If product needs to be reworked (one or more times), the manufacturer shall document the rework in a work instruction that has undergone the same authorization and approval procedure as the original work instruction.

• 若产品需要重行加工,制造业者应将重工之工作指导文件予以书面化,确定其重行加工与原工作指示均经相同之授权与核准程序。