Rework Form

What is a Rework Form?

A rework form enables recording results of a rework process when a component, subassembly or device is found to have a nonconforming part or material. These results should be accurate and act as an official record as part of design controls and are usually countersigned by a supervisor or program manager. Rework forms are an important part of the design process because they help ensure compliance, promote safety and maintain high-quality standards that fulfill regulatory requirements. Rework may also require a Nonconforming Material Report (NCMR), a Corrective and Preventive Action (CAPA) and/or a Supplier Corrective Action Request (SCAR), depending on the defect’s origin and severity. 

Tips on completing a Rework Form:

Completing a Rework Form for a medical device requires attention to detail and adherence to regulatory standards. Below are tips to help you make progress in the right direction.

1. Clearly identify what is being reworked and how. Document the changes in the fields of the rework form, as well as any resulting inspection of the newly reworked component.
2. Access whether there is any residual risk after the rework has been completed. Any residual risk must be approved by all parties and is documented in the rework form for the Device History Record (DHR).
3. Conduct a thorough root cause analysis to determine why a nonconformance occurred and why a rework is necessary. Document all findings, actions and decisions.