Commentary as well, If the customer is a contractual partner or OEM I would typically share reports and such the contractual agreement between the two parties identify responsibility/liability and corporate lawyers involved. I believe the user manual is adequate for all other customers. Being the professional people we are the user manual will typically define the hazards adequately for the end user. So if one of your customers employee uses or abuses the instrument in any other manner outside the scope of its intended use (defined in the user manual) then they are responsible for their employees misuse and not your company. I know you make some pretty niche market stuff so if it were me I would hold my ground and not produce the RA. Your EN12100 and User manual is sufficient. It continues to amaze me as I grow old, how people in the corporate world have nothing better to do with their time but to create chaos. Making corporate life difficult and sometimes meaningless. There was a time where Company A produced and sold a product and Company B said wow what a great product. The end.
Regards, Mark Schmidt From: Ken Javor [mailto:ken.ja...@emccompliance.com] Sent: Thursday, May 17, 2018 2:57 PM To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: Re: [PSES] Customer Requests for Risk Assessments Just commentary - no authoritative information. This sounds like the customer company's lawyers looking to divert blame in the event of a lawsuit by showing due diligence on their part, and maybe, just maybe, redirecting the blame vector towards your company if someone can make the case your company didn't adequately assess your product's risk. Ken Javor Phone: (256) 650-5261 ________________________________ From: "Kunde, Brian" <brian_ku...@lecotc.com> Reply-To: "Kunde, Brian" <brian_ku...@lecotc.com> Date: Thu, 17 May 2018 18:43:38 +0000 To: <EMC-PSTC@LISTSERV.IEEE.ORG> Conversation: Customer Requests for Risk Assessments Subject: [PSES] Customer Requests for Risk Assessments Our company makes Laboratory Equipment (test and measurement analyzers). Our company performs a Risk Assessment early in the development stage of all new products as so suggested by such documents. We generally use the EN ISO 12100. Creating this document highlights the possible sources of risks and allows our engineers to design products with an inherent design which minimizes the risks as much as possible. Our Risk Assessment becomes a document with a lot of detailed information including calculations, test results, detailed data, and other design specifications. Such information is considered highly confidential by our company. On occasion, and in increasing frequency, our company is asked by potential customers to provide them with a Risk Assessment Report for our products. Sometimes they threaten us such as they will not or cannot consider our products unless we provide such documentation. 1. Why are customers asking for a Risk Assessment? Where did that requirement become from? 2. Other than the potential loss of a sale, are we obligated to provide our customer with a Risk Assessment? I do not see such a requirement in the Directives or Standards we use. 3. Any of you been receiving similar requests? If so, do you provide a Risk Assessment? If so, are you not worried about providing such information? Couldn't this information be used against you in court? Is there a fear of providing useful information to your competitors? Part 2: I have requested a sample of the Risk Assessment our customers are expecting our company to provide. The examples documents are for the most part meaningless with little real detail about anything. But, if that is all they want to make them happy, we are considering generating such a document just to satisfy these requests. Any comments? When I ask our customers what information they are looking to gain from the Risk Assessment, they tell me they want to know the level of residual risks our products might have. I reply that all residual risks are well documented and warned about in the provided User Manual. However, this doesn't seem to satisfy them. They still want a Risk Assessment Report. So are other companies having to generate a stripped down Risk Assessment with no real detail to satisfy these customer requests? Or is it just us? Thanks for your input, comments, and suggestions. The Other Brian ________________________________ LECO Corporation Notice: This communication may contain confidential information intended for the named recipient(s) only. If you received this by mistake, please destroy it and notify us of the error. Thank you. - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. 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