Disposition of quality records

A note in clause 4.16.1 points out that disposition of quality records includes disposal and that quality records include customer-specified records. 

The standard requires the supplier to establish and maintain documented procedures for the disposition of quality records. 

The procedure is established and maintained for identification, collection, indexing, filing, storage, maintenance, and disposition of quality records. 

Quality records are identified, established, and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Quality records are legible, readily identifiable, and retrievable for quality records. A procedure is established to define the controls needed for the identification, storage, protection, retrieval, retention time, and disposition. 

The quality control department should also be responsible for the full examination of returned drugs to determine whether such drugs should be released, reprocessed, or destroyed. Adequate records of the disposition of such drugs should be maintained. 

All returned good, regardless of reason, shall be impounded to prevent integration with other material. No such material shall be released without approval by Quality Control. Records shall be maintained of quantity and date received and actual disposition of the product. 

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