The primary difference between quality control (QC) and quality assurance (QA) is that QA correlates the industry’s standards to the project at hand, whereas QC ensures that the standards are being met as a project proceeds. From an industry perspective, QC is more engaged with real time testing while QA works more with documentation and compliance with protocol. The company I work for is a project-based clinical research organization that manufactures autogeneic and allogeneic cell-based products for patient infusion. Since the product we work with is considered to be high risk (ISO 5 cleanroom standards), it requires QC to acquire daily samples of cell cultures for sterility analysis as they are currently being processed. At the same time, it is the role of QA to ensure that the batch record of the process was completed as per standard operating procedures (SOPs) and that all supporting documentation was fulfilled. For a company such as my own, QC essentially regulates the lab work and QA regulates all paperwork and electronic documentation.

According to lecture, there are 3 major processes that fall under quality control management: QC, QA, and quality planning. How does quality planning affect the QC and QA processes? The PMBOK Guidebook defines quality as “the degree to which a set of inherent characteristics fulfills requirements”. Is it more efficient to determine FDA requirements prior to or after initiating a project? The PMBOK guide also covers quality-related topics such as quality metrics, quality audits, quality function deployment, etc. How do each of these contribute to the overall integrity of a project?