The main purpose of an audit or inspection is to check if the regulatory standards are being followed in the way and magnitude that they need to be followed by the company. While I was working as a quality control associate in the medical imaging operations of a clinical research company, we were trained twice a year on audits and inspections for various projects. There are two types of regulatory checks in the form of FDA audit and Sponsor audit. Some of the points that need to be kept in mind while facing an audit inspector are: confidentiality and sensitivity of the information being revealed while also not withholding the information that the auditor is seeking. While it is important to assure the auditor that the work is being carried out according to protocol, it is also important to maintain the confidentiality of the company’s clients and their project data.

An auditor in my perspective, is looking for two things: to point flaws in the regulatory framework of the project and to identify non-compliance by the employees. While it is at least partially assumed that the project’s regulatory guidelines meet the FDA standards (otherwise it wouldn’t have been approved in the first place), I think a lot of focus is on how well the regulatory policies are adhered to and the confidence that a company and its team can project to the auditor ensuring the safety and effectiveness of the product.

To outline some of the ways to ensure quality is to:

a. Train all the project members on quality control for all phases of the study to highlight the importance and significance of maintaining quality in their own departments is actually interdependent with regards to overall quality of the project.
b. To discuss corrective measures/actions during possible violations of regulatory policies early on in the study. That way, one can assess the magnitude of impact of the violation and take necessary measures.
I can cite a similar example of quality violation from my previous experience. We received a few scans in between the actual scheduled visits for a few patients who showed different reactions to the drug. As there were not detailed instructions regarding the naming convention for unscheduled visits in the study protocol, the images were saved with varying random naming conventions by different members in the team which lead to a lot of confusion during study close out as to how these images should be sorted out and processed. The study protocol was later amended and a new naming convention for unscheduled visits was laid out. Eventually, these already processed images had to be rolled out again for re-processing which lead to quality issue in the project.

I think quality and proactiveness in ensuring quality go hand-in-hand to identify any possible setbacks of the current regulatory structure of the project.