Nonconforming Material Report (NCMR)

What is a Nonconforming Material Report (NCMR)? 

A Nonconforming Material Report (NCMR) is a critical document in the medical device industry, used to identify materials related to design-controlled products that fail to meet specified standards. This form meticulously details the type and source of the defect, as well as the actions taken and the rationale behind them. In the context of medical devices, the NCMR is essential for maintaining compliance with stringent regulatory requirements and ensuring patient safety. Reviewing an NCMR can lead to the initiation of a Corrective and Preventive Action (CAPA) or a Supplier Corrective Action Request (SCAR), depending on the defect’s origin and severity. This process is vital for continuous improvement and adherence to design controls.

Tips on completing a Nonconforming Material Report (NCMR):

Completing a Nonconforming Material Report (NCMR) for a medical device requires attention to detail and adherence to regulatory standards. Below are three tips to help you make progress in the right direction.

1. Clearly identify the nonconforming material, provide a comprehensive description of the nonconformance and immediately segregate the nonconforming material to prevent its unintended use or distribution.
2. Conduct a thorough root cause analysis to determine why the nonconformance occurred. Document all findings, actions and decisions.
3. Clearly define the disposition of the nonconforming material, whether it will be reworked, scrapped, returned to the vendor, or used as-is.