From Compliance to Excellence: Why SOPs Alone Don’t Guarantee Quality

An Interview with Dr. Christina Larisch, Head of Quality Assurance

Quality management is a core responsibility in the pharmaceutical industry. Processes, documentation, and regulatory requirements form the foundation for product safety and reliable supply chains. Yet audits repeatedly reveal a common challenge: even well-documented procedures do not automatically ensure that quality is consistently embedded in daily operations.

We spoke with Dr. Christina Larisch, Head of Quality Assurance at MSK, about why the key challenge often lies not in the quality management system itself, but in how it is applied in practice.

Christina, many companies have comprehensive quality management systems in place. Why do deviations still occur?

A quality management system provides the framework for quality, but it does not create quality on its own.

Most companies already have established processes, SOPs, and digital documentation systems. These are essential. The real question is whether those processes are consistently followed in day-to-day operations.

During audits, we often find that the procedures themselves are not the problem. In many cases, they are already well defined. The challenge arises when a gap develops between documented requirements and operational reality.

How do such gaps arise?

There is rarely a single cause. More often, several factors come together over time.

Processes are continuously expanded to accommodate new regulatory requirements, audit findings, and risk mitigation measures. While this is understandable from a compliance perspective, it can result in increasingly complex SOP structures.

Employees then have to navigate numerous documents, forms, and decision-making steps. Under time pressure, some activities may be handled more pragmatically. This is usually not due to a lack of quality awareness, but because operational realities sometimes demand flexibility that procedures on paper do not fully reflect.

Another important factor is understanding. People often know what they need to do, but not always why a specific requirement exists. When the purpose behind a process is unclear, compliance can easily become a box-ticking exercise instead of a quality-driven mindset.

Can you give a practical example?

A common example is the management of temperature deviations during transportation.

Typically, the SOP clearly defines the required steps: documenting the deviation, escalating the issue, assessing the product, and making a release decision. From a quality perspective, this is exactly how the process should work.

In reality, however, situations are often more complex. A delayed shipment may arrive shortly before the end of a shift while several other tasks are competing for attention. With limited resources available, products may be stored first and documented later.

The process itself is known and understood. The challenge is that it is not always executed exactly as defined. These are the kinds of gaps that frequently become visible during audits.

What observations do you encounter most frequently during audits?

Interestingly, many audit findings are not related to missing procedures, but to their consistent application.

Typical examples include incomplete training records, inconsistently maintained logbooks, or situations where different employees describe the same process differently.

The greatest challenges often emerge at organizational interfaces. In the pharmaceutical supply chain, Quality, Logistics, Supply Chain Management, and external service providers all need to work closely together. The more stakeholders involved, the more important it becomes to maintain a shared understanding of responsibilities and quality expectations.

Even when procedures are clearly documented, inconsistencies can arise if information is not communicated effectively across teams.

Many companies invest heavily in digital systems. Isn’t that enough?

Digital solutions are an important part of modern quality management. They increase transparency, support documentation, and help organizations track actions and deadlines.

The challenge begins when organizations assume that technology alone will guarantee compliance.

A system can document that a corrective action has been completed. What it cannot assess is whether the root cause has truly been understood and sustainably eliminated.

This is why audits occasionally reveal a phenomenon known as paper compliance. On paper, everything appears complete and compliant. Yet the actual effectiveness of the measures taken may remain questionable.

Technology is a valuable enabler, but true quality requires critical thinking, communication, and a culture of continuous improvement.

Why are SOPs often not consistently followed in practice?

In my experience, this is rarely caused by a lack of motivation. More often, several contributing factors come together:

• Processes are technically correct but not sufficiently aligned with day-to-day operations.
• Documentation requirements are perceived as overly complex.
• Employees know the requirements but do not always understand the rationale behind them.
• Managers take shortcuts themselves and unintentionally establish new norms.
• Responsibilities at organizational interfaces are not clearly defined.

When these factors overlap, teams gradually develop working practices that differ from the processes originally described.

What does it take for a quality management system to remain effective in the long term?

Processes must be designed to work under real-world conditions.

That means considering factors such as time pressure, staffing changes, and exceptional situations that cannot be fully standardized.

In many cases, simplifying processes and clearly highlighting critical decision points can improve compliance significantly. Not every requirement needs to be explained through lengthy text documents. Visual aids, flowcharts, and structured decision trees often provide employees with more practical guidance.

Training is equally important. People tend to learn more effectively when they can discuss real situations from their own work environment and understand how quality requirements apply in practice.

What does this mean for pharmaceutical companies?

Quality should not be viewed solely as a documentation exercise.

Ultimately, what matters is whether processes are understood, accepted, and consistently applied in everyday operations. The effectiveness of a quality management system is not measured by the number of SOPs in place, but by how reliably processes function when it matters most.

Real quality is achieved when people understand the purpose behind procedures, take ownership of their responsibilities, and translate regulatory requirements into practical action. Systems, SOPs, and digital tools are indispensable foundations, but their true value lies in how consistently they are applied in daily practice.

About Dr. Christina Larisch: As Head of QA at MSK, Dr. Christina Larisch supports clients across the pharmaceutical supply chain in matters related to quality management, audits, CAPA processes, and compliance. Her focus is on translating regulatory requirements into practical, sustainable, and effective solutions that work in real-world operations.