Achieving Next-Level Quality With Digital Technology in Manufacturing

For manufacturers regulated by the U.S Food and Drug Administration (FDA), quality documentation follows manufacturing operations through every step of production. Managing this documentation manually, on paper, increases the risk of human errors and decreases the ability to track changes, identify quality events, and take corrective action in real time.

Even when manufacturers have automated some core operations, such as with a traditional manufacturing execution system (MES), critical production processes are still paper-based or disconnected. Using a legacy MES, all production capacity that isn’t automated still has paper-based production records.

In fully or partially paper-based manufacturing environments, the production line is an underappreciated opportunity to make quality proactive rather than reactive.

Digital Technology in Manufacturing to Embed Quality in Production

Digital technology in manufacturing can ensure quality at every step of production. Manufacturing Excellence, MasterControl’s modern MES solution with digital production records, eliminates data entry errors, improves right-first-time metrics, and proactively tracks production data that affects quality on the line

For example, automated data integrity checks and error-proofing features reduce mismarked, illegible, or missing information on production records. Automated real-time quality review at each step on the production line helps ensure lots are right the first time. Using Manufacturing Excellence, manufacturers can digitally authenticate user signatures and automate the review and traceability of edits.

By using MasterControl’s modern MES solution, manufacturers can further embed quality in production by:

• Automatically assessing risk and launching quality forms and events, such as nonconformance and deviations, directly from the production line.

• Linking their standard operating procedures (SOPs) and work instructions directly to each step of production.

• Automatically launching training, enforcing training compliance, and ensuring training records match production record documentation.

In short, the solution enables organizations to track changes automatically, identify quality issues, take corrective action in real time, and essentially validate production processes in real time – dramatically reducing good manufacturing practice (GMP) review times.

Document Control Software for Manufacturing to Achieve Quality at the Source

MasterControl’s modern MES solution incorporates core quality elements into its document control software for manufacturing, including electronic documentation, the good documentation practice (GDP) process, and quality review.

Manufacturing Excellence provides a digital master production record template and a digital production record. System functionality supports the need to review, approve, and execute a master production record template to create the electronic production record templates and final documents. For templates, that includes approval routing, watermarks and signature manifest, and version and revision control. For the production record, that includes a legible and auditable report.

MasterControl’s modern MES also serves as a GDP guidance system for better data integrity, with integrated, data-driven prompts that:

• Guide operators through work instructions using proper GDP.

• Enforce numeric limits and thresholds.

• Ensure operator training records are always current

• Navigate corrections and signatures using GDP.

• Inform operators of related open deviations.

Finally, Manufacturing Excellence makes complete review-by-exception possible, with every step and human interaction digitized. Reviews happen in conjunction with production, so there’s no more manually sifting through papers to fix errors after the fact. When production is finished, there are fewer issues needing review and you can simply review exceptions to processes and documentation.

Quality Benefits of Digital Technology in Manufacturing

By using digital technology in manufacturing to embed quality directly into production, organizations achieve significant efficiencies in both quality and manufacturing teams’ shared processes, including document revisions, GMPs, training, and review and release. Proven benefits of the Manufacturing Excellence solution include:

• 90% fewer data input errors.

• 80% faster GMP record review.

• 30% faster product release.

• 25% fewer deviations.

When operators have the digital tools to deliver quality at the source – when quality is embedded in production – every operator, step, and output of the production process is an opportunity to ensure quality and compliance.

To learn more about how digitizing manufacturing can improve quality, download “The Ultimate Guide to Digitizing the Shop Floor.”