by akronbiotech

Quality Assurance (QA) and Quality Control (QC) are two terms that are often used interchangeably.  However, while some QA and QC activities are interrelated, the two are defined differently and encompass different activities. ISO 9000 defines Quality Assurance as “all the planned and systematic activities implemented within the quality system that can be demonstrated to provide confidence that a product or service will fulfill requirements for quality”. Quality Control, on the other hand, focuses on the operational techniques and activities used to fulfill quality requirements.

In other words, while QA relates to how a process is performed or how a product is made, QC is the aspect that deals with the inspection or review of the quality of a product. Viewed from the ‘industry perspective,’ QA activities would include process checklists, process standards, process documentation and project audits – all activities based on engineering and maintaining a system that provides a reduction in errors that could be costly and unsafe. QC activities center on product inspections, deliverable peer reviews, and the product testing process. These are all in place to gather data about the product or raw material being manufactured or used. QC is therefore a kind of final check to determine if the quality systems were indeed effective in creating a product of consistent quality.

Every person involved in making a product is responsible for ensuring its quality; one cannot inspect quality into the product. The Quality Department, as a whole, exists to play an internal audit function within the manufacturing and packaging areas of the operation. It establishes a system for process control and provides assurance that it is not only functioning but effective. Learn more about how Akron’s QA and QC Departments work together to ensure that our products meet our high quality standards from raw material inspection to final package configuration, thereby ensuring safety and functionality of the materials we commercialize for use in the production of advanced therapies.



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