GxP Lifeline
On the Road to More Efficient Manufacturing: A Digital Solution
Global Positioning System (GPS). The now seemingly ubiquitous smartphone app or vehicle-installed device even has a nice high-tech ring to it, with technological infrastructure that to this day is still bankrolled by Uncle Sam.1 Developed by the U.S. Department of Defense in 1978 and originally restricted to military use, the technology was made available to the public in 1983. In the past 20 years, GPS technology has exploded in the commercial sector in virtually every industry and is used by everyone from the UPS deliveryman to your family member trying to find their orthopedic specialist.
But this digital gadget that provides paperless, virtually error-free navigation in cars, on boats, on bicycles or even on foot, is a relatively new concept in the world’s history of technological marvels. In the still not-too-far-distant past, people relied on often dubious verbal directions, cumbersome maps and road atlases, and their father’s unrelenting and infallible memories – “Don’t worry, I got this.” – to get us from point A to point B.
Whether you look back nostalgically at those days of frantically scanning the Rand McNally on a family road trip so as not to miss the highway exit to the World’s Largest Spud or you cringe at memories of Pop driving 50 miles in the wrong direction because he had too much pride to stop at a service station to ask for directions, one thing is true. GPS has revolutionized the way people navigate the globe, and in doing so, has saved people inestimable amounts of time and headaches for travelers in getting to their destinations.
And it’s not just the younger crowd using Google Maps. According to Statista.com, 154.4 million Americans used the app last year, and three major demographic populations use it nearly equally – 54 percent of ages 18 to 29, 55 percent of ages 30 to 49 and 53 percent of ages 50 to 64.2
But tech that is getting you to your next job interview with plenty of time to spare is just the tip of the iceberg when it comes to the marketplace’s digital transformation, and this shift is forcing us to rethink the way we do business in fresh and startling ways.
Maps as Mementos, Not Tools
Much like the way your cherished backpacking line map of Switzerland in ’87 is no longer useful to you from a navigational standpoint, neither are the half dozen road maps stuffed in the glove compartment of your car. They’re relics of a bygone era or, at the very best, manual backups in case the zombie apocalypse hits and all our electronic technologies go dark.
It’s a similar situation in the manufacturing world where the rapid pace of technological innovations is fundamentally changing the way production floors operate. Instead of outmoded paper-based production record systems that are slow, inefficient and prone to human error, manufacturing executives, to lower costs and stay competitive, are turning to digital solutions. In a new white paper titled “21st Century Manufacturing: An Investment in Digital Data and Operational Efficiency” manufacturing executive and industry veteran Dave Edwards makes the case that manufacturers can substantially improve quality and efficiency on their shop floors through intelligent automation.
Though a wide cross section of manufacturers continues to rely on paper-based production record systems, the quantity of errors these antiquated systems introduce during all phases of the manufacturing process result in costly delays and lost revenue. A 2017 study by Vanson Bourne found that nearly 20 percent of unexpected manufacturing downtime was the result of human error.3 Cumulative human errors turn into poor data that then snowballs into deviations and delays. The net impact is that more revenue must be earmarked to quality control instead of value-added activities such as a company’s lean programs or product improvement. This uncontrolled (and unnecessary) bleeding of time and money due to poor quality data fouling up manufacturing processes is underscored by the fact that, in 2016, poor quality data resulting from shop floor errors cost manufacturers $3.1 trillion in the U.S. alone.4 And in regulatory circles, the U.S. Food and Drug Administration stated that data integrity issues resulted in 86 percent of the 483 warning letters sent to pharmaceutical manufacturers between 2014-2018.5
Simply put, paper-based systems in today’s competitive manufacturing environment are analogous to the printed road navigation of the past: they’re more prone to human error, they’re bound to waste precious time and they’ll cumulatively end up costing more money than they’re worth.
The GPS of Production Records
So, how do you effectively and efficiently navigate and manage production records on your organization’s shop floor in 2019? Along with the numerous innovation technologies that are currently transforming factories, including artificial intelligence, the cloud, blockchain, predictive analytics and many others, there is the digital production records solution. To help your company achieve the ideals of Industry 4.0 and smart manufacturing, an automated production records solution balances rather than replaces your existing data systems, such as manufacturing execution system (MES), materials requirements planning (MRP) and enterprise resource planning (ERP). But what the digital production records solution does for a manufacturer that those other systems can’t is to create and manage electronic versions of your batch records (also known as device history records, production traveler, etc.) to help eliminate human error by preventing bad data entry at the source. With a decrease in poor or missing data in your production systems – often the result with paper-based systems – the digital solution significantly reduces deviations, downtime and the associated quality control expenses that waste time and prevent product from getting to customers faster.
For the C-suite, a digital production records solution means considerable time savings, expedited delivery and product throughput, and greater ROI and cash flow for your organization. It means no more wild goose chases or traveling in the wrong direction when it comes to ensuring that your organization remains competitively sharp in an increasingly more cost-conscious and cost-competitive manufacturing marketplace.
Read the new white paper “21st Century Manufacturing: An Investment in Digital Data and Operational Efficiency” to learn more about how the investment in digital quality and efficiency pales in comparison to high costs of poor data, human error, deviations and downtime, including specific metrics examples from early adopters of the digital production records solution. Technological solutions are replacing paper-based systems on the shop floor precisely because they can have a drastic effect on a manufacturer’s bottom line by eliminating waste and error from the production equation.
References
- “Open Data’s Impact: United States GPS System Creating a Global Public Utility” By Young, Rogawski and Verhulst, Omidyar Network,January 2016.
- “People who use their cell phone for maps and GPS navigation in the USA” Statista.com, June 2018.
- “After the Fall: The Costs, Causes & Consequences of Unplanned Downtime” Vanson Bourne, Oct. 18, 2017.
- “Bad Data Costs the U.S. $3 Trillion Per Year” Thomas C. Redman, Harvard Business Review, Sept. 22, 2016.
- “Data Integrity Trends in 483s and Warning Letters: Part 1"" by Michael de la Torre, FDAZilla, May 16, 2019.
Mike Rigert is a content marketing specialist at MasterControl’s headquarters in Salt Lake City, Utah. A native of the Chicago area, he has nearly a decade and a half of experience creating journalism and marketing content for the news media, public safety and higher education. He has a bachelor’s degree in political science from Brigham Young University.
