QA Transitions Don't Create Inspection Risk — They Reveal It

By Wijdan Suliman, MD, MHA, HolistiNova Research

Quality assurance leadership transitions in clinical research are typically approached as structured handovers, with defined timelines, documentation review, training, and overlap between outgoing and incoming personnel. These transitions may involve roles such as QA leads, quality managers, GCP auditors, or sponsor oversight professionals responsible for activities including inspection readiness, deviation management, CAPA oversight, vendor oversight, and risk-based quality decision-making. In most organizations, these elements are well managed. Despite this, many teams still experience subtle shifts in consistency during transitions, sometimes without immediately recognizing their impact.

Process-Driven Systems Still Rely On People

Most clinical organizations operate within well-defined quality frameworks. SOPs, training programs, and oversight structures are designed to ensure consistency regardless of who is performing the work.

However, in practice, experienced QA professionals inevitably apply judgment, interpreting risk in context, making decisions in situations not fully defined in procedures, and applying consistency across complex or evolving scenarios.

This is both necessary and valuable.

Over time, though, these decisions and the reasoning behind them are not always fully captured in a structured or accessible way.

As a result, an additional layer develops within the system: how things are actually done in practice.

What Changes During A Transition

When a key QA individual steps out of a role, the formal system remains in place. But the practical layer — the interpretation, the context, and the consistency — may not transfer as completely. In most cases, operations continue, and timelines are met, but several patterns tend to emerge:

• Differences in the interpretation of the same process
• Reduced access to historical decision context
• Increased reliance on informal communication
• Gradual changes in consistency across teams or studies

For example, in one organization, two quality teams followed the same deviation handling procedure but applied different thresholds for escalation after a QA leadership transition. One team escalated deviations that could potentially affect subject safety or data integrity, while the other handled similar events at the site level without formal escalation. Both approaches were considered reasonable within the existing SOP framework, but the differences became visible during sponsor review when similar events were handled inconsistently across studies. Although no major compliance findings resulted, the situation raised questions around consistency in risk interpretation and decision-making. Individually, these differences may have seemed manageable. Collectively, they affected how consistently the quality system performed.

Where This Becomes Visible

From an internal perspective, these patterns are not always easy to detect because the system appears to be functioning properly. Documentation is present, processes are followed, and activities continue as expected. However, inspection environments introduce a different level of scrutiny that reveal variability.

Inspectors and sponsors often assess consistency in decision-making, traceability of rationale, and alignment between written procedures and actual execution. It is within this context that variability becomes more apparent.

In another case involving one of my clients, a new QA lead made decisions aligned with existing SOPs, but without access to the historical rationale behind prior risk-based decisions. For example, protocol deviations that had previously been escalated to sponsor-level review due to potential data integrity impact were later assessed as site-manageable events because the prior escalation logic had not been formally documented. Although the decisions themselves were not considered noncompliant, similar events began to be managed differently across studies. During audit preparation, the organization had difficulty explaining why comparable situations had received different levels of escalation and oversight over time. The differences were subtle but noticeable during the audit. Situations that had previously been handled consistently now showed variation, and decisions, while appropriate, were not always fully traceable. In this sense, the transition did not create the issue, but it made the underlying variability more visible.

A Shift In How Transitions Are Viewed

QA transitions are not only operational events but are also indicators of how a system behaves under change. Rather than asking whether the transition was managed effectively, companies might want to ask to what extent the QA system relied on individual expertise to maintain consistency.

In the earlier example, the inconsistency did not result from missing procedures or lack of oversight. The organization had established documentation and experienced personnel in place. However, much of the historical decision logic behind escalation practices had never been formally captured, only consistently applied by the same QA leadership over time. After the transition, similar protocol deviations were interpreted differently across teams, leading to inconsistencies in escalation decisions and audit narratives during sponsor review. A well-managed transition within a system that depends heavily on individual interpretation may still lead to variability. A system that is more structurally consistent is more likely to maintain alignment, even during change.

Practical Questions For Clinical Research Professionals

For those overseeing clinical operations, development, or quality, transitions offer an opportunity to examine system behavior more closely. Some practical questions to ask include:

• Where do key QA decisions rely on individual interpretation rather than clearly documented logic?
• How is historical context captured and made accessible across teams?
• Are processes applied consistently across similar situations or shaped by experience?
• How easily can a new QA lead understand and replicate prior decision-making approaches?
• Would inspection readiness remain consistent during an unexpected transition?

These questions are not always straightforward to answer. In many cases, systems appear stable until they are tested.

Stability Beyond Compliance

Quality systems are often evaluated based on compliance, whether processes are defined, followed, and documented. Equally important is how consistently those processes are applied over time, particularly during periods of change. Transitions provide a natural point at which this consistency can be observed. Organizations that capture decision rationale more explicitly reduce reliance on informal knowledge and align interpretation across teams are often better positioned to maintain stability under inspection conditions.

About The Author:

Wijdan Suliman, MD, MHA, is a clinical research quality professional with experience in clinical trial quality management, sponsor oversight, inspection readiness, and risk-based quality operations. Her work focuses on how quality systems behave under organizational change, particularly during QA leadership transitions and evolving oversight environments. She specializes in identifying hidden operational dependencies that can affect consistency, traceability, and inspection readiness across clinical programs. Wijdan is the founder of HolistiNova Research.