Q
Hello,
If a customer requests for a product to be changed (deviation from requirement specifications) to meet their need. Is that acceptable? What are regulation implications to consider?
I am aware of FDA's 820.70, but I believe that speaks to internal mfg deviations.
Sec. 820.70 Production and process controls.
(a)General. Each manufacturer shall develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications. Where deviations from device specifications could occur as a result of the manufacturing process, the manufacturer shall establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications...
Here is an example:
We build a product that processes in the range of 60-70mL, but the customer wants it to read 75mL.
Any guidance you can give would be great?
If a customer requests for a product to be changed (deviation from requirement specifications) to meet their need. Is that acceptable? What are regulation implications to consider?
I am aware of FDA's 820.70, but I believe that speaks to internal mfg deviations.
Sec. 820.70 Production and process controls.
(a)General. Each manufacturer shall develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications. Where deviations from device specifications could occur as a result of the manufacturing process, the manufacturer shall establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications...
Here is an example:
We build a product that processes in the range of 60-70mL, but the customer wants it to read 75mL.
Any guidance you can give would be great?