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]
