Most manufacturers have digitized their core enterprise processes using software systems like enterprise resource planning (ERP), manufacturing execution systems (MES) or material requirements planning (MRP). However, even with these digital efforts, a critical gap remains between quality assurance and manufacturing operations, as people on the production line still rely on paper-based production records and spreadsheets.
This digital gap has left manufacturers susceptible to data entry errors, long good manufacturing practice (GMP) review times, shipment delays and other paper-based challenges. By relying on outdated, manual processes in a data-driven world, organizations are increasing their risk of using bad data and racking up operational costs. They are also missing out on proven benefits of digitization, including:
A paperless approach can deliver measurable results that have a notable impact on manufacturing operations, product quality and the bottom line.
In initial conversations for a MasterControl report titled “Metrics That Matter for Quality Manufacturing,” life sciences companies considering a move to digitized production records said they anticipate being 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 measurable benefits.
#1: Fewer Production Errors
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 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.
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, after implementing MasterControl’s Manufacturing Excellence solution, nutraceuticals contract manufacturer Wellington Foods saw a 90%-100% decrease in common data input errors.
#2: Fewer Deviations
A manual production record process will cause problems such as slow detection of necessary deviations and higher occurrence of disruptive in-process deviations. The longer you have to wait for a document to be completed and uploaded, the longer it can take 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 or delayed.
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) by providing greater access to data and insights from the factory floor. Contract manufacturer Legacy Pharmaceutical Packaging, an early adopter running a parallel pilot of the MasterControl Manufacturing Excellence solution, anticipates a 21% reduction in total deviations.
#3: Faster Review and Release
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. Physical document review is slow and often inaccurate. 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. Wellington Foods cut its review period from 10-15 days after production completes down to three days, a 75%-80% reduction. Changes and corrections that used to take Legacy Pharmaceutical Packaging two to three hours per record during the quality review processes have been reduced to 10-15 minutes per record with the digital solution.
Ultimately, digitizing and automating paper-based production record processes frees up 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 the MasterControl 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.”
Before letting go of traditional, paper-based or hybrid solutions, manufacturers must evaluate any new technology on its ability to drive measurable impact on their operational performance and product quality. A digital production system like MasterControl Manufacturing Excellence can close the digital gap left by paper processes on the shop floor and deliver significant, measurable productivity and quality improvements.
To learn more about how fully digitizing and automating production records helps life sciences manufacturers improve key performance metrics in their digital transformation journey, download the complimentary “Metrics That Matter for Quality Manufacturing” report.
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