What is the Pharmaceutical Quality System (PQS) actually optimizing for today?
If we are honest, in many organizations it is not primarily learning, improvement, or better outcomes for patients. It is compliance. More specifically, it is compliance shaped by interpretation, and sometimes by fear.
That may not be the intent. But as Stafford Beer reminded us,” the purpose of a system is what it does” – not what individuals or companies might like it to do.
Which raises a critically important question. If the system behaves this way, what is driving it?
A good place to start is the ‘one step at a time with the direction in mind’ approach and introduce a VAR (Video Assisted Referee) system for pharmaceutical inspection observations. The objective is to ensure consistent interpretation of the cGMPs and to avoid outliers that are not grounded in data and science, but that often end up embedded in the Pharmaceutical Quality System (PQS) for the reasons described below.
When Outlier Observations Become Embedded in the PQS
Pharmaceutical companies are inspected regularly by investigators from national regulatory agencies. The vast majority of inspectional findings are relevant and help companies improve their cGMP compliance. That is important to acknowledge. However, there are occasions where observations emerge as outliers, not consistently grounded in science, data, or risk. In these cases, the observation reflects a single investigator’s opinion.
Here is why that becomes a problem, and why it is time to start a broader conversation about the purpose and use of the PQS.
Companies will often accept these outlier observations because they fear that challenging them could put approval of a site, line, or product at risk. Whether that fear is justified or not, the reality is that decisions are made based on it. As a result, companies change their PQS across their network to accommodate an outlier observation, even when it adds no value for patients, for cGMP compliance, or for the company. In some cases, these changes make the PQS more complicated and burdensome for employees, such as observations that have led to operators being required to stand for a full eight-hour shift.
Why Companies Don’t Push Back
In pharmaceutical inspections, there is currently no meaningful arbitration or neutral escalation pathway for these types of observations. If a company escalates, it is ultimately the same agency reviewing the concern that issued the observation in the first place. In practice, this means companies accept the observation, and the PQS gradually becomes a system that caters to individual investigator opinions, regardless of whether they are grounded in science or risk.
What Gets Left Out — And Why It Matters
At a broader level, the PQS has increasingly become a system designed to satisfy regulatory expectations by demonstrating cGMP compliance. In doing so, companies often leave out critical elements that would otherwise demonstrate how quality contributes to the business. This includes documentation of continuous improvement plans and progress, identified risks with mitigation strategies, lessons learned from major projects and failures, key decisions and actions from management review, and other activities that reflect the true value of quality.
These elements are often excluded because companies are concerned that identifying improvement activities that are not yet completed could lead to an observation. This is not theoretical. It happens. I have seen it many times. The irony is that these activities are often taking place within the company, but they are documented outside of the PQS.
Stafford Beer defines “the purpose of a system is what it does” – not what we intend it to do, or what we say it should do. By that definition, the PQS today satisfies compliance expectations. It is not acting as a system that continuously improves product quality, supply, or business outcomes.
A VAR System for Pharmaceutical Inspections
This gap between what the PQS does and what it should do is something we need to address, together. Companies and regulatory agencies alike. It requires a shift toward systems thinking, rather than relying solely on traditional cause-and-effect approaches to individual problems.
One place to start is by addressing outlier observations that are not based on data, science, or risk, but are nevertheless embedded into the PQS through fear-driven decisions. In soccer, there is a VAR (Video Assisted Referee) system that provides an additional, objective set of eyes when there is uncertainty around a referee’s decision in critical moments.
We need an equivalent concept in pharmaceutical inspections. Not a literal replication, and not a formal appeal mechanism, but a limited, predefined process for reviewing rare, high-impact inspection observations that are scientifically or risk questionable. The outcomes of such a “VAR” process could also serve as valuable training examples for investigators.
An Invitation to Start the Conversation
It is time to work together, regulators, companies, and other stakeholders, with a systems thinking approach to change what the PQS actually does. A system driven by fear rather than learning ultimately serves no one, including patients.
This is an invitation to start a conversation that is long overdue.
