We have a supplier that changes operating software often. They fail to inform us on a timely basis, which causes more work and lost time on our end. I'd like to send them an official CAPA to try and rectify this problem, but I am not sure what CFR clause to base my request. Does anyone have a suggestion?

Thanks. :thanks:

A complaint on your end does not necessarily have to reference a standard. Are the suppliers failing to meet any of your contractual requirements? A complaint is a complaint, if it is causing you hardship, you should be able to bring it to your supplier. But, remember, a complaint is a complaint, the supplier may have a good reason not to change (not just this situation, but all) and you may need to accept that or renegotiate your contract.I usually welcome feedback from my customers, because typically what I can do to make one happy, the rest will also appreciate. But of course, there are always that group that cann't be made happy at all, just make sure you don't fall into that group!

We have a supplier that changes operating software often. They fail to inform us on a timely basis, which causes more work and lost time on our end. I'd like to send them an official CAPA to try and rectify this problem, but I am not sure what CFR clause to base my request. Does anyone have a suggestion?

Thanks. :thanks:You should send them a SCAR based on your QS requirements. The section you are interested in is 21cfr820.50 (http://a257.g.akamaitech.net/7/257/2422/26mar20071500/edocket.access.gpo.gov/cfr_2007/aprqtr/21cfr820.50.htm).Subpart E_Purchasing Controls

Sec. 820.50 Purchasing controls.


Each manufacturer shall establish and maintain procedures to ensure
that all purchased or otherwise received product and services conform to
specified requirements.
(a) Evaluation of suppliers, contractors, and consultants. Each
manufacturer shall establish and maintain the requirements, including
quality requirements, that must be met by suppliers, contractors, and
consultants. Each manufacturer shall:
(1) Evaluate and select potential suppliers, contractors, and
consultants on the basis of their ability to meet specified
requirements, including quality requirements. The evaluation shall be
documented.
(2) Define the type and extent of control to be exercised over the
product, services, suppliers, contractors, and consultants, based on the
evaluation results.
(3) Establish and maintain records of acceptable suppliers,
contractors, and consultants.
(b) Purchasing data. Each manufacturer shall establish and maintain
data that clearly describe or reference the specified requirements,
including quality requirements, for purchased or otherwise received
product and services. Purchasing documents shall include, where
possible, an agreement that the suppliers, contractors, and consultants
agree to notify the manufacturer of changes in the product or service so
that manufacturers may determine whether the changes may affect the
quality of a finished device. Purchasing data shall be approved in
accordance with Sec. 820.40.

You should send them a SCAR based on your QS requirements. The section you are interested in is 21cfr820.50 (http://a257.g.akamaitech.net/7/257/2422/26mar20071500/edocket.access.gpo.gov/cfr_2007/aprqtr/21cfr820.50.htm).

All I agree with what you are saying, only if the supplier complies with FDA requirements. If they don't it would be hard to hold them to it. Now with that being said, most companies have a no change clause on the PO.