Brian I'm not sure I quite understand your post, but I think I agree with you!
However, my experience indicates that many companies - and even some very big ones! - DON'T always have adequate control of their sub-contract suppliers! Again, I'm not sure, but I think a lot of the issues come down to inadequacies in: a) How much understanding the sub-contract supplier has of the required technology, regulatory requirements and design/manufacturing controls for a particular product; b) How much understanding the company that lets a contract to that sub-contract company REALLY has of a) above, and thus what IT itself then needs to specify, and to do, in order to ensure those requirements can and are, on an ongoing basis, met; c) How much time/effort and money is then put in by both sides in adequately documenting the requirements specifications, and in "policing" of the on-going manufacturing and delivery processes, to ensure that what the design team specified is "correct", and is what the customer actually gets! (and the above is all predicated by the assumption that all the parties are "honest" in what they do - which, as we all know, is not always the case :-( ) Unfortunately, over the years, I have seen many notable examples of how a), b, and/or c) have not been done correctly, or, in some cases, not at all - and we all have a pretty good idea of where that sort of thing is likely to lead! John Allen W.London, UK -----Original Message----- From: Brian Ceresney [mailto:bceres...@delta-q.com] Sent: 05 March 2015 22:52 To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: Re: [PSES] Safety standards versus safety engineering I tend to disagree. For example, for a company who uses contract manufacturing, the Supply, Quality, and Manufacturing teams have a significant amount of responsibility for Safety, which can be quite separate from the Design team. The management must keep good control over all of the groups involved in the process, to ensure that safety is built-in to each and every product. Best Regards, Brian C. Brian Ceresney Regulatory Lead Delta-Q Technologies Corp. Phone: +1.604.566.8827 E-mail: bceres...@delta-q.com This is my own opinion, and does not reflect that of Delta-Q Technologies. Confidentiality Notice: This email message, including any attachments, is for the sole use of the intended recipient(s) and may contain confidential and privileged information. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail and destroy all copies of the original message. -----Original Message----- From: Richard Nute [mailto:ri...@ieee.org] Sent: March-05-15 2:37 PM To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: Re: [PSES] Safety standards versus safety engineering > ... the management of the company has to own the safety of the > product. They control the resources > needed to ensure that the products are designed, and > manufactured to be safe. Cop-out. For every product, there is a development team. The product safety engineer is a member of that team, overtly or not, and owns the safety of the product. Best regards, Rich - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. 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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>
