Ginny, I've been helping to develop and implement regulatory programs for clients for a couple of years now. I'm proud of some solutions, frustrated that others weren't better. Anyway, attached are some general guidelines that may help to ease the economic and engineering pain somewhat.
Contact me directly if you wish to explore the options a bit further Rick Towner 888-2CE-Mark ---------- Forwarded Message ---------- From: Ginny Lee/Shiva Corporation, INTERNET:[email protected] TO: "'Treg'", INTERNET:[email protected] DATE: 1/8/97 2:41 PM RE: Questions regarding approval process Sender: [email protected] Received: from europe.std.com (europe.std.com [199.172.62.20]) by arl-img-1.compuserve.com (8.6.10/5.950515) id OAA27751; Wed, 8 Jan 1997 14:27:48 -0500 Received: by europe.std.com (8.7.5/BZS-8-1.0) id OAA01001; Wed, 8 Jan 1997 14:21:31 -0500 (EST) X-Authentication-Warning: europe.std.com: daemon set sender to treg-approval using -f Received: from world.std.com by europe.std.com (8.7.5/BZS-8-1.0) id OAA00971; Wed, 8 Jan 1997 14:21:27 -0500 (EST) Received: from shiva-dev.shiva.com (shiva.shiva.com) by world.std.com (5.65c/Spike-2.0) id AA16756; Wed, 8 Jan 1997 14:21:22 -0500 Received: from SMTP.shiva.com (smtp.shiva.com [140.248.128.40]) by shiva-dev.shiva.com (8.7.6/8.6.4) with SMTP id OAA18587 for <@shiva-dev.shiva.com:[email protected]>; Wed, 8 Jan 1997 14:19:39 -0500 (EST) Received: by SMTP.shiva.com (IBM OS/2 SENDMAIL VERSION 1.3.17/1.0) id AA2048; Wed, 08 Jan 97 14:19:28 -0800 Message-Id: <[email protected]> Received: by Shiva Corporation (Lotus Notes Mail Gateway for SMTP V1.1) id 2DB0B3261C159DBC85256419006984FA; Wed, 8 Jan 97 14:19:28 EDT To: "'Treg'" <[email protected]> From: Ginny Lee/Shiva Corporation <[email protected]> List-Post: [email protected] Date: 8 Jan 97 14:20:23 EDT Subject: Questions regarding approval process Mime-Version: 1.0 Content-Type: Text/Plain Sender: [email protected] Precedence: list Reply-To: [email protected] Hello All! I am new to the approvals world and am being tasked with looking at our process for approving products into other countries outside the U.S. I am attempting to benchmark how other companies implement this process but have been unable to find a good source of information. My main questions are as follows: (1) Roles and responsibilities of approval engineers. Is the person doing Safety and EMC testing separate from the telecom approvals guy? In smaller companies, they are often the same person by default: He/She with the most to do and least amount of time to do it, also gets compliance! In larger companies, my experience says, usually the overall compliance effort is headed up by a person with US Safety experience. Under this person are the EMC Compliance Department and Telco. So it's not always the same person, mostly because the compliance problems with EMC, Safety and the Telco Interface are not seen to be related -- though I think I'll get consenus that they often are, with frustrating results. (2) How does the process tie into the main development process? For example, is there a certain country criteria that must be met before shipping? If so, how does the approval process get structured in? In my experience the most effective (cost-effective and effort-effective) programs start by identifying the potential market, discussing the regulatory requirements and options in each market, then going from the general to the specific based on market priority. All of this should happen during the design or beta phase to keep costs down. For Example: If the US, Europe and Japan are your primary markets, and your product is standard consumer electronics, then start with the design aspects of CISPR 22, IEC 950, And the common Telco standards. If you're at the end of the process, and the standards don't make physical or economic sense, find out what your alternatives are, again, thinking in general terms. Once the generalities have been covered, work to specific country deviations if there are any, trying to minimize these with a holistic perspective of the requirements. Whatever you do, plan according to priority. If the US is first, cover it first. If Europe is the issue, how many countries first? Which countries are the most important? Shoot at the big targets first and save your bullets for the smaller targets later...they often take more bullets and yield smaller scores. Essentially you can boil the primary regulatory compliance questions down to these (courtesy of the person who hired me into the biz): What's your product? What's your market? What's your priority? What're your compliance options? >From there it's research, design, sweat, money, and oh, yes...a little bit of >luck. If it sounds like common sense, it pretty much is in general. It's the specifics that will drive you to...do whatever it is you do when your driven to do it! Hope this helps give some perspective. RT Mostly, I am looking for anyone that would be willing to share their experiences with me. I am more than willing to share mine! Thanks! Ginny Lee
