Identification

To be in compliance with this section of identification, sponsor should always establish procedures and protocols to provide a system and instruction for product identification. Product identification not only apply to finished products, but should also apply to materials, parts, subassemblies and other critical components.

Sponsor should establish part number and device configuration record and traceability record. Purchased materials, parts and components are identified with unique numbers, codes, or names. The identifications should be maintained while the ‘products’ are in the production, finished product, storage and even at consumers locations. In the present day, there are many software which can help sponsor to identify all the parts like SAP.

Identification should be performed during production. During all stages of production, manufactured parts and subassemblies are identified by the work order. Work orders accompany products as they move from one workstation or production process to the next.

Identification should be performed during finished product. Finished products are identified by a label that is permanently affixed to the product. The identification label includes the name and model of the product; the name, address and phone number of the manufacturer; and the serial or lot number.

The identity of the product sold to each customer should also be tracked in a software system like SAP. Should there be a product recall or field advisory, it will be a lot easy for the sponsor to do so.

Identification of Returned Product: Products returned for servicing are brought to the receiving desk in the servicing department and are tagged with the service job number. New products returned for exchange, refund or for any other reason are labeled HOLD and are placed in a designate a holding (quarantine) area before moving redistribution area or being repaired.

Reference	Criteria
ISO 13485 7.5.3	Has the company identified the product by suitable means throughout product realization?
ISO 13485 7.5.3.1	Has the company identified the product by suitable means throughout product realization, and established documented procedures for such product identification?
ISO 13485 7.5.3.1	Has the company established documented procedures to ensure that medical devices returned to the company are identified and distinguished from conforming products?
ISO 13485 7.5.3.3	Does the company identify product status with respect to monitoring and measurement requirements?
ISO 13485 7.5.3.3	Is the identification of product status maintained throughout production, storage, installation and servicing of the product to ensure that only product that has passed the required inspections and tests (or released under an authorized concession) is dispatched, used or installed

Disclaimer: Although the author had exhaustively researched all sources to ensure the accuracy and completeness of the information contained in this blog, but no warranty and fitness is implied. I assumed no responsibility and implied warranty of any kind for errors, inaccuracies, omission, or any inconsistency herein. No liability is assumed for incidental or consequential damages in connection with the use of the information contained herein. Readers should always use their own judgment and review all related regulatory guidelines. Guidelines can change over time.