It goes without say that the implementation of a QC/QA system in a pharmaceutical/medical device company is a vital necessity. With costs aside, the lack of a quality system can easily compromise the well-being of a patient, which according to lecture can result in a business not only going under, but also result in its personnel being incarcerated. The reason for this is evident in that a business without a QC/QA system is simply gambling on human life. One technique of properly implementing a quality system is through the use of CAPA (corrective and preventive action) system, which is a quality management system that the FDA requires and looks for during audits. A CAPA consists of QA personnel along with members of other departments, ideally those involved in the manufacturing process, to identify and eliminate root causes of defects and inconsistencies along the production process in an effort to improve both the product being processed and other similar complications within the company.

(1) CAPAs are also easily perceived as burdensome for a few reasons: First it requires cross-functionality from all departments taking part in a particular project, which can result in communication complications between personnel who only specialize in their own field of interest. Secondly, CAPAs can be overused to the point that they exceed the FDAs standards, such as including too much detail in reports and prolonging investigations for months. CAPAs are also said to have protocols that focus more on being reactive than proactive (more corrective than preventative) in that quality departments prioritize the handling of an adverse incident rather than focus on preventing such incidents from ever occurring in the first place. This could be attributed to a quality department’s lack of understanding a manufacturing process and only being able to address issues by “finding out the hard way”. Nonetheless, when it comes to ensuring the safety and efficacy of a medical device, it’s better to invest over than under in its quality.

Are there any other quality-based systems implemented in medical device companies? What are their pros and cons? Are there any ways these systems can reformatted to be less burdensome while still ensuring the quality of the product?

(1) https://www.greenlight.guru/blog/corrective-action-and-preventive-action-capa-medical-devices#3