|Defined Plans: (Enable / Ensure)
Identification of nonconforming and/or suspect product;
Segregation of nonconforming and/or suspect product;
Ability to meet the customer and/or regulatory response time requirements;
Records are retained in the format that enables the organization to meet the response time requirements;
Serialized identification of individual products, if specified by the customer or regulatory standards;
Identification and traceability requirements are extended to externally provided products with safety/regulatory characteristics.