Level 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.
What a level is not
The five levels are SPEQ’s progression, labelled synthesis. They are not the FDA’s Quality Management Maturity rating scale, no regulator assigns them, and reaching one is not a compliance status.
A quality system rarely sits at one level everywhere. This is the character of each of the twelve GxP domains when it is operating at Level 2 — and the move that lifts it to the next.
SOPs and a change form exist, but execution is inconsistent and impact assessment is thin.
TO ADVANCE →Make impact assessment substantive — force each change to identify and close its downstream actions before closure.
A CAPA log exists but most entries fix symptoms and close without verification.
TO ADVANCE →Require an effectiveness check against a predefined criterion before any CAPA closes.
Protocols exist but are executed inconsistently and treated as a one-time event.
TO ADVANCE →Adopt a risk- and science-based lifecycle (ICH Q8/Q9, ASTM E2500) so effort follows impact.
An EM program exists but is reactive; excursions drive activity rather than trends.
TO ADVANCE →Make limits and sample plans risk-based and tie EM to a documented contamination control strategy.
Change is tracked ad hoc; awareness depends on individuals rather than a system.
TO ADVANCE →Make horizon scanning systematic with a defined source list and a routine impact-assessment step.
SOPs and monitoring exist but oversight is one-size-fits-all and paper-heavy.
TO ADVANCE →Adopt risk-based monitoring/quality management (ICH E6(R2)/(R3)) focused on what matters to participants and data.
Study plans and SOPs exist but QA oversight and archiving are weak.
TO ADVANCE →Stand up a functioning GLP QA program with a defined inspection schedule and controlled archives.
Basic GDP controls exist but excursions are handled reactively and lanes are unqualified.
TO ADVANCE →Qualify shipping lanes and containers and define excursion-assessment criteria in advance.
Case processing works but signal management and the PSMF are underdeveloped.
TO ADVANCE →Stand up systematic signal management and keep the PSMF current.
ALCOA+ is understood and some controls exist, but review and coverage are incomplete.
TO ADVANCE →Make audit-trail review routine and risk-based, and extend controls across all critical systems.
Basic C&Q exists but is document-heavy and duplicates vendor testing.
TO ADVANCE →Adopt a science- and risk-based approach (ASTM E2500) that leverages vendor evidence and focuses on critical aspects.
A quality-culture policy exists on paper but the felt experience has not changed.
TO ADVANCE →Make it observably safe to raise concerns — visibly thank the messenger and act on what is raised.