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Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about the difference between the roles of quality assurance and quality control.
Q. Theoretically, what’s the primary focus of quality assurance (QA) vs. the primary focus of quality control (QC)?
A. The short, simple answer to this question is that QA focuses primarily on the process and QC focuses primarily on the product. However, I don’t think the short, simple answer is adequate, because while the focus of these disciplines may be different, their goal is the same: to ensure that the product produced is safe and effective. QA concentrates on monitoring and perfecting the manufacturing process. This function is considered proactive because the activities and actions associated with QA try to deal with issues before product quality is compromised. In contrast, QC concentrates on testing the product after manufacturing to ensure it meets the acceptable quality product criteria and specifications, making QC more reactive in nature.
I think it is important to recognize and explore that, at times, QC is proactive, and QA is reactive. QA can adopt a reactive role when dealing with a deviation that occurred during manufacturing, especially if the deviation segues into an investigation. Deviations and investigations are reactions to mistakes made during manufacturing, thus putting QA in a reactive position. QC can adopt a proactive role, especially if the QA department is involved in in-process testing or incoming raw material testing because of the potential for out-of-specification (OOS) investigations.
OOS investigations are initiated by the QC test laboratory when the active ingredient, excipients, or the product fails to meet specification. When the OOS is initiated because of an aberrant result from an in-process product test, the laboratory is in a proactive position because their goal is to determine whether the OOS is due to a laboratory error in testing. If the OOS is determined not to be the result of a laboratory error, then the information needs to be communicated quickly to QA so they can investigate the potential that the OOS was due to a processing error, ideally before the manufacturing run is completed.
The bottom line is that QA and QC perform complementary tasks with the same goal of ensuring patient safety/product quality regardless of their point of reference (product vs. process).
Q. Does the QC department report into the QA department?
A. The current thinking is that the QC and QA departments should report independently to the head of Quality. This makes sense and maintains a check and balance approach to ensuring product quality and patient safety. It also makes sense when we consider the responsibilities of each discipline. As indicated, QC focuses on the product so their responsibilities can include, but are not limited to, batch inspection, product sampling, validation testing, and laboratory testing. QA focuses on the processes so their responsibilities can include, but are not limited to, documentation system management, audits, supplier management, personnel training, change control, and investigation procedures. Another way to look at the difference is the QA department manages the quality management system of the organization by ensuring the standard operating procedures (SOPs) are appropriately initiated, changed, or made obsolete using the change-control procedure, and QC provides the information that is included in the SOPs that are used to generate the product test results. QA and QC should work together from their different perspectives to ensure that products not meeting their safety and efficacy standards are not released to patients. The issues uncovered by QC through testing should prompt a QA review. An example of this synergistic relationship would be repeat non-conforming test results on a raw material leads to a corrective and preventive action (CAPA) investigation that determines the root cause of quality issues is due to a material change made but not reported by the supplier. QA would then use the information generated by QC to update processes and supplier oversight to prevent the problem from recurring in the future. This independent but complementary relationship between QA and QC is critical to be sure the product reaching patients is safe and effective. The best relationship between QA and QC is one in which QC informs QA of issues and QA uses the information to initiate continuous process improvements to the manufacturing procedures. Because QA and QC aren’t optional and it’s impossible to say which is more valuable to an organization, it is important to make sure these two distinct and important departments work together.
Q. Should the QA department be responsible for all training?
A. No. QA should be responsible for making sure training is conducted and documented and all employees are current in the expectations defined by the training program, but it is not realistic to assume QA can conduct all the training needed in an organization. QA might conduct some training, such as annual training on good manufacturing practices, data integrity, etc., but they would not have the expertise to train QC personnel on how to conduct laboratory tests.
Again, this is a great opportunity for the two departments to complement each other by working together to find the most suitable training programs for employees to attend when in-house training is not feasible.
It is important for QA and QC to work together to ensure a holistic and comprehensive approach to the overall health of the company’s quality culture.
Volume 34, Number 12
Page: 46, 45
When referring to this article, please cite it as S. Schniepp, “Frequently Asked Questions About Quality Control vs. Quality Assurance,” BioPharm International 34 (12) 2021.