AM, Scott Xe <scott...@gmail.com> 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 > > <ronald.pick...@compoundphotonics.com> 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:char...@sulisconsultants.com] > > Sent: Tuesday, March 29, 2016 11:34 PM > > To: Ronald Pickard <ronald.pick...@compoundphotonics.com>; EMC- > > p...@listserv.ieee.org > > 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/ > > translati ons/en/renditions/native (referenced from > > http://ec.europa.eu/growth/sectors/electri > > cal-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=&s > > ubmit1=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/transla > > tions/e n/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/translation > > s/e n/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:ronald.pick...@compoundphotonics.com] > > Sent: 29 March 2016 23:46 > > To: EMC-PSTC@LISTSERV.IEEE.ORG > > 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. To post a message to the list, send your > > e-mail to <emc- p...@ieee.org> All emc-pstc postings are archived and > > searchable on the web at: http://www.ieee- pses.org/emc-pstc.html > > Attachments are not permitted but the IEEE PSES Online Communities > > site at http://product-compliance.oc.ieee.org/ can be used for > > graphics (in well-used formats), large files, etc. > > Website: http://www.ieee-pses.org/ > > Instructions: http://www.ieee-pses.org/list.html (including how to > > unsubscribe) List rules: http://www.ieee-pses.org/listrules.html > > For help, send mail to the list administrators: > > Scott Douglas <sdoug...@ieee.org> > > Mike Cantwell <mcantw...@ieee.org> > > For policy questions, send mail to: > > Jim Bacher <j.bac...@ieee.org> > > David Heald <dhe...@gmail.com> > > - > > ---------------------------------------------------------------- > > > > This message is from the IEEE Product Safety Engineering Society > > emc-pstc discussion list. To post a message to the list, send your > > e-mail to <emc- p...@ieee.org> All emc-pstc postings are archived and > > searchable on the web at: http://www.ieee- pses.org/emc-pstc.html > > Attachments are not permitted but the IEEE PSES Online Communities > > site at http://product-compliance.oc.ieee.org/ can be used for > > graphics (in well-used formats), large files, etc. > > Website: http://www.ieee-pses.org/ > > Instructions: http://www.ieee-pses.org/list.html (including how to > > unsubscribe) List rules: http://www.ieee-pses.org/listrules.html > > For help, send mail to the list administrators: > > Scott Douglas <sdoug...@ieee.org> > > Mike Cantwell <mcantw...@ieee.org> > > For policy questions, send mail to: > > Jim Bacher <j.bac...@ieee.org> > > David Heald <dhe...@gmail.com> > > > > - > > ---------------------------------------------------------------- > > This message is from the IEEE Product Safety Engineering Society > > emc-pstc discussion list. To post a message to the list, send your > > e-mail to <emc- p...@ieee.org> All emc-pstc postings are > > archived and searchable on the web at: http://www.ieee- > > pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES > > Online Communities site at http://product-compliance.oc.ieee.org/ can > > be used for graphics (in well-used formats), large files, etc. > > Website: http://www.ieee-pses.org/ > > Instructions: http://www.ieee-pses.org/list.html (including how to > > unsubscribe) List rules: http://www.ieee-pses.org/listrules.html > > For help, send mail to the list administrators: > > Scott Douglas <sdoug...@ieee.org> Mike Cantwell > > <mcantw...@ieee.org> For policy questions, send mail to: > > Jim Bacher <j.bac...@ieee.org> > > David Heald <dhe...@gmail.com> > > > > - > > ---------------------------------------------------------------- > > This message is from the IEEE Product Safety Engineering Society > > emc-pstc discussion list. To post a message to the list, send your > > e-mail to <emc- p...@ieee.org> All emc-pstc postings are archived and > > searchable on the web at: http://www.ieee- pses.org/emc-pstc.html > > Attachments are not permitted but the IEEE PSES Online Communities > > site at http://product-compliance.oc.ieee.org/ can be used for > > graphics (in well-used formats), large files, etc. > > Website: http://www.ieee-pses.org/ > > Instructions: http://www.ieee-pses.org/list.html (including how to > > unsubscribe) List rules: http://www.ieee-pses.org/listrules.html > > For help, send mail to the list administrators: > > Scott Douglas <sdoug...@ieee.org> > > Mike Cantwell <mcantw...@ieee.org> > > For policy questions, send mail to: > > Jim Bacher <j.bac...@ieee.org> > > David Heald <dhe...@gmail.com> > > > > - > > ---------------------------------------------------------------- > > This message is from the IEEE Product Safety Engineering Society > > emc-pstc discussion list. To post a message to the list, send your > > e-mail to <emc- p...@ieee.org> All emc-pstc postings are archived and > > searchable on the web at: http://www.ieee- pses.org/emc-pstc.html > > Attachments are not permitted but the IEEE PSES Online Communities > > site at http://product-compliance.oc.ieee.org/ can be used for > > graphics (in well-used formats), large files, etc. > > Website: http://www.ieee-pses.org/ > > Instructions: http://www.ieee-pses.org/list.html (including how to > > unsubscribe) List rules: http://www.ieee-pses.org/listrules.html > > For help, send mail to the list administrators: > > Scott Douglas <sdoug...@ieee.org> > > Mike Cantwell <mcantw...@ieee.org> > > For policy questions, send mail to: > > Jim Bacher <j.bac...@ieee.org> > > David Heald <dhe...@gmail.com> > > > > - > > ---------------------------------------------------------------- > > This message is from the IEEE Product Safety Engineering Society > > emc-pstc discussion list. To post a message to the list, send your > > e-mail to <emc- p...@ieee.org> > > > > All emc-pstc postings are archived and searchable on the web at: > > http://www.ieee-pses.org/emc-pstc.html > > > > Attachments are not permitted but the IEEE PSES Online Communities > > site at http://product-compliance.oc.ieee.org/ can be used for > > graphics (in well-used formats), large files, etc. > > > > Website: http://www.ieee-pses.org/ > > Instructions: http://www.ieee-pses.org/list.html (including how to > > unsubscribe) List rules: http://www.ieee-pses.org/listrules.html > > > > For help, send mail to the list administrators: > > Scott Douglas <sdoug...@ieee.org> > > Mike Cantwell <mcantw...@ieee.org> > > > > For policy questions, send mail to: > > Jim Bacher: <j.bac...@ieee.org> > > David Heald: <dhe...@gmail.com> - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <emc-p...@ieee.org> All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <sdoug...@ieee.org> Mike Cantwell <mcantw...@ieee.org> For policy questions, send mail to: Jim Bacher: <j.bac...@ieee.org> David Heald: <dhe...@gmail.com>
