Avoiding the Ripple Effect of Bad Data: Quality and Manufacturing

This is Part 1 of a series on maximizing efficiency and improving data analysis. Read Part 2: Integrating Disconnected Data Systems and Part 3: Using Process Automation to Reduce Human Error.

In today’s marketplace, building in quality is a critical competitive differentiator, but seemingly conflicting priorities between quality and manufacturing departments have put each of these critical pieces at odds and undermined their shared objective of getting the best possible products into the market. However, fully connected digital solutions in either quality or manufacturing help the other department and show how interdependent these two groups are.
 
For example, less than a decade ago, Megadyne Medical Products, an end-to-end, full-solution electrosurgical equipment and accessory developer and manufacturer, used a paper-based system for document control and change control processes. During the routing process, the company discovered multiple employees from different departments were making changes to documents, which caused additional delays as each revision needed to be rerouted through the approval process again. This inefficient system made it difficult to comply with regulations standards. Megadyne’s paper-based system also caused delays during audits with regulatory agencies. Their warehouse contained stacks of banker’s boxes for storing documents. When auditors requested specific documentation to show compliance, the document control staff needed to sort through piles of hard copies to find the documents they needed.
 
“The paper-based system was constraining for us,” said Haven McCall, vice president of quality and regulatory affairs at Megadyne Medical Products. “It soaked up a lot of time, money and resources just to make a minimal change.”
 
Making the Switch
Once Megadyne implemented an electronic quality management system (QMS), the effects were immediate. Challenges the company had relating to the amount of time spent searching for documents and routing documents for reviews and approvals was drastically reduced. Review and approval processes that had taken weeks, or months, to finish, were completed in a matter of days. Digitizing also allowed Megadyne to have increased reporting and visibility into where a change order was located, where it was within the approval process, who it was with and if it was open and aging.
 
Similarly, companies that digitize manufacturing are seeing benefits that extend to the quality department. These benefits are at their greatest when employing a manufacturing solution that completely rids the shop floor of paper as opposed to only digitizing part of the process. For example, medical device manufacturers have invested in manufacturing execution systems (MES) and industrial automation technologies, but final production documentation and records are often still paper-based. These analog processes, regardless of how meticulously data is recorded, can result in disconnected data, blind spots, wasted cycles, and inefficiency. Further, manual data entry errors and remediation drive production costs up while reducing efficiency and can result in shipping delays and lost revenue.
 
Contrast that with a fully connected, errorless, frictionless, paperless solution. This doesn’t just make the manufacturing process smoother and faster; it also makes quality’s job of production records easier. Legacy Pharmaceutical Packaging implemented MasterControl Manufacturing Excellence and saw their quality review time decrease from 2-3 hours per batch to 10-15 minutes per batch. Speeding up the review process is partly due to the solution’s ability to reduce errors as the production records are filled out. Contract manufacturer Wellington Foods reduced their data entry errors by 90-100%. These benefits reduce frustration for both quality and manufacturing as well as making the goals of both compatible.
 
These experiences are not unusual. By digitizing and automating production records and other key manufacturing processes, manufacturers can eliminate any discrepancies between line performance and product quality and reduce the friction between manufacturing operations and quality assurance priorities. This paperless process avoids the “ripple effect” of bad data in medical device manufacturing, wherein inaccurate production record data leads to paperwork issues and deviations. Those in turn lead to extensive downtime, which increases quality expenditures, and culminates in decreased revenue and product throughput. Digitizing can assist with achieving new levels of operational efficiency, not only between quality and manufacturing, but systems and data and humans and machines.
 

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Terrance Holbrook is the director of product at MasterControl, where he is responsible for market research, product design and development of functionality for MasterControl’s full suite of solutions. He has 25 years of experience in manufacturing and seven years of experience in international medical device development. Holbrook has led the AI/ML development for Fortune 50 companies, launched over 400 products and hosted FDA inspections and mitigations, ISO certifications, and international registrations. Holbrook holds patents on risk-based upgrade and validations and has four patents pending. He has a bachelor’s degree in business administration from Purdue University and an MBA from Westminster College.