EDITOR’S NOTE: This is part of a series of highly popular GxP Lifeline blog posts that we are republishing in order to share their important subject matter and insights with a wider audience and those who may be new to the blog.
Life science and other companies doing business in FDA- and ISO-regulated environments understand how critical quality control and quality assurance are to successful quality management.
“Quality control” and “quality assurance” are often used interchangeably when referring to activities conducted to ensure the quality of a product, service or process. Some quality control and quality assurance activities are interrelated, but the two are not necessarily interchangeable.
Understanding the difference between the two quality processes is important, and a robust electronic quality management system (EQMS) will enable organizations to better manage both.
As defined by ISO 9000:2015’s Quality management systems — Fundamentals and vocabulary, 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. EU Good Manufacturing Practice (GMP) guidelines state that quality control is “concerned with sampling, specifications and testing, and with the organisation, documentation and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor products released for sale or supply, until their quality has been judged to be satisfactory.
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 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.
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