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Michael Jovanis

Management

How to Break Out of the QMS Investment Cycle

Don’t be trapped by legacy systems

Published: Wednesday, April 5, 2017 - 11:01

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Particles of metal in children’s medicine. Adulterated baby formula. Spontaneously combusting smartphones. When scandal is only a tweet away, companies can’t hide from quality failures.

High-profile quality problems like these can not only harm consumers, but also lead to huge remediation costs, damaged brand perception, and risk of legal and regulatory actions to the parent company and its suppliers. More than ever, it’s critical for today’s companies to maintain the highest level of quality.

Reducing costs while trying to enhance margins have driven many organizations to use a range of global suppliers and external manufacturing partners. Operational norms have evolved, but many organizations have been slow to invest in modern quality systems and technology infrastructure. As a result, these companies continue to manage quality and compliance activities with disconnected legacy systems, further complicated by a series of appended manual steps and workarounds.

To stay competitive and ensure their companies meet regulations, quality and regulatory managers should implement a modern, unified quality solution that supports a single source of centralized quality content, processes, and data across internal groups and external partners.

Trapped

The investment cycle for quality management systems aggravates existing issues. Even when you know your quality management system (QMS) is siloed and outdated, objections like the following often delay investment in quality systems until a significant quality issue occurs:

“This on-premises QMS is all we’ve ever known. Using it can be frustrating and painful, but at least it’s familiar.”

“We’ve already invested so much in our QMS and related systems. We’ve got to keep trying to make it work. An entirely new system has to be more expensive than maintaining what we have, right?”

For example, your disconnected QMS fails to flag and communicate a deviation before the product ships. The issue is big enough to require a public product recall. Upper management is facing bad press coverage and unanticipated costs, so all of a sudden they’re willing to dedicate resources to quality management that were deemed unnecessary in years past.

But rather than looking at quality management as a whole, they overbuild processes in just the affected functional area. So a cycle begins, with patch after patch but declining overall effectiveness and a higher total cost of quality.

Unifying quality management

The use of cloud software in quality is a huge step forward in breaking this cycle of ineffective, reactionary quality management investments.

A unified quality solution can support direct collaboration with outside partners and suppliers, and provide the right people with access to the right information, every time and from anywhere.

Investing in such a system will improve visibility, transparency, and quality across the entire network of stakeholders.

Bringing content and quality management together

Modern systems that bring together quality content and QMS processes in a seamless cloud environment create a single source of truth that results in a connected, efficient process. Users are no longer required to toggle between systems to complete tasks that span quality content and structured work processes.

From audit templates and artifacts to version-controlled supporting materials and root cause analysis, quality managers could save time and resources by using best-in-class content management functionality for a broad range of additional processes within the QMS.

For example, manufacturing change control within a QMS often has a downstream effect on documents. With a legacy system, users experience a manual, tedious process to ensure that all relevant documents are identified and amended. Modern cloud applications, in contrast, connect QMS actions with applicable document changes, significantly increasing efficiency.

Easy to implement, always current

Modern cloud applications are delivered with the ability to implement best practices immediately after implementation.

Unlike piecemeal legacy systems, there is no need to recreate the quality system process with every implementation. A vendor with the right domain expertise can create best practices that accelerate implementation. With automatic updates multiple times per year, quality systems in the cloud will simply never be out of date.

Depending on how many disparate, on-premise systems a company uses to manage quality, early customer results show that adopting a unified, cloud-based solution can lead to significant cost and time savings. These savings allow IT resources to focus on higher-value tasks such as incremental configuration changes based on current business needs.

Breaking out of the QMS investment cycle

Best-in-class organizations will proactively choose to modernize their QMS and document control systems in the cloud. These organizations are more likely to avoid high-profile quality problems and their significant consequences. Supplier and contract manufacturing business relationships will become closer partnerships when they are enabled by technology. Efficiency improvements will be realized by consolidating siloed quality systems.

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About The Author

Michael Jovanis’s picture

Michael Jovanis

Michael Jovanis serves as vice president, Vault Quality at Veeva Systems. He has spent more than 15 years developing and designing quality solutions. Before Veeva, Jovanis served as vice president of product management and strategy for Sparta Systems. He can be reached at michael.jovanis@veeva.com.