Despite the advanced manufacturing technology available today, the top challenge facing manufacturers is connecting their machines, IT systems, personnel, and the data produced by these entities to gain access to actionable performance insights. This, along with critical functionality gaps in available manufacturing solutions has resulted in many manufacturers struggling to digitize the last mile of their factory floor.
Compounding the difficulty to go paperless are swirling fears surrounding the idea of automation replacing a human workforce. When any organization brings up the topic of digitizing processes, employees begin to fear their jobs are on the chopping block. Automation has often implied downsizing human employees in favor of machines, but any digital technology implemented within an organization should support and enhance people, not replace them. Instead of optimizing workers out of the process completely, automation should take care of repetitive tasks and free up employees to focus on projects that involve more critical thinking and less data entry.
Using Automation to Enhance the Human Workforce
Process automation is about optimizing people and processes to increase efficiencies and decrease the chance of human error. Human error and siloed data are currently preventing companies from performing complete and reliable analysis. Without data integrity an organization can’t accurately analyze, trend, and make informed decisions about production data. In minimizing manual data entry and utilizing paperless documentation, data integrity is preserved through the reduction of errors in quality and production records. Similarly, this reduction in error speeds up the production process by decreasing the time needed to review a device history record (DHR) so product can be shipped faster.
The time saved from automation and digitization can be reinvested in value-added activities. According to LNS Research, “Manufacturers should harmonize processes, automate these processes with software, connect automated processes to other systems and operations, and leverage collective analytics and learnings to continuously improve system autonomy. This approach shifts the focus of high-value staff away from the mechanics of execution and toward innovation and improvement.”
Through employing a human-centric approach to technology, life sciences manufacturers can extend process improvement activities to the edges of operations and empower digitally connected workers to thrive within data-driven manufacturing environments while leveraging new technologies across production, maintenance, and field service departments. Digital solutions should also enable operators to drive any digital transformations and to focus on activities that leverage their intuition, experience and insight.
With the right software implemented and improved access to shop floor data, process engineers can make better, quicker decisions about nonconformances, deviations, and corrective/preventive actions (CAPAs). Data from the DHR can be used for real-time insights, identifying bottlenecks and evaluating the results of quality and compliance checks. Data-driven manufacturing and electronic DHRs (eDHRs) will additionally give greater visibility throughout the production life cycle, improve efficiency, optimize operations, address production issues before problems arise, improve overall product quality, streamline production processes, reduce unplanned downtime, ensure process compliance, enable end-to-end traceability throughout production, and generate a cost savings for any organization.
Terrance Holbrook is the director of product at MasterControl, where he is responsible for market research, product design and development of functionality for MasterControl’s full suite of solutions. He has 25 years of experience in manufacturing and seven years of experience in international medical device development. Holbrook has led the AI/ML development for Fortune 50 companies, launched over 400 products and hosted FDA inspections and mitigations, ISO certifications, and international registrations. Holbrook holds patents on risk-based upgrade and validations and has four patents pending. He has a bachelor’s degree in business administration from Purdue University and an MBA from Westminster College.