It’s a common misperception that an electronic device history record is merely a DHR converted from paper into an electronic format—a change of media. Rather, companies employing eDHRs have changed much more than the means of recording and documenting a device’s history; they’ve transformed the way they approach product quality, and in doing so have moved it forward so they can compete more effectively in today’s highly regulated environment.
Product quality really happens at the intersection of a company’s value and product lifecycle chains. At this juncture, you must execute at the point of manufacturing, being right the first and every time; otherwise, you’re dissipating product and profitability.
A manufacturing organization takes five steps in advancing product quality:
- Define the product and process.
- Enforce the manufacturing build per the DMR.
- Manage service and repair, leveraging both internal and customer feedback.
- Improve current and future product designs through learning at all prior stages; look at information to see where product quality fails.
- Enhance process and product quality continuously.
Companies that adopt these steps find regulatory compliance a natural outcome, not a singular objective; as such they continue to advance product quality. (Companies who see compliance as a singular objective may be compliant but won’t improve product quality on a continual basis.)
How eDHR Facilitates Product Quality
Variability is inherent in manufacturing. The process of product variability in the manufacturing environment has multiple components:
- Material certification
- Operator certification
- Equipment calibration
- Process control and test data
- Route assurance
These form the “five Ms” that eDHR systems manage: man, material, machines, measurement, and methods. By providing visibility across the whole enterprise, eDHR enables forwards and backwards identification and comprehensive traceability. It also creates a system that self-audits. Implementing this process has allowed huge improvements in product quality for medical device manufacturers, because they are enforcing the way to build a product to the exact specifications of the Device Master Record (DMR).
Everything needed to analyze a non-conforming material report is housed in an eDHR system, which empowers the user to look at quality from a holistic perspective. The system provides the data necessary to understand machine, operator, product, and process events from the shop floor, as well as from customer and supplier input.
Importantly, the systems can be applied on a global basis, providing access to real-time information anywhere, anytime. This ability helps to determine quickly whether corrective and preventive actions (CAPAs) need to be taken anyplace in the enterprise’s manufacturing pantheon.
While moving product quality forward, eDHR helps manufacturers improve process visibility, enforce in-process controls, ensure full product traceability, and minimize manufacturing and regulatory overhead. In essence, these factors significantly reduce cycle times, increase yields, and improve capacity.