Interesting thread . . . At the companies for which I managed the regulatory programs over the last 20 years, it has always been engineering's responsibility to release to production a compliant product,and I have always been a member of the engineering department. In the early days, before regualtory compliance became the industry that it is now, it was basically 'putting out the fires' after formal evaluation. After a couple of costly rework projects, 'design for compliance' became my mantra, and I have been able to carry that along to other companies as well. And fortunately for me, it has been well received. As part of the design team, I am able review all product designs before and during the prototype stage and provide guidance/input as necessary. Each time I announce that the product passed the first time (don't get me wrong, I do have the occassional 'gotcha') it gets easier to justify the 'design for compliance' concept. It's a lot more difficult to cost-effectively rework a product. So, besides making my job easier (and the cognizant design engineer's as well), 'design for compliance' does save costs in the long run. Additionally, as part of the corporation's quality team providing the opportunity to ensure continued compliance. John Juhasz Fiber Options Bohemia, NY -----Original Message----- From: Tania Grant [mailto:[email protected]] Sent: Wednesday, November 28, 2001 11:15 PM To: John Woodgate; [email protected] Subject: Re: Quality Assurance and Product Approvals
My personal experience agrees with John. I prefer to work with Engineering and reporting someplace in Engineering;-- it makes my job easier when compliance is "designed" right from the very beginning rather than be responsible later to get it past agencies. At that point, it suddenly became my "problem" when it did not comply! When I told management that they should fix things before we submitted the product formally, the response was "let's see what the agency will do...." This left me frustrated and embarrassed my ego. If you catch things in the very beginning, engineering is usually amenable to changing things. Later, it is very difficult and, obviously, much more costly. [email protected] <mailto:[email protected]> ----- Original Message ----- From: John Woodgate Sent: Wednesday, November 28, 2001 2:48 PM To: [email protected] Subject: Re: Quality Assurance and Product Approvals I read in !emc-pstc that Mark Werlwas <[email protected]> wrote (in <[email protected]>) about 'Quality Assurance and Product Approvals', on Wed, 28 Nov 2001: > On the aspect of the "where to put Product Safety/Compliance in the > organization" discussion bears mentioning on the forum. In general I > advocate that the Product Safety/Compliance department be separate from > Engineering, Sales, and Operations. The Safety/Compliance group should avoid > conflicts of interest (real or apparent) that may arise in the above > mentioned groups. Even the occasional appearance of a conflicting interest > can undermine the credibility of the Safety/Compliance team. But this militates strongly against 'designing-in compliance', and is very liable to create a 'them and us' conflict between Design Engineering and Compliance. The *maintenance* of compliance in manufacture is a Quality function. -- Regards, John Woodgate, OOO - Own Opinions Only. http://www.jmwa.demon.co.uk After swimming across the Hellespont, I felt like a Hero. ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson: [email protected] Dave Heald [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] All emc-pstc postings are archived and searchable on the web at: No longer online until our new server is brought online and the old messages are imported into the new server.
