In a way, the audits performed by regulatory agencies are a way to measure the performance of the QA and QC departments. However, I would also argue the regulatory department within that same company is observing the QA and QC departments as regulatory affairs acts as an intermediary between the QA/QC and the regulatory body. Regulatory affairs must assemble the documentation to present to the FDA. Therefore, they are also responsible for assessing whether the manufacturing processes and results/data are on par with regulatory standards. While I was an intern, I had met a senior regulatory affairs associate who described her job as acting as a lawyer representing the product. I found her analogy interesting because it put more in perspective how essentially regulatory affairs is defeating the product through presenting the product and negotiating for its market approval. While regulatory affairs act as the first line of observation of QC/QA, the FDA audit is the final line of observation.

Audits serve as an invaluable tool in this matrix, acting as an overarching review mechanism. When a company undergoes an audit, especially one conducted by external entities, it's a rigorous assessment of the QA and QC mechanisms in place. Such audits, particularly in sectors with stringent regulatory frameworks like biotech or pharmaceuticals, often involve a meticulous review by external regulatory or certification bodies. So, pondering over the oversight of QA leads us to a multifaceted answer. Internally, a distinct team may be entrusted with auditing various departments, including QA, to ensure it remains faithful to its protocols. Externally, bodies like regulatory agencies undertake comprehensive audits, ensuring that the QA department itself upholds industry standards. Furthermore, organizational leadership often scrutinizes QA/QC outcomes and metrics, ensuring alignment with corporate quality objectives. Lastly, embracing philosophies like Six Sigma embeds a culture of perpetual refinement, where every process, including QA's, undergoes relentless scrutiny for potential enhancement. This system ensures a holistic commitment to quality across all organizational levels.

Building on this discussion, it's essential to recognize that quality assurance (QA) has to prepare for both internal and external audits. 

The primary purpose of internal audits is to assess whether internal processes, including those within the QA and QC departments, adhere to the company's quality standards and regulatory requirements. These audits are often scheduled regularly and can be more flexible, focusing on specific areas needing improvement. The QA team (may be with the help of a contractor) itself might be involved in performing or preparing for these audits, and findings typically result in corrective actions, employee retraining, or process adjustments.

On the other hand, external audits are conducted by third-party entities such as regulatory agencies (e.g., the FDA, ISO auditors, or certification bodies). These audits are more formal and stringent, as they ensure the company meets industry standards and regulatory requirements. External auditors are independent, and their objective is to evaluate compliance impartially. QA and QC departments must prepare by ensuring complete documentation, traceability of processes, and adherence to protocols.

The outcomes of internal audits often drive continuous improvement, while external audits can lead to certifications, approvals, or penalties if non-compliance is identified. Both types of audits are vital for maintaining the integrity of quality systems, ensuring both internal standards and regulatory requirements are met.

To answer the overarching question: yes. Audits play a critical role in assessing whether QA and QC are following proper protocols. However, they are only part of a much broader system for ensuring compliance and quality. In your case, as a scientist being observed by QA, it's important to recognize that QA itself undergoes constant scrutiny both internally and externally.

First, QA is often monitored internally by other departments like Regulatory Affairs, which ensures that their practices align with both company standards and regulatory requirements. This interdepartmental collaboration acts as a regular check on QA’s work. For example, regulatory teams frequently review QA documentation to ensure it’s accurate and meets the necessary standards before being submitted externally to places like the FDA.

Externally, audits from third-party entities such as the FDA or ISO are rigorous evaluations of the company’s entire quality system, including QA and QC processes. These audits ensure compliance with regulatory standards and industry best practices. The goal of these audits is to identify any gaps that could compromise product safety or efficacy.

Additionally, companies today often use automated quality management systems (QMS) which continuously monitor QA processes in real-time. This technology is able to track deviations and corrective actions, displaying flags for issues that need attention to allow them to be corrected before they escalate. In short, QA is not just observed during scheduled audits internally and externally but is also monitored on an ongoing basis through both human and digital oversight, ensuring that protocols are consistently followed throughout the process.

I agree that audits, both internal and external, play a crucial role in ensuring that QA and QC follow proper protocols. It"s interesting how QA is observed on multiple levels—internally by teams like Regulatory Affairs, which act as an additional checkpoint, and externally by regulatory bodies like the FDA during formal audits. I also think the point about automated quality management systems is particularly important. These systems not only help with ongoing real-time monitoring of QA processes but also flag deviations and trigger corrective actions long before an official audit occurs, adding another layer of assurance that everything is on track.

This integration of human oversight and digital tools really underscores the importance of continuous improvement in QA. By addressing issues as they arise and not solely relying on audits, companies can ensure that they maintain a consistent standard of quality and compliance throughout the entire lifecycle of their products. It’s a robust system where audits act as a safeguard, but the real day-to-day success lies in how well processes are monitored and refined in between those audits.

thank you for your question. When a company is audited, the QA/QC processes themselves are indeed being examined to ensure they are functioning properly and that they adhere to the required standards and protocol. 

Audits can be done internally and externally. Internally, this is done by Regulatory Affairs. They identify any gaps that could compromise product safety or efficacy. Additionally, external audit can be done by FDA or ISO which are third party companies.  External audits are independent. 

Finally, I believe that audits provide the mechanism by which QA is held accountable and observed. Auditors, whether internal or external, act as the "observers of QA". Internal and external audit ensure that QA process are enforcing the protocols and standards as intended.

This post raises some interesting points about the role of QA/QC in ensuring compliance and product quality within an organization. When a company goes through an audit, they are essentially being checked on the effectiveness of their quality systems. The purpose of an audit is to make sure that everything is in compliance and that the company is doing what they say they are doing. Audits can also be valuable tools to help companies identify potential areas of improvement. Given this information, I would say that yes, an audit is a way of checking the QA/QC systems are operating up to regulatory and company standards. 

It is important to differentiate between internal and external audits as a quality check. Internal audits come from the company's own team and serve as a way to evaluate the effectiveness of QA systems. These types of audits serve as a tool to identify areas of improvement with less consequences that an external audit may have. It is important for companies to perform regular internal audits to ensure that their quality system is working and catch any faults in their system. Management review is another form of internal audit that can serve as a check to the QA department. 

External audits typically come from a third-party organization or regulatory body. A third-party organization performing an audit could be a company that collaborates in some way on a medical device and needs to ensure that the process is being run up to their standards. Regulatory bodies include the FDA, who would check that the company is operating in compliance with industry standards and regulations. There can be high consequences for companies who fail an external audit, and any findings would require immediate action to avoid losing a third-party relationship or being shut down by the FDA

Overall, the interaction between QA and other departments is part of a broader quality management system, where multiple layers of oversight help to ensure that quality is maintained throughout the organization.