A quality management plan is defined in our PMBOK guidebook as “a component of the project or program management plan that describes how an organization’s quality policies will be implemented”. This is especially important in the biotech field in which products mainly act by interfacing intimately with a patient in such a way that even the slightest defect in the device can result in it causing more harm than good. The FDA was the first major entity to take action against the risks and hazards of faulty medical devices and has since enforced the formation of quality departments within any production company (not just biotech). Quality assurance states the certain standard of acceptability that a device must pass in order for it to further develop, which in turn governs the regulations of quality control who in turn must ensure that a product’s output meet its set standards. The necessities for generating a quality plan would be a project to start as well as the proper documents and paperwork that clearly defines the product/project and how the quality plan addresses any and all associated risks/hazards associated with device use.

As mentioned in lecture, an important role of a quality department is to anticipate FDA audits and handle them in a way that all questions are addressed and the product can properly be submitted for animal/human testing or proceed to market. What expectations may the FDA have when conducting their audits in a biotech manufacturing facility? How might their level of scrutiny change depending on the classification of the device? What might be a few reasons as to why an IND (investigational new drug) or IDE (investigational device exemption) might get rejected by the FDA? Are there any known cases of major biotech projects having to stop midway due to an FDA discrepancy?

“A Guide to the Project Management Body of Knowledge (PMBOK Guide)” (2013) project Management Institute, pp 247-248.