It’s not surprising that in some industries—including food and beverage, pharmaceutical, and medical device manufacturing—electronic record keeping is required by the Food & Drug Administration (FDA) 21 CFR Part 11. To remain compliant and ensure product safety for consumers, manufacturers must properly manage documents and records on monitoring traceability and recalls, providing corrective and preventive action (CAPA), and handling food safety audit requirements. That’s why—in an age when electronic data is the norm—it’s shocking that many manufacturers are still working with manual, paper-based data collection systems.


The Pitfalls of Paper

While it may seem cheaper to manually administer quality and safety programs on paper, it is by no means efficient—and it leaves too much room for error. Paper records can be lost, altered, or misplaced. It’s far too easy to introduce errors with illegible entries. And it’s difficult—or impossible—to retrieve accurate information.

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All of this ultimately results in costly delays, lost business opportunities, and frustrated plant staff. Of course, manufacturers need to consider a range of factors as they move to handle records electronically. However, the change provides an array of advantages when compared with paper-based data collection methods.

Let’s look at how to get off paper—and transform your quality management practice.


Digitize Quality Management Data

The move from paper to electronic record keeping begins with data collection. It’s the first thing manufacturers mention when they talk about their paper-based systems. They already know that a move from paper to electronic data—what we sometimes call “digital transformation”—is not only good for your modern manufacturing business but also becoming a necessity as well.

Some organizations have hesitated to make the change from paper to electronic records because changing the paper habit seems difficult. They believe moving to a new technology system will be time-consuming and expensive. But manufacturers have realized that paper is very expensive and incredibly inefficient. Consider the variety of high costs that you bear with paper-based systems:

  • Constant monitoring for errors and skipped entries
  • Waste and scrap from missed or incorrect data
  • Maintenance of your burgeoning library of paper documentation
  • Lost manpower and time during audits, when you have to assign key individuals to research and report from that paper-based information

When you consider the declining cost of cloud-based digital technology—and the immediate ROI of being able to see issues and prevent scrap and recalls—staying on paper just doesn’t make sense.

But the primary reason for digitizing quality management is that quality matters to your customers and your business. If you produce goods that are sub-par, consumers will not buy them. And if they do, they won’t buy them again. If you ship goods that are unsafe or in breach of regulations, the authorities will soon be knocking at your door.

So, the first step in your transformation journey should be moving to electronic data collection. You reduce errors, catch problems early, save time and money, and—in the long run—hang on to your customers by producing consistently high-quality goods.


Why Handle Data Electronically? Top 5 Reasons

When you’re making the case for moving to electronic data, start with these five key considerations.

  • Do more with less: Get visibility into your processes to ensure they are optimized and efficient.
  • Improve agility and responsiveness: Adapt to volatility and uncertainty on both the demand and supply sides of your manufacturing organization.
  • Quality never rests: If you produce goods that are sub-par, sales suffer.
  • Tribal knowledge is a high-risk strategy: Plant-floor knowledge that is locked in the heads of experienced people is vulnerable to loss.
  • Remote work is the new reality: We must find a way to give people access to the data, analytics, and information they need—wherever they are located.


Paper-to-Electronic Conversion in 3 Steps

1.Standardize

Standardization makes everything easier in quality management—from collecting quality data to analyzing and reporting.

Centralizing your quality data in the cloud is the easiest way to standardize. Standardizing naming conventions (e.g., product codes, feature names, lot number formats) is crucial to bringing order to your manufacturing efforts. It ensures a common code of communication across all plants. And it supports system-to-system integration, enabling simplified high-level reporting and data analysis across all plants.

When naming conventions are standardized, your quality management system can easily aggregate data across production lines and plants, providing corporate-wide quality insights that are otherwise impossible to uncover.

2. Select the right solution

Deciding on an implementation architecture for your data collection software is a critical factor. If it’s necessary to get up and running quickly with minimal internal IT commitment or structure, then a cloud-based quality management solution is in order. Without a robust and well-maintained infrastructure in place, an on-premises solution may not be preferable.

Also consider ongoing maintenance and upkeep. Will IT staff be available to maintain upgrades and licensing, or would it be beneficial for the software provider to handle that in the cloud? With the cloud, time-consuming and costly “upgrades” become easy, painless, behind-the-scenes “updates”—handled by the software vendor. The beauty of this is that everyone using the software always has the most up-to-date version. Always.

And cost is always a concern. Cloud solutions offer a recurring subscription expense, whereas on-premises deployments often require updated technical infrastructure. And cloud subscriptions are easily scalable. Buy only what you use at a given time—when things get hectic, add subscriptions; when things slow down, remove some. Easy!

3. Instill positive change

The last hurdle in every company-wide change is ensuring that everyone is using the software properly and taking full advantage of its features and functionality.

Never assume that because there is a change, everyone will know how to adjust. Every employee must know the proper standards and protocol to ensure a seamless move to digital. Creating a culture of quality and instilling proper change management smooths the way to full usage and benefits.

At InfinityQS, our quality experts recommend that manufacturers start small and then expand iteratively. This agile approach allows your operators, quality professionals, and managers to gradually become more comfortable with the software system and how it may change the way staff members think about their new digital world.

Once managers and operators truly understand the power they have at their fingertips, they will begin to modify their approach to gathering and entering quality data into the system. This iterative approach can also be less disruptive to overall manufacturing operations and the individual users, reducing the impact of the change.

Moving from paper to electronic data might seem like a seismic shift for some organizations. But freedom from paper brings immediate benefits for everyone in your organization—from operators to supervisors to executives. It’s time to make the change.


We invite you to visit the InfinityQS website to learn more about how a digital solution will make your critical production data actionable in real time.