Quality is an important part of doing business in regulatory environments. However, the differences between quality assurance and quality control can be hard to pin down. Quality assurance and quality control are both essential to meeting regulations and standards and there is some overlap between the two. Because of this the two terms are often used interchangeably although they are distinct.
If anyone should know the difference between quality assurance and quality control, it’s the American Society for Quality (ASQ). According to ASQ, quality control is the part of quality management focused on fulfilling quality requirements, whereas quality assurance is the part focused on providing confidence that quality requirements will be fulfilled. In simple terms, quality assurance relates to how a process is performed or how a product is made, whereas quality control stands for evaluating — e.g., inspecting, sampling, testing — a product or service to detect whether it fulfills certain requirements for quality, is free of defects, conforms to specifications and functions as required. One way to look at it would be to think of quality control as product oriented and reactive, and quality assurance as process oriented and preventive. Quality control is often considered a post-event activity, identifying defects after the product is produced.
Although it may identify problems and facilitate ways to resolve them, a quality control system alone does not ensure quality. Quality control by itself has limitations, particularly the ability to detect and prevent quality problems early. Per current industry practice, quality systems being developed today generally stress quality management, quality assurance and risk management tools in addition to quality control. Leveraging a robust enterprise quality management system (EQMS), organizations can connect and streamline these complex quality processes.
Increasingly more organizations have begun to understand how an optimal EQMS can ensure that each product meets specific efficacy, safety, quality and compliance requirements. A robust EQMS will automate, monitor and effectively manage all core areas necessary to maintain quality in products and processes, including:
A comprehensive EQMS is designed to work as a single end-to-end solution, rather than a combination of components (often from multiple vendors), and will help an organization address critical aspects of quality control and assurance, as well as risk management as it relates to quality management. Some vendors can offer solutions that extend beyond the quality department, connecting other processes and functions. A prime example of this is MasterControl Manufacturing Excellence, which lets you bring quality control and quality assurance directly to the shop floor.
Quality control and quality assurance are both vital to maintaining regulatory compliance. Doing either effectively is considerably easier with an EQMS, which automates and connects all your quality processes. Not only does this make quality management as a whole easier, it makes it easier to deal with other aspects of the business and makes quality a priority for the whole organization.
Sarah Beale is a content marketing specialist at MasterControl in Salt Lake City, where she writes white papers, website landing pages, and is a frequent contributor to the company’s blog, GxP Lifeline. Her areas of expertise include the nutraceuticals, cannabis, and food industries. Beale has been writing about the life sciences and health care for over five years. Prior to joining MasterControl she worked for a nutraceutical company in Salt Lake City and before that she worked for a third-party health care administrator in Chicago. She has a bachelor’s degree in English from Brigham Young University and a master’s degree in business administration from DeVry University.
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