Jeff,
My answers below yours, encased in << >>.
Tania Grant, Lucent Technologies, Octel Messaging Division
[email protected]
______________________________ Reply Separator _________________________________
Subject: Compliance Mgmt. for OEM's, Turnkey, Joint Ventures, etc.
Author: [email protected] at P_Internet_Mail
List-Post: [email protected]
Date: 1/20/98 9:15 AM
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?
<<Self certification-- NO; NRTL reports-- YES.>>
2) With an OEM, who takes responsibility for future changes /
modifications to the product or the standards?
<<This is a contractual issue and these questions should have
been raised at the time the contract was written. The following
are some of the questions that should have been raised before
coming to any sort of decision:
- whose name is on the product? whose name is on the electrical
nameplate? (these are 2 separate questions)
- from which location is the finished product shipped to the
customer?
- whose name is shown on any existing agency approval documents?
We prefer that the OEM take all responsibility for their agency
approvals; it would be extremely difficult for us (and unadvised)
to assume responsibility for their product when it is not manufactured
under our direct supervision and control.
In a few cases where that has not been done, I have submitted the
OEM product under name, but have shown the manufacturing address of
the OEM (not ours). This way, we pay for the inspection fees to be
made at their location, but the immediate brunt of any non-compliance
is at their location. Additionally, they cannot claim that their
product has any agency approvals; it has only been approved in our
application and nowhere else.>>
3) With an OEM's DOC and other documents, who maintains responsibility
for it's accuracy, availability, and location.
<<By DOC you mean CE Declarations of Conformity? If so, whoever
signs these DOC has the appropriate test reports that prove
compliance. If you sign them, you are responsibility for their
accuracy.>>
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.
<<A comprehensive contract is crucial here that would detail all
of your above concerns. Yes, we have a unit manufactured in Japan
under our name and model number. We show their location as the
manufacturing address. We "own" the approvals. We perform EMC tests
for any changes to make sure we stay in compliance. We pay quarterly
inspection fees to maintain compliance (but the contract could have
been written so that they pay these fees.) Any agency non-compliance
issues are sent to us to take action. Keeps everybody honest.>>
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?.
<<Your question is somewhat unclear. You cannot re-certify a product
without supplying complete technical data and information to the
agencies. Are you getting this from your OEM? With certain agencies,
this can be done, but they require letters from both companies (from
Officers of both companies, if memory servers me correctly) that
allows company B to hold approvals of the same product from company A.
I believe UL calls it dual or joint Listing (something like that).
However, even though it is the same product, company B usually wants
it under a different model name. Thus, to third parties, it is not
evident that a Frigidaire Model XYZ is the same as a Sears Model
ABC.>>
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.)
<<I believe this has been answered previously.>>
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? <<Again,
in whose interest is it to continue shipments? How was the
contract written?>>
Particularly if they are passing a European standard but not a USA
standard.
<<Were they meeting the US standard to start with? Do they want
to continue having your business? They might decide that it is
no longer cost effective for them to deal with US standards issues.
This is the time to renegotiate the contract.>>
Best Regards,
Jeff Collins Sr.EMC/Safety Engineer
Perkin-Elmer Applied Biosystems [email protected]
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