Quality Control, Quality Assurance and the EQMS That Improves Both


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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.

What Is a Quality Control System?

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. 

How an EQMS Improves Quality Control (and Assurance)

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:

  • Quality audits — An EQMS will streamline and better manage the entire audit process, from scheduling and planning through execution and completion; automate scheduling of all recurring audit-related activities; and leverage advanced tracking, analytics and reporting capabilities for a real-time view of the audit process.
  • Quality events — An EQMS will enable you to more effectively identify, evaluate and handle nonconformance, deviations, customer complaints and other quality events; automate data collection, routing, follow-up and escalation of quality events; and leverage forms and processes that connect personnel for quick disposition of a nonconformance.
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  • Corrective and preventive action (CAPA) — An EQMS with strong CAPA capabilities will automate and more effectively manage every step of CAPA implementation, from identification of the problem through corrective action; integrate the CAPA process with other quality processes, such as nonconformance and audit; and help keep your quality system always ready for inspections and audits.
  • Change control — An end-to-end EQMS will allow you to streamline the entire change control process and quality control system; leverage forms that incorporate priority level and prompt risk assessment and classification of the change; and customize reports that will provide real-time status of change control tasks as well as the entire quality system.
  • Document control — An EQMS with robust document management abilities will enable you to automate and better manage all tasks relating to documents-based processes; maintain all documentation in a single repository; and integrate quality processes like CAPA and audits.
  • Training management — A robust EQMS will automate the assigning and monitoring of training tasks; and integrate training management with the rest of the quality control system, so any change to a quality document or process that requires new training will automatically prompt training tasks upon approval of the change.
  • Risk — An integrated EQMS can help organizations identify and mitigate long-term systemic risks by tracking and analyzing the recurrence of issues; unify all risk-related activities and documentation in a single, centralized repository; automatically receive information (about a deviation, for example) that triggers a risk analysis; and gain a complete view of risk across product lines, business processes and business units.

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.

Conclusion

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.




2019-bl-author-sarah-bealeSarah 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.