4.3.4 Requalification. The device shall be subjected to
another First Article as stipulated in the contract if:
a. The contractor's manufacturing techniques or process
affect the form, fit, function or internal geometry of the device by
either the contractor or one of his sub-contractors supplying parts
b. The contractor relocated his assembly facilities.
c. The contractor uses a new sub-contractor for material,
parts, or assembly.
d. A change occurs in devices material, performance, or