The smart factory has been a top manufacturing initiative for years as shop floors continue to become digital, automated, and intelligent. Today, companies are investing heavily in smart manufacturing, intelligent automation, and advanced robotics. A 2019 report from PricewaterhouseCoopers and the Manufacturing Institute found that 73 percent of manufacturers planned to increase their investment in smart factory technology over the next year.1

Even as Industry 4.0 and its underlying technologies increase in various areas of manufacturing, many manufacturers still struggle to digitize the “last mile” of their factory floor, where operators typically still use paper-based device history records (DHRs), or production records. No matter what other investments in plant digitization have been made — enterprise resource planning (ERP), manufacturing execution systems (MES), material requirements planning (MRP), learning management systems (LMS), the list goes on — the investments are too often impeded by critical processes such as DHR execution and review that remain manual, disconnected, and often paper-based activities.

Paper may seem like a cost-effective option for managing DHRs, but even a small amount of it on the factory floor carries high costs associated with quality alone. For manufacturers, risks of relying on paper-based processes in a data-driven world include disconnected and inefficient DHR processes, inaccurate information on the DHRs, poor data tracking throughout the production life cycle, preventable quality issues and costly delays. In a survey of senior executives from medical device, contract manufacturing, and pharmaceutical companies, Accenture found that quality testing and batch release accounts for upwards of 70 percent of manufacturing lead time mainly due to manual processes, disconnected instruments, and nonstandard paper-based documentation and control procedures.2

Simply put, paper on the last mile of production — FDA 21 CFR Part 820 review and product release — remains a barrier even for manufacturers making strides in their digital transformation efforts. When people on the production line are left to rely on paper, line workers and quality teams are forced to rely on inefficient processes, outdated tools, and inadequate data. With just one missing link in the technology chain, that smart factory future can feel far removed from day-to-day operations.

Digital technology can help manufacturers bridge the paper gap between quality and manufacturing to improve operational efficiencies and product quality during the last mile of production (see Figure 1).

Fig. 1 - Manufacturers can configure a DHR system to match their current forms with the familiar look of paper and easily manage templates. During production, data is captured in real time with data-integrity checks to ensure complete and correct entries or to address in-line quality events. In this digital environment, review cycles are dramatically reduced with review by exception, allowing manufacturers to speed time to market.

How a Digital DHR System Can Bridge the Production/Quality Gap

While many medical device manufacturers have already implemented Industry 4.0 or digital transformation initiatives, they continue to rely on a variety of paper-based or disconnected information systems to monitor, collect and aggregate data surrounding production and quality processes. Poor synchronization between these disconnected data sources severely limits the throughput between manufacturing, quality and other critical business areas, which tends to impede physical operations. As a result, these manufacturers struggle to connect their machines, enterprise systems and the data produced by these entities to access actionable performance insights.

To capture the data and insights needed to optimize production, reduce deviations and corrective/preventive actions (CAPAs), improve right-first-time (RFT) metrics, and accelerate product release, manufacturers must integrate their DHR processes with their ERP, MES, LMS, and other manufacturing systems for a more complete view of the data within their business.

With a paperless DHR system, medical device organizations can create productive connections between systems, processes, and people throughout the entire manufacturing organization for a holistic view of data. Machine operators can input data directly into tablets or computers on the shop floor and pull information directly from an ERP system. They can link standard operating procedures (SOPs) and work instructions to DHR phases, launch deviations, CAPAs, and other quality processes directly from the DHR for constant visibility, automatically launch and enforce training on the production line, and ensure equipment compliance in real time.

By integrating critical manufacturing applications such as ERP, MES, MRP, and others with a digital DHR solution, manufacturers can leverage their data in ways that a paper-based, disconnected system won’t allow:

  • Collect data. Easily configure the type, timing and frequency of data to be collected, eliminate errors in data input and transfer, and ensure data integrity as data moves between systems.

  • Connect data sources. Integrate the DHR process with other systems, seamlessly share data between those systems in real-time, and consolidate bill of materials data in a single system.

  • Contextualize data. Guide operators and enforce limits, thresholds, and training with integrated, data-driven prompts, and gain real-time visibility into production lines, batches or lots.

By connecting users across the shop floor and eliminating manual data management, a digital DHR solution has shown to increase shop floor productivity so manufacturers can focus on their product rather than on their paperwork.

Collecting, connecting, and contextualizing data needed by both quality and manufacturing teams helps address shared processes like document revisions, GMPs, training, testing/sampling, and review and release. By fully integrating production and quality digitally, manufacturers gain the actionable performance insights necessary to improve processes and mitigate errors of manual, paper-based DHRs.