Poor data quality costs the United States economy approximately $3.1 trillion a year. In the medical device industry alone, McKinsey & Company estimates the total direct cost of quality at 6.8-9.4% of industry sales, which equals $26-$36 billion annually. By relying on outdated, manual processes in a data-driven world, organizations are increasing their risk of using bad data, racking up operational costs and missing out on proven benefits of digitization.
Before letting go of paper-based production processes, manufacturers must evaluate any new technology on “its ability to drive measurable, scalable impact to your production operations, product quality and site performance,” according to a new MasterControl customer spotlight titled “Metrics That Matter for Quality Manufacturing.”
In initial conversations, life sciences companies considering a move to digital production records told MasterControl they anticipate they will be able to achieve 30% efficiency gains, and as new data is collected, those anticipations are becoming reality.
To date, manufacturers that have fully digitized their production record processes have realized three real benefits that are having a measurable impact on operational performance.
At every step of a manual production record process, tasks are slow, cumbersome and subject to human error. Records must be filled out on paper, by hand, as each step of manufacturing is completed. For companies relying on a manual, paper-based production record process, inaccurate or missing information can have real consequences in the ability to ship products, remain profitable and maintain audit-readiness.
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Digitizing the production record process can reduce data input errors that create data integrity issues across your organization, including mismarks and missing or illegible fields, and can automate review and traceability of changes or edits. For instance, Wellington Foods struggled to overcome persistent production documentation errors and rising manufacturing costs. But after implementing MasterControl’s Manufacturing Excellence solution, the nutraceuticals contract manufacturer has seen a 90-100% decrease in common data input errors.
A manual production record process will cause problems such as slow detection of necessary deviations and higher occurrence of disruptive in-process deviations. For example, if you must wait hours or days for a document to be completed and uploaded, it can take longer to see when a deviation is necessary. This lack of deviation control increases the risk of deviations resulting in a product that is outside of acceptable delivery parameters, delayed or over budget.
An integrated, digital solution can help companies reduce deviations, deviation impact and the number of those deviations that turn into corrective and preventive actions (CAPAs). Greater access to data and insights from the factory floor facilitates more informed decisions about when to deviate from prescribed procedures and improves controls to ensure that any deviations are within acceptable margins. Legacy Pharmaceutical Packaging, an early adopter running a parallel pilot of the MasterControl Manufacturing Excellence solution, anticipates a 21% reduction in total deviations.
When records must be assessed manually before the manufactured product can be released, the time it takes to check entries, request corrections and make revisions adds up. Just as physical document review is slow, it is often inaccurate because the human eye is more likely than a digital solution to overlook key forms and data. In addition to tying up resources with paperwork, a manual, paper-based review process can lead to lot release delays and slow cash flow.
Digital data input, built-in controls, in-process training enforcement and automated workflow routing enable a dramatic reduction in time spent reviewing and correcting documentation. For example, Wellington Foods has cut its review period from 10-15 days after production completes by 75-80%. Legacy Pharmaceutical Packaging has more than 200 batch records that must 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 with the digital solution.
Ultimately, digitizing and automating paper-based production record processes frees workers from manual, time-consuming tasks to focus on more value-adding activities.
“We have seen customers achieve a 50% reduction in the number of individuals dedicated to management of production record paperwork in the first three months of going live,” according to MasterControl’s customer spotlight report. “They have been able to reallocate individuals to production process improvement instead of paperwork, which means more people working to get higher quality products to market faster.”
To learn more about how life sciences manufacturers measure the impact of digital transformation, download the “Metrics That Matter for Quality Manufacturing” report. For an idea of how much your company could save by fully digitizing and automating production records, use MasterControl’s ROI calculator for manufacturing.
Download MasterControl’s other informative knowledge briefs, “The War on Paper: A Corrective Action Plan for Going Paperless” and “Architecting for Change: Embracing a Platform Approach” for additional insights and perspectives on automation and digitization.
“Metrics That Matter for Quality Manufacturing,” MasterControl, 2019.
"Extracting Business Value from the 4 V's of Big Data," IBM Big Data & Analytics Hub.
"Capturing the Value of Good Quality in Medical Devices," McKinsey & Company, February 2017.
David Butcher has covered business and technology trends in life sciences and industrial manufacturing for more than 15 years. Currently a marketing communications specialist at MasterControl, he previously served as editor of Thomas Publishing’s Industry Market Trends and as assistant editor for Technology Marketing Corp.’s Customer Interaction Solutions. He holds a bachelor’s degree in journalism from the State University of New York, Purchase.