Quality Assurance – Current Status and Outlook

Excerpt from the GMP Compliance Adviser, Chapter 1.C Quality Assurance Duties

6 min. reading time | by Christian Gausepohl, PhD
Published in LOGFILE 21/2025 

What role does Quality Assurance play in the tension between consulting and monitoring, and between systemic and operational levels? What trends are emerging in the self-perception and role of modern quality assurance? Read more on this topic in Chapter 1.C Quality Assurance Duties in the GMP Compliance Adviser.

The overall role of Quality Assurance in companies varies and depends on many factors such as size, complexity, history, but also on the organization’s quality culture.

The trend here in the development of Quality Assurance is a movement from a coordinative and advisory function to a pronounced monitoring function. In principle, the move towards operational Quality Oversight in particular can offer a significant improvement for the quality culture, continuous improvement and the reduction of errors. This also offers the opportunity to integrate shop-floor QA operationally as part of lean management. 

Nevertheless, for each new Quality Assurance task – e.g. additional inspections or observation roles – the extent to which these are sensible, effective and efficient should be questioned. Above all, the definition of such measures should follow on the results of quality risk management. To this end, it must first be determined whether there is actually an unacceptable risk associated with an activity, e.g. a possible error with sufficient severity and reduced probability of detection.

The following example is intended to illustrate this:

Labels are to be applied to update the expiry date as part of a clinic sample production process. The labels are applied manually by employees in the Operations department. Correct application is verified by a second employee from the same department. Due to errors, further verification is now to be carried out through additional monitoring by the Quality Assurance department.

Correct labelling must be ensured to avoid risks for the patient. A second verification step can conceal possible weaknesses of the process and avoid faulty products in the finished product batch. The root cause of the problem is not being addressed, namely the process weakness of ensuring the detection in the initial verification step. The call from the Operational department for additional checks by QA – possibly to reduce its own workload – should therefore be critically scrutinized each time.

However, when setting standards and regulating their interpretation, Quality Assurance should also be aware that readjustments should actually serve the purpose of improvement. A clear distinction must be made here between "nice to have" and "need to have", i.e. whether this is really necessary or represents an embellishment of the requirement from a Quality Assurance perspective. Every adjustment should be clearly communicated to all stakeholders in advance. Examples include increasing requirements and more critical evaluation of documentation errors, e.g. readability and corrections. 

As in all companies and organizations, there is a risk that administrative processes will continue to grow and multiply over time, becoming more complex and detailed and thus increasing the demands on resources and processes. In this realm, Quality Assurance should always bear in mind that these tasks are not an end in themselves and that the management of processes should always be streamlined. 

Quality Assurance and its responsibilities are also part of the value chain. Without batch certification at the end of production, without the necessary steps, such as batch record review, product release is not possible. In addition, a successful Quality Assurance department contributes to the continuous improvement of processes and products within the scope of its tasks. Demonstrating this time and again is an important task in the cooperation between Operations and QA.

A common metric used by companies is the so-called cost of poor quality (Figure 1). It is intended to show the costs incurred by errors in the company. This can be helpful to emphasize and raise awareness of the importance of assuring quality and upholding standardized processes. Care should be taken to ensure that this metric is not seen as a reproach, but rather as an informative assessment of the current situation.

Figure 1 | Cost of Poor Quality

Ideally, Quality Assurance is both monitoring and consulting and also actively supporting the Operations departments. This active collaboration serves to yield and promote suggestions for improvement and result in their implementation. QA is not located in an "ivory tower" within the company but is an active partner for improvements and sustainable success. It should accompany and monitor processes and do the same for changes but not prevent them on principle. In risk management, QA ensures an honest and transparent assessment, even if this is not always the easiest way. In this way, Quality Assurance contributes to a positive development of the quality culture. 

Quality Assurance is a key pillar on which the Qualified Person bases their tasks and responsibilities. Cooperation is therefore naturally close.

Figure 2 | Aspects of "good" quality assurance