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Productive Connections: Integrating Quality and Production


Today’s enterprise systems are so powerful that manufacturing companies can report on virtually anything. Yet manufacturers rely on multiple systems to monitor, collect and aggregate data across operations, and these data sources are often disconnected, with little communication or interoperability between each system. Worse still, many manufacturers are still using paper-based systems to manage production processes or records, severely limiting their ability to gain insight from data in electronic systems.

If manufacturers can’t turn the deluge of data into intelligence, they can’t translate that intelligence into action and make sure those actions drive results.

In a recent presentation at MD&M Minneapolis, Terrance Holbrook, director of product at MasterControl, and Robert DePalma, VP of regulatory affairs at Pyrexar Medical, explained how manufacturers that digitally connect their production record system with other data sources will quickly stand apart from competitors.

Data Challenges of a Disconnected Production Record System

For companies using disconnected production record processes, the inability to interface with multiple systems poses serious problems. Even electronic systems, if disconnected, offer insufficient tracking of information and documents from different areas throughout the production life cycle. This practically ensures the occurrence of bottlenecks, a critical problem if defective batches must be identified.

Meanwhile, if data is offline or partially digitized, it is disconnected from electronic systems, making it impossible to analyze and use in context with other cross-functional data. That means no real meaningful insights can be gleaned. Manual, paper-based production records are also subject to data-input errors – illegible, missing or inaccurate entries – which can have a ripple effect as data advances through the production process and create data integrity issues across the organization.

Digitally Connecting Production Records With Other Systems

Considering the number of people who must collaborate and share shop floor information, the value of replacing paper-based production record processes with digitized processes extends to several operational areas and data sources. A digital solution can bridge quality and manufacturing by integrating common enterprise applications in a manufacturing IT ecosystem, including:

  • Enterprise resource planning (ERP).
  • Material requirements planning (MRP).
  • Manufacturing execution systems (MES).
  • Laboratory information management system (LIMS).
  • Supervisory control and data acquisition (SCADA).
  • Customer relationship management (CRM).
  • Learning management system (LMS).

By integrating these disparate, but critical, software applications with a fully digital production record system like MasterControl’s Manufacturing Excellence solution, manufacturers can leverage their data in three valuable ways:

  • Collect data. Easily configure the type, timing and frequency of data to be collected, eliminate human errors that are common when manually inputting and transferring data, and ensure data integrity as data moves between systems.
  • Connect data sources. Integrate the production record process with other business systems, including ERP, MRP, MES and LMS, and share data between those systems and functional areas completely, seamlessly and in real time.
  • Contextualize data. Guide operators and enforce limits, thresholds and training with integrated, data-driven prompts, gain real-time visibility into lines, batches or lots, and access current runtime data alongside historic runtime data.

Benefits of Digitally Connecting Production With Quality

A fully digital, integrated solution that consolidates data from the systems listed above can bridge the gap between manufacturing and quality in some key ways:

Collecting, connecting and contextualizing data needed by both quality and manufacturing teams helps address shared processes like document revisions, good manufacturing practices (GMPs), training, sampling/testing, and review and release.

  • Building quality into the manufacturing system. Manufacturers can link their standard operating procedures (SOPs) and work instructions directly to production record phases, launch quality forms directly from the production record, and automatically launch training and enforce training compliance.
  • Improving right-first-time (RFT) metrics. Manufacturers can leverage error-proofing features that reduce mismarks or missing information on records to help ensure lots are right the first time. They can digitally authenticate users/signatures and automate the review and traceability of changes and edits.
  • Increasing shop floor productivity. Manufacturers can connect all users across the shop floor, with operators able to input data directly into tablets and pull information from their ERP, MRP, MES or other enterprise applications. Personnel can focus on product rather than paperwork.

Specifically, manufacturers that have fully digitized their production record process have reduced production errors and total deviations and accelerated review and release. (See “Paperless Manufacturing: 3 Metrics That Matter”)

Integrated digital tools can enable productive connections between enterprise systems, data sources and people throughout the entire manufacturing organization. Although these connections may be possible using a manual production record system, the challenges resulting from siloed data are a serious threat to both quality and production alike.


“Making Connections: Integrating Production With Quality,” Terrance Holbrook and Robert DePalma, MD&M Minneapolis, October 2019.

"MasterControl Manufacturing Excellence Systems Integrations," MasterControl, 2019.

“Metrics That Matter for Quality Manufacturing,” MasterControl, 2019.


David Butcher has covered business and technology trends in life sciences and industrial manufacturing for more than 15 years. Currently a content marketing 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.

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