Risk Management

Effective risk management sits at the intersection of quality, supply chain, and operational decision-making. Whether driven by formal standards such as ISO 14971, ICH Q9, and ISO 31000, or the need for a pragmatic, business-focused risk framework, Harbyne Consulting supports organisations to identify, assess, control, and actively manage risk in a way that is both compliant and workable.

Our approach goes beyond static risk registers. We support active risk management across quality systems and supply chains, identifying compliance gaps, supplier risks, continuity threats, and operational vulnerabilities before they become regulatory or commercial issues. Risk assessments are fit for purpose, proportionate, and decision-focused, not theoretical exercises.

We work with established tools including FMEA, FMECA, risk ranking and filtering, decision trees, and quality risk management methodologies, tailoring their application to the maturity and needs of the organisation. Importantly, we also support the training and upskilling of teams, enabling staff to understand, own, and apply risk management confidently within their day-to-day roles.

The result is risk management that supports better decisions, stronger compliance, resilient supply chains, and operational efficiency.

QMS & Digitalisation

A quality management system should enable the business, not slow it down. Harbyne Consulting supports organisations across the design, review, implementation, and optimisation of QMS frameworks, ensuring systems are compliant, scalable, and operationally effective.

We work closely with quality and operational teams to build QMS structures that align with how the organisation actually operates. This includes end-to-end coverage of governance, document control, change management, deviations, CAPA, risk management, supplier management, training, and management review, all designed to support regulatory expectations while maintaining efficiency.

Beyond traditional paper-based systems, we support the digitisation of QMS processes, assisting with digital solution selection, configuration, and implementation. Our focus is on designing lean, flexible workflows that reduce administrative burden, improve data visibility, and support timely decision-making, rather than simply replicating paper processes in electronic form.

With experience across global, regulated environments, we help organisations implement QMS frameworks that are fit for purpose, inspection-ready, and capable of evolving as the business grows - delivering compliance that works in practice, not just on paper.

Regulatory Inspection & Audit Readiness

Regulatory inspections are not a one-day event, they are the outcome of how an organisation operates every day. Harbyne Consulting supports companies with end-to-end regulatory inspection readiness, ensuring teams, systems, and evidence are aligned well before inspectors arrive.

With significant experience working with major global regulatory authorities, including the TGA, FDA, and European regulators, we assist organisations to prepare for inspections through targeted gap assessments, inspection readiness reviews, and practical training. This includes preparing staff to confidently respond to auditor questions, manage interviews, and present evidence clearly and consistently.

During inspections, we support the management and hosting of audits, helping organisations control information flow, manage requests efficiently, and maintain a structured, professional interface with inspectors.

Following an inspection, we support organisations to respond effectively to observations and non-conformances, developing well-reasoned, risk-based CAPAs founded on robust root cause analysis. Corrective actions are designed to address systemic issues, not just symptoms, ensuring findings are closed out sustainably and stand up to regulatory scrutiny.

The result is confidence before inspection, control during inspection, and effective closure afterwards - supporting regulatory compliance while protecting operational performance.