GxP Lifeline

Get Quality Clarity: Your Guide to Understanding Quality’s Interactive Elements


In life sciences manufacturing, product quality affects everyone’s job. When engaging with quality as a function, however, the lines between the various elements that contribute to an organization’s overall quality efforts can get blurry. Conversations with and within your organization’s quality department are sure to include more Q-word initialisms than can be found in a bowl of alphabet soup: QA, QC, QMS — the list seems endless. But what do they all mean?

A new joint white paper from Coda Corp USA and MasterControl, titled “Quality With Clarity: Bringing the Interactive Components and Roles of Modern Quality Systems Into Focus,” clears up this “Qonfusion.” It examines the definitions and purposes of quality assurance (QA) and quality control (QC) and explores their interactive roles in a company’s broader quality management system (QMS).

First Things First: How Do You Define Quality?

When we say the word quality, what exactly do we mean? The short answer is that quality entails the efficient manufacture of a defect-free product that meets predetermined specifications and satisfies customers’ expectations and the producer’s requirements. The longer answer is more nuanced and depends on a variety of factors (i.e., whether you are the producer or a consumer of the product, whether the product is manufactured in a regulated or non-regulated industry, what your specific function in that industry is, etc.). Given these variables, it is up to individual organizations to identify and prioritize specific quality objectives that align with their business, industry, customer, and regulatory requirements. For quality to be continually maintained, a company must design these objectives into all processes and systems throughout the enterprise.

Understanding Quality as a Control Mechanism

If a company intends to adhere to the fundamental quality principles defined in current good manufacturing practice (cGMP) regulations, its personnel must first understand that quality is a function of control. This principle is at the root of any effective quality system, according to the white paper’s author, Gina Guido-Redden.

Two complementary groups are the primary drivers of quality as a control apparatus: QA and QC.

  • QA activities are the proactive actions that contribute to the overall quality system via the performance of continual checks of its implementation. The goal of QA is to eliminate process variation through the creation, revision, and implementation of explicitly defined procedures that ensure product quality when followed precisely.
  • QC activities support QA guidelines. They involve inspection and testing processes for the purpose of detecting and shelving nonconforming products.

It’s easy for an organization’s personnel to slip into the mindset that QA and QC professionals alone are responsible for maintaining product quality. And while these specialists may formally oversee the various processes that contribute to quality, it is critical for everyone in the organization to understand that quality is not the responsibility of any single department or designated individuals. Quality is a culture that must permeate the entire organization to be truly effective. Equally as important as the principle of a “quality culture” is the fact that quality cannot be achieved without an intelligently designed system.

The Rise of Intelligent, Digitized Quality Systems

To effectively realize continuous quality and harness its power as a launch pad for continual improvement, an organization needs dynamic tools that are designed in accordance with its needs. The implementation of a digitized platform that provides a closed-loop framework for quality management improves an organization’s ability to consolidate knowledge and streamline processes.

A digital QMS platform can drive a variety of improvements, not just in QA and QC departments, but across an entire organization. QMS platforms fully integrate quality-related processes, link data across the product life cycle, and provide greater visibility into up-to-the-moment metrics. Natively linked quality solutions connect data and processes to ensure a company can maintain quality consistency from concept to commercialization.

For a more in-depth look at the unique, critical roles of the various quality functions and the ways they can be enhanced with digital platforms, download the new “Quality With Clarity” white paper from Coda Corp USA and MasterControl.


James Jardine is the editor of the GxP Lifeline blog and the marketing content team manager at MasterControl, Inc., a leading provider of cloud-based quality, manufacturing, and compliance software solutions. He has covered life sciences, technology and regulatory matters for MasterControl and various industry publications since 2007. He has a bachelor’s degree in communications with an emphasis in journalism from the University of Utah. Prior to joining MasterControl, James held several senior communications, operations, and development positions. Working for more than a decade in the non-profit sector, he served as the Utah/Idaho director of communications for the American Cancer Society and as the Utah Food Bank’s grants and contracts manager.

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