21 CFR 820.65 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.

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.

The following is the exact wording of the traceability requirement from the FDA website.

Sec. 820.65 Traceability.

Each manufacturer of a device that is intended for surgical implant into the body or to support or sustain life and whose failure to perform when properly used in accordance with instructions for use provided in the labeling can be reasonably expected to result in a significant injury to the user shall establish and maintain procedures for identifying with a control number each unit, lot, or batch of finished devices and where appropriate components. The procedures shall facilitate corrective action. Such identification shall be documented in the DHR.

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.