Non-Conforming Product

The quality system provides for the identification, documentation, evaluation, segregation, and disposition of non-conforming product.

Quality Assurance administers the non-conforming materials system with the participation of the Material Review Board (MRB). Within departments producing research use only materials, appropriate technical personnel will review non-conforming material and make decisions concerning disposition of that material. Any employee with knowledge of non conforming material may call for a Material Review Board meeting. Minor non-conformities may be released by Quality Control with adequate documentation. Disposition of major non conformities lies with the MRB. QA is responsible for documenting the activities of the MRB. The Biotech MRB is composed of representatives from Quality, Manufacturing, and Development. Additional representatives from Product Support, Marketing, Technical Service or Sales may also participate as required. All corrective actions must be fully documented. Minutes from meetings of the MRB are published and maintained in Master Control.

The MRBs are documented using the Material Review Board (MRB) form. Minutes from meetings of the MRB are published and maintained in Master Control. A summary of MRBs is distributed quarterly to managers for review.

All non-conforming material is clearly marked with Quarantine stickers or labeled appropriately. In addition, it is physically separated from conforming material until final disposition.

A Specification Deviation is issued for any deviation in the manufacturing procedure even if it ultimately meets final release specifications. If a product is reworked, it must undergo all required inspections and tests as well as any additional inspection or testing required by the MRB. Reworked material must pass the same release criteria as the original product.

Related Procedures:

-           Specification Deviation Procedure

-           Corrective and Preventive Action

-           Material Review Board Responsibility Procedure

-           Reprocessing Procedure

-           Procedure for Quarantine/Rejecting Approved Product

-           Adjustment/Replacement of a Finished Product

-           Material Review Board Procedure

-           Rework Procedure

-           Corrections, Removals and Recalls for  Products