List-Post: [email protected] Date: 20-Jan-98 12:05:05 MsgID: OUTBOX MgTo: [email protected] >INTERNET:[email protected] Subj: Re: Compliance Mgmt. for OEM's, Turnkey, Joint Ventures, etc.
In past lives (g) I've had to deal with this. The way my employers ended up doing things was to accept certifications -- then test and hold the OEM's feet to the fire when they failed. Sometimes they didn't fail! As manufacturers whose own self-certifications were subject to review, we had to be sure what we shipped would comply if tested... and if you ignore a problem and LATER get caught, your supplier will deny any responsibility for what you didn't check, saying _his_ tests showed no problem. Plus, you'll be stuck with non-compliant subassemblies you've already bought. Check what you buy! Cortland ====================== Original Message Follows ==================== >> Date: 20-Jan-98 11:27:05 MsgID: 1057-31521 ToID: 72146,373 From: [email protected]³>INTERNET:[email protected] Sender: [email protected] Received: from ruebert.ieee.org (ruebert.ieee.org [199.172.136.3]) by hil-img-4.compuserve.com (8.8.6/8.8.6/2.10) with ESMTP id OAA17695; Tue, 20 Jan 1998 14:27:15 -0500 (EST) Received: (from daemon@localhost) by ruebert.ieee.org (8.8.8/8.8.8) id OAA29947 for emc-pstc-list; Tue, 20 Jan 1998 14:20:34 -0500 (EST) From: [email protected] Message-Id: <[email protected]> X-Mailer: ccMail Link to SMTP R6.0 List-Post: [email protected] Date: Tue, 20 Jan 98 10:07:41 -0500 To: <[email protected]> Subject: Compliance Mgmt. for OEM's, Turnkey, Joint Ventures, etc. MIME-Version: 1.0 Content-Type: text/plain; charset=US-ASCII Content-Transfer-Encoding: 7bit Sender: [email protected] Precedence: bulk Reply-To: [email protected] X-Resent-To: Multiple Recipients <[email protected]> X-Listname: emc-pstc X-Info: Help requests to [email protected] X-Info: [Un]Subscribe requests to [email protected] X-Moderator-Address: [email protected] Good Day All, Can anyone share any of their experiences with managing their suppliers for regulatory compliance. As many of us are using OEM's, Turkeys, and Alternate Mfg Sites (usually out of the country) it can become quite hectic to ensure that all applicable requirements are being met. I will list some of the major issues we are facing. Any information on how you've dealt with this or any good/bad experiences would be appreciated. My intent is to define a clear Regulatory Compliance Mission Statement for our suppliers that can be adopted company wide. 1) Validation of compliance from your supplier; do you accept self certification or data from a NRTL? 2) With an OEM, who takes responsibility for future changes / modifications to the product or the standards? 3) With an OEM's DOC and other documents, who maintains responsibility for it's accuracy, availability, and location. 4) Alternate Mfg Sites: If you have your products completely manufactured by someone else, what controls have you implemented to ensure compliance, tracability, and quality. Has anyone had their products manufactured by a company that's out of the USA? Please elaborate on the details of this. 5) If you OEM a project and put your company's logo on it, do you re-certify it or use the original manufacturer's data?. 6) If your OEM or supplier is based out of the USA, are they charging you to meet the USA requirements? i.e. (UL, FCC, FDA, etc.) 7) If an OEM is retested and found to be non-compliant, how willing have they been to resolve the issue and at who's expense? Particularly if they are passing a European standard but not a USA standard. Best Regards, Jeff Collins Sr.EMC/Safety Engineer Perkin-Elmer Applied Biosystems [email protected] ====================== End of Original Message =====================
