Ok, I’ll pile on. I have never been involved in a market surveillance inspection so I really have no right to comment, but I am trying to understand what constitutes itself as a Technical Non-Compliance.
Many of my products get inspected post-sale at our customer sites by third-party labs or union inspectors doing a “Field Evaluation”. Most inspections go very smoothly, but some labs/inspectors write up every little thing they don’t understand or cannot test in the field as a “Non-Compliance”. Sometimes they have their OWN interpretations of the rules and documentation requirements. Then our customer is placed in the middle as we try to make the lab/inspector understand why the product really is compliant. I’m sure many of you have had similar experiences. When I see market surveillance reports with tens of thousands of non-compliances listed but only a few dozen cases where any kind of real “action” is taken, the first thing I wonder is how legitimate or serious are the bulk of the non-compliances in the first place. It makes me think that maybe the mass majority of these cases are so minor that they simply become learning experience for someone and only the rare and more serious non-compliances result in fines or legal action. Am I the only one who thinks this way? Don’t get me wrong; I love these types of reports with big numbers. If I want, I can use them to scare my superiors into doing what I say. I might even get more budget money to hire more people or get more lab space. But I really would like to know how many of these non-compliances are really bad bad product verses barely failed product verses a poor execution of the difficult to interpret rules and regulations. Please don’t beat me up too bad. When I’m bored my mind drifts down dark paths of no return. The Other Brian From: Regan Arndt [mailto:reganar...@gmail.com] Sent: Thursday, November 01, 2018 7:37 PM To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: Re: [PSES] CE non-conformity statistics Hi Pete. Yes, it's a sad state of affairs. Our profession needs to do more or something different to turn this around. I wish AdCo could release where these products originated from so we can focus our attention on improvements in these regions. Anybody know of some examples of penalties/fines that have occurred recently? I'm also surprised there was no cross-border market surveillance of just LVD or Machinery. It appears they are just cherry picking the high profile products/categories. On Thu, Nov 1, 2018 at 9:01 AM Pete Perkins <peperkin...@cs.com<mailto:peperkin...@cs.com>> wrote: Regan, Thanx for chasing down these statistics; very interesting. For most of the folks on this forum the most interesting are the technical non-conformity issues. The best/lowest is 14% for EMC and higher 24%/25% for safety/radio. Doesn’t speak well for our profession and influence on industry. Yes, there are many others but most of them are Technical File paperwork issues. :>) br, Pete Peter E Perkins, PE Principal Product Safety & Regulatory Affairs Consultant PO Box 23427 Tigard, ORe 97281-3427 503/452-1201 IEEE Life Fellow p.perk...@ieee.org<mailto:p.perk...@ieee.org> From: Regan Arndt <reganar...@gmail.com<mailto:reganar...@gmail.com>> Sent: Wednesday, October 31, 2018 3:52 PM To: EMC-PSTC@LISTSERV.IEEE.ORG<mailto:EMC-PSTC@LISTSERV.IEEE.ORG> Subject: Re: [PSES] CE non-conformity statistics Thanks Charlie. I checked the latest on the RED. Below is an excerpt on the stats. Amazing. Wonder what the penalties were..... hmmmm.. ADCO RED report to TCAM WG on market surveillance statistics for 2016 2. Results for 2016 Totally, 13,488 R&TTE equipment has been inspected by 25 market surveillance authorities in 2016: Austria, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, The Netherlands and United Kingdom. About 10391 equipment were been found non-compliant to the provisions of the R&TTE Directive. However, due to the fact that not all provisions were checked by all involved market surveillance authorities, the effective amount of non compliant equipment may be higher. Summary of the results: • Overall : 10391 non compliant equipment (13488 inspected equipment) * Declaration of conformity : 9372 non compliant DoC (13224 inspected equipment) * CE marking : 8307 non complaint CE marking (13371 inspected equipment) * Geographical area for use : 3773 not compliances (11750 inspected equipment) * Essential requirements : 579 technical non compliances (of 2131 measured equipment) * Safety (art.3.1.a): 116 technical non compliances (of 488 measured equipment) * EMC (art 3.1.b.): 84 technical non compliances (of 583 measured equipment) * Radio (art.3.2.) : 434 technical non compliances (of 1755 measured equipment) * Technical documentation: 276 non compliances (of 651 inspected equipment) * Test reports: 236 non compliances (of 603 inspected equipment) * Drawings and explanations: 47 non compliances (of 212 inspected equipment) * Other elements: 79 non compliances (of 326 inspected equipment) Regan On Mon, Oct 29, 2018 at 4:47 PM Charlie Blackham <char...@sulisconsultants.com<mailto:char...@sulisconsultants.com>> wrote: Regan Market enforcement reports from the various “AdCos”, Administrative Cooperation Groups, can be found at http://ec.europa.eu/growth/single-market/goods/building-blocks/market-surveillance/organisation/administrative-cooperation-groups_en under the “Documents from the AdCo Groups) As well as a number of reports on EMC, you may wish to look at the R&TTE/RED ones as well Regards Charlie Charlie Blackham Sulis Consultants Ltd Tel: +44 (0)7946 624317 Web: www.sulisconsultants.com<https://outlook.hslive.net/owa/redir.aspx?C=02be3bf3e3a544d1bdf7b6c99fbd12f5&URL=http%3a%2f%2fwww.sulisconsultants.com%2f> Registered in England and Wales, number 05466247 From: Regan Arndt <reganar...@gmail.com<mailto:reganar...@gmail.com>> Sent: 29 October 2018 23:34 To: EMC-PSTC@LISTSERV.IEEE.ORG<mailto:EMC-PSTC@LISTSERV.IEEE.ORG> Subject: [PSES] CE non-conformity statistics Greetings fellow members, Out of curiosity, has anyone been privy to any recent EU statistics for those manufacturers who have been subjected to customs investigations pertaining to CE marking, penalties, sales bans, etc. due to, not only selling an unsafe product but, having no CE marking on product, no DoC, insufficient technical files, non-compliance to the directives, etc? The only thing I can find on the web that has something close is from Yvonne Halpaus of QNET, LLC where she recently published a guide on CE marking in 2015. An excerpt is below: Findings in earlier reports show that 37,600 items of equipment tested in Switzerland showed 1,100 cases of CE Conformity problems. Of 3,962 items that were subjected to rigorous measurements, a high proportion of the devices were found defective (976 altogether) and that none of these met the EMC specified requirements. In 23 cases a sales ban was imposed and legal proceedings were launched. Two other Member States also revealed problems when testing against the EMC & Machinery Directive: 33% failed the EMC tests, 47% did not meet the Machinery Directive formal rules and 89% had technical non-conformities. These negative findings were not the result of regular surveillance mechanisms, 58% was based on examinations triggered by accidents, 33.3% following inspection of equipment installation, 8.5% based on complaints from competing manufacturers and 0.2% following visits to trade fairs. Thanks for sharing any information you have. I'm wanting to update my CE marking training slides with some good solid facts. Regan Arndt - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. 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