posted 02 May 2001 09:43 AM               

Basically, the FDA sees contractors and consultants as providing a service, but does not see much difference between service and product. From the FDAâs Small Entity Compliance Guide:

Contractors and consultants often provide information or a service rather than a physical component. However, the thought and control processes are similar whether one is working with services or with physical product. The input from contractors and consultants have a definite impact on the finished device. Services may include: design activities, various product verification/validation activities, sterilization, routine maintenance, and calibration of equipment.

Also the manufacturer is held responsible for work done by outside contractors or consultants. Thus, it is in the manufacturer's best interest to keep providers adequately informed and to monitor contractors to ensure that the correct design, production, or process controls are applied to contractor services to ensure the service or finished product conforms to its specifications (820.30, 820.50, 820.70, and 820.80).

In my case, the evaluation for my calibration provider was based on location, capability and certifications that I maintain in a separate portion of my approved vendors database.

Hope this helps.

Regards,
dWizard

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I was better but I got over it.