Batch History Records

The manufacture of medical devices is both a complex and highly regulated process. Medical device manufacturers are required to maintain extensive records of each batch, lot or unit manufactured, and to retain these records for a period of time equivalent to the expected life of the device, at minimum two years. The FDA explicitly requires that manufacturers compile the Device History Records (DHR), a collection of records which contain the production history of the finished and released products. The DHR provides objective evidence that the devices were manufactured in accordance with the Device Master Records, and acts as a record of traceability information for all units or lots. While ISO 13485:2003 does not call for creating the DHR specifically, it does require the generation of the individual records contained within the DHR.

FDA and ISO regulated production documents and records also include the results of all acceptance activities performed during and after production, as well as records of any rework activities performed.

Challenges faced by manufacturers

Due to the often complicated nature of the medical device production processes, compiling and maintaining the DHR may place a significant burden on the manufacturers. Collecting all required data and information, along with the required signatures may involve gathering highly varied types of data ranging from inspection results to material traceability and sample labels. Signatures or pieces of information missing from the DHR constitute a common source of nonconformance. In fact, most FDA-483 observations on DHRs result from deficiencies in traceability or inspection data, or from missing or poorly defined guidelines for establishing the traceability records.

Maintaining the DHR inevitably results in immense amounts of paperwork. Specific information in the DHR is difficult to find, cross-reference, track, and manage. As a result, a significant portion of the manufacturing cycle time may become consumed by documentation processing.

Furthermore, creating lot quality acceptance and QC reports requires the conversion of paper-based inspection records into digital form, and for the subsequent generation of reports and statistics based on this digital data. This results in further demands on the time of production and QA personnel and introduces the risk of errors when data is manually transformed into digital form.

Finally, while performing root cause or other types of analysis during product deficiency or nonconformance investigations, a significant amount of resources can be wasted on time-consuming document and information searches on paper-based records.