By Emmet Tilley
To operate successfully in a Good Manufacturing Practice (GMP)-regulated contract testing environment, an organization needs more than documented procedures and validated systems. Sustained compliance depends on the culture surrounding those systems and shaping how people apply them every day.
Emmet Tilley, Quality Director at Broughton, outlines how creating a quality culture through established practices and new perspectives enables growth while maintaining regulatory integrity.
Quality in regulated science is often framed through documentation, audit readiness and procedural control. These elements form the backbone of any effective Quality Management System (QMS), but systems alone do not determine performance.
Ultimately, performance is shaped by people. People interpret procedures, record data, escalate issues and exercise judgment, and it is this collective mindset that guides the actions defining the strength of an organization’s quality culture.
The importance of scaling a QMS in an expanding business
As a business expands its technical capability and workforce to meet increasing client demand, growth requires careful stewardship of compliance obligations that remain constant regardless of scale.
Leadership must recognize that recruitment decisions influence the integrity of the QMS from the outset. Hiring should be treated as the first point of integration into the QMS, rather than a separate operational activity.
At Broughton, for example, recruitment assesses not only technical competence and regulatory knowledge but also an individual’s approach to quality. Equal importance is placed on behaviors such as data integrity awareness, professional accountability and the confidence to raise concerns in a regulated environment.
Early conversations, structured onboarding and targeted training set these expectations for every employee, embedding ownership of quality into daily practice.
A robust QMS provides structural consistency as teams grow. Standardized workflows, clearly defined responsibilities and controlled documentation create clarity in how analytical and consultancy activities are performed. In contract testing, this consistency is essential to ensure reliable execution and fully traceable records.
Clients depend on that consistency when submitting products for evaluation under stringent regulatory requirements, but the system must also support professional judgment rather than constrain it.
Engagement with the rationale behind procedures is therefore critical. When employees understand not just the instruction but the intent, adherence becomes stronger because the regulatory and scientific basis of each control is clear. In this way, the QMS functions not only as an operational tool but as a framework embedded in strategic oversight and day-to-day governance.
The role of diverse perspectives in a growing business
Growth also introduces new perspectives. When experienced professionals join from other laboratories and regulated sectors, they bring familiarity with alternative documentation systems, deviation management processes and audit preparation techniques. These insights can highlight inefficiencies that established teams may overlook through routine practice.
Broughton channels this input through formal quality mechanisms. Deviation investigations, Corrective and Preventive Action (CAPA) review meetings, internal audits and management review forums provide structured opportunities for discussion. Teams examine suggestions against regulatory expectations and operational suitability, protecting compliance while encouraging improvement.
Open questioning of existing processes is also encouraged. Broughton has removed the phrase “We’ve always done it that way” from its vocabulary, recognizing that it can lead to stagnation and inefficiency.
Instead, staff articulate the justification behind each procedure. When a clear rationale cannot be explained, the process enters review, reinforcing accountability and sharpening collective understanding of risk.
At the same time, leadership guards against the unstructured adoption of external practices. Experience from previous employers informs discussion, but proposed changes undergo assessment within the existing QMS architecture. The objective is to strengthen established systems rather than replicate another organization’s framework.
Scrutiny of these systems depends on continual evaluation. Constructive challenge sustains alignment with regulatory guidance and client expectations as the company evolves.
Evolving a quality culture therefore requires deliberate integration of new expertise into established governance structures. Broughton’s approach connects recruitment, training and quality oversight into a unified strategy that supports expansion while maintaining the scientific rigor expected of a regulated contract research organization.
Read our blog today to stay informed on the latest scientific research, development and regulation on nicotine, pharmaceuticals and cannabinoid products.
Broughton is a life sciences contract research organization and scientific consultancy specializing in testing and regulatory compliance for next generation nicotine products, aiming to support tobacco harm reduction.
