GxP Lifeline
3 Quantifiable Benefits Manufacturers Can Achieve by Eliminating Paper
While digitization brings many advantages and efficiencies to our modern lives — whether it’s the ability to hail a ride with a click of a button or stream your favorite movie from a screen that fits in your pocket — most of those intangible benefits can’t be calculated (unless facial-recognition software is already monitoring the size of the smiles on our faces, that is). But in the world of manufacturing, a measurable metric is the only thing that can guarantee a reproducible outcome.
Manufacturers that have replaced their manual, paper-based processes and production record management practices with fully digitized systems have discovered three tangible benefits that are having appreciable effects on key performance indicators (KPIs).
#1. Improved Production Accuracy
Digital systems give manufacturers the power to get production right the first time by eliminating preventable errors, minimizing review cycles and reducing the resources and effort wasted during manual data entry processes.
Like most manufacturers that rely on paper-based systems to manage production records, Legacy Pharmaceutical Packaging recognized that its insufficiencies with KPIs like right first time were largely due to an outmoded system. So the contract pharmaceutical packaging company sought a solution that could seamlessly connect production records and processes with line performance, operations and quality assurance personnel. After implementing a fully digitized production record management solution, the company now has the tools to measure the accuracy of production and eliminate many errors that previously inhibited production performance and led to costly rework.
“By preventing documentation issues in real time to minimize error corrections, we mitigate the need for deviations and rework, and also strengthen our compliance efforts,” said Cory Robinson, director of quality at Legacy Pharmaceutical Packaging. Robinson said the company’s choice to digitize manufacturing processes has improved production accuracy in measurable ways by “ensuring data integrity the first time, which has improved our overall quality performance and positively impacted the customer experience across our entire production life cycle.”
#2. Improved Production Efficiency
Paper-based processes and production records are not only prone to error, they also make inefficient use of resources, increase the likelihood of deviations, and have a greater tendency to delay product releases.
Wellington Foods, a contract manufacturer of nutritional supplements, continually found itself perpetuating the vicious cycle inherent in traditional paper-based manufacturing processes: small errors aggregate into entrenched inefficiencies that result in continual increases to avoidable costs.
“Like many manufacturers, we’ve struggled to overcome persistent production documentation errors and rising manufacturing costs,” said Robin Joyner, Wellington Foods’ system administrator. After implementing a fully digital solution, however, the company has seen a noticeable reduction in errors and far less friction between operations and quality assurance. “We experienced a 90% decrease in data input errors, which allowed us to accelerate production record execution and product releases to grow our business more efficiently.”
Legacy Pharmaceutical Packaging’s digital transformation has wrought similar efficiencies. The company has more than 200 batch records that need to go through quality review processes, and changes and corrections that used to take two to three hours per record have been reduced to 10-15 minutes per record thanks to a streamlined digital system.
#3. Improved Quality
Reducing the number and severity of quality events is critical to optimizing manufacturing processes. Yet many manufacturers continue to rely on paper-based systems that often exacerbate the impact and complexity of quality events.
“When manufacturers have a paper or hybrid process, data becomes trapped in the paper, making it much harder to see the trends,” said Matt Lowe, executive vice president of cloud-based quality and compliance software provider MasterControl Inc. Companies that take preventive measures in their quality and manufacturing environments can significantly reduce deviations, variances and similar types of quality events, Lowe said. “Siloed data, paper records and disparate systems are low-hanging fruit for these companies to make the move to digitization, which ties processes together and improves both quality and manufacturing excellence.”
The integrated digital production records management system implemented by Legacy Pharmaceutical Packaging includes a built-in quality event analyzer that automatically applies a risk-based approach to assessing a deviation’s potential to develop into a full-fledged corrective and preventive action (CAPA). The contract manufacturer is leveraging this functionality to dramatically reduce the impact of deviations in their production environment and anticipates a 21% reduction in total deviations in comparison with its quality output when using the defunct paper-based system.1
Digital Baby Steps
It’s not difficult for manufacturers see the many upsides of digitization, but most are hesitant to initiate a full war on paper and embrace their own digital evolution without firsthand experience of the benefits. Many are overwhelmed by the prospect because of the scale of their operations and the ripple effects that switching from a legacy system to a fully digital solution might have throughout their organizations. Lending credence to these fears is the fact that, despite steady investments in innovative technologies, 70% of complex, large-scale transformation initiatives don’t reach their stated goals.2
Fortunately, not everything has to be digitized at once. By taking a “small automation” approach, manufacturers can eat the digital elephant one bite at a time, so to speak, and focus on the fast implementation of flexible and adaptable technologies to fill any gaps in their existing enterprise systems. One digital pilot initiative in one specific function or department can prove digitization’s value to stakeholders, often in a short amount of time. According to PwC, research indicates that small automation can improve individual process productivity by 80% (or as much as 100% in the case of touchless solutions) and overall functions by 20 percent or more.3
Take the example of the systems used by medical device manufacturers to manage device history records (DHRs). One manufacturer cited in McKinsey & Company research achieved spectacular results when it replaced its inefficient paper-based DHR management system with a digital manufacturing execution system (MES). The digital solution profoundly enhanced the company’s ability to detect and prevent problems by enhancing visibility and accelerating quality processes like root-cause detection. Digital empowerment allowed the manufacturer to decrease documentation errors by 100% and make substantial reductions in workmanship complaints (65% decrease), overall complaints (58%) and production noncompliance reports (41% decrease).4
The proof is in the outcomes. Eliminating your paper processes doesn’t just save a few trees and a lot of storage space — it has a quantifiable impact on production KPIs.
Learn more about the transformative power of digitization in the insightful executive brief “The War on Paper: A Corrective Action Plan for Going Paperless” from MasterControl.
References
1. “Metrics That Matter For Quality Manufacturing,” MasterControl customer spotlight.
2. “The ‘how’ of transformation,” by M. Bucy, A. Finlayson, G. Kelly, and C. Moye, McKinsey & Company, May 2016.
3. “The New Automation Is Smart, Fast, and Small,” by D. Priest, K. Krishnamurthy, and A. Blanter, Strategy+Business, April 24, 2018.
4. “Capturing the value of good quality in medical devices,” by T. Fuhr, E. Makarova, S. Silverman, and V. Telpis, McKinsey & Company, Feb. 2017.
James Jardine is the editor of the GxP Lifeline blog and the marketing content team manager at MasterControl, Inc., a leading provider of cloud-based quality, manufacturing, and compliance software solutions. He has covered life sciences, technology and regulatory matters for MasterControl and various industry publications since 2007. He has a bachelor’s degree in communications with an emphasis in journalism from the University of Utah. Prior to joining MasterControl, James held several senior communications, operations, and development positions. Working for more than a decade in the non-profit sector, he served as the Utah/Idaho director of communications for the American Cancer Society and as the Utah Food Bank’s grants and contracts manager.
