[ THE MATURITY SCALE ]

The five quality-systems maturity levels.

Every SPEQ maturity score sits on this five-level scale, from reactive to predictive. Each level has its own page: what it means, what it looks like across all twelve GxP domains, and the move that lifts a site to the next.

1

Foundational

Reactive — quality happens after the fact.

Your quality system is operating reactively. The priority is to formalise core procedures and stand up basic change control — this is where inspection risk is highest and quick wins are most available.

Read Level 1 →
2

Defined

Documented, but inconsistently executed.

You have documented procedures but execution is inconsistent. The focus now is driving consistent application and introducing formal, risk-based decision-making across your operations.

Read Level 2 →
3

Managed

Structured, proactive, inspection-ready.

You run a structured, inspection-ready quality system. To advance, instrument your processes with metrics and trending so decisions are evidenced by data rather than judgement alone.

Read Level 3 →
4

Quantified

Data-driven — decisions backed by trends.

Your quality system is data-driven and demonstrably in control. The path to Level 5 runs through predictive analytics and a fully closed-loop continuous improvement culture.

Read Level 4 →
5

Optimized

Predictive — a genuine competitive advantage.

Your quality system is operating at industry-benchmark level. The objective now is to sustain excellence and share leading practice across your network and the wider industry.

Read Level 5 →