Traceability

Basically, traceability is based on identifying the finished product with unique control numbers. It is a regulatory requirement. This traceability is useful should there be a product recall.

The extent of traceability includes

·       Serial or batch numbers.

·       identification of Purchase Order for critical materials and components used;

·       Identification of key processes and inspection equipment and their operators;

·       Inspection and testing results and identification of inspectors;

·       Identification of personnel performing final labeling operations.

The actual traceability information required for a given medical device should be able to be called out in the production work order for this product. Typically in this day and age, there are several enterprise software like SAP to help sponsor manage all the traceability information.

Traceability Records for purchased materials and components. Their origination and verification records, such as certificates of analysis, testing inspection reports supplied with the product, etc., are linked to the products through their purchase orders. Purchase Orders are maintained by Purchasing. Purchasing department must keep all of these records for a certain period even after the product is discontinued. It is because there might be old product out in the market.

Traceability Records for finished products can be achieved by the work order. Work order is the main traceability record linking the product to its production history. Some data may also be recorded in logs, tables, or databases associated with particular workstations or processes. Work orders and any additional traceability records are maintained in the Device History Record (DHR) or Lot History Record (LHR).

Sponsor should also have a recall plan to test the efficiency of the traceability program. Perform a mock recall periodically.

Reference	Criteria
ISO 13458 7.5.3	Where traceability is a requirement, does the company control and record the unique identification of the product?
ISO 13458 7.5.3.2.1	Has the company established documented procedures for traceability? If appropriate, is traceability of products ensured contractually in those cases where external parties are used for the distribution of CE-marked products?
ISO 13458 7.5.3.2.2	Has the organization included records of all components, materials and work environment conditions, in defining the records required for traceability, if these could cause the medical device not to satisfy its specified requirements?
ISO 13458 7.5.3.2.2	Has the organization required that its agents or distributors maintain records of the distribution of medical devices to allow traceability and that such record are available for inspection?
ISO 13458 7.5.3.2.2	Has the organization ensured that the name and address of the shipping package consignee is maintained (see 4.2.4)?

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.