What is Quality Assurance? 

Quality assurance in business means maintaining the quality of a product or service. In the life sciences industry, quality assurance mostly applies to screening methods that work on the entire process of manufacturing and marketing a device.

Quality assurance is what makes businesses reliable and builds rapport. The first steps of quality assurance are also the very first steps of medical products: designing and research. Quality assurance then stays along with every step. Whether it is the methods of testing a medicine (clinical trials) or ensuring the durability of a device itself, the function of quality assurance is to “ensure” that every step is monitored and standardized and each product passes with flying colors.

Regulatory requirement of quality assurance

Quality assurance is a big part of developing any medical product and ensuring the end result stays consistent. Hence, regulatory authorities are keen to keep quality assurance processes effective. As such, the FDA, EU-MDR, and UK-MDR focus heavily on quality assurance.

The FDA defines a quality management system (the system that ensures quality assurance) as “a collection of business processes focused on achieving quality policy and quality objectives to meet customer requirements.” Establishing and maintaining a quality management system is also part of the CGMP or Current Good Manufacturing Practice.

The EU MDR also requires a thorough quality management system to be in place. It outlines the requirements of QMS clearly. According to MDR, the manufacturer should have a quality management system that ensures regulatory compliance, safety, performance and risk management, and responsibility, among others.

The UK-MDR, similar to the EU MDR, also emphasizes maintaining a standard quality management system. Apart from these three, regulatory bodies worldwide also focus on quality management systems. International authorities like the International Organization of Standardization have their own requirement for QMS (ISO 9001).

QA vs QC: What’s the difference?

QA stands for quality assurance, and QC stands for Quality Control. While the terms are very similar, these teams work differently. QA teams usually work actively during the production and development process. QC team, on the other hand, are more reactive. They work to examine for errors and trace the roots of the problems.

For example, QA teams would do audits annually or biannually to check the entire manufacturing process. They would check every single procedure, work with the researcher, follow clinical tests, oversee the training of the staff, work through reviews, etc. Their goal is to standardize every step, set up quality “checkpoints,” and make sure the end product has zero to minimal risk while working as per its “intended use”.

QC teams, on the other hand, will work with the developed product. They will often go through adverse events and trace the sources. Their action is more reactive than QA. Most of the time, the QC team works after the medical product is on the market. These teams will go through medical product reviews and reports to find out what went wrong and why.

QA also emphasizes heavily on documentation. The documents to prove an adequate “quality management system” for submitting to regulatory authorities usually come from QA teams. QC teams are also part of the “Quality Management System”.

How to implement quality assurance in the life sciences

Quality assurance is a fundamental part of creating safe and effective medical products. Whether it is medical devices or pharmaceuticals, maintaining quality is significantly more important in life sciences because the risks are significant.

Implementing quality assurance, hence, takes precedence. Authorities also focus heavily on quality assurance and risk management when allowing medical products to be on the market. This takes quality assurance measures pretty high on the manufacturer's priority list.

To implement quality assurance in life sciences, one can follow some guidelines. The International Organisation for Standardisation provides a roadmap to establish quality assurance in their ISO 9001 requirements.

Here is a simplification of what implementing quality assurance could look like:

1. Setting up quality-assuring processes at appropriate steps of the development and manufacturing process.
2. Establishing the inputs and outputs expected from these processes.
3. Establishing sequence, criteria, and methods for optimum operation and quality control.
4. Determining resources, responsibilities, risks, and need for change.

Apart from ISO, there is also the EU MDR and FDA to look for guidance regarding quality assurance.

The EU MDR requires manufacturers to draw up QMS plans and risk management plans before establishing them. A quality assurance system that follows EU-MDR should include general safety and performance requirements, risk management requirements, accountability, resource management, device identification, etc. It should also take into consideration the findings of the clinical evaluation report and post-market clinical follow-up. FDA also requires a full-fledged quality assurance system that closely follows the production of the device.

The precise requirements are followed depending on the class of the device or product. It also depends on the process of development of the medical product and the desired outcome.