Creating a quality culture

To operate successfully in a Good Manufacturing Practice (GMP) regulated contract testing environment, an organisation needs more than documented procedures and validated systems. Sustained compliance depends on the culture that surrounds those systems and shapes how people apply them every day. Here, Emmet Tilley, Quality Director at scientific and regulatory consultancy Broughton Group, outlines how creating a quality culture through established practices with 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 judgement, and it’s this collective mindset that guides the actions that define the strength of the organisation’s quality culture.

The importance of scaling a QMS in an expanding business

As a business continues to expand its technical capability and workforce to meet increasing client demand, this growth requires careful stewardship of compliance obligations that remain constant regardless of scale.

Leadership must recognise 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 behaviours 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. Standardised 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 judgement 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 introduces new perspectives too. For example, 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.

In addition, open questioning of existing processes must be encouraged. Broughton has removed the phrase “We’ve always done it that way” from its vocabulary, because this can lead to employee stagnation and inefficient processes that hinder company growth.

Instead, staff articulate the justification behind each procedure. When a clear rationale cannot be explained, the process enters review, a discipline that reinforces accountability and sharpens collective understanding of risk.

At the same time, leadership guards against unstructured adoption of external practices. Experience from a previous employer informs discussion, yet proposed changes undergo assessment within the existing QMS architecture. The objective centres on strengthening established systems rather than replicating another organisation’s framework.

Scrutiny of these systems depends on continual evaluation. Constructive challenge sustains alignment with regulatory guidance and client expectations as the company evolves.

That’s why evolving a quality culture requires deliberate integration of new expertise into established governance structures. Broughton’s approach is an example of connecting recruitment, training and quality oversight with a unified strategy, which supports expansion while maintaining the scientific rigour expected of a regulated contract research organisation.

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