Design for Quality Device History Record
A Design for Quality approach also streamlines the process of creating and submitting device history records (DHR) to regulatory agencies.
Medical devices must meet certain requirements and validations that are more stringent than in other industries, so a DHR plays an important role in the quality management system. It conveys to regulatory agencies a product’s entire history, including who built it and when, who performed testing and when, and details on the calibration and maintenance of testing equipment.
A typical DHR can run between dozens, even hundreds, of pages depending on the complexity of the product. It has traditionally been a person-dependent, intensive process that is prone to inconsistent results. This is a recipe for failure to meet FDA requirements.
80%
of all warning letters the FDA issued in 2016 included data integrity deficiencies.
Just one typo or a seemingly minor paperwork error such as a missing signature, correction initials or date on a page can delay the regulatory approval process.
Creating the DHR can be particularly difficult for startups or other companies that do not have much experience in manufacturing or in navigating the regulatory review and approval process. It requires ensuring that all manufacturing operators working on the product follow strict procedures and provide accurate records at the appropriate times.
It is a daunting task that requires a lot of training, and it is ultimately fallible because it relies on human input and behavior to ensure consistent, accurate results. Transitioning from paper to electronic DHR (eDHR) eliminates the reliance on manual processes to ensure reliability and verification.
An eDHR is the automated output of the enormous volumes of data that manufacturing systems generate to improve the analysis of potential issues, generate consistent results, and substantially reduce the risk of FDA review.
Once the desired output and outcome is achieved, the manufacturer has a process for building the product correctly that will make it easier to scale up volume production in the future. This also facilitates Corrective and Preventive Action (CAPA) and Complaint Investigations to demonstrate prompt and effective completion of actions and reduce product liabilities and impact to patient safety, compliance, and business risk when conducting field actions (recalls).
Design for Quality
Not a DIY Project
It’s not uncommon for the assembly of complex medical equipment to require thousands of parts. The resulting DHR can run dozens, hundreds, or even thousands of pages with several entries on each page. That requires completing, inspecting and approving thousands and thousands of entries.
A single data entry error - even one that would not affect the quality or performance of the device - could lead to FDA rejection. Leveraging the automation capabilities of an eDHR process eliminates that risk.