Brian, I have been asked to provide a risk assessment prior to the contract being signed. In my case it is for large systems to be installed on a customer site by an EPC (engineering procurement & construction). When I received an example report from the EPC, it too was a fairly "*dumbed down*" version of what I would normally do. It was in the form of an FMEA, which matches what we do.
When I submitted my version (PDF only) to the EPC, they immediately came back with several comments related to format and the color highlights I used on the RPN numbers as related to thresholds, but nothing of actual substance. So, I took the opportunity to reformat. - All conditional color highlights are now tied to a flag I can turn on and off for printing. This made for a basically B&W report and we use the colors with our team of SMEs. - Proprietary information is masked and marked as such prior to printing in PDF. The topic headings were listed, proprietary information masked and resulting RPN numbers given. This was not done if the company has a confidentiality agreement of some kind. - Any FMEA risk items we felt had no direct impact on the customer, end users, etc.and would not change based on customer any known action or protections were removed. We kept the master list for internal purposes only. Examples may be found in PFEMA or MFMEA as opposed to DFMEA. - I developed various report formats using original data and based on requirements from IEC/ISO, UL/CSA, MIL-STD, etc. - I never put a functional excel worksheet in our company document system as too often our sales people would tell the customer, "*Oh, I have something here, let me just send it long*" On the topic of removed items, in one example we listed a risk of fire ants (genus Solenopsis) attracted to electrical fields in equipment and causing damage; not applicable in many parts of the world. And taking this out it streamlines the review process as it avoided questions like "*what does this mean?*". Out of curiosity, I decided to look up the professional profile a few of these people who are making the requirements and found they are often non-technical, paper pushers. So in the end what they wanted was a document to add to their files to show they are exercising due diligence and to check off one more box on their checklist. -Doug Douglas E Powell Laporte, Colorado USA doug...@gmail.com http://www.linkedin.com/in/dougp01 --------------------------------------------------------------------------- I don't get lost, I accidentally go on adventures. On Thu, May 17, 2018 at 12:43 PM, Kunde, Brian <brian_ku...@lecotc.com> wrote: > 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. 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) <http://www.ieee-pses.org/list.html> > 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> > -- Douglas E Powell doug...@gmail.com http://www.linkedin.com/in/dougp01 - ---------------------------------------------------------------- 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>